Does Enrollment in Cancer Trials Improve Survival?

Abstract

Background Stakeholders derive many benefits from cancer clinical trials, including guidance for future oncologic treatment decisions. However, whether enrollment in cancer trials also improves patient survival independently of trial outcomes remains under-investigated. We hypothesized that cancer trial enrollment is not associated with patient survival outcomes. Methods Using the 2002–2008 California Cancer Registry, we identified 555,469 patients with stage I–IV solid organ tumors. Baseline characteristics were compared by trial participation status. Logistic regression determined predictors of trial enrollment. Multivariate Cox proportional hazards regression examined the impact of trial participation on overall and cancer specific mortality with adjustment for covariates. Results Only 0.33% of our cohort was enrolled in clinical trials. Trial participants were likely to be younger than 65 (OR 2.13; 95% CI 1.90–2.38), Hispanic rather than non-Hispanic white (OR 0.78; 95% CI 0.67–0.90) and have breast cancer (OR 3.14; 95% CI 2.62–3.77). Multivariate survival analyses demonstrated that enrollment in cancer trials predicted a lower hazard of death. However, when stratified by disease site, this survival benefit was only observed in lung, colon and breast cancers (Table). Sensitivity and interaction analyses confirmed these relationships. Conclusions In this first population-based study examining trial effect in solid organ cancers, enrollment into cancer trials predicted lower overall and cancer specific mortality among common cancer sites. While these findings may demonstrate a survival benefit due to trial enrollment, they likely also reflect the favorable attributes of trial enrollees. Once corroborated, stakeholders must consider broader cancer trial designs representative of the cancer burden treated in the real world.

Twenty years post‐NIH Revitalization Act: Enhancing minority participation in clinical trials (EMPaCT): Laying the groundwork for improving minority clinical trial accrual

“…This study based on the California Cancer Registry, the 1846 patients who enrolled in cancer clinical trials experienced a lower hazard of death in lung, colon, and breast cancer. 8 …”

“…7 Participating in most clinical trials offers benefits to patients such as the provision of the state-of-the-art care compared to a potentially more effective intervention and improved survival. 6,8 Appropriate participation of minorities in cancer clinical trials thus offers the prospects of generating new hypotheses that affect treatment, explore differences in responses to risk factors and treatment, and the access to potentially life-saving or life-prolonging therapies. 9 The purpose of this paper is to review the case for enhancing minority participation in cancer clinical trials.…”

Effective Recruitment Strategies and Community-Based Participatory Research: Community Networks Program Centers' Recruitment in Cancer Prevention Studies

“…Information on racial/ethnic minorities could very well lead to new discoveries of value to all populations (53). Because cancer research should offer cutting-edge prevention and treatment strategies to high-risk and vulnerable populations, there are ethical implications from not accruing racial/ethnic minorities to these trials in percentages reflective of their representation in the population (54). …”

Clinical impact of IMPORT HIGH trial (CRUK/06/003) on breast radiotherapy practices in the United Kingdom

“…2 The 32-page IMPORT HIGH planning pack prepared jointly by the RT QA group and trial TMG, detailed the trial requirements on volume delineation, RT planning, treatment delivery and verification and on how centres could adapt their local techniques to tackle these practical challenges. Chow et al 17 reported that clinical outcomes were improved in patients treated within clinical trials as compared with non-trial patients such that the percentage of patients included in a trial could be used as a quality indicator for a RT centre. Clearly, the simultaneous boost RT as under investigation within IMPORT HIGH has not been adopted as routine practice outside the trial because outcome measures are not yet mature.…”