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.”

Clinical Trial Participation Low in Lung, Colorectal Cancers

The gist: There is a low rate of enrollment in clinical trials by cancer patients. Clinical trials are research studies with volunteer patients. They allow patients to access promising new treatments, and are essential for driving the development of new treatments.

“Despite the importance of clinical trials for driving medical discovery and innovations, only 14% of patients with newly diagnosed lung or colorectal cancer surveyed in a recent trial reported having discussed participation in clinical trials with their physician, and even fewer went on to participate.

“ ‘Even among patients treated with chemotherapy for advanced cancer, for whom investigational approaches should arguably be integrated into all initial considerations about treatment options, given a low chance of cure with standard therapy, the discussion rate was only 25.7%, with a participation rate of 7.6%,’ wrote researchers led by Kenneth L. Kehl, MD, MPH, of Harvard Medical School.

“Kehl and colleagues also found that discussions occurred less frequently among older patients, and black and Asian patients compared with white patients.

“In the study, the researchers surveyed 7,887 patients with lung or colorectal cancer between 3 and 6 months after cancer diagnosis. Respondents were asked if they learned that clinical trial participation might be an option for them, and who discussed trials with them. The results were published in the Journal of the National Cancer Institute.

“Overall, 1,114 participants, or 14.1%, reported having discussed the possibility of participating in a clinical trial, with the majority reporting that the discussion occurred with their physician. Participating in a clinical trial occurred in 3.6% of all participants and in 25.8% of participants who reported discussing clinical trials with their physician. In addition, higher rates of clinical trial discussion occurred among patients who reported being treated by a medical oncologist compared with those who were not.”

Analysis of SWOG Trials Indicates No Survival Difference After 1 Year in Cancer Patients Treated In vs Out of Clinical Trials

“In a study reported in the Journal of the National Cancer Institute, Unger et al evaluated whether cancer patients from SWOG clinical trials were similar to nontrial patients in baseline characteristics and survival. They found that, overall, trial participation in standard treatment arms did not influence overall survival after 1 year, suggesting both that findings in clinical trials can be generalized to the wider population and that eligibility requirements might be relaxed to encourage greater clinical trial participation.

“Key Points:

“In good-prognosis patients, there was no significant difference in overall survival between patients treated in vs out of clinical trials.

“In poor-prognosis patients, there was a significant difference in overall survival during the first year after diagnosis (favoring trial participation), but not thereafter.”

Editor’s note: This study compared outcomes for patients treated in clinical trials with outcomes for patients not enrolled in trials. Learn more about clinical trials here.

On the Failure of Lung Cancer Drug Onartuzumab in a Phase III Clinical Trial

Most new cancer drugs fail clinical testing. Because they don’t make it to the pharmacy, we usually hear very little about them. But widespread media coverage made it hard to ignore the recent termination of a trial testing the drug onartuzumab. Details of the story raise concerns about the patient enrollment processes of some clinical trials. Continue reading…