Simron Singh, MD
As reported in The Lancet Oncology by Pavel and colleagues, no significant difference in deterioration of health-related quality of life was observed with everolimus (Afinitor) vs placebo in the phase III RADIANT-4 trial, which included patients with advanced nonfunctional well-differentiated gastrointestinal or lung neuroendocrine tumors. RADIANT-4 showed prolonged progression-free survival with everolimus treatment. Simron Singh, MD, of the Sunnybrook Odette Cancer Center, Toronto, is the corresponding author of The Lancet Oncology article.
In the trial, 302 patients were randomized 2:1 to receive everolimus (n = 205) or placebo (n = 97). For the health-related quality-of-life study, patients were assessed with the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire at baseline, every 8 weeks for the first 12 months, and every 12 weeks thereafter until study drug discontinuation. The primary outcome measure, a prespecified secondary outcome of the trial, was time to definitive deterioration in FACT-G total score, defined as a reduction of ≥ 7 points.
Health-Related Quality-of-Life Outcomes
The FACT-G was completed by 94% of everolimus patients and 98% of placebo patients at baseline and by 70 of 84 everolimus patients (83%) and 22 of 26 placebo patients (85%) at week 48. Median time to definitive deterioration was 11.27 months in the everolimus group vs 9.23 months in the placebo group (adjusted hazard ratio [HR] = 0.81, P = .31). A post hoc analysis of FACT-G subscales showed a prolonged time to deterioration with everolimus on the emotional subscale (median 22.21 vs 17.64 months, P = .021) and no significant differences on the physical (13.63 vs 11.10 months, P = .958), social (23.03 vs not estimable, P = .182), and functional subscales (17.45 vs not estimable, P = .775).
The investigators concluded: “[Health-related quality of life] was maintained for patients with advanced, non-functional, gastrointestinal or lung [neuroendocrine tumors] with no relevant differences noted between the everolimus and placebo groups. In view of the previous RADIANT-4 findings of longer progression-free survival with everolimus, our findings suggest that everolimus delays disease progression while preserving overall [health-related quality of life], even with the usual toxic effects related to active targeted drug treatment for cancer.” ■