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Annals of Oncology Advance Access originally published online on March 12, 2007
Annals of Oncology 2007 18(5):925-930; doi:10.1093/annonc/mdm002
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© 2007 European Society for Medical Oncology

urogenital tumors

A phase II study using a topoisomerase I-based approach in patients with multiply relapsed germ-cell tumours

J Shamash*, T Powles, K Mutsvangwa, P Wilson, W Ansell, E Walsh, D Berney, J Stebbing and T Oliver

The Department of Medical Oncology, St Bartholomew's Hospital, London, UK

* Correspondence to: Dr J. Shamash, Department of Medical Oncology, St Bartholomew's Hospital, 7th Floor, Gloucester House, London EC1A 7BE, UK. Tel: +44-207-6017313; Fax: +44-207-6017577; E-mail: jonathan.shamash{at}bartsandthelondon.nhs.uk

Background: The outcome of patients with germ-cell tumours (GCTs), who relapse more than once or relapse with a mediastinal primary is poor. We have shown that topoisomerase 1 may be an attractive target in relapsed GCT. We investigated the role of irinotecan, paclitaxel and oxaliplatin (IPO) followed by topotecan-based high-dose therapy in responding patients, in this patient population.

Patients and methods: Twenty-eight patients with multiply relapsed gonadal and mediastinal GCT were recruited to this phase 2 study. All patients received IPO chemotherapy and 12 (43%) went on to receive high-dose therapy. The outcome of these patients was assessed using the Kaplan–Meier method with a median progression-free follow-up of 1 year.

Results: Twenty patients (71%) responded to the therapy including five complete remissions (18%), 13 (46%) marker-negative partial responses and two (7%) marker-positive partial responses. Nine (32%) patients continue to be progression free, and the median survival for the whole group currently measures 17 months. Out of 12 individuals who received subsequent high-dose therapy consolidation, seven (58%) remain progression free. The commonest grade III/IV toxicity was infection (68%) and there were no IPO-related toxic deaths; there was one death from high-dose therapy.

Conclusion: Topoisomerase I-based IPO chemotherapy that lacks etoposide is very active in multiply relapsed GCT. This data merit further investigation.

Key words: germ-cell tumour, mediastinal, phase 2, relapsed

Received for publication August 22, 2006. Revision received January 9, 2007. Accepted for publication January 10, 2007.


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