“ASCO and Friends of Cancer Research (Friends) applaud the National Cancer Institute’s (NCI) recent revision of its clinical trial protocol template to broaden eligibility criteria for cancer clinical trials. The protocol template was expanded to help increase the opportunity for participation in NCI-funded clinical trials for patients with certain health-care conditions, as well as to provide an opportunity for patients younger than age 18 to participate in adult clinical trials in certain circumstances.”
“ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific areas: minimum age requirements for trial enrollment, HIV/AIDS status, brain metastases, organ dysfunction, and prior and concurrent malignancies.”
“Clinical trials of new anti-cancer therapies have often excluded patients whose disease has spread to the brain or central nervous system (CNS) or, if such patients were allowed on trial, trials have often failed to clearly capture information on the drug’s effect in the brain. Today new guidelines from an international, multidisciplinary group published in the journal Lancet Oncology describe how to most appropriately address cancer patients with CNS involvement within clinical trials of anti-cancer drugs.”
“When 29-year-old Carly Bastiansen was diagnosed in January 2016 with advanced pancreatic cancer, doctors told her a clinical trial was her best shot at slowing the notoriously quick-killing and hard-to-treat disease. She found one that appeared promising and went through the screening process. But the trial would not accept her.
“ ‘Participating in a clinical trial is really my only chance at living longer,’ Bastiansen, a children’s librarian in Baltimore, said this fall as she was growing weaker. ‘To have had that option taken off the table was devastating.’ ”
“Historically, patients with melanoma who develop brain metastases have been excluded from clinical trials, according to Harriet Kluger, MD.
“As of late, an increasing number of patients in this subgroup are being included now on studies, particularly those who have received prior treatment. Yet this is still not enough, says Kluger, as brain metastases is no longer the dismal prognosis that it once was.”
“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.”
“ ‘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.’ “
“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.”