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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.

Latest Research on SBRT for Lung Cancer Shows Better Survival Rates

 A new study on SBRT for metastatic lung cancer published in Radiation Oncology, shows that excellent overall survival rates and local control is achievable with SBRT.

Click here for more information on the results from the study.

 The Radiosurgery Society® Announces Publication of Sixth Manuscript from its RSSearch® Patient Registry


The Radiosurgery Society (RSS), a non-profit medical society dedicated to advancing the science and clinical practice of radiosurgery, announced today the publication of a sixth manuscript leveraging data from its RSSearch Patient Registry, a multi-institutional, observational registry established to standardize data collection from patients treated with stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT).

The recent study, entitled Lung metastases treated with stereotactic body radiotherapy: the RSSearch® patient Registry’s experience, published in the February issue of Radiation Oncology, examined outcomes from 447 patients treated for lung metastases using SBRT. The study found 5 year survival of 21.8 percent consistent with the survival benefit of local treatment such as surgery previously published for low volume metastatic disease (oligometastases). The study also found that patients with smaller metastases treated with higher doses of SBRT with a biological effective dose of at least 100Gy had the best local control. There was no difference in local control between different tumor types however survival was improved for breast and head and neck cancer consistent with a longer natural history. 

"The strength of our RSSearch Registry study is the large number of patients treated in a uniform manner with high dose SBRT, representing the largest series reported in the literature to date," said Rachelle Lanciano, M.D., Chair of Radiation Oncology at Crozer-Keystone Health System/Philadelphia CyberKnife and Adjunct clinical associate professor Drexel University. "Randomized trials are underway to assess the survival benefit of local treatment for oligometastases and until those trials are reported, prospective registry series like our recent study are extremely valuable in helping to guide treatment decisions."

"The RSSearch Patient Registry is an important resource in expanding knowledge and understanding of SRS and SBRT treatment practices and outcomes," said Joanne Davis, Ph.D., Executive Director, RSS, "Not only is this the sixth manuscript generated from RSSearch data, it is the third focused on SBRT for the treatment of lung tumors, providing clinicians with important clinical information on the use of SRS/SBRT to treat this highly prevalent and very deadly form of cancer."

Currently, more than 40 centers worldwide are participating in the RSSearch Patient Registry with screening, treatment and follow-up data from more than 19,000 patients treated with SRS/SBRT. Data includes patient demographics, payer information, treatment practices and outcome information.
The RSSearch Registry is managed by the RSS and the RSSearch Clinical Advisory Committee, made up of professionals involved in the management and care of patients treated with SRS/SBRT. Participation is voluntary and all centers treating patients with SRS/SBRT clinically are encouraged to participate by emailing Jan Jenkins, RN, Clinical Programs Manager RSS, at jjenkins@therss.org.

The RSSearch Patient Registry (formerly known as ReCKord Registry) was developed in 2005 by a Clinical Advisory Board of radiation oncologists, neurosurgeons, medical oncologists and medical physicists to provide a method to collect standardized data on SRS/SBRT.
About The Radiosurgery Society®

The Radiosurgery Society (RSS) - a non-profit, independent, multi-disciplinary organization of surgeons, radiation oncologists, physicists, and allied professionals, who are dedicated to advancing the science and clinical practice of radiosurgery. Originally formed in 2002 and becoming (501c6) in 2008, the Radiosurgery Society today (http://www.therss.org) represents approximately 700 members who perform stereotactic body radiotherapy and radiosurgery in hospitals and freestanding centers throughout the world.


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: