No link between progression-free survival, quality of life in cancer trials
In clinical trials evaluating cancer interventions, there was no significant association between progression-free survival and health-related quality of life, according to research published in JAMA Internal Medicine.
“Progression-free survival has become a commonly used outcome to assess the efficacy of new cancer drugs,” Bruno Kovic, PhD, from McMaster University, Canada, and colleagues wrote. “However, it is not clear if delay in progression leads to improved quality of life with or without overall survival benefit.”
Kovic and colleagues performed a systematic review and quantitative analysis of 38 randomized controlled trials to examine how progression-free survival and health-related quality of life in oncology are associated.
The trials included in the analysis evaluated oral, IV, intraperitoneal or intrapleural chemotherapy or biological treatments for 12 different cancer types in relation to progression-free survival or health-related quality of life. The cancer types assessed included breast cancer, non-small cell lung cancer, melanoma, multiple myeloma, pancreatic adenocarcinoma, prostate cancer, renal cell carcinoma, gastrointestinal cancers and gynecological cancers.
The researchers found that there was a mean difference in median progression-free survival between the intervention and the control groups of 1.91 months.
For the global domain, the mean differences in change of health-related quality of life adjusted to per-month values was –0.39. Additionally, the mean differences were 0.26 for the physical domain and 1.08 for the emotional domain.
For global health-related quality of life, the slope of the association between the difference in median progression-free survival and the difference in change was 0.12 (95% CI, –0.27 to 0.52). the slope of the association between the difference in median progression-free survival and the difference in change was –0.2 (95% CI, –0.62 to 0.23) for physical health-related quality of life and 0.78 (95% CI, –0.05 to 1.6) for emotional health-related quality of life.
“The present systematic review and quantitative analysis failed to find a significant association between progression-free survival and health-related quality of life in oncology randomized controlled trials,” Kovic and colleagues concluded. “This finding challenges the use of progression-free survival as the primary efficacy endpoint in oncology trials. The results suggest that optimally meeting the needs of cancer patients requires trials that are adequately powered for overall survival, and/or designed to ensure rigorous and trustworthy measurement of health-related quality of life.” – by Alaina Tedesco
Disclosure: The authors report no relevant financial disclosures.