“Separate phase III trials presented at the 2016 Genitourinary Cancers Symposium demonstrated that modest hypofractionated radiotherapy is noninferior to conventional radiotherapy for men with intermediate- and low-risk prostate cancer and should be considered a new standard of care.1,2 However, it is not clear how widely adopted hypofractionation schedules will be.
“NRG Oncology RTOG 0415 was a randomized, phase III, noninferiority study comparing two fractionation schedules in men with low-risk prostate cancer: conventional radiotherapy (73 Gy in 41 fractions over 8.3 weeks) vs hypofractionation (70 Gy in 28 fractions over 5.6 weeks).1
“The study enrolled 1,115 patients with low-risk prostate cancer. No androgen suppression was given. Patients were stratified according to Gleason score 2–4 and Gleason score 5–6.”
“The surface has only been scratched in the investigation of radiation and immunotherapy in combination for the treatment of patients with prostate cancer, says Steven Finkelstein, MD, of 21st Century Oncology.
“ ‘There is so much undiscovered territory with respect to this research. The fact there that are only a few clinical trails now of any significance in this area means that we need to do more work,’ says Finkelstein, a Scottsdale board certified radiation oncologist, adjunct associate professor at Translational Genomic Research Institute, and executive director of the Arizona Cancer Research Alliance. ‘I’ve spent a career working on this topic, and only now, after 20 years, are we starting to make progress.’
“While progress has been slow, the outlook is bright for the use of immunotherapy and radiation together in prostate cancer, says Finkelstein. He is currently working on a multicenter trial, which is investigating the effects of radiation therapy to augment anti-tumor responses from immunotherapy with sipuleucel-T (Provenge).”
Cancers that arise in the lung are mostly of the type known as NSCLC (non-small cell lung carcinoma). A much smaller proportion of lung tumors arise from neuroendocrine cells in the lungs. These cells (which are also found in most other organs) secrete a variety of hormones that are necessary for normal organ function, as well as for healing after injury or infection. Like other lung cells, neuroendocrine cells may transform to become cancers. Lung cancers that arise from neuroendocrine cells are called pulmonary neuroendocrine tumors (NETs), or lung NETs. Continue reading…
The gist: A cancer pain drug called Sativex was not found to be any better than a placebo in a recent clinical trial. However, the makers of the drug are still optimistic about it, based on previous successful studies. They will continue to test it to see whether they can get better results.
“GW Pharmaceuticals plc and Otsuka Pharmaceutical Development & Commercialization, Inc., have reported the top-line results from the first of three Phase 3 trials for the investigational product Sativex in the treatment of pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy. In this first trial, Sativex (as adjunctive treatment to optimized chronic opioid therapy) did not meet the primary endpoint of demonstrating a statistically significant difference from placebo.
” ‘Although we missed the primary endpoint in this trial, based upon the positive data seen in the Phase 2 program, we remain confident in the ability for Sativex to relieve cancer pain in this patient population’, stated Justin Gover, GW’s Chief Executive Officer. ‘We have two additional pivotal Phase 3 trials ongoing which, if positive, would still allow us to submit a New Drug Application with the US FDA. We look forward to results from these two further studies later this year.’ “
The gist: Lung cancer patients who have previously had cancer are excluded from most clinical trials testing new lung cancer treatments.
“In a study reported in the Journal of the National Cancer Institute, Gerber et al found that patients with prior cancer were excluded from most clinical trials in lung cancer, including nearly all with overall survival as a primary endpoint.
“The study involved review of data from 51 lung cancer clinical trials (total target enrollment, 13,072 patients) sponsored or endorsed by the Eastern Oncology Cooperative Group. Prevalence of prior primary cancer diagnoses among lung cancer patients was estimated using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database…
“Overall, 41 trials (80%) excluded patients with prior cancer diagnosis, including any prior diagnosis (14%), diagnosis within 5 years (43%), diagnosis within 2 to 3 years (7%), and diagnosis of active cancer (16%). In SEER-Medicare data on 210,509 lung cancer patients, 56% of prior cancers were diagnosed within 5 years before lung cancer diagnosis. The estimated proportion of patients excluded from lung cancer trials due to prior cancer diagnosis ranged from 0% to 18%.”
“The American Society of Clinical Oncology (ASCO) today called for greater access to and education about phase I clinical trials, the first-in-human studies of new agents designed to fight cancer.
“In a just-released policy statement, the Society stresses the critical importance of phase I clinical trials in cancer research and treatment, emphasizing that this research offers greater potential as a treatment option for many patients than was the case in the past, due to development of molecularly targeted agents, biomarker tests to identify patients likely to respond to treatments and innovative clinical trial designs.
“ ‘The Critical Role of Phase I Trials in Cancer Research and Treatment’ ASCO policy statement, which updates a 1997 version, was published today in the Journal of Clinical Oncology.
“ ‘With new agents that target specific abnormalities in a patient’s tumor, better tests to identify those abnormalities and more sophisticated clinical trial designs, today’s phase I trials in cancer offer patients a greater likelihood of benefit than ever before,’ said ASCO President Peter Paul Yu, MD, FACP, FASCO. ‘Patients shouldn’t shy away from phase I trials and doctors should present these trials as options for eligible patients throughout the period of active cancer treatment, not only when all other treatment options have failed.’ ”
“Latina breast cancer patients provided with information about clinical trials in multiple ways, including a culturally sensitive, computer-based video on breast cancer clinical trials, had much greater awareness of clinical trials compared with patients who received usual-care information, according to data presented at the American Association for Cancer Research (AACR) conference on The Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, held Nov. 9–12.
“After receiving the additional information, the proportion of Latina breast cancer patients taking steps toward participating in a clinical trial increased from 38 percent to 75 percent.
” ‘Latinos represent 17 percent of the U.S. population but only 5.6 percent of participants in National Cancer Institute treatment clinical trials,’ said Patricia Chalela, DrPH, assistant professor of epidemiology and biostatistics at the Institute for Health Promotion Research (IHPR) at The University of Texas Health Science Center at San Antonio. ‘Underrepresentation of minorities in clinical trials results in disparities of cancer outcomes and limits generalizability of the findings because researchers cannot study how minority patients respond to new treatments.’ “
“Experts from The Cancer Genome Atlas Research Network – a US-wide government-funded research project – analysed 295 samples of stomach cancers to find similarities that may be targeted when developing treatments.
“Research into the biology of stomach cancer and the development of new therapies has been difficult because of the different forms that the disease can take.
“Lead author Dr Adam Bass, from the Dana-Farber Cancer Institute, said that, despite stomach cancer being a diverse disease up until now researchers had tended to take a ‘one-size-fits-all’ approach to stomach cancer treatments.”
“The nation’s cancer clinical trial network, which provides care to thousands of patients across the United States, may have no choice but to abandon life-saving and life-extending research studies, including support for patients participating in those studies, due to crippling proposed budget cuts. For decades, federally-supported clinical trials have produced critical advances in the fight against cancer, representing one of the greatest returns on research investment anywhere. But this progress could soon grind to a halt due to far-reaching—and largely unnoticed—budgeting decisions that are happening in plain sight.”
Editor’s note: Clinical trials are not only important for testing the safety and effectiveness of new drugs; they also provide an avenue for patients who cannot benefit from standard treatment options to access new, cutting-edge treatments that could help them. In fact, our founder’s life was saved by his involvement in a clinical trial.