Safety, efficacy and prognostic analyses of sunitinib in the post-marketing surveillance study of Japanese patients with gastrointestinal stromal tumor

• Published in: Japanese journal of clinical oncology 2015-11, Vol.45 (11), p.1016-1022
• Main Authors: Komatsu, Yoshito, Ohki, Emiko, Ueno, Naomi, Yoshida, Ai, Toyoshima, Yasuharu, Ueda, Eiji, Houzawa, Hiroyuki, Togo, Kanae, Nishida, Toshirou
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Asian Continental Ancestry Group - statistics & numerical data; Disease-Free Survival; Female; Gastrointestinal Neoplasms - drug therapy; Gastrointestinal Stromal Tumors - drug therapy; Hand-Foot Syndrome - epidemiology; Hand-Foot Syndrome - etiology; Humans; Incidence; Indoles - administration & dosage; Indoles - adverse effects; Indoles - therapeutic use; Japan - epidemiology; Male; Middle Aged; Neutropenia - chemically induced; Neutropenia - epidemiology; Original; Prognosis; Proportional Hazards Models; Pyrroles - administration & dosage; Pyrroles - adverse effects; Pyrroles - therapeutic use; Severity of Illness Index; Thrombocytopenia - chemically induced; Thrombocytopenia - epidemiology; Treatment Outcome
• ISSN: 0368-2811; 1465-3621
• DOI: 10.1093/jjco/hyv126

This study was conducted to expand the sunitinib safety database in Japanese imatinib-resistant/-intolerant gastrointestinal stromal tumor patients. Retrospective analyses investigated common adverse events as potential prognostic markers. Four hundred and seventy patients who received sunitinib between June 2008 and November 2009 were analyzed for safety, progression-free survival and overall survival; 386 for objective response rate; 88% received sunitinib on Schedule 4/2 starting at 50 mg/day. No unexpected safety issues occurred. Grade ≥ 3 adverse events occurred in 70%, most commonly thrombocytopenia (33%), neutropenia (22%) and leukopenia (15%). Objective response rate was 20% (95% confidence interval 16-24). Median progression-free survival was 22.4 weeks (95% confidence interval, 21.7-24.0). The overall survival rate at 24 weeks was 91% (95% confidence interval, 88-94). Higher relative dose intensity (≥70 vs.