作者: Hideyuki Akaza , Seiji Naito , Naomi Ueno , Kouji Aoki , Hiroyuki Houzawa
DOI: 10.1093/JJCO/HYV045
关键词:
摘要: Objective: This prospective, post-marketing study collected sunitinib safety and efficacy data in Japanese patients with unresectable/metastatic renal cell carcinoma. Retrospective analysis investigated adverse events as potential biomarkers. Methods: Patients administered sunitinib, after its release, were registered until reaching a pre-specified number of cases. Primary starting dose was 50 mg/day orally on 4-weeks-on 2-weeks-off schedule. Physicians completed investigation forms at 6-week intervals for 24 weeks. Associations between baseline characteristics analyzed by Cox proportional hazards model compared χ 2 test. The log-rank test survival subpopulations based selected factors. Results: Of note, 1689 receiving June 2008 November 2009. Most them males (75%), aged <65 years (56%), had Eastern Cooperative Oncology Group performance status 0/1 (90%), metastatic disease (88%) previous systemic therapy (66%). Grade ≥3 occurred 70%, reduced platelet count the most common (34%). Characteristics significantly associated female sex, age ≥55 years, ≥2, history several medical conditions prior treatment. Objective response rate 22%. Median progression-free 22.7 overall not reached; however, 24-weekoverall ratewas 84%. Improved higher relative intensity during first 6 weeks specific events: hypertension, hand–foot syndrome, hypothyroidism, leukopenia thrombocytopenia. Conclusions: Sunitinib demonstrated acceptable useful Potential biomarkers greater events.