Annals of Oncology 11:673-678, 2000
© 2000 European Society for Medical Oncology
research-article |
Multicenter phase II trial of docetaxel and carboplatin in patients with stage IIIB and IV non-small-cell lung cancer
1University ofPittsburgh Cancer Institute Pittsburgh, Pennsylvania
2Albert Einstein College of Medicine Bronx, New York
3Rush-Presbyterian Medical Center Chicago, Illinois
4Baptist Medical Center Knoxville, Tennessee
5Aventis Pharmaceuticals, Inc., Collegeville Pennsylvania, USA
Correspondence to: C. P. Belani, MD, University of Pittsburgh Cancer Institute, Medical Oncology, MUH N-725, 200 Lothrop Street, Pittsburgh. PA 15213, USA
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.
carboplatin, docetaxel, non-small-cell lung cancer
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