Clinical Study

British Journal of Cancer (2007) 96, 1052–1056. doi:10.1038/sj.bjc.6603683 www.bjcancer.com
Published online 13 March 2007

Mitomycin C and Vinorelbine for second-line chemotherapy in NSCLC – a phase II trial

A Babiak1,4,5, J Hetzel1,4,6, F Godde1, H-H König2, M Pietsch3 and M Hetzel1,5

  1. 1Department of Internal Medicine II, Division of Pulmonary Medicine, University Medical Center, Ulm, Germany
  2. 2Health Economics Research Unit, University of Leipzig, Leipzig, Germany
  3. 3Medac, Wedel, Germany

Correspondence: PD Dr M Hetzel, E-mail: martin.hetzel@rkk-stuttgart.de

4These authors contributed equally to this work.

5Current address: Red Cross Hospital, Clinic of Pulmonary Medicine, Bad St 35-37, 70372 Stuttgart, Germany.

6Current address: Heidenheim Hospital, Department of Internal Medicine – Pulmonary Medicine, Schlosshausstrasse 100, 89522 Heidenheim, Germany.

Received 23 November 2006; Revised 12 February 2007; Accepted 12 February 2007; Published online 13 March 2007.

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Abstract

Single-agent therapy with Docetaxel or Pemetrexed is the current therapy of choice for second-line treatment in advanced non-small-cell lung cancer (NSCLC). The role of older agents was underattended over the last years. This study presents the combination of Mitomycin C and Vinorelbine in pretreated patients. Forty-two patients (stage IIIB and IV, pretreated with platinum-based chemotherapy) received 8 mg m-2 Mitomycin C on day 1 and 25 mg m-2 Vinorelbine on days 1 and 8 of a 28-day cycle. End points were objective tumour response, survival, and toxicity. Additionally, quality of life (QoL) was assessed. Five patients (11.9 %) achieved partial responses and 13 patients (31.9%) stable disease. Progression-free survival was 16 weeks. The median overall survival was 8.5 month. Eleven patients (26.2 %) suffered from grade 3 or 4 neutropenia and four patients (9.52%) from grade 3 or 4 anaemia. Evaluation of QoL showed that some items ameliorated during therapy. The therapeutic concept including Mitomycin C and Vinorelbine offers an efficacious and well-tolerated regimen, with relatively low toxicity. Objective response and survival data correlate with other second-line studies using different medication. As costs of Mitomycin C and Vinorelbine are lower compared with current drugs of choice, this regimen is likely to be cost-saving.

Keywords:

lung cancer, NSCLC, chemotherapy, second-line therapy, mitomycin, Vinorelbine