Post-hoc analytical data of the randomized phase 3 SANET-ep trial indicate that multitargeted tyrosine kinase inhibitor surufatinib therapy was associated with maintenance of health-related quality of life (HRQoL) in previously treated patients with progressive, well-differentiated, advanced extrapancreatic neuroendocrine tumors (NETs).
The HRQoL results of the randomized, placebo-controlled phase 3 SANET-ep study (NCT02588170), demonstrating significant prolongation of progression-free survival (PFS) with surufatinib therapy compared with placebo in patients with progressive, well-differentiated, advanced extrapancreatic NETs, were reported at the 2020 American Society of Clinical Oncology Virtual Scientific Program.
Eligibility criteria of the SANET-ep study included patients with advanced, well-differentiated grade 1 or 2 extrapancreatic NETs with documented disease progression (DP) in the past 1 year, and progression on ≤2 types of systemic antitumor therapies. Eligible patients were randomized in a 2:1 ratio to receive oral surufatinib 300 mg once daily or placebo until DP or intolerable adverse events. The primary study end point was investigator-assessed PFS. Quality of life was an exploratory end point; post-hoc quality-of-life analysis was conducted in the intent-to-treat (ITT) population. Patient-reported outcome questionnaires, including the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ)-C30 and the QLQ-GINET21, were collected at baseline, on day 15 of the first cycle (28 days/cycle), on day 1 of every cycle thereafter, and at discontinuation. A retrospective analysis was done on time until definite deterioration (TUDD), defined as time from randomization to deterioration of 10 points in domain score compared with baseline score (without subsequent observations of deterioration of <10 points or any improvement compared with baseline score) or death resulting from any cause, and mean change from baseline (based on a longitudinal repeated measures analysis of each domain). Completion rate was defined as the proportion of patients in the ITT population who completed ≥1 scales of the QLQ-C30 questionnaire at each visit; compliance rate was defined as the proportion of patients who completed ≥1 scales of the QLQ-C30 questionnaire at each visit among those expected to complete the instruments at each visit.
At data cutoff (March 31, 2019), 198 patients were randomized (surufatinib, N = 129; placebo, N = 69); of these, 197 (99.5%) patients completed HRQoL questionnaires at baseline. The compliance rate was >90% for most on-treatment assessments. In the QLQ-C30 scales, TUDD was significantly longer in the dyspnea domain in the surufatinib arm compared with the placebo arm (hazard ratio [HR], 0.52; P = .0103); TUDD in the diarrhea domain was significantly shorter in the surufatinib arm compared with the placebo arm (HR, 2.68; P = .0074). In the GINET21 scales, TUDD in the social function domain was significantly longer for the surufatinib cohort versus the placebo cohort (HR, 0.58; P = .0222). No other significant differences of TUDD were observed in the remaining domains of QLQ-C30 and GINET21. In terms of the mean change of scores from baseline up to week 40, a significant increase in diarrhea was noted in the surufatinib cohort (increase of 14.0 points; 95% confidence interval [CI], 9.6-18.4) versus the placebo cohort (2.1 points; 95% CI, –4.1-8.3; P = .0007); no significant differences in other domains were observed between the 2 arms.
Based on these data, the authors concluded that surufatinib demonstrated superior efficacy and acceptable toxicity while maintaining HRQoL in previously treated patients with progressive, well-differentiated advanced extrapancreatic NETs.
Source: Bai C, et al. J Clin Oncol. 2020;38(15_suppl). Abstract 4613.