1. ¹Medical Oncology Unit, C Level West Wing, Southampton General Hospital, Southampton SO16 6YD, UK
2. ²University Hospital Birmingham NHS Foundation Trust, Birmingham B15 2TH, UK
3. ³Royal Marsden Hospital, Sutton SM2 5PT, UK
4. ⁴Guy's Hospital, London SE1 9RT, UK
5. ⁵Mt Vernon Hospital, Harrow HA6 2RN, UK
6. ⁶MRC Clinical Trials Unit, London NW1 2DA, UK
7. ⁷Velindre Hospital, Cardiff CF4 7XL, UK

Correspondence: Dr GM Mead, E-mail: Ben.Mead@suht.swest.nhs.uk

⁸Now National Cancer Research Institute Testis Cancer Clinical Studies Group. For full list of participants, see Appendix A1.

Received 10 March 2005; Revised 26 May 2005; Accepted 27 May 2005; Published online 5 July 2005.

Abstract

This phase II trial describes the use of TIP chemotherapy (paclitaxel, ifosfamide and cisplatin) as salvage for patients with metastatic germ cell cancer (GCC) who have failed initial BEP (bleomycin, etoposide and cisplatin) chemotherapy. Patients with first relapse following BEP for metastatic GCC, confirmed by biopsy or sequentially rising markers, received four courses of TIP (paclitaxel 175 mg m^-2 day 1, followed on days 1–5 by ifosfamide 1 g m^-2 intravenously (i.v.) and cisplatin 20 mg² i.v.) at 3-weekly intervals. The primary outcome measure was response to TIP. In all, 51 patients were registered, of whom 43 were eligible for response assessment. Eight achieved complete remission (CR) and 18 a partial remission with negative markers (PR^-ve); favourable response rate (FRR=CR+PR^-ve) 60%, 95% CI (44–75%); survival at 1 year was 70% (56–84%) and failure-free survival 36% (22–50%). In the group of 26 patients meeting the 'good-risk' criteria described by the Memorial Hospital, the FRR was 73% (52–88%) compared with 41% (18–67%) for the 17 'poor-risk' patients. These results are inferior to those previously reported for TIP in a single-centre study when it was given more intensively, at higher dose and with growth factor support. Nonetheless, TIP as described here can cure a substantial proportion of patients.