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  • Phase II study with fractio...
    Kwon, Jung Hye; Kim, Jung Han; Lee, Jung-Ae; Shin, Hyun Chun; Kim, Hyo Jung; Song, Hun Ho; Jung, Joo Young; Kim, Ho Young; Choi, Dae Ro; Kim, Hyeong Su; Park, Young-iee; Zang, Dae Young

    Cancer chemotherapy and pharmacology, 10/2010, Volume: 66, Issue: 5
    Journal Article

    Background Docetaxel and cisplatin combination chemotherapy is established first-line chemotherapy for advanced non-small cell lung cancer (NSCLC). We evaluated a weekly schedule of docetaxel and cisplatin for efficacy and tolerability in patients with chemotherapy-naive NSCLC. Methods Patients enrolled in this study had stage IIIB or IV NSCLC with measurable disease, no prior chemotherapy, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2. Treatment consisted of docetaxel 40 mg/m² and cisplatin 35 mg/m² given on D1 and D8 every 3 weeks. Patients were evaluated for response after every 2 cycles of treatment. Results Thirty six patients were enrolled, and 35 underwent treatment. Of these, 29 were males and 7 females, median age was 61 years (range, 38-68). About 31 patients had ECOG PS 0-1 and 4 patients had ECOG PS 2. Fifty seven percentage (20/35) of patients had adenocarcinoma and 74.3% (26/35) had stage IV disease. A total of 153 cycles of chemotherapy were administered. Of the 35 patients treated, 17 (48.6%) achieved partial response, 11 (31.4%) showed stable disease, and 6 (17.1%) had progressive disease. Median duration of response was 5.3 months (95% CI: 4.2-6.2 months), and median time to disease progression was 4.6 months (95% CI: 2.9-6.3 months). Estimated overall survival at 1 year was 65.7%. The major hematologic toxicity was myelosuppression. Grade 3 or 4 anemia occurred in 6 cycles, and grade 3 or 4 neutropenia was observed in four cycles. Major non-hematologic toxicities were grade 3 nausea in three patients and grade 3 fatigue in two patients. Three patients developed pneumonia and one patient had infectious colitis. There were no treatment-related deaths in this study. Conclusions Weekly schedule of docetaxel and cisplatin as first-line treatment for NSCLC had good efficacy and manageable toxicity.