1. Progression free survival demonstrates poor-correlation with measures of health related quality of life (HRQoL) in oncology trials.
2. Current study demonstrate poor follow-up and reporting of HRQoL measures, likely introducing bias into published results.
Evidence Rating Level:3 (Average)
Study Rundown: Current stated goals for the American Society of Clinical Oncology include the focus on patient-centered outcomes in oncology clinical trials. Established themes on the values of patients include overall-survival (OS) and HRQoL. Trials evaluating OS require large study populations, long-term follow-up, high expense, and added complexity if cross-over is allowed. Evaluation of surrogate markers including progression-free survival (PFS) has become more common, with many medications being approved based on this outcome. How PFS correlates with patient-centered outcomes such as HRQoL is unclear. The current study sought to evaluate the relationship between reported HRQoL and PFS in oncology trials. The study demonstrated poor correlation between HRQoL and PFS, but with a noted high probability of bias from the HRQoL results and poor follow-up of HRQoL outcomes.
The current study highlights the need for further investigation into HRQoL outcomes as a primary endpoint of drug development in oncology. The strength of the study include the large number of included studies. The main limitations of the study stem from the poorly reported HRQoL outcomes in many published studies resulting in high degree of bias.
In-Depth [systematic review]: This study was a systematic review of randomized trials of patients with cancer evaluating chemotherapy from 2000 to 2016. The study excluded trials without PFS or HRQoL outcomes reported.
The study included 52 trials involving 38 randomized trials of chemotherapy agents for cancer. There was no strong association between PFS and global HRQoL (slope of association 0.12, 95%CI, −0.27 to 0.52); physical HRQoL (−0.20, 95%CI, −0.62 to 0.23); or emotional HRQoL (0.78, 95%CI, −0.05 to 1.60). There was a high risk of bias in84% of trials reporting at least 1 health-related quality of life measure.
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