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CyberKnife Stereotactic Radiation Therapy

Case Studies

CyberKnife Center of Miami has helped thousands of patients experience a cancer-free life, even after they’ve been told that there are no further treatments that will help. We have successfully treated many people treated for lung cancer, brain cancer, and other difficult or inoperable cancers.

Cancer patients across the United States have benefited from CyberKnife treatments. Here are just a few of the many case studies on the safety and efficacy of CyberKnife stereotactic radiation therapy.

Randomized phase II trial evaluating pain response in patients with spinal metastases following stereotactic body radiotherapy versus three-dimensional conformal radiotherapy

Abstract

Background

To report the primary endpoint of a randomized trial comparing pain response following palliative stereotactic body radiation therapy (SBRT) versus conventionally-fractionated 3D-conformal radiotherapy (3DCRT) for previously untreated spinal metastases.

Methods

Fifty-five patients with histologically/radiologically confirmed painful spinal metastases were analyzed in this single-institutional, non-blinded, randomized explorative trial. Participants were randomly assigned (1:1) to receive single-fraction SBRT (24 Gy) or 3DCRT (30 Gy in 10 fractions). The primary endpoint was pain relief of >2 points on the visual analog scale (VAS) measured within the irradiated region at 3 months following radiotherapy completion. Other recorded parameters included pain response (per International Bone Consensus response definitions), use of concurrent medications and opioid usage (oral morphine equivalent dose, OMED). All parameters were assessed at baseline and at three and six months after RT. Intention-to-treat analysis was applied. This trial is registered with ClinicalTrials.gov, number NCT02358720.

Findings

Despite no significant differences for VAS at 3 months between groups (p = 0.13), pain values decreased faster within this time period in the SBRT arm (p = 0.01). At 6 months following RT, significantly lower VAS values were reported in the SBRT group (p = 0.002). There were no differences in OMED consumption at 3 (p = 0.761) and 6 months (p = 0.174). There was a trend toward improved pain response in the SBRT arm at 3 months (p = 0.057), but significantly so after 6 months (p = 0.003). No patient in the SBRT group experienced grade ≥3 toxicities according to the Common Terminology Criteria for Adverse Events v.4.03.

Conclusions

This randomized trial demonstrates the utility of palliative SBRT for spinal metastases, which was associated with a quicker and improved pain response. Larger ongoing randomized studies will assist in further addressing these endpoints.

Abbreviations

Approximately one third of cancer patients will develop bone metastases, approximately two thirds of which involve the vertebral column, most commonly at the thoracic and lumbar levels [1][2]. Conventionally fractionated 3D-conformal radiotherapy (3DCRT) is a well-recognized palliative treatment for painful bone metastases [3][4][5][6][7][8][9][10][11][12][13][14]. Comprehensive meta-analyses by Sze et al. and Wu et al. have provided consistent data regarding pain response after conventional external beam radiotherapy [13][14]. The overall (pain) response (OR) was up to 60% and complete (pain) response (CR) around one third [13][14]. A systematic review by Chow et al. yielded similar results in respect to OR, but lower CR rates of approximately 23% [3].

It has long been questioned whether an increase in radiation dose may lead to increased pain control while maintaining few toxicities. Although 3DCRT is limited in its capacity to dose-escalate owing to spinal cord dose constraints, stereotactic body radiation therapy (SBRT) is a highly conformal technique that does allow for safe dose-escalation [15][16][17][18][19]. These notions have been supported by phase I–II data demonstrating a clinical benefit of SBRT in the primary or salvage treatment of stable spinal lesions [20]. Phase II results of the RTOG 0631 study showed stereotactic radiosurgery to be feasible and accurate [21]. The latter is the basis for the currently ongoing RTOG 0631 phase III assessment, which aims to compare pain response and quality of life (QoL) between SBRT (single dose of 16 Gy) and EBRT (external beam radiotherapy) (single dose of 8 Gy).

To date, no randomized trials are available comparing SBRT with conventional 3DCRT in terms of pain relief. Furthermore, the interaction between ablative doses and pain response remains unclear. The aim of this randomized trial was to analyze pain response after high-dose SBRT versus conventional 3DCRT for this patient population.

Materials and methods

Subjects, recruitment strategy, and eligibility for enrollment

From November 2014 to March 2017, 60 patients with histologically confirmed cancer and painful bone metastases of the thoracic or lumbar vertebral column were randomized in both arms: high-dose single-fraction SBRT (24 Gy) versus standard fractioned 3DRT (10 × 3 Gy).

Inclusion criteria were ages 18–80, a Karnofsky performance score [22]≥70, ability to provide written informed consent, a maximum of two irradiated vertebral bodies per region, a maximum of two different vertebral regions affected, and tumor distance >3 mm to the spinal cord. Exclusion criteria were subjects with significant neurological or psychiatric disorders precluding informed consent, previous RT to the given irradiation site, contraindications for MRImultiple myeloma or lymphoma histology, or involvement of the cervical spine.

In total, five patients were duly excluded. Four patients in the SBRT arm had an insufficient distance between tumor and spinal cord. One participant from the control arm was excluded because of the confirmed diagnosis of multiple myeloma after randomization. 55 patients met the inclusion/exclusion criteria and were enrolled into the trial (Fig. 1).

 

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1.     Download high-res image (484KB)

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Fig. 1. Trial profile.

The randomized trial, registered on clinicaltrials.gov (NCT02358720), was approved by the Heidelberg University Independent Ethics Committee (Nr. S-431/2013). Additionally, approval was given from the German Federal Office of Radiation Protection (BfS).

Design, randomized allocation, and procedures

This was a randomized, single-institutional, explorative study with the intention to compare pain response after high-dose single fraction SBRT versus conventional 3DCRT in patients with painful untreated spinal bone metastases. Details of the study design have been published previously [23]. A block randomization approach (block size of 6) was used to ensure that the two groups were balanced.

Two different techniques were evaluated on a 1:1 basis according to the randomization list: high-dose, single-fraction (24 Gy to the 80% isodose line) SBRT versus 30 Gy in 10 fractions of conventional radiotherapy.

The randomization procedure was carried out by a central office. Prior to their enrollment into the study, patients underwent staging of the vertebral column in connection with planning computed tomography (CT) and MRI to measure the spinal cord dimension. The prerequisite for participation in the study was the exclusion of spinal cord compression, along with a sufficient distance (>3 mm) between the metastasized vertebral body and spinal cord on MRI.

The primary endpoint-related parameters were measured at the start of RT (t0), at the end of RT (t1), 3 months post-RT (t2), and 6 months post-RT (t3). These parameters included the following: documentation of pain according to the Visual Analog Scale (VAS), neuropathic pain, OMED [5], and as well as individual patient-specific data such as use of concurrent medications.

During therapy, treating physicians documented each of these parameters; subsequently, patients continued complete documentation by means of pain diaries. VAS (collated as weekly mean values) and concurrent medication usage were documented daily for 3 months, and once after 6 months. In addition, use of basic pain medications and other concurrent medications (or medication changes) were continuously recorded from the start of RT to 6 months. In addition to patient-reported neuropathic pain use, opioid analgesic usage was converted into an oral morphine equivalent dose (OMED), and any non-opioid analgesics were also recorded.

Patient records were collected by the authors. The evaluation included all recorded data up to the 6-month follow-up interval. The baseline data of the patient characteristics are presented in summary (Table 1).

 

Thyroid Tumors May Be Susceptible to Primary Targeted Radiation Treatment, Suggests Study

May 22, 2018

Anaplastic thyroid cancer is almost uniformly fatal, with an average lifespan of about 5 months after diagnosis. And standard treatment for the condition includes 7 weeks of radiation, often along with chemotherapy.

"We put patients through toxic treatment for seven weeks when most will only live five months. I'm not sure that's how I would want to spend my time," says Sana Karam, MD, PhD, investigator at the University of Colorado Cancer Center and assistant professor in the CU School of Medicine Department of Radiation Oncology.

Now a paper published in the journal Thyroid suggests an alternative. Rather than conventional radiotherapy, the paper suggests that thyroid tumors may be more susceptible to treatment with precisely targeted radiation known as stereotactic body radiation therapy (SBRT), and possibly with fewer side effects.

The study was made possible by one of Karam's patients.

"It was one of those journeys that reminds you why we are so fortunate to be physicians," Karam says. The patient was only 50 years old at the time of diagnosis. "I treated him with six or seven weeks of radiation only to find that the cancer had already progressed elsewhere in his body. He had six kids, five of them adopted, and at the end of his life one of the only things he could enjoy eating was ice cream, and so they all enjoyed it together."

After her patient passed, the family created a fundraiser called Cream Cancer that accepted small donations from ice cream parlors near where they lived. Eventually the family raised $10,000, which they donated to the Karam lab to fund research to improve treatments for future thyroid cancer patients.

"My biggest thing was seeing if we could replace seven weeks of radiation with a shorter regimen, say three sessions of targeted radiation instead of thirty of conventional radiation," Karam says.

Because the laboratory of CU Cancer Center colleague, Bryan Haugen, MD, holds one of the largest existing batteries of thyroid cancer cell lines, Karam and first co-authors Andy Phan and Ayman Oweida, PhD, were able to show that anaplastic thyroid cancer cells are almost universally resistant to conventional radiotherapy.

Karam wondered if targeted radiation might succeed where conventional radiation failed. In collaboration with the lab of CU researchers Rebecca Schweppe, PhD, and Nikita Pozdeyev, MD, Karam tested these two radiation strategies in mouse models of the disease.

"What we found is that not only is this condensed regimen of targeted radiation equivalent to conventional radiation therapy, but it's actually superior, not only in terms of local control but also distantly," Karam says.

Karam's last point is an important one. A common criticism of targeted radiation is the idea that while it may treat the deposits of cancer at which it is aimed, it may not treat invisible deposits of cancer elsewhere in the body - invisible deposits that might be irradiated as a byproduct of more system-wide, conventional radiation therapy. However, recent work in the Karam lab and elsewhere shows that focused radiation may have a systemic effect.

"It may be that SBRT eradicates the root of the cancer so that it can't continue to send out cells that lead to metastases, or it may be that SBRT wakes up the immune system to the presence of cancer, which helps the immune system combat cancer elsewhere in the body," Karam says.

Whatever the mechanism, mice treated with SBRT had less cancer and lived longer than mice treated with conventional radiation.

The work also found a genetic signature of cancers that resist radiotherapy, namely hyper-activation of the gene CXCR4, which is associated with inflammation and has been shown to aid tumor growth in models of other cancer types.

"Because of our patients who are willing to contribute their tumor tissue to create the cell lines we need for our experiments, and because of our expertise with animal models, Colorado is known to be one of the best places for thyroid cancer research," Karam says.

And because of her patient's motivated family who raised money for research through loose change from ice cream parlors, Karam is able to take another step on the path toward demonstrating more effective, less toxic strategies against anaplastic thyroid cancer.

Source:

http://www.coloradocancerblogs.org/ice-cream-funds-research-showing-new-strategy-against-thyroid-cancer/

 

CyberKnife May Provide New Option for Recurrent Gynecologic Cancers

The administration of stereotactic body radiation therapy (SBRT) through the use of CyberKnife therapy appears to be a safe and effective salvage treatment for women with previously irradiated, locally recurrent gynecologic cancers, according to study results presented at the 2018 Society of Gynecologic Oncology (SGO) Annual Winter Meeting.1

Findings from a retrospective analysis of patients treated with CyberKnife therapy for recurrent gynecologic malignancies at NYU Winthrop Hospital in Mineola, New York, over a 10-year period demonstrated a median progression-free survival (PFS) of 11.7 months and a median overall survival (OS) of 20.5 months, with a median time to progression of 11.7 months (95% CI, 8.8-22.4). There were few serious adverse events.

“The use of CyberKnife for locally recurring gynecologic malignancies in a prior radiated field can be an alternative nonsurgical salvage option providing additional local control,” said Courtney Griffiths, DO, an obstetrician and gynecologist at NYU Winthrop, during a presentation at SGO.

Griffiths said 20% to 40% of patients who receive conventional radiation therapy (RT) for gynecologic cancers will experience locoregional relapse. These patients have a poor prognosis and few treatment options. Reirradiation using conventional techniques can lead to morbidity and damage to the surrounding tissue.

For those with central pelvic recurrences, pelvic exenteration is curative in up to 50% of selected patients, Griffiths said. She said study findings have indicated that mortality from this aggressive surgery has fallen from rates as high as 30% to 10% or less, but that the morbidity associated with the procedure remains high at 13% to 65%.
2 Chemotherapy is considered only for patients who are not candidates for radical surgery.

The rationale for studying the impact of SBRT in gynecologic malignancies stems from research establishing its effectiveness in prostate and colorectal cancers, Griffiths said. She cited several studies whose findings show high rates of disease-free survival and PFS with no grade ≥4 toxicities in patients with recurrent prostate cancer treated with SBRT. Similar responses were seen in a small study of patients with pelvic recurrences from colorectal cancer.

To determine if CyberKnife, could deliver similar results in patients with gynecologic cancers, Griffiths and colleagues analyzed data from all patients treated with CyberKnife at NYU Winthrop Hospital from 2005 to 2015. The hospital says it was the first medical institution in the New York metropolitan region to offer CyberKnife radiosurgery, which uses image-guided robotic technology to target RT delivery.

They identified 29 patients who had undergone prior RT and had been diagnosed with radiologically confirmed, locally recurrent gynecologic cancer in the central pelvis, pelvic side wall, or para-aortic lymph nodes.

Most patients were treated for endometrial cancers (n = 22), followed by vulvar (n = 4), ovarian/primary peritoneal (n = 2), and cervical (n = 1) cancers. The median age of the patient population was 66 years and the median body mass index (BMI) was 30. Twenty-five patients had ECOG performance status scores of 0 or 1.

The analysis consisted of data from 27 patients, with a median follow-up of 13.7 months. These patients had received a median dose of 60 Gy as primary RT and 25 Gy of CyberKnife therapy for recurrence. The median time between primary RT and CyberKnife treatment was 24 months. There were 17 recurrences in the central pelvis, 9 in the para-aortic region, and 4 in the pelvic side wall.

At 12 months, the median overall response rate was 85%. Griffiths said researchers observed only 6 in-field progressions. Gross tumor volume was a negative prognostic factor for both PFS (hazard ratio [HR], 1.01; 95% CI, 1.0-1.01; P = .017) and OS (HR, 1.01; 95% CI, 1.0-1.02; P = .008). Similarly, age was a negative prognostic factor for PFS (HR, 1.06; 95% CI, 1.01-1.1; P = .012) and OS (HR, 1.08; 95% CI, 1.03-1.14; P = .004). There was a slight protective effect associated with BMI for PFS (HR, 0.9; 95% CI, 0.81-0.99; P = .035).

All patients completed the prescribed CyberKnife dose. Griffiths said the treatment was well tolerated, with only 3 incidences of grade 3/4 toxicities: 2 patients developed small bowel obstruction and 1 experienced rectovaginal fistula.

Griffiths said the study has several strengths, including that it was conducted in a well-defined group of similar size as that of the populations of other SBRT studies. Nevertheless, she said it had several weaknesses, including its retrospective nature, a selection bias in the population, and the relatively small size of the cohort.

She said future research options involving the use of CyberKnife therapy in gynecologic malignancies include comparing response rates with those in other cancers, analyzing quality of life, and studying the efficacy of primary RT with a CyberKnife therapy boost for recurrences.

 

Latest Research on SBRT for Lung Cancer Shows Better Survival Rates

In a follow­-up to a previous study on the safety and efficacy of stereotactic body radiotherapy for patients with small hepatocellular carcinomas, researchers found that incidence of grade 3 or higher adverse events did not increase after longer follow­ up times. 


“In several reports on the results of HCC treatment with [stereotactic body radiotherapy (SBRT)], the median follow­ up duration was close to 30 months and the authors assessed the outcomes at 3 years,” Katsumaro Kubo, MD, from the Hiroshima Prefectural Hospital, Japan, and colleagues wrote. “However, radiation therapy is not considered as an option for the treatment of HCC in the [Barcelona Clinic Liver Cancer (BCLC)] guidelines and the reason may be the uncertainty of the long­ term outcomes. To address this concern, we extended the follow­-up period and analyzed the long­ term outcomes at 5 years.” 


In the previous study, 77 patients with a total of 93 tumors underwent SBRT. Patients had either Child­ Pugh class A or B and had fewer than 3 HCC nodules no larger than 50 mm in diameter per lesion. Kubo and colleagues included 65 of the original patients in the new study. 


Sixty patients underwent transarterial chemoembolization (TACE) before SBRT and 13 patients underwent TACE within 1 month to 3 months after SBRT. 

Median follow­ up at the time of evaluation was 41 months (range, 3 79 months), while median follow­-up for the 26 survivors was 62 months (range, 24­79 months). 


In the original study, the 2­ year overall survival rate was 76% (95% CI, 65.4­86.7), progression­ free survival (PFS) was 40% (95% CI, 27.6­52.3) and local control (LC) was 100%. 


Comparatively, the 3­ year OS rate was 56.3% (95% CI, 44.1­68.5 and the 5­ year OS rate was 41.4% (95% CI, 28.7­54.1). 


Further, the 3 year PFS rate was 25.4% (95% CI, 14­36.8) and the 

5­ year PFS rate was 10.6% (95% CI, 1.5­19.8). 


Both the 3­ year and 5­ year LC rates were 100%. 


Fifteen patients experienced grade 3 or higher liver toxicities at 6 months follow­ up. 


After 1 year of follow­ up, 5 other patients experienced grade 3 or higher liver toxicities. No adverse events worsened in any patients and no patients developed gastrointestinal disorders or ulcers.


Multivariate analysis showed that tumor­node­metastasis stage at treatment was a significant prognostic factor for PFS at 3 years (P = .0008) and that grade 3 or higher adverse events were a prognostic factor for OS at 5 years (P = .0049). 


“Most patients in this study underwent resection and [radiofrequency ablation (RFA)] as initial therapies, which may have confused the results, including the OS and PFS rates,” the researchers wrote. “To compare with surgery or RFA, a prospective study of SBRT in HCC is necessary. If the efficacy and safety of SBRT are proved, it will be added as a treatment option that is comparable to resection or RFA for patients who were considered unfit or refused these other therapies.”  


To learn more talk to our cancer experts at the CyberKnife Center of Miami 305-279-2900



Role of SBRT in the Treatment of Elderly and Poor Performance Patients with Pancreatic Cancer

 Abstract

Literature on the management of nonmetastatic pancreatic ductal adenocarcinoma in patients who are elderly or have poor performance status is sparse. The median survival of this unique cohort of patients is < 6 months, and most patients are only offered single-agent gemcitabine or supportive care. Recently, adding nanoparticle albumin-bound paclitaxel to gemcitabine was shown to improve survival of patients with metastatic disease with Eastern Cooperative Group performance status of 2. Although standard chemoradiotherapy provides long-term locoregional control in locally advanced pancreatic cancer, it is difficult for this group of patients to tolerate 6 weeks of therapy. Stereotactic body radiotherapy (SBRT) can be delivered in only 3 to 5 days, does not require concurrent chemotherapy, and has limited toxicity, and tumor control rates appear to be equivalent to or better than those achieved with standard chemoradiotherapy. Additionally, SBRT has been shown to improve cancer-related pain and patient-reported quality of life. Given the favorable toxicity profile, SBRT seems like an obvious choice for patients who are elderly, have multiple comorbidities, or have poor performance status. Herein, we review the literature on SBRT in this unique patient population and discuss future directions.

Read the full article here.

CyberKnife Therapy vs. Surgery for Lung Cancer

Stereotactic Ablative Radiotherapy (SABR) Achieves Better Overall Survival than Surgery for Early Lung Cancer

First randomized clinical trial comparing the two therapies suggests that the non-invasive SABR treatment should be considered an alternative to surgery, especially for elderly patients and those with comorbidities.

Patients with operable stage I non-small cell lung cancer (NSCLC) could achieve better overall survival rates if treated with stereotactic ablative radiotherapy (SABR) rather than the current standard of care – invasive surgery – according to research from a phase III randomized international study from the University of Texas MD Anderson Cancer Center.

The findings, published today in The Lancet Oncology, are from the first randomized clinical trials comparing SABR and surgery.

“For the first time, we can say that the two therapies are at least equally effective, and that SABR appears to be better tolerated and might lead to better survival outcomes for these patients,” said the first author and principal investigator Joe Y. Chang, M.D., Ph.D., professor, radiation oncology. “Stereotactic radiation treatment is a relatively new approach for operable early stage lung cancer, while surgery has been the standard for a century. This study can give physicians confidence to consider a non-invasive option.”

The researchers analyzed overall survival, recurrences, and toxicity in 58 patients. Estimated three-year survival rates were 79 percent in the surgery group and 95 percent in the SABR group, while recurrence-free survival rates at three years were 80 percent and 86 percent, respectively. Six patients in the surgery group died versus one death within the SABR group. None of the patients treated with SABR had high-grade toxicity.

The authors suggest that the lower survival rate following surgery could be attributed to other simultaneous conditions that were worsened by the surgical reduction of lung function. As such, the findings support SABR as a non-invasive alternative, especially for elderly patients and for those with significant comorbidities.

According to the Centers for Disease Control and Prevention, lung cancer is the leading cancer killer in both men and women in the United States.

The American Cancer Society reports that over half of people with lung cancer die within one year of being diagnosed, and, according to the National Cancer Institute, an estimated 158,040 Americans are expected to die from the disease in 2015.

“The findings of our study provide strong support for a large clinical trial to investigate the potential superiority of SABR for patients with early-stage disease,” said senior author Jack A. Roth, M.D., Professor and Bud Johnson Clinical Distinguished Chair, Department of Thoracic & Cardiovascular Surgery. “While we wait for more data, physicians can consider SABR an effective treatment for these patients, especially for those whom surgery brings high risk.”

Over the last decade, SABR has been used to treat patients with inoperable NSCLC, showing outcomes that are better in some cases than traditional radiation.

However, there has been no data on SABR for patients with operable early-stage NSCLC because of concerns about the risk of recurrence after SABR. Surgery on the other hand, lobectomy (removal of half of a lung) with dissection of the lymph nodes, was thought to have less chance for cancer to recur.

However, lung cancer surgery is a major operation with a high complication rate and while recurrence rates are low, there is a 10-20 percent chance of the cancer coming back in the other lobes, regional lymph nodes and distant organs, noted Chang. In this study there was no difference between SABR and surgery for tumor recurrence.

He added that these findings should be interpreted with some caution, due to the small patient sample size and limited follow up time.

Two new randomized studies are in preparation and expected to be opened in 2015: VALOR (Veterans Affairs Lung cancer surgery Or stereotactic Radiotherapy trial) in the US, and, in the UK, SABRtooth, a multicenter pilot study of SABR versus surgery in patients with peripheral stage I NSCLC considered at higher risk of complications from surgical resection.

Other researchers contributing to this study include: Jack A. Roth, M.D.; Ritsuko Komaki, M.D.; Reza J. Mehran, M.D.; Peter Balter, Ph.D.; Stephen E. McRae, M.D.; Lei Feng, M.S.; Mark F. Munsell, M.S., Donald A. Berry, Ph.D. from MD Anderson; John J. Kresl, M.D. from the Phoenix CyberKnife and Radiation Oncology Center; Omar Dawood, M.D. from Kona Medical, Inc.; Larry S. Carpenter, M.D. from St. Luke’s Health Houston; Suresh Senan, F.R.C.R.; Alexander V. Louie, M.D.; Cornelis JA Haasbeek, M.D.; Ben J. Slotman, M.D.; Marinus A. Paul, M.D.; Egbert F. Smit, M.D. from VU University Medical Center in Amsterdam, The Netherlands; Harry JM Groen, M.D.; Joachim Widder, M.D. from University of Groningen and University Medical Center Groningen in Groningen, The Netherlands; Ben EEM van den Borne, M.D.; Katrien De Jaeger, M.D.; Coen Hurkmans, Ph.D. from Catharina Hospital in Eindhoven, The Netherlands; Erik van Werkhoven, M.S.c. from the Netherlands Cancer Institute in Amsterdam, The Netherlands and Anne-Marie Dingemans, M.D. from Maastricht University Medical Center, The Netherlands.

See more at: http://www.interventionaloncology360.com/content/stereotactic-ablative-radiotherapy-achieves-better-overall-survival-surgery-early-lung#sthash.9wltTc3G.dpuf

Lung Cancer

Patient History
G. M. is a 68-year-old with a history of adenocarcinoma of the left lower lobe of the lung, and a similar tumor in the right lower lobe of the lung, both treated surgically in 1999 and 2006, respectively. He also received postoperative chemotherapy. Later he presented with a PET positive 2.5 cm nodule in the right lower lobe. G.M. refused further surgery and contacted CyberKnife Miami for treatment alternatives.

CyberKnife Advantage
Scientific data suggests that stereotactic radiosurgery with devices such as the CyberKnife can deliver ablative doses of irradiation, potentially resulting in treatment outcomes similar to surgery. This approach is indicated for the medically inoperable or patient who refuses surgery for early stage carcinoma of the lung.

Treatment
The patient was treated on the CyberKnife. Stereotactic irradiation was delivered to the periphery of the tumor using three fractions.

Follow-up
At two weeks post treatment, the patient experienced moderate esophagitis, lasting two weeks. At three months post treatment, the PET scan showed no hypermetabolic activity within the treated field or elsewhere. Clinically, the patient is well with no complaints.

Recurrent Head and Neck Cancer

Patient History
This is a 68-year-old white female who presented with recurrent squamous cell carcinoma of the oral cavity with node recurrence, status post-modified neck dissection. She presented with a large recurrent mass in the parapharyngeal region treated with hyperfractionated radiotherapy and multiple surgical procedures. She had a large skull base parapharyngeal mass for plan boost radiosurgery.

CyberKnife Advantage
Because of both the prior history of multiple surgeries and the close proximity of this tumor to the skull base, major blood vessels and brain stem, surgical resection was not an option.

Treatment
The patient was treated on the frameless CyberKnife at Miami CyberKnife with 3 fraction of 7 Gy each with a total dose of 21 Gy plus the external radiation therapy.

Follow-Up
Four months post treatment patient was doing well and gaining weight.

Possible World's First: Using Cyberknife to Treat Vocal Cord Cancer

Robotic Device Restores Man’s Voice

Stephen Wiley, a lifelong cowboy from Terrell, TX, has helped UT Southwestern Medical Center pioneer a new treatment for vocal cord cancer.

Mr. Wiley volunteered to be the world’s first known patient to be treated for vocal cord cancer with CyberKnife, a surgeon-controlled robotic device that destroys tumors with highly precise doses of radiation.

Mr. Wiley, a yard driver for a manufacturing company who also raises horses on his own time, said he started waking up in the morning with a hoarse voice and thought it was nothing more than aging. It got continually worse, until one day he was reduced to a whisper.

“We have to talk on the radio constantly and whenever my voice went away, it was a safety issue,” said Mr. Wiley, 59.

Doctors found tumors in both his vocal cords, and referred him to UT Southwestern, where he met with Dr. Larry Myers, Associate Professor of Otolaryngology.

“Dr. Myers said, ‘Well, we’ve been looking for someone like yourself for a research project that’s never been done before.’ I said, ‘Heck, if it works and it’s going to help other people, I’m willing to go for it,’” Mr. Wiley recalled. “It has worked out great. People here at work say, ‘Your voice is back to normal.’”

Six doctors had to unanimously agree that Mr. Wiley was a good candidate for the procedure, which he said gave him confidence that the CyberKnife trial was right for him.

The $7 million CyberKnife, built by the California-based company Accuray, has a small linear particle accelerator and a robotic arm that allows it to treat tumors on any part of the body with radiation, explained his surgeon, Dr. Baran Sumer, Associate Professor of Otolaryngology – Head and Neck Surgery. There are no records from the maker or in medical literature of the robotic device previously being used to treat vocal cord cancer.

UT Southwestern doctors’ success with treating Mr. Wiley yielded important information that UT Southwestern physicians are already using to make treatment shorter for other people with vocal cord tumors, said Dr. Sumer, also a member of the Harold C. Simmons Comprehensive Cancer Center, the only National Cancer Institute-designated cancer center in North Texas.

Only about 200 of these cutting-edge machines exist in the world, most of them in the United States.

Dr. Susie Chen, Assistant Professor of Radiation Oncology, oversaw Mr. Wiley’s treatments and said the unique resources, expertise, and collaborative atmosphere at UT Southwestern aligned perfectly to break new ground in cancer treatment and find the right solution for Mr. Wiley.

“We’re in a very unique situation at UT Southwestern where we have the tools to do it. It takes a lot of collaboration between the surgeons and the radiation doctors to actually get that done. The technology just hasn’t been there until recently,” she said.

Patients must be as still as possible for the CyberKnife treatment to be precise, but vocal cords move when people breathe and swallow, presenting a challenge in using the precision robot.

Dr. Sumer injected tiny bits of gold into Mr. Wiley’s neck for the CyberKnife to track so the robotic arm could adjust to even the slightest movements.

Mr. Wiley’s head also was covered with a mesh mask that held him snug and still.

“With the CyberKnife, it’s real time. When something moves, it’s actually moving. We adjust to the movement,” Dr. Chen said. “The whole time you’re getting treated, there are little X-rays that are being done that allow the machine to lock on to these little gold markers that are placed near the vocal cords. It’s just like you’re a fighter pilot, and you lock on to a target.”

Mr. Wiley completed his 15 treatments at St. Paul University Hospital.

“With the CyberKnife, I never lost my voice and never lost any weight. It’s great, and I feel great,” he said.

Three other UT Southwestern patients have since had CyberKnife treatment on vocal cord tumors, and Dr. Chen said they have been able to reduce the number of treatments each time as more is learned about the CyberKnife’s effectiveness on vocal cord tumors.

“What we’ve done is taken a treatment that takes 5 1/2 weeks, and we’re decreasing it,” Dr. Chen said. “The true goal of this study is to maintain excellent cure rates while decreasing the time of radiation and side effects. That’s the biggest thing – ease for the patient.”

New Data Validates CyberKnife SBRT for Prostate Cancer Treatment

Updated: ASTRO Model Policy Endorses Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

SUNNYVALE, Calif., /PRNewswire/ -- Accuray Incorporated (Nasdaq: ARAY), announced today the publication of study results involving hundreds of prostate cancer patients treated with the CyberKnife® Robotic Radiosurgery System, the most widely used form of prostate stereotactic body radiation therapy (SBRT).

The study followed 304 patients for a median of 5 years, and many to 6 years post-treatment and found that 97 percent of patients with low-risk and 90.7% of patients with intermediate-risk prostate cancer remained cancer-free throughout that time.

The CyberKnife treatment was also shown to be minimally harmful, producing low levels of toxicity that are similar to the level produced by other radiation treatment options including brachytherapy.

Preservation of sexual function was achieved for 75 percent of patients who were sexually potent prior to CyberKnife treatment. The positive quality of life outcomes, low side effects, and brief duration of CyberKnife treatment are especially encouraging for men weighing their many treatment options.

"Stereotactic Body Radiotherapy for Localized Prostate Cancer: Disease Control and Quality of life at 6 Years," appears in the May 2013 edition of Radiation Oncology and was led by Dr. Alan Katz, a radiation oncologist with more than 30 years of experience who currently practices at Flushing Radiation Oncology in Queens, N.Y.

In related SBRT news, the American Society for Radiation Oncology (ASTRO) recently updated its position on the use of SBRT for prostate cancer.

According to its recently posted Model Policy, the Society believes that enough clinical evidence now exists to so that "SBRT could be considered an appropriate alternative for select patients with low to intermediate risk disease."

"These latest long-term CyberKnife data coupled with ASTRO's new position on SBRT for prostate cancer confirm what I have seen in my clinical practice," said Dr. Alan Katz. "CyberKnife SBRT is a safe and effective treatment for prostate cancer that offers men the opportunity to complete a non-invasive treatment in five days and should be considered for patients with organ-confined prostate cancer."

“Dr. Katz's five-year CyberKnife prostate SBRT data show good disease-free survival, low toxicity, and preservation of sexual function. The data support prior findings that validate an approach to prostate SBRT that includes dynamic tracking and automatic correction for target motion," said Fabienne Hirigoyenberry-Lanson, vice president of medical affairs at Accuray.

The first five-year outcomes on CyberKnife SBRT for prostate cancer patients were published in January 2011. For more information, please visit www.accuray.com.

Why Watchful Waiting May Not Be A Good Idea For Men With Prostate Cancer

Research finds that more than half of a group of men whose cancer was classified as slow growing turned out to be more dangerous then thought.

Men with prostate cancer are being given false hope by tests that underestimate the aggressiveness of their disease, according to a study.

Researchers found that more than half of a group of men whose cancers were initially classified as slow growing and confined later turned out to have more dangerous tumors.

The findings, published in the British Journal of Cancer, call into question the ability of experts to grade and stage prostate cancers on the basis of biopsy samples.

It also casts doubt on the "active surveillance" strategy of avoiding unnecessary radical treatment for patients with slow-growing prostate cancer.

Instead, these patients are closely monitored but left alone until tests suggest their condition has worsened.

Urological surgeon Greg Shaw, from the Cancer Research UK Cambridge Institute, said, "Our results show that the severity of up to half of men's prostate cancers may be underestimated when relying on tests before they have surgery."

Slow-growing prostate cancers, known as "pussycats", are very different from the more aggressive "tiger" variety.

In some cases, especially when he is older when diagnosed, a patient can live to the end of his normal life span before a "pussycat" cancer becomes a threat.

An aggressive "tiger," on the other hand, may quickly spread if it is not surgically removed or destroyed.

Biopsy samples examined under a microscope are used to rate prostate tumor aggressiveness with a score ranging from two to 10. A score of between two and six is a low-grade "pussycat." A score of seven is intermediate, while scores of eight to 10 are high-grade "tigers."

Tumors are also staged according to how far they have spread. A T2 tumor is contained completely inside the prostate gland, while a T3 tumor has started to break out, and one classified T4 has spread to other organs or sites in the pelvic cavity.

The Cambridge scientists compared the staging and grading of more than 800 men's cancers before and after they had surgery to remove their prostate.

They found that of 415 patients whose cancer was classified as slow-growing and confined to the prostate, just over half (209) were found to have a more aggressive disease than originally thought when assessed after surgery.

Almost a third (131) had cancers that had spread beyond the prostate gland.

The prostate specific antigen (PSA) blood marker test used to identify men who might have prostate cancer has long been known to be unreliable and prone to giving false readings.

Professor Malcolm Mason, Cancer Research UK's prostate cancer specialist, said, "At the moment the biopsy, MRI, and PSA tests that we use to assess the severity of prostate cancers are the best methods we have but, as this study shows, they don't always get it right. Despite the limitations that this study shows, all evidence so far points to active surveillance being safe, provided that men are carefully selected. But we need better methods of assigning a grade and stage so that no man has to unnecessarily undergo treatment, while at the same time making sure we detect and treat the cancers that really need it."

Each year around 41,700 men in the UK are diagnosed with prostate cancer and 10,800 die from the disease.

The scientists concluded in their paper, "In counseling patients for AS (active surveillance), the surgeon should be explicit regarding uncertainty in predicting stage/grade despite apparent short-term safety. There is an urgent need for development of a means by which to exclude aggressive PC (prostate cancer) in patients wishing to undergo conservative treatment."

Dr. Iain Frame, director of research at the charity Prostate Cancer UK, said, "Accurate prostate cancer diagnosis continues to be one of the biggest challenges facing the disease today. The results of this study highlight yet again that existing tests cannot provide a precise picture of the aggressiveness of a man's cancer, often leaving men and their doctors to make difficult decisions about treatment without all the facts.

Prostate Cancer UK is committed to finding a better diagnostic option for the 40,000 men diagnosed with the disease every year through research. In the meantime, until the accuracy of tests improves, it is important that men have the opportunity to discuss the pros and cons of every treatment option available with their clinician, so that they can decide what is best for them and their situation."

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CyberKnife Improves Survival Rates for Elderly Lung Cancer Patients

Widespread Adoption of CyberKnife Body Radiation Therapy (SBRT) has Improved Survival Rates for Elderly Patients With Early Stage Lung Cancer

SEER database study finds dramatic rise in overall and lung cancer-specific survival following SBRT for patients age 60 and older with stage I NSCLC

 BOSTON, September 26, 2016 -- Survival rates for elderly patients who received stereotactic body radiation therapy (SBRT) for early stage non-small cell lung cancer (NSCLC) rose from roughly 40 to 60 percent over the past decade, concurrent with the increasing adoption of SBRT, according to research presented today at the 58th Annual Meeting of the American Society for Radiation Oncology (ASTRO).

In recent years, SBRT has become the standard of care for patients with inoperable early stage NSCLC. Compared to the conventional radiation therapy (RT) approach of small doses given daily over several weeks, SBRT delivers a highly targeted, escalated dose of radiation in a single session or as many as five of treatments, usually between one and five fractions.

For this study, researchers examined records from the nation’s largest cancer patient database to determine how rates of overall and disease-specific survival have changed as use of SBRT has increased, as well as to draw population-based comparisons between SBRT and surgery alone for elderly patients.

Records for the 62,213 patients age 60 and above who were diagnosed with stage I NSCLC between 2004 and 2012 were extracted from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database. Patients with squamous, adenocarcinoma and adenosquamous histologies and those with definite records defining local therapy were eligible for inclusion.

Overall survival (OS) and lung cancer-specific survival (CSS) rates were calculated for patients grouped into five-year subsets (i.e., 60-64, 65-69, 70-74, 75-79, 80-84, 85-89, and 90 and older). Researchers analyzed OS and CSS change over time based on type of therapy and age using Kaplan-Meier, logarithmic ranking and Cox multivariate hazard ratio (HR) methods as well as comparative analysis with Fisher test.

Over the study period, survival rates for SBRT rose dramatically among this large, nationally- representative population of elderly stage I NSCLC patients. From 2004 to 2012 -- the years in which adoption of SBRT in community practice became widespread -- the overall survival rate at 23 months following SBRT alone rose nearly 20 percentage points, from 39 to 58 percent (p < 0.001). OS rates for surgery alone rose five percentage points, from 79 to 84 percent (p < 0.001). There was no improvement for patients who received neither RT nor surgery (from 28 to 33 percent, p = 0.29).

In the same time period, CSS increased from 48 to 72 percent of patients who received SBRT alone (p < 0.001) and from 87 to 91 percent of patients receiving surgery alone (p < 0.001). CSS rates remained stable for patients who received neither surgery nor radiation, although the difference approached statistical significance (38 to 45 percent, p = 0.06).

“Our findings indicate that physicians should feel confident recommending radiation therapy to patients who are too sick to undergo surgery or who choose not to undergo surgery for other reasons,” said Andrew M. Farach, MD, a radiation oncologist at Houston Methodist Hospital and lead author on the study. “With continued adoption of SBRT in community cancer centers, it is our hope that more patients will receive curative SBRT and the number of patients left untreated based on age or medical comorbidity will continue to fall.”

The use of surgery to treat stage I NSCLC declined with age (p < 0.001). While 81 percent of patients age 60-64 underwent surgery, only 47 percent of patients age 80 or older were able to undergo surgery. The use of RT, conversely, rose with increasing age, ranging from 11 percent of patients age 60-64 to 39 percent of patients age 90 or above (p < 0.001). The number of patient receiving no treatment also increased from 7 to 40 percent for the youngest and oldest elderly patient cohorts in the study.

Despite improvements in OS and CSS, survival rates following RT remained lower than those for elderly patients who received surgery. Researchers explained that this difference may be due, in part, to a selection bias where healthier patients were treated with surgery, and they underscored the need for a controlled clinical trial with matched patients receiving each treatment first-line to compare the efficacy of these therapies. Instances of palliative SBRT or conventional RT also may have skewed results in favor of surgical outcomes.
 
“While survival rates remain highest for surgical candidates, this study demonstrates both clear benefits from SBRT for nonsurgical NSCLC patients and that outcomes following radiation therapy have improved at a more accelerated pace over the past decade than those for any other therapeutic approach,” said Dr. Farach. “With increased access to this potentially life-saving treatment, we can continue to improve outcomes for the growing population of elderly patients fighting early stage cancer.”

Purpose/Objective(s): Stereotactic body radiation therapy (SBRT) is now considered the standard of care for patients with inoperable stage I non-small cell lung cancer (NSCLC). For elderly patients, competing comorbidities limit operability. With widespread adoption of SBRT in community practice, an increasing number of elderly patients are receiving definitive SBRT. The purpose of this study is to review population-based outcomes based on treatment modality using the Surveillance, Epidemiology, and End Result (SEER) database for stage I NSCLC patients treated between 2004-2012 in the SBRT era.

Materials/Methods: The national SEER database was used to draw NSCLC patients age 60 and above between 2004 and 2012 with squamous, adenocarcinoma, and adenosquamous histologies. Only patients with definite records defining local therapy were included. Survival analysis included Kaplan-Meier, log-rank, cox-multivariate hazard ratio (HR), and comparative analysis with Fisher test. Patients were grouped in 5-year bins: 60-64, 65-69, 70-74, 75-79, 80-84, 85-89, and 90 and older for survival based on local therapy. Temporal trends in survival based on local therapy and age were also analyzed.

Results: For the 62,213 patients meeting criteria for analysis, the distribution by histology was comparable across all age groups. The use of surgery declined with age as patients aged 60 to 64 had surgical rates of 81% compared to 21% for ages 90 and over (p < 0.001). Radiation use increased from 11 to 39% (p < 0.001), as did the percentage of patients receiving neither surgery or radiation treatment from 7 to 40% (p < 0.001) for the same age groups. Multivariate analysis demonstrated HR of treatment types compared to surgery at baseline as radiation only = 3.1, surgery and radiation = 2.3, and neither surgery or radiation = 5.9 (all p < 0.01). From 2004 to 2011, overall survival (OS) at 23 months improved dramatically for patients treated with radiation only (39 to 58%, p < 0.001) and more subtly for those receiving surgery only (79 to 84%, p < 0.001), while it was stable for those having neither surgery nor radiation (28 to 33%, p = 0.29). Similarly, lung cancer specific survival (CSS) at 23 months improved significantly for patients treated with radiation only (48 to 72%, p < 0.001), and less so for those receiving surgery only (87 to 91%, p < 0.001), while it was stable for those having neither surgery nor radiation (38 to 45%, p = 0.06).

Conclusion: With advancing age, radiation replaces surgery as the most appropriate modality for early stage NSCLC. Concurrent with the adoption of SBRT as a community standard, both OS and CSS have improved significantly for elderly stage I NSCLC patients treated with radiation alone.

Here is a link to the original study:

 


Study Concludes CyberKnife Therapy is Safe & Effective for Most Patients With Previously Irradiated Head & Neck Cancer

Study Concludes CyberKnife Therapy is Safe & Effective for Most Patients With Previously Irradiated Head & Neck Cancer

Biology - Radiation Effects on Normal Tissue
Risk of severe toxicity based on site of recurrence in patients treated with stereotactic body radiation therapy for recurrent head and neck cancer

DC Ling, J Vargo, RL Ferris, J Ohr, DA Clump II, WYW Yau, U Duvvuri, S Kim, JT Johnson, JE Bauman, BF Branstetter, DE Heron

Summary: Researchers assessed the risk of severe toxicity based on site of recurrence in patients treated with stereotactic body radiation therapy (SBRT) for recurrent head and neck cancer because recently, SBRT ± cetuximab has emerged as a viable re-irradiation strategy for patients with locally-recurrent, previously-irradiated head and neck cancers, with potentially lower rates of acute and late toxicity compared to conventional treatment options.

They concluded that salvage SBRT is a safe and effective option for most patients with previously-irradiated head and neck cancer. They did find, however, that patients treated to the larynx or hypopharynx experienced significantly more late toxicity compared and should be carefully selected.

Methods:
    •    Researchers conducted this retrospective review in 291 patients treated with SBRT± cetuximab or recurrent, previously-irradiated head and neck cancer between April 2002 and March 2013.
    •    They included patients treated in both of their previously-reported institutional phase I dose-escalation study UPCI 04-144 and phase II study of SBRT + concurrent cetuximab UPCI 06-093.
    •    The primary endpoints were incidence of severe acute and late toxicity, defined as ≥ Grade 3 above baseline according to Common Terminology Criteria for Adverse Events v4.
    •    They performed both univariate and multivariate logistic regression analysis to identify predictors of severe acute and late toxicity.
    •    Patients with < 3 months of follow-up (n=43) or who died within 3 months of treatment (n=21) were excluded from late toxicity analysis.

Results:
    •    Among surviving patients, median time to death or last clinical follow-up was 9.8 (interquartile range: 5.3-21.7) months among the entire cohort and 53.1 (interquartile range: 35.4-72.5) months.
    •    The 1-year, 3-year, 5-year, and 10-year actuarial overall survival rates were 41.4%, 16.6%, 10.8%, and 3.6%, respectively.
    •    Overall, 33 (11.3%) patients experienced ≥ Grade 3 acute toxicity, and 43 (18.9%) experienced ≥ Grade 3 late toxicity.
    •    Fifty percent of patients with a larynx/hypopharynx recurrence experienced severe late toxicity, compared to 6-20% for other sites.
    •    Upon univariate analysis, researchers observed that, compared to larynx/hypopharynx, treatment of nodal recurrence was associated with a lower risk of severe acute toxicity (P=0.03), with no significant differences in severe acute toxicity among other sites.
    •    On both univariate and multivariate analysis, patients treated for a recurrence in the larynx/hypopharynx experienced significantly more severe late toxicity than all other recurrence sites (P < 0.05 for each) except for nasopharynx.

Here's a link to the original study:

5 Years After CyberKnife Treatment for Prostate Cancer 97% of Patients Remain Cancer Free

5 Years After CyberKnife Treatment for Prostate Cancer 97% of Patients Remain Cancer Free

BOSTON -- High dose stereotactic body radiotherapy (SBRT) for men newly diagnosed with low- or intermediate- risk prostate cancer results in shorter treatment times, low cancer recurrence rates, and few severe side effects, according to research presented here.

A multi-institutional trial found that at 5 years follow up, 97% of patients treated with SBRT remained cancer free, while just 2% experienced any serious side effects.

SBRT -- which can precisely deliver high doses of radiotherapy to tumors in a small number of treatments -- is a fairly new approach to prostate cancer treatment, and one that has shown promising results in single institution studies, Robert Meier, MD, Swedish Cancer Institute, Seattle reported at the annual meeting of the American Society for Radiation Oncology (ASTRO).

"Prostate cancer should be ideally suited for SBRT," said Meier. "Higher doses may translate into better cancer control rates, while the accurate targeting avoids the bladder, the rectum and the sex organs that are immediately adjacent to the prostate. This should reduce side effects."

Meier also pointed out that SBRT is more cost effective than intensity modulated radiation therapy (IMRT), and more convenient for the patient, since the treatment is completed in just five visits.

While individual institutional studies involving SBRT have been promising, Meier and his colleagues wanted to see whether a multi-institutional study would demonstrate that SBRT could be both effective at controlling cancer and be safely delivered to patients.

The trial enrolled 309 men newly diagnosed with prostate cancer from 21 community, regional, and academic hospitals across the U.S. Of those patients, 172 had low-risk disease (CS T1-T2a, Gleason 6, PSA<10), while 137 had intermediate-risk prostate cancer (CS T1c-T2b with either Gleason 7 and PSA<10, or Gleason 6 and PSA 10-20).

All the patients received SBRT via a robotic linear accelerator, with a radiation dose to the prostate of 40 Gy administered in five treatments of 8 Gy each.

Patients were followed an average of 5.1 years. Less than 2% experienced serious side effects during the course of the follow-up period, far less than the 10% rate deemed excessive by the researchers.

"This is another example of how advanced technology has radically improved our ability to target cancer," Meier said.

No grade 4 or 5 toxicities were reported, while just five grade 3 genitourinary (GU) toxicities were reported, More than half of the patients did experience less serious side effects - 53% and 59% for grade 1 GU and gastrointestinal (GI) toxicities, and 35% and 10% for grade 2 GU and GI toxicities, respectively -- but most of were usually temporary, the researchers reported.

As far as the efficacy of treatment, using the definition of a 2- point increase in PSA as defining cancer recurrence, Meier and his colleagues found that in the entire group of 309 patients, 97.1% did not experience cancer recurrence after 5.1 years, while the rates were 97.3% and 97.1% for the low- and intermediate-risk groups respectively. Overall actuarial 5- year survival for the entire population was 95.6%.

For the low risk group, the recurrence rate "proved superior to the 93% historical control we compared against," Meier said, adding that the results for the intermediate-risk group matched the best results for radiotherapy "and look better than dose-escalated IMRT."

"For men with newly diagnosed prostate cancer, when appropriate technology and planning is employed, SBRT is safe, with a low rate of serious side effects," Meier concluded. "Cancer control rates are very favorable compared to historic data, thus SBRT is a suitable option for low-and intermediate-risk prostate cancer and may be preferable to other treatment approaches."

Colleen Lawton, MD, vice-chair of the Department of Radiation Oncology at the Medical College of Wisconsin, Milwaukee, commented that the study is encouraging because it includes multi-institutional data.

"This certainly suggests that [SBRT] may become a standard treatment in time," she said. "We certainly need more data, but we are headed in the right direction."

Meier reported research funding from Accuray. Other authors declared they had no relevant financial

Reviewed by Henry A. Solomon, MD, FACP, FACC Clinical Associate Professor, Weill Cornell Medical College and Dorothy Caputo, MA, BSN, RN, Nurse Planner

Primary Source: American Society for Radiation Oncology

Here is a link to the original article and study:

For Men With Early-Stage, Low-risk Prostate Cancer, a Short Course of Radiation Therapy Offers Comparable Quality of Life Outcomes in 1/3rd Less Treatment Time Than Conventional Radiation

Hypofractionated Radiation Therapy Can Reduce Treatment Time by One-third With Comparable Quality of Life for Prostate Cancer Patients

NRG Oncology/RTOG 0415 trial shows similar side effects following conventional and accelerated Radiation Therapy for early stage, low-risk disease

BOSTON, September 26, 2016 -- For men with early stage, low-risk prostate cancer, treatment with hypofractionated radiation therapy (RT) offers comparable health-related quality of life outcomes in one- third less treatment time than conventional RT, according to research presented today at the 58th Annual Meeting of the American Society for Radiation Oncology (ASTRO).

While efficacy results from NRG Oncology/RTOG 0415 were reported previously, this study is the first to report patient-reported outcomes from the trial, which included patients from across the U.S. and Canada.

This trial assessed the differences in health-related quality of life (HRQoL), including bowel, urinary, sexual and hormonal side effects, following a conventional or fractionated RT schedule. Compared to conventional (C) RT, hypofractionated (H) RT is delivered in larger doses over a shorter period of time.

“Studies have suggested that higher amounts of radiation over shorter periods of time might be more effective in destroying cancer cells, but the concern has been that stronger doses might also cause quality of life issues such as more diarrhea or decrease in sexual function,” said lead study author Deborah Watkins Bruner, PhD, a professor at the Nell Hodgson Woodruff School of Nursing and a professor of radiation oncology at Emory University School of Medicine in Atlanta.

Patients in the study were randomly assigned to receive either conventional RT, consisting of 73.8 Gy in 41 daily treatments delivered over 8.2 weeks, or hypofractionated RT, consisting of 70 Gy in 28 daily treatments delivered over 5.6 weeks. A total of 962 patients reported HRQoL data, including 478 men from the C group and 448 men from the H group. The median patient age was 67 years, and baseline characteristics were similar between the treatment groups.

HRQoL was assessed with the Expanded Prostate Index Composite (EPIC),a comprehensive instrument designed to evaluate patient-reported side effects after prostate cancer treatment.

The questionnaire measured side effects in each of EPIC’s four domains – bowel, urinary, sexual and hormonal.

EPIC assesses prostate cancer-specific HRQoL on a Likert scale with responses transformed to 0-100, where higher scores indicate a better HRQoL. Participant feedback was collected at baseline, six months after treatment began and one year post-treatment, with change scores compared between the C and H groups. A Wilcoxon test was used to assess differences.

At baseline, there were no statistically significant differences between treatment groups in any of the HRQoL domains. Results indicated that, compared to men without prostate cancer, most patients in both groups reported poor baseline EPIC sexual domain scores, with the C group’s score averaging 47.5 and the H group’s score averaging 44.2. At baseline, the groups reported only slightly lower than average bowel and urinary scores.

Following treatment, patients who received higher doses of RT in fewer sessions (the H group) reported similar HRQoL as the patients who received conventional RT (the C group).

There were no differences in change scores for either group on any EPIC domain at six months follow-up. At 12 months follow-up, hypofractionation patients reported a larger decline in the bowel domain compared to those who received conventional RT, with an average from baseline of -3.6 vs. -1.8, respectively, (p = 0.0037), but the change was not deemed clinically significant to patients.

“This research shows that hypofractionated radiation therapy offers patients value-based care for their disease. If patients with low-risk prostate cancer choose radiation therapy, they can live equally long and have the same quality of life outcomes with 28 daily treatments, compared to what has been the standard care of 41 daily treatments,” said Dr. Bruner. “This reduction of treatment time by almost a third translates into other types of value for patients, such as decreased drive time, lower transportation costs and fewer days off of work.”

Purpose/Objective(s): To assess differences in health related quality of life (HRQoL) between hypofractionated (H) and conventional (C) schedule radiation therapy (RT) in men with low-risk prostate cancer.

Materials/Methods: Eligibility included: stage T1-2a, Gleason ≤6, PSA <10, randomized to a C schedule (3D/IMRT 73.8 Gy in 41 fractions [fx] over 8.2 wks) or a H schedule (3D/IMRT 70 Gy in 28 fxs over 5.6 wks). HRQoL was assessed with the Expanded Prostate Index Composite (EPIC) at baseline, 6 and 12 mos. EPIC assesses prostate cancer-specific HRQoL on a Likert scale with responses transformed to 0-100 (higher scores indicating better HRQoL; 0.5 SD change indicating clinical significance). EPIC has 4 domains: bowel, urinary, sexual, and hormonal.

Each domain requires at least 80% of items to be completed. Change scores, calculated as follow-up – baseline, at 6 and 12 mos were compared between arms. Wilcoxon test was used to assess differences. A significance level of 0.0125 to adjust for multiple comparisons with respect to the 4 domain scores was used for an overall two-sided type I error of 0.05.

Results: Of 1092 pts analyzable for the primary endpoint, 962 consented to HRQoL (478 on 73.8 Gy arm; 448 on 70 Gy arm). Baseline characteristics were similar between treatment arms. Median age = 67 yrs; HRQoL compliance was 89.4% at baseline, 72.7% at 6 mos, and 65.9% at 1 yr. Compared to men without cancer1, most pts reported poor baseline EPIC sexual domain scores in both H and C arms, median 44.2 and 47.5, and only slightly lower than average bowel and urinary scores.

No statistically significant differences with regard to any of the HRQoL baseline domains were measured between treatment arms. There were no differences in change score between arms of any domain scores at 6 mos. At 12 mos, those on the 70 Gy arm experienced a larger decline as compared to those on the 73.8 Gy arm in the bowel domain (median 12 mo. scores 91.1 vs 94.6; median change scores from baseline -3.6 vs. -1.8, respectively, p=0.0037), but not clinically significant.

Conclusion: Compared to a study of EPIC norms1 in men without cancer, baseline scores for bowel and urinary domains were about 5-6 points lower and sexual function was 15 points lower than norms. Men receiving either H or C fractionation schedules demonstrated 12 mo. bowel, urinary, and better sexual HRQoL comparable to the recent large European H study.2 EPIC scores exhibited only a small magnitude of decline at 1 yr follow-up from baseline. As compared with C fx, pts treated with H demonstrated a small statistically, but not clinically significant, larger decline in bowel HRQoL at 1 yr, thus late toxicity is comparable between arms, supporting value based care with H.

Acknowledgements: This project was supported by grants U10CA21661 (RTOG-Ops-Stat), U10CA37422 (RTOG- CCOP), U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC) from the National Cancer Institute (NCI).

Here is a link to the original study:

CyberKnife for Liver Cancer Shows Long-term Safety! 

CyberKnife for Liver Cancer Shows Long-term Safety! 


In a follow­-up to a previous study on the safety and efficacy of stereotactic body radiotherapy for patients with small hepatocellular carcinomas, researchers found that incidence of grade 3 or higher adverse events did not increase after longer follow­ up times. 


“In several reports on the results of HCC treatment with [stereotactic body radiotherapy (SBRT)], the median follow­ up duration was close to 30 months and the authors assessed the outcomes at 3 years,” Katsumaro Kubo, MD, from the Hiroshima Prefectural Hospital, Japan, and colleagues wrote. “However, radiation therapy is not considered as an option for the treatment of HCC in the [Barcelona Clinic Liver Cancer (BCLC)] guidelines and the reason may be the uncertainty of the long­ term outcomes. To address this concern, we extended the follow­-up period and analyzed the long­ term outcomes at 5 years.” 


In the previous study, 77 patients with a total of 93 tumors underwent SBRT. Patients had either Child­ Pugh class A or B and had fewer than 3 HCC nodules no larger than 50 mm in diameter per lesion. Kubo and colleagues included 65 of the original patients in the new study. 


Sixty patients underwent transarterial chemoembolization (TACE) before SBRT and 13 patients underwent TACE within 1 month to 3 months after SBRT. 

Median follow­ up at the time of evaluation was 41 months (range, 3 79 months), while median follow­-up for the 26 survivors was 62 months (range, 24­79 months). 


In the original study, the 2­ year overall survival rate was 76% (95% CI, 65.4­86.7), progression­ free survival (PFS) was 40% (95% CI, 27.6­52.3) and local control (LC) was 100%. 


Comparatively, the 3­ year OS rate was 56.3% (95% CI, 44.1­68.5 and the 5­ year OS rate was 41.4% (95% CI, 28.7­54.1). 


Further, the 3 year PFS rate was 25.4% (95% CI, 14­36.8) and the 

5­ year PFS rate was 10.6% (95% CI, 1.5­19.8). 


Both the 3­ year and 5­ year LC rates were 100%. 


Fifteen patients experienced grade 3 or higher liver toxicities at 6 months follow­ up. 


After 1 year of follow­ up, 5 other patients experienced grade 3 or higher liver toxicities. No adverse events worsened in any patients and no patients developed gastrointestinal disorders or ulcers.


Multivariate analysis showed that tumor­node­metastasis stage at treatment was a significant prognostic factor for PFS at 3 years (P = .0008) and that grade 3 or higher adverse events were a prognostic factor for OS at 5 years (P = .0049). 


“Most patients in this study underwent resection and [radiofrequency ablation (RFA)] as initial therapies, which may have confused the results, including the OS and PFS rates,” the researchers wrote. “To compare with surgery or RFA, a prospective study of SBRT in HCC is necessary. If the efficacy and safety of SBRT are proved, it will be added as a treatment option that is comparable to resection or RFA for patients who were considered unfit or refused these other therapies.”  


To learn more talk to our cancer experts at the CyberKnife Center of Miami 305-279-2900



Latest Research: Most Effective Way to Treat Recurrent Trigeminal Neuralgia With CyberKnife

The latest research evaluates the use of CyberKnife Radiation Therapy for recurrent Trigeminal Neuralgia. 

This Non-Invasive Radiosurgery technique often eliminates the pain with just one treatment but is also highly effective if it returns. 

Click the link below to see the full study & talk to our Trigeminal Neuralgia experts at the CyberKnife Center of Miami who were part of this vital research involving multi medical centers 305-279-2900.

Latest Study on CyberKnife for Treating Recurrent Trigeminal Neuralgia: