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.”

Trial Availability, Patient Eligibility Barriers to Enrollment onto Genomically Matched Trials

“Only a small percentage of patients with actionable gene alterations are eventually enrolled onto genotype-matched trials targeting these alterations, according to study results.

“With the influx of targeted molecular therapies for the treatment of cancer, genomic profiling and matching patients to targeted therapies are imperative, according to study background.

“ ‘However, implementation of genomically informed therapy requires not only access to genomic profiling, but also the availability of molecularly targeted therapies matched to the genomic testing results,’ Funda Meric-Bernstam, MD, chair of the department of investigational cancer therapeutics, at The University of Texas MD Anderson Cancer Center, and colleagues wrote. ‘Availability of clinical trials may not only differ from institution to institution, but may also differ between tumor types. Enrollment onto clinical trials is also limited by trial eligibility criteria, as well as availability of slots.’ ”

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.”

Living With Cancer: Clinical Trials Looking for Patients

“President Obama’s initiative to advance personalized medicine depends on the sort of breakthroughs in cell biology that have produced cancer drugs like the one extending my life. Yet very few adults with cancer enroll in clinical trials. Why do many trials fail to enroll sufficient patients, when scientists now test less debilitating therapies than those commonly used?

“I entered a Phase I trial in August 2012. Recurrences had proved that standard treatments could not eradicate my ovarian cancer. The pills from my trial, which I take at home, have kept the cancer at bay for more than two years — without destroying my appetite, muddling my mind, or dampening my spirit the way three cycles of chemotherapy did when infused intravenously in the hospital. A reader informs me that for seven months this same drug gave him a “wonderful respite” from an aggressive prostate cancer.

“Instead of destroying all quick-growing cells as well as tumors, targeted drugs pinpoint cancer cells, enabling them to mature into normal cells or disabling them from reproducing. Researchers are using personalized medicine on virtually every type of malignancy with some success. A significant percentage of patients with leukemia have experienced a remission with the clinical drug AG-221, while the lives of a significant population of women with metastatic breast cancer have been extended by the drugs Kadcyla and Perjeta. Scientists in immunotherapy — which unleashes the immune system to kill cancer cells — have produced medicines that help people survive with metastatic melanoma and lung cancer.”

Super Patient: Patient Advocates Help Susan Steel Win Admittance to Clinical Trials

Update:  We are deeply saddened to report that Susan passed away on January 13, 2016. It is a privilege to continue to share her story and keep her memory alive.

When Susan Steel first noticed the mole that derailed her life ten years ago, she was busy raising two children and running two businesses. “I just wasn’t paying attention,” she says. It wasn’t until the mole grew and started to bleed that she finally saw a doctor—and then she was hit with the news that she had melanoma and that it had spread to her lymph nodes.

“My life changed very fast,” Susan recalls. “I was told that my chances were very slim and that I should get my affairs in order.” Continue reading…

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.’ “

ASCO Policy Statement Urges Removal of Barriers to Patient Participation in Phase I Clinical Trials

“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.’ ”

Note: Learn more about clinical trials, and explore our Clinical Trial Finders for lung cancer and melanoma.

Geography May Limit Access to Cancer Clinical Trials

“Where advanced cancer patients live affects the likelihood that they can enroll in a treatment clinical trial, a new study found.

“Fewer than 10 percent of U.S. cancer patients participate in clinical trials, the authors note.

“ ‘Clinical trials are the basis for the vast majority of advances in cancer care, so, the only way to move the field forward is for patients to participate in clinical trials,’ said lead author Dr. Matthew D. Galsky of the Icahn School of Medicine at Mount Sinai in New York.

“ ‘In addition, participation in clinical trials may offer patients access to a novel treatment, that ultimately goes on to markedly change the outlook for patients with the disease, but is not otherwise available outside of the context of a trial,’ Galsky told Reuters Health by email.

“Some data has suggested that patients who participate in clinical trials may have better outcomes regardless of the treatment they receive, which could be due to the very close follow-up, and strict guidelines, for management of patients enrolled in trials, he said.”

Lung Cancer Clinical Trials Routinely Exclude Cancer Survivors

“Many patients are automatically excluded from lung cancer clinical trials due to previous cancer, according to findings.

“Additionally, this criterion appears to be used in trials with a variety of characteristics, including more than two-thirds of trials with non-survival endpoints, the researchers wrote.

“ ‘Our research demonstrates that a substantial proportion of potential subjects are reflexively excluded from lung cancer clinical trials due to prior cancer,’ researcher David Gerber, MD, associate professor of internal medicine in the division of hematology and oncology at the UT Southwestern Medical Center, said in a press release.

“Due to the assumption that a prior cancer diagnosis could hamper clinical trial outcomes, cancer survivors are frequently excluded. To assess the prevalence of this trend in lung cancer clinical trials and its influence on trial accrual, Gerber and colleagues reviewed lung cancer clinical trials, including 13,072 patients, sponsored or endorsed by the ECOG for exclusion criteria related to a prior cancer diagnosis.”