Patient-reported outcomes among patients with resected high-risk melanoma (AJCC7 IIIB, IIIC, M1a, M1b) randomized to low- or high-dose adjuvant Ipilimumab (ipi) versus high-dose interferon alfa-2b (HDI): Health-related quality of life (HRQL) analysis of ECOG-ACRIN E1609.

Abstract

e22078 Background: The primary objective of the patient-reported outcomes (PRO) study of E1609 patients (pts) was to compare overall HRQL among pts receiving ipi (ipi10, ipi3) or HDI. We hypothesized that ipi would be superior to HDI in HRQL. Secondary analyses compared HRQL and GI distress between ipi10 and ipi3. Methods: PROs were administered among pts enrolled from NCI Community Oncology Research Program (NCORP) sites at baseline, every 12 weeks (wks) during treatment, and every 24 wks off-treatment for one year. Differences between ipi arms and HDI in overall HRQL at 12 wks (completion of ipi induction) was defined a priori as the primary outcome. HRQL was assessed using the 27-item Functional Assessment of Cancer Therapy –General (FACT-G) total score. GI toxicity was a secondary outcome measured by the 11-item FACIT-Diarrhea (FACIT-D) scale. Two sample t-test was used to compare scores between arms. Results: 548 pts completed PROs at baseline and 334 at 12 wks. Among 322 (59%) pts with PRO data at both time points, mean FACT-G total change scores from baseline to 12 wks were significantly lower (indicating less decline in HRQL) among pts randomized to ipi10 (-4.9,SD:14.1) or ipi3 (-3.4 points,SD:13.2) vs. HDI (-12.9, SD:14.1), p < 0.05 for both ipi10 vs. HDI and ipi3 vs. HDI. Mean FACIT-D change scores indicated higher GI distress from baseline to 12 wks among pts randomized to ipi10 (-3.7, SD:6.9) or ipi3 (-2.2, SD:5.1) vs HDI (-0.7, SD:2.7), p < 0.05 for both comparisons. In comparing ipi10 to ipi3, FACT-G total and FACIT-D total change scores from baseline to wk 12 were comparable. Conclusions: Overall decline in HRQL from baseline to completion of ipi induction was less among pts receiving ipi compared to HDI. Pts randomized to ipi reported a greater increase in diarrhea compared to HDI. HRQL and diarrhea were comparable between ipi3 and ipi10. Our findings are based on PRO data, thus increase our confidence in capturing pts’ experience with treatment from the pt’s perspective. Clinical trial information: NCT01274338. [Table: see text]