Everolimus may delay disease progression while sustaining health-related quality of life (HRQOL) in patients with advanced, non-functional, gastrointestinal or lung neuroendocrine tumors (NETs), according to a study published in The Lancet Oncology.1
Researchers for the phase 3 RADIANT-4 trial (ClinicalTrials.gov Identifier: NCT01524783) randomly assigned over 300 patients 2:1 to receive oral everolimus 10 mg once daily or placebo, and disease progression was assessed every 8 weeks for 1 year, then every 3 months until disease progression or new antineoplastic therapy.
A previous analysis demonstrated that everolimus prolonged progression-free survival ― the primary endpoint of the study ― compared to placebo.
For the secondary outcome, study authors investigated the effects of everolimus on HRQOL as assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire. The prespecified secondary outcome measure was time to definitive deterioration by at least 7 points on the FACT-G total score.
At baseline, 94% (193 of 205) and 98% (95 of 97) of patients in the everolimus group and placebo group, respectively, had completed the FACT-G questionnaire. By week 48, 83% (70 of 84) and 85% (22 of 26) of patients reported their FACT-G scores.
Median time to definitive deterioration in FACT-G score was 11.27 months (95% CI, 9.27-19.35) with everolimus vs 9.23 months (95% CI, 5.52-not estimable) with placebo (adjusted hazard ratio [AHR], 0.81; 95% CI, 0.55-1.21; P = 0.31).
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The authors concluded that “everolimus delays disease progression while preserving overall HRQOL, even with the usual toxic effects related to active targeted drug treatment for cancer.”
- Pavel ME, Singh S, Strosberg JR, et al. Health-related quality of life for everolimus versus placebo in patients with advanced, non-functional, well-differentiated gastrointestinal or lung neuroendocrine tumours (RADIANT-4): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Aug 21. [Epub ahead of print] doi: 10.1016/S1470-2045(17)30471-0