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Annals of Oncology Advance Access published online on April 2, 2008
Annals of Oncology, doi:10.1093/annonc/mdn122
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

A phase II multicenter study of oxaliplatin in combination with paclitaxel in poor prognosis patients who failed cisplatin-based chemotherapy for germ-cell tumors

C. Theodore1,*, C. Chevreau2, Y. Yataqhene3, K. Fizazi1, J.-P. Delord2, J.-P. Lotz4, L. Geoffrois5, P. Kerbrat6, V. Bui7 and A. Flechon8

1 Department of Medicine, Institut Gustave Roussy, Villejuif
2 Department of Medicine, Institut Claudius Regaud, Toulouse
3 Department of Oncology, Sanofi aventis pharmaceuticals Paris
4 Department of Medicine, Hopital Tenon, Paris
5 Department of Oncology, Centre Alexis Vautrin, Nancy
6 Department of Medicine, Centre Eugène. Marquis, Rennes
7 Department of Medicine, Institut Bergoniè, Bordeaux
8 Department of Medicine, Centre. Léon Bérard, Lyon, France

* Correspondence to: Dr C. A. Theodore, Institut Gustave Roussy—Medecine, rue camille desmoulins, Villejuif 94800, France. Tel: +33-142114898; Fax: +33-142115238; E-mail: c.theodore{at}hopital-foch.org

Background: The aim of this study is to determine feasibility and efficacy of the combination regimen oxaliplatin and paclitaxel in patients with cisplatin (CDDP)-refractory germ-cell tumors (GCT).

Patients and methods: Patients with either a cisplatin absolute-refractory GCT defined as progressive disease (PD) during or within 1 month of CDDP administration or with a poor prognosis relapse, defined as PD between the second and the sixth month after CDDP administration, were treated with a combination of oxaliplatin (130 mg/m2) and paclitaxel (175 mg/m2) administered every 21 days. Primary end point was efficacy.

Results: Twenty-seven patients were included. Patients were pretreated with a median of two lines of cisplatin-based chemotherapy (range 1–5). Sixteen patients were absolute refractory. Five patients had relapsed after high-dose chemotherapy plus stem-cell support. There were no complete responses but there was one marker-positive partial response and nine disease stabilization (34, 6%). After a median follow-up of 65 months, two patients are disease-free survivors. Main toxicity was leucocytopenia grade 3/4 in 30% of the patients.

Conclusion: Combination chemotherapy with oxaliplatin and paclitaxel is feasible with acceptable toxicity and may be effective if combined with additional treatment in patients with CDDP-refractory GCT.

cisplatin refractory, germ-cell tumors, oxaliplatin, paclitaxel

Received for publication January 6, 2008. Revision received February 28, 2008. Accepted for publication February 29, 2008.


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