Phase II study of docetaxel and cisplatin combination chemotherapy in metastatic or unresectable localized non-small-cell lung cancer

Y. H. Kim, J. S. Kim, Y. H. Choi, K. H. In, H. S. Park, D. S. Hong, T. J. Jeong, Y. Y. Lee, E. Nam, S. N. Lee, K. S. Lee, H. K. Kim

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19 Scopus citations


Background. Docetaxel is highly active in the second-line treatment of patients with metastatic or unresectable locally advanced nonsmall-cell lung cancer (NSCLC). As there is a need for first-line chemotherapy that is more effective than standard platinum-based chemotherapy, this study was undertaken to evaluate the efficacy and tolerability of a docetaxel/cisplatin combination as first-line chemotherapy in advanced NSCLC. Methods. Newly diagnosed, chemotherapy-naive patients with histologically confirmed NSCLC (measurable stage IIIB/IV NSCLC; Karnofsky performance status, 70-100; adequate bone marrow, renal, hepatic, and cardiac function) were eligible for the study. Docetaxel 75mg/m2 was administered IV over 1 h, followed immediately by cisplatin 75mg/m2, given IV over 30min, with cycles repeated every 3 weeks, for up to six or nine cycles. Results. Thirty-nine patients were enrolled and treated. Their median age was 59 years (range, 32-71 years) and median performance status, 90 (range, 70-100). Histologically, 23 patients (59%) had adenocarcinoma, 12 (30.8%) had squamous cell carcinoma, and 16 patients (41%) had stage IV disease. Thirty-seven patients were eligible for inclusion. In the 39 patients evaluable for safety, significant grade 3/4 toxicities included neutropenia (82%), nausea (10.3%), fatigue (10.3%), and diarrhea (7.7%). Of the 33 patients evaluable for response, 16 patients (48.5%) achieved a partial response and 7 showed progressive disease. Median overall survival time in all eligible patients was 10.5 months. Conclusion. Docetaxel/cisplatin produced promising response rates that compare favorably with those of current standard platinum combinations, with manageable toxicity. Further investigations of this first-line combination in NSCLC are warranted.

Original languageEnglish
Pages (from-to)114-119
Number of pages6
JournalInternational Journal of Clinical Oncology
Issue number2
StatePublished - 2002


  • Chemotherapy-naive patients
  • Cisplatin
  • Docetaxel
  • Non-small-cell lung cancer


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