Study design and treatment
toxicities, proteinuria, hemoptysis, Cancer
ONCOLOGY, THORACIC, S; HEMOGLOBIN, CANCER
Patients received induction chemotherapy of cisplatin (75 mg/mThe criteria to start maintenance therapy included: PS 0 or 1; neutrophil count ≥1500/μL; hemoglobin ≥8.0 g/dL; platelet count ≥7.5 × 10Administration of maintenance therapies was suspended if any of the following occurred: neutrophil count <1500/μL; platelet count <75,000/μL; hemoglobin <8.0 g/dL; total serum bilirubin >2.0 mg/dL; AST and ALT >100 IU/L; serum creatinine >1.5 mg/dL; or Grade 3 non‐hematological toxicities. Administration of only bevacizumab was suspended if there was active hemoptysis or proteinuria ≥2+. When these conditions improved, maintenance therapies were resumed.This randomized, Phase II study was registered with the UMIN Clinical Trials Registry (number UMIN000010681). The present study protocol was approved by the ethics committees of Tochigi Cancer Center and all participating centers. The present study was conducted in accordance with the Declaration of Helsinki. All patients provided their written, informed consent according to the protocol before study entry. Patients were recruited at 19 investigational sites of the Thoracic Oncology Research Group (TORG) in Japan.