Many reports of cancer drug trials frame quality of life (QOL) outcomes in an inaccurate or misleading way, according to research published in JAMA Oncology.
Researchers found favorable reports of QOL outcomes for roughly half of trials that actually showed no improvement in QOL.
The researchers conducted this study to investigate how unchanged or detrimental QOL outcomes are reported in trial publications and whether trials that show improvement in overall survival (OS) or progression-free survival (PFS) also show improvements in global QOL.
The study included 45 phase 3 randomized clinical trials of cancer drugs reporting QOL data. The trials included a total of 24,806 patients — 13,368 in experimental arms and 11,438 in control arms.
The most common tumor types were lung (16%), ovarian (13%), and breast (11%). Targeted therapies were the most commonly used treatment type (47%), followed by cytotoxic drugs (27%) and immunotherapies (16%). A majority of trials (76%) received industry funding, and 51% were double-blind, placebo-controlled trials.
There were 11 trials showing superior QOL with the experimental arm, 6 trials showing inferior QOL with the experimental arm, and 28 trials showing unchanged QOL.
The researchers found that trials with improved QOL were more likely than those without improved QOL to show improved OS — 64% and 29%, respectively (P =.04). The same was not true for PFS — 55% and 50%, respectively (P =.87).
QOL outcomes differed according to the type of cancer therapy. Superior QOL was reported in 54% of trials of immunotherapy drugs, and inferior QOL was observed in 50% of trials of targeted drugs (P =.002).
The researchers noted that, for 50% of trials with inferior QOL outcomes (3/6), the published article “seemed to downplay those outcomes.” For the 28 trials with unchanged QOL outcomes, 46% of the articles appeared to frame QOL outcomes in a positive light.
So, of the 34 trial reports showing inferior or unchanged QOL, 47% reported QOL outcomes favorably, according to the researchers. They noted that industry-funded trials were associated with favorable reporting of QOL.
“[T]he downplaying of inferior QOL outcomes or portraying lack of improvement in QOL as ‘not worse’ is concerning,” the researchers wrote. “Stakeholders of QOL research, such as physicians, patients, regulators, and payers, must be aware of these issues to interpret QOL data from cancer drug trials accurately and meaningfully.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Samuel JN, Booth CM, Eisenhauer E, et al. Association of quality-of-life outcomes in cancer drug trials with survival outcomes and drug class. JAMA Oncol. Published online April 28, 2022. doi:10.1001/jamaoncol.2022.0864.