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).
RELATED: Bevacizumab, IFN Show Similar Efficacy in Neuroendocrine Tumors
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.”