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Annals of Oncology 14:449-454, 2003
© 2003 European Society for Medical Oncology

Original Paper

Docetaxel and carboplatin is an active regimen in advanced non-small-cell lung cancer: a phase II study in Caucasian and Asian patients

M. J. Millward1,3,+, M. J. Boyer1, M. Lehnert2, S. Clarke1, D. Rischin3, B.-C. Goh2, J. Wong2, E. McNeil1 and J. F. Bishop1

1 Cancer Therapeutics Research Group, Sydney Cancer Centre, Sydney, Australia; 2 Cancer Therapeutics Research Group, National University Hospital, Singapore; 3 Peter MacCallum Cancer Institute, Melbourne, Australia

Received 21 May 2002; revised 12 November 2002; accepted 21 November 2002

Background:

The purpose of this study was to report response rates, survival and toxicity in advanced non-small-cell lung cancer (NSCLC) following docetaxel and carboplatin, and to explore potential differences in these end points between Caucasian and Asian patients.

Patients and methods:

Sixty-eight patients of good performance status with Stage IIIB or IV NSCLC were entered on a phase II study at three sites in Australia and Singapore. Docetaxel 75 mg/m2 and carboplatin AUC 6 were given every 3 weeks. Response to treatment and toxicity were graded by standard criteria. The Kaplan–Meier method was used to estimate survival rates, and subgroups compared by the log-rank test. Cox’s proportional hazards regression was used to determine which potentially explanatory variables independently affected the outcome.

Results:

The response rate was 39% (95% confidence interval 27% to 52%), and 42% in evaluable patients. Response occurred in 65% of Asian and 31% of Caucasian patients (P = 0.01). Ethnicity was the only significant predictor of response in multivariate analysis. The 1-year survival rate was 53%. Performance status (P = 0.021), ethnicity (P = 0.035) and presence of bone or liver metastases (P = 0.011) were independent predictors of overall survival. Neutropenia (grade IV in 73% of patients), febrile neutropenia (26% patients) and diarrhea (grade III/IV in 11% of patients) were the major treatment related toxicities. A high rate (three of six) of febrile neutropenia in Singapore, including one treatment-related death in the initial patients treated, resulted in a reduction in the carboplatin dose to AUC 4.5 at that site.

Conclusions:

This regimen is active in advanced NSCLC. The potential impact of ethnicity on efficacy and toxicity of treatment requires further investigation.

Key words: docetaxel, ethnicity, non-small-cell lung cancer


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