Median PFS was 12.6 months in the sunitinib group as compared with 5.8 months in the placebo group (HR for progression or death, 0.32; 95% CI, 0.18 to 0.55; P<0.001). The ORR was 9.3% in the sunitinib group versus 0% in the placebo group.r The median OS was 38.6 months for the sunitinib group and 29.1 months for placebo (HR for death 0.73; 95% CI, 0.50 to 1.05; P=0.09) with 69% of placebo patients having crossed over to sunitinib.r
Kaplan-Meier Analysis of Progression-free Survival based on investigator-assessment (INV) versus blinded independence central review (BICR).r
Asterisk indicates sunitinib versus placebo.
© Ann Oncol 2017
Kaplan-Meier Analysis of Overall Survival in the Intention-to-Treat Populationr
© Ann Oncol 2017
The self-administered European Organisation for Research and Treatment of Cancer (EORTC) quality-of-life questionnaire (QLQ-C30, version 3.0) was used to measure patient-reported outcomes. A post-hoc analysis of patient-reported outcomes found that patients in the sunitinib arm had overall clinically and statistically significant worsening of diarrhoea (p < 0.001). In this arm there was also a significant trend towards worsening of insomnia (p = 0.04) vs placebo. However, in QoL, cognitive, emotional, physical, role, and social functioning domains and other symptoms and scales, there were no overall clinically or statistically significant differences.r
The results of a phase IV open-labelled trial conducted in support of phase III study, confirmed initial data. Sixty-one treatment-naive and 45 previously treated patients with advanced/metastatic, well-differentiated, unresectable pancreatic neuroendocrine tumours received sunitinib 37.5 mg per day. Median treatment duration was 11.7 months. Median PFS was 13.2 months (95% CI, 10.9 to 16.7): 13.2 (95% CI, 7.4 to 16.8) in treatment-naive and 13.0 (95% CI, 9.2 to 20.4) in previously treated patients. ORR was 24.5% (95% CI, 16.7 to 33.8) in the total population: 21.3% (95% CI, 11.9 to 33.7) in treatment-naive and 28.9% (95% CI, 16.4 to 44.3) in previously treated patients. Median OS, although not yet mature, was 37.8 months (95% CI, 33.0 to not estimable).r