Multicenter phase II trial of docetaxel and carboplatin in patients with stage IIIB and IV non-small-cell lung cancer

C. P. Belani, A. Einzig, P. Bonomi, T. Dobbs, M. J. Capozzoli, R. Earhart, L. J. Cohen, J. D. Luketich

Research output: Contribution to journalArticle

45 Scopus citations

Abstract

Purpose: To evaluate the safety and efficacy of docetaxel and carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC). Patients and methods: In this multicenter, phase II trial, 33 patients with previously untreated stage IIIB (n = 8) or IV (n = 25) NSCLC received intravenous infusions of docetaxel 80 mg/m2 followed immediately by carboplatin dosed to AUC of 6 mg/ml/min (Calvert's formula) every three weeks. Patients also received dexamethasone 8 mg orally twice daily for three days beginning one day before each docetaxel treatment. Filgrastim was not allowed during the first cycle and was added only if a patient experienced febrile neutropenia or grade 4 neutropenia lasting ≥ 7 days. Results: There were 1 complete and 11 partial responses for an objective response rate of 43% (95% CI: 24%-63%) in 28 evaluable patients and 36% (95% CI: 20%-55%) in the intent-to-treat population. The median duration of response was 5.5 months (range 3.0-12.5 months). The median survival was 13.9 months (range 1-35+ months); one-year survival was 52%. The most common toxicity was hematologic, which included grade 4 neutropenia (79% of patients and 7% percent of cycles) and febrile neutropenia (15% of patients); there were no episodes of grade 3 or 4 infection. The most common severe nonhematologic toxicities were asthenia (24%) and myalgia (12%); there were no grade 3 or 4 neurologic effects. Conclusions: The combination of docetaxel and carboplatin has an acceptable toxicity profile and is active in the treatment of previously untreated patients with advanced NSCLC. This combination is being evaluated in a randomized phase III trial involving patients with advanced and metastatic NSCLC.

Original languageEnglish (US)
Pages (from-to)673-678
Number of pages6
JournalAnnals of Oncology
Volume11
Issue number6
DOIs
StatePublished - Nov 15 2000

Keywords

  • Carboplatin
  • Docetaxel
  • Non-small-cell lung cancer

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Belani, C. P., Einzig, A., Bonomi, P., Dobbs, T., Capozzoli, M. J., Earhart, R., Cohen, L. J., & Luketich, J. D. (2000). Multicenter phase II trial of docetaxel and carboplatin in patients with stage IIIB and IV non-small-cell lung cancer. Annals of Oncology, 11(6), 673-678. https://doi.org/10.1023/A:1008342116536