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

J. D. Winegarden, A. M. Mauer, G. A. Otterson, C. M. Rudin, M. A. Villalona-Calero, V. J. Lanzotti, L. Szeto, K. Kasza, P. C. Hoffman, E. E. Vokes

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)915-920
Number of pages6
JournalAnnals of Oncology
Issue number6
StatePublished - Jun 2004
Externally publishedYes


  • Non-small-cell lung cancer
  • Oxaliplatin
  • Paclitaxel

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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