Preliminary Result of Phase II Study of Paclitaxel and Cisplatin Chemotherapy for Advanced Non-Small-Cell Lung Cancer in Chinese Patients

Abstract

This phase II study was designed to assess the response rate and toxicity of paclitaxel and cisplatin chemotherapy in Chinese patients with untreated advanced non-small-cell lung cancer (NSCLC). Eligibility requirements included histologically confirmed stage IIIb-IV NSCLC, Eastern Cooperative Oncology Group performance status less than 2, no previous chemotherapy, and adequate bone marrow, renal, and hepatic function. From April 1996 through March 1997, 32 patients were treated. The dose of paclitaxel was 135 mg/m2 as a 3-hour infusion on day 1 and cisplatin 75 mg/m2 on day 2. The regimen was repeated every 3 to 4 weeks for up to 6 to 8 cycles unless there was evidence of tumor progression. The median age was 57 years (range, 31-77 years). Sixty-five percent were men. Sixty-nine percent had adenocarcinoma, and 75% had stage IV disease. One hundred seventy-two cycles were administrated; 18 patients (56%) completed all six cycles. Peripheral neuropathy and myelosuppression were the principle toxicities. Neurotoxicity appeared to be dose limiting and manifested primarily as paresthesia. Grade 2 neurotoxicity was observed in 5% of courses, which was slowly reversible. However, the severity of myelosuppression was generally mild to moderate. No episode of neutropenic fever was noted. Thrombocytopenia remained infrequent throughout the study. Other nonhematologic toxicities were also generally mild. The objective response rate was 50%. In conclusion, this combination of paclitaxel and cisplatin is active in Chinese patients with advanced NSCLC. It merits further investigation in phase III trials.