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Clinical trial participation studies show possible survival benefit, misconceptions of patient concerns
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Participation in therapeutic drug trials appeared associated with longer OS among patients with non-small cell lung cancer, according to results of a retrospective study scheduled for presentation at Quality Care Symposium.
A wide gap exists, however, between providers’ and patients’ attitudes and beliefs about clinical trial enrollment, with physicians and research staff often misunderstanding the reasons patients decline to participate, results of a separate study to be presented at the symposium showed.
“It is our duty as oncologists to enroll our patients in clinical trials when appropriate,” Merry-Jennifer Markham, MD, FACP, an ASCO expert who was not involved with either study, said in a press release. “We must work to better understand factors associated with trial enrollment so that the prospective benefits can be made accessible to all who are eligible.”
Clinical t rials for NSCLC
Clinical trial participation not only supports drug development, but also benefits individuals with NSCLC by offering them access to experimental drugs and enhanced supportive care, Cristina Merkhofer, MD, MHS, hematology-oncology fellow at Fred Hutchinson Cancer Research Center and University of Washington, and colleagues wrote.
However, previous studies have yielded conflicting evidence on whether enrollment in therapeutic drug trials improves survival for patients with NSCLC.
Merkhofer and colleagues retrospectively analyzed data from 371 patients (median age, 63.9 years; 53% women) with metastatic NSCLC diagnosed between 2007 and 2015 and who received treatment at Seattle Cancer Care Alliance.
The majority (94%) of patients had nonsquamous histology, 30% were never-smokers, 20% harbored EGFR mutations, 8% had ALK mutations and 27% had brain metastases. Patients received at least one anticancer drug within 180 days of M1 diagnosis, had no active second cancer and had minimum survival of 60 days.
Dates of death were obtained from Washington State Cancer Registry.
Thirty-two percent of patients (n = 118) had enrolled in at least one clinical trial. Among the trial enrollees, 19% enrolled in more than one trial, 89% enrolled in phase 1/phase 2 trials, 15% in phase 3 trials, 26% in randomized trials, and 51% in trials of drugs subsequently approved by the FDA.
Researchers investigated whether enrollment in at least one clinical trial had an impact on OS using multivariate Cox regression models.
Results showed median OS of 838 days (95% CI, 688-1,021) among clinical trial enrollees compared with 454 days (95% CI, 378-511) for patients who did not enroll in a trial.
Trial enrollees had a 47% lower risk for death (HR = 0.53; 95% CI, 0.13-0.92) than nonenrollees after adjusting for sex, ECOG score, smoking, histology, EGFR and ALK status, and brain metastases.
The researchers intend to conduct subgroup analyses to explore whether certain aspects of trial design are associated with a survival benefit.
“The study can support research evaluating health care policies or research that looks at incentives for patient participation in trials, such as financing transportation or lodging,” Merkhofer said in a press release. “It can help with research that addresses some of these important barriers to trial participation.”
Misconceptions of barriers
Fewer than 10% of adults with cancer are enrolled in clinical trials, which are crucial to advance treatment. Research also has shown that 18% of publicly funded cancer studies cannot recruit enough participants. Low accrual can force trials to close before conclusions can be drawn, wasting time and resources, according to researchers.
Grace Clarke Hillyer, EdD, MPH, assistant professor of epidemiology at Columbia University’s Mailman School of Public Health, and colleagues sought to evaluate barriers to clinical trial enrollment by surveying physicians and research staff and comparing their responses with those of adults with cancer not enrolled in a trial.
A total of 120 physicians and research staff members and 150 adults with cancer completed the survey, which researchers used to examine differences in perceptions, attitudes and beliefs about clinical trial enrollment.
More than a quarter of patients (27.3%) expressed a belief that clinical trials are only open to people whose disease is hopeless, whereas only 8.7% of physicians/staff believed this to be true (P < .001). About one-third of patients (32.9%) also believed that clinical trial enrollment would not help them, compared with 1.8% of physicians/staff (P < .001).
Physicians and research staff members were significantly more likely than patients to believe that patients decline trial participation because of a language or cultural barrier (57.5% vs. 27.3%; P < .001); a lack of understanding about clinical trials (63.3% vs. 9.1%, P = .001), mistrust of the medical system (69.2% vs. 36.4%; P = .043), concerns about invasive procedures (41.7% vs. 9.1%; P = .02), toxicity (60% vs. 18.2%; P = .006), or reluctance to be randomly assigned treatment and receive placebo (70.8% vs. 27.3%, P = .005).
Researchers also observed differences in beliefs between physicians and research staff members. Survey results showed 44% of staff members believed interacting with a patient’s family is a barrier to clinical trial enrollment, compared with 18.2% of physicians (P = .007).
“We found that commonly held beliefs in the research community about why a patient joins or does not join a clinical trial are not in sync with barriers reported by our [patients with] cancer,” Hillyer said. “Physicians and staff involved in cancer care and treatment may not be aware of barriers perceived by patients or hold misperceptions about reasons for patients’ reluctance to join a clinical trial that could result in the lack of an offer of a trial to a patient or refusal to join by the patient.” – by John DeRosier
Reference:
Merkhofer C, et al. Abstract 137. Scheduled for presentation at: Quality Care Symposium; Sept. 6-7, 2019; San Diego.
Hillyer G, et al. Abstract 170. Scheduled for presentation at: Quality Care Symposium; Sept. 6-7, 2019; San Diego.
Disclosures: Merkhofer and Hillyer report no relevant financial disclosures. Please see the abstracts for all other authors’ relevant financial disclosures. Markham reports institutional research funding from Aduro Biotech, Eli Lilly and Tesaro.