Clinical Study

British Journal of Cancer (2005) 93, 29–34. doi:10.1038/sj.bjc.6602667 www.bjcancer.com
Published online 14 June 2005

Phase II study of gemcitabine plus oxaliplatin as first-line chemotherapy for advanced non-small-cell lung cancer

F Cappuzzo1, S Novello2, F De Marinis3, V Franciosi4, M Maur5, A Ceribelli6, V Lorusso7, F Barbieri5, L Castaldini1, E Crucitta8, L Marini8, S Bartolini1, G V Scagliotti2 and L Crinò1

  1. 1Division of Medical Oncology, Bellaria Hospital, Bologna, Via Altura 3, 40139 Bologna, Italy
  2. 2Division of Pneumology, S Luigi Gonzaga Hospital, Regione Gonzole 10, 10043 Orbassano, Italy
  3. 3Pulmonary-Oncology Unit, Forlanini Hospital, Piazza Carlo Forlanini 1, 00151 Rome, Italy
  4. 4Division of Medical Oncology, Azienda Ospedaliera di Parma, Via Gramsci 14, 43100 Parma, Italy
  5. 5Division of Medical Oncology, Policlinico di Modena, Via Del Pozzo, 71, 41100 Modena, Italy
  6. 6Department of Medical Oncology A, Regina Elena Cancer Institute, Istituto Regina Elena 291, 00161 Rome, Italy
  7. 7Operative Unit of Medical Oncology, Oncology Institute of Bari, Via Samuele Hahnemann, 209 Bari, Italy
  8. 8Medical Division, Eli Lilly, Via Gramsci 731, 50019 Sesto Fiorentino, Florence, Italy

Correspondence: Dr F Cappuzzo, E-mail: federico.cappuzzo@ausl.bo.it

Received 8 April 2005; Revised 16 May 2005; Accepted 16 May 2005; Published online 14 June 2005.

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Abstract

This phase II study evaluated the response rate and tolerability of gemcitabine–oxaliplatin chemotherapy in non-small-cell lung cancer (NSCLC) patients. Chemonaive patients with stage IIIB or IV NSCLC received gemcitabine 1000 mg m-2 on days 1 and 8, followed by oxaliplatin 130 mg m-2 on day 1. Cycles were repeated every 21 days for up to six cycles. From February 2002 to May 2004, 60 patients were enrolled into the study in seven Italian institutions. We observed one complete response (1.7%) and 14 partial responses (23.3%), for an overall response rate of 25.0% (95% confidence interval, 14.7–37.9%). The median duration of response was 5.9 months (range 1.5–17.1 months). With a median follow-up of 6.7 months, median time to progressive disease and overall survival were 2.7 (range 1.9–3.4 months) and 7.3 months (range 7.2–8.6 months), respectively. The main grade 3–4 haematological toxicities were transient neutropenia in 11.7% and thrombocytopenia in 8.3% of the patients. Nausea/vomiting was the main grade 3–4 nonhaematological toxicity, occurring in 10.0% of the patients. Two (3.3%) patients developed grade 3 neurotoxicity. Our results show that gemcitabine–oxaliplatin chemotherapy is active and well tolerated in patients with advanced NSCLC, deserving further study, especially for patients not eligible to receive cisplatin.

Keywords:

oxaliplatin, gemcitabine, chemotherapy, non-small-cell lung cancer