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Annals of Oncology 15:915-920, 2004
© 2004 European Society for Medical Oncology

Original Paper

A phase II study of oxaliplatin and paclitaxel in patients with advanced non-small-cell lung cancer

Received 19 May 2003; revised 19 December 2003; accepted 29 January 2004

Purpose:

To evaluate the efficacy and toxicity of oxaliplatin and paclitaxel as first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC).

Patients and methods:

The treatment regimen was given as defined in a phase I investigation in patients with previously treated ovarian cancer. It consisted of paclitaxel 175 mg/m2 (1-h infusion) and oxaliplatin 130 mg/m2 (2-h infusion) given every 21 days. Eligible patients had stage IIIB (pleural effusion)/IV NSCLC, measurable disease, no prior chemotherapy, Eastern Cooperative Oncology Group performance status 0–2, and adequate hematological, renal and hepatic function.

Results:

A total of 38 patients were enrolled with the following characteristics: 29% male (n = 11); 71% female (n = 27); median age 64.5 years (range 37–78); performance status of 0–1 84% (n = 32); stage IIIB 8% (n = 3); stage IV 92% (n = 35). One hundred and eighty-one cycles were administered, with a median of four per patient (range one to 12). The overall objective response rate for all 38 patients was 34.2% [95% confidence interval (CI) 19.6% to 51.4%]. This response rate includes 13 patients who met criteria for a partial response. No complete responses were observed. Median overall survival time was 9.2 months (95% CI 6–12.4) and median progression-free survival time was 4.3 months (95% CI 2.1–6.5). The 1- and 2-year overall survival rates were 37% and 21%, respectively. Hematological toxicity included six patients with grade 4 neutropenia. Non-hematological toxicity consisted mainly of grades 1 and 2 neurosensory toxicity. Laryngodysesthesia was observed in two patients following oxaliplatin infusion. No grade 4 non-hematological toxicities were encountered.

Conclusion:

This regimen is well tolerated, and demonstrates activity in patients with advanced NSCLC.

J. D. Winegarden1, A. M. Mauer1,*, G. A. Otterson2, C. M. Rudin1, M. A. Villalona-Calero2, V. J. Lanzotti2, L. Szeto1, K. Kasza1, P. C. Hoffman1 and E. E. Vokes1

1 University of Chicago Section of Hematology/Oncology and University of Chicago Cancer Research Center, Chicago, IL; 2 The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA

Key words: non-small-cell lung cancer, oxaliplatin, paclitaxel


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