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Phase II Evaluation of Docetaxel-Modulated Capecitabine in Previously Treated Patients with Non–Small Cell Lung Cancer

¹ Division of Hematology/Oncology, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute; ² Department of Pathology, Ohio State University Medical Center, Columbus, Ohio; and ³ Department of Pharmacology and Toxicology, University of Alabama, Birmingham, Alabama

Requests for reprints: Miguel A. Villalona-Calero, Arthur G. James Cancer Hospital, Ohio State University, B406 Starling-Loving Hall, 320 West Tenth Avenue, Columbus, OH 43210-1240. Phone: 614-293-7511; Fax: 614-293-7529; E-mail: villalona-1{at}medctr.osu.edu.

Purpose: Based on the preclinical observation of upregulation of thymidine phosphorylase, the last enzymatic step in the conversion of capecitabine to 5-fluorouracil, by docetaxel along with good clinical tolerability of the combination of docetaxel and capecitabine using an optimized schedule in a previous phase I trial, we conducted this phase II study of this combination in patients with refractory or relapsed non–small cell lung cancer (NSCLC).

Patients and Methods: Patients with NSCLC previously treated with at least one platinum- or paclitaxel-based regimen received docetaxel 36 mg/m² on days 1, 8, and 15 and capecitabine 625 mg/m² twice daily on days 5 to 18, every 4 weeks. The primary objective of the study was evaluation of progression-free survival (PFS) 26 weeks from initiation of treatment.

Results: Thirty-six evaluable patients received 104 cycles of the combination. Severe toxicities were infrequent with only one patient requiring toxicity-related hospitalization. The 26-week PFS rate was 25% (95% confidence interval, 12-42) with an intent to treat median survival and 1-year survival rate of 9.1 months and 37%, respectively. Among 31 patients with measurable disease (Response Evaluation Criteria in Solid Tumors criteria), eight (26%; 95% confidence interval, 12-45) achieved partial responses.

Conclusion: The combination of capecitabine and weekly docetaxel is well tolerated in previously treated patients with NSCLC. The relatively high 26-week PFS and 1-year survival, as well as the high response rate observed, encourages further evaluation of this regimen in NSCLC, either in randomized trials for refractory patients or as a potential treatment option for chemotherapy naive patients.

Key Words: thymidine phosphorylase • fluoropyrimidines • taxanes • thymidylate synthase • upregulation

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				J. J. Lee, J.-Y. Han, D. H. Lee, H. Y. Kim, J. H. Chun, H. G. Lee, S. M. Yoon, S. Y. Lee, and J. S. Lee A Phase II Trial of Docetaxel Plus Capecitabine in Patients with Previously Treated Non-Small Cell Lung Cancer Jpn. J. Clin. Oncol., December 1, 2006; 36(12): 761 - 767. [Abstract] [Full Text] [PDF]