Study Questions Exclusion of Cancer Survivors from Trials

Excerpt:

“A quarter of newly diagnosed cancer patients 65 or older are survivors who had a prior cancer — often preventing them from participating in clinical trials, researchers from UT Southwestern’s Simmons Cancer Center have found.

“The UT Southwestern scientists found that 11 percent of individuals ages 20-64 had a history of a prior cancer, and 25 percent of individuals 65 or older had a history of a prior cancer.

“As the number of cancer survivors grows, more individuals are being excluded from cancer clinical trials that could benefit them when diagnosed with a second cancer.”

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Clinical Trial Eligibility Criteria a Growing Obstacle

Excerpt:

“Despite a decade-long call for simplification of clinical trials, the number of criteria excluding patients from participating in clinical trials for lung cancer research continues to rise.

“Researchers found a nearly 60 percent increase in exclusion criteria by reviewing 74 National Cancer Institute-sponsored lung   from 1986 to 2016.”

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NCI-MATCH to Assess Treatments Based on Genetic Abnormalities, Not Cancer Type

“The ECOG-ACRIN Cancer Research Group has opened the largest precision medicine cancer trial to date.

“The phase 2 National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) trial will evaluate the efficacy of targeted therapies in patients whose tumors share specific gene abnormalities. Treatment choice will be made based on these abnormalities rather than the site of origin of the malignancy.

“ ‘The primary underpinning of the trial comes from genetic characterization of various cancer types, which has become increasingly common place but is not yet routine,’ Keith T. Flaherty, MD, an oncologist at Massachusetts General Hospital, associate professor at Harvard Medical School andECOG-ACRIN chair of the NCI-MATCH trial, told HemOnc Today. ‘When looking at cancers as defined by their site of origin, there are threads of continuity across those cancer types. Within a cancer type, there also is heterogeneity, and understanding what this patchwork looks like was really the main motivator for setting up a trial like this.’ “


ASCO Calls for Cancer Trials to Include More Seniors

“In a position statement published online July 20 in the Journal of Clinical Oncology, the American Society of Clinical Oncology has called on the U.S. government and the cancer research community to broaden clinical trials to include older adults.

” ‘Older people living with cancer often have different experiences and outcomes in their treatment than younger cancer patients,’ Julie Vose, M.D., M.B.A., society president, said in a news release from the group. ‘As we age, for example, the risk of adverse reactions from treatment significantly increases. Older adults must be involved in clinical trials so we can learn the best way to treat older cancer patients, resulting in improved outcomes and manageable toxicity,’ she explained.

“More than 60 percent of cancers in the United States occur in people aged 65 and older, the statement authors say, noting the number of seniors will increase in coming years. However, there is a lack of evidence about cancer treatments for the elderly because too few are included in clinical trials, and clinical trials designed specifically for seniors are rare.”


Low Enrollment in Genomically Matched Clinical Trials After Genomic Testing

“In an analysis reported in the Journal of Clinical Oncology, Meric-Bernstam and colleagues at The University of Texas MD Anderson Cancer Center found that a small minority of patients with potentially actionable genes identified in large-scale testing were enrolled onto clinical trials targeting the alterations.

“The study included 2,000 consecutive patients with advanced cancer who underwent testing in a genomic testing protocol. Standardized hotspot mutation analysis was performed using either an 11-gene (251 patients) or a 46- or 50-gene (1,749 patients) multiplex platform. A total of 35 genes were considered potentially actionable, given the potential to be targeted with approved or investigational therapies.

“In total, 789 patients (39%) had at least one mutation in potentially actionable genes. Of them, 83 (11%) were enrolled in genotype-matched trials targeting these alterations. Among 230 patients with PIK3CA/AKT1/PTEN/BRAF mutations who returned for therapy, 116 (50%) received a genotype-matched drug; of them, 40 (17%) were treated in a genotype-selected trial requiring a mutation for eligibility, 16 (7%) were treated in a genotype-relevant trial targeting a genomic alteration without biomarker selection, and 40 (17%) received a genotype-relevant drug off trial.”


ASCO Launches First-ever Clinical Trial: Aims to Learn from Patients with Advanced Cancer Who Lack Standard Treatment Options

“The American Society of Clinical Oncology (ASCO) today announced its first-ever clinical trial that will offer patients with advanced cancer access to molecularly-targeted cancer drugs and collect ‘real-world’ data on clinical outcomes to help learn the best uses of these drugs outside of indications approved by the Food and Drug Administration (FDA). Plans for the Targeted Agent and Profiling Utilization Registry (TAPUR) study, including the participation of major pharmaceutical companies that will contribute free drugs, were released in a news briefing at the Society’s 2015 Annual Meeting in Chicago.

“The ASCO-sponsored prospective, non-randomized clinical trial will collect information on the anti-tumor activity and toxicity of commercially available, targeted cancer drugs in a range of cancer types, including any advanced solid tumor, multiple myeloma, or non-Hodgkin lymphoma with a genomic variation known to be a drug target.

“ ‘Oncologists often use therapies approved for a specific cancer indication to treat people with other types of advanced cancer, but we very rarely learn from that experience to benefit other patients,’ said ASCO President Peter Paul Yu, MD, FACP, FASCO. ‘TAPUR will document the real-world experience of patients who receive commercially available targeted anti-cancer drugs and will describe the effectiveness and side effects of a range of targeted agents available in this study.’ “


Novel Government Cancer Study Will Test Precision Medicine

“The federal government is launching a very different kind of cancer study that will assign patients drugs based on what genes drive their tumors rather than the type.

“The National Cancer Institute’s NCI-MATCH trial will be a massive precision medicine experiment at more than 2,400 sites around the country.

“Starting in July, about 3,000 patients will have their tumor genes sequenced to see what mutations or pathways fuel their disease. About 1,000 patients whose tumor characteristics most closely match one of the 20 or so gene-targeting drugs offered in the study will be put into groups of about 30 patients to get that drug.

” ‘The goal is really to try to get the information faster, so when we see responses we can expand rapidly’ and offer the drug more widely, said Dr. Douglas Lowy, the Cancer Institute’s acting director.”


Study Finds No Reason for Cancer Survivors to Be Excluded in Advanced Stage Lung Cancer Trials

“The common practice of excluding patients with a prior cancer diagnosis from lung cancer clinical trials may not be justified, according to a study by researchers from UT Southwestern Medical Center.

“Having previously had cancer did not impact clinical outcomes in advanced lung cancer patients and these patients therefore should be considered for inclusion in clinical trials seeking new therapies, according to the study, appearing in the Journal of the National Cancer Institute.

” ‘When it comes to clinical trial eligibility, a history of prior cancer should not count against you,’ said senior author Dr. David Gerber, Associate Professor of Internal Medicine in the Division of Hematology and Oncology in the Harold C. Simmons Comprehensive Cancer Center. ‘For patients with advanced lung cancer, previous cancer does not adversely affect survival, regardless of the type, stage, or timing of the prior cancer.’ “


Docetaxel Was Widely Used to Treat Metastatic Prostate Cancer before Conclusive Evidence Showed Its Superiority

The gist: The drug docetaxel was widely used to treat patients with metastatic prostate cancer before phase III clinical trials showed it was better than standard treatment. This is significant for a few reasons. First, it shows that many doctors are willing to prescribe promising drugs “off-label,” before the U.S. Food and Drug Administration (FDA) has approved them  for treating certain conditions. It also shows that a drug that is used for one type of cancer is more likely to be prescribed off-label for other types of cancer. Some are concerned that off-label prescriptions undermine the clinical trial process and put some patients at risk by giving them drugs that may not turn out to be better.

‘Docetaxel was being widely used by patients with metastatic prostate cancer before phase III evidence that it was more effective than standard-of-care for patients with castration-resistant prostate cancer, according to an analysis of Medicare claims from before and after the trial results and approval of docetaxel by the U.S. Food and Drug Administration. The uptake of new treatments, or diffusion, “prior to definitive evidence indicates the prevalence of off-label chemotherapy use,” wrote Unger et al in the Journal of the National Cancer Institute

“Rapid and widespread use of docetaxel was not observed among all study participants receiving chemotherapy for metastatic prostate cancer. Statistically significant docetaxel uptake (P < .01) was seen in patients older than 65 years of age, blacks, patients in lower income areas, and those who experienced poverty. This observation ‘presents opportunities to improve the uptake of proven new therapies in subpopulations,’ the authors wrote, adding that direct-to-consumer advertising ‘could be a useful tool.’

Another potential method cited for encouraging more rapid adoption of new treatments was ‘enhancing communication channels among physicians, especially between key opinion leaders and their colleagues,’ the authors noted. ‘One factor that has been repeatedly identified to increase adoption rates is attendance at scientific symposia, which serve as forums for disseminating information about new treatments.’ ”