Gemcitabine and oxaliplatin (GEMOX) in patients with cisplatin-refractory germ cell tumors: a phase II study

Pectasides, D.
Pectasides, M.
Farmakis, D.
Aravantinos, G.
Nikolaou, M.
Koumpou, M.
Gaglia, A.
Kostopoulou, V.
Mylonakis, N.
Skarlos, D.

¹Second Department of Medical Oncology, Metaxas Memorial Cancer Hospital, Piraeus, Greece
²Third Department of Medical Oncology, ‘Ag. Anargiri’ Cancer Hospital, Athens, Greece
³Second Department of Medical Oncology, ‘Eric Dynan’ Hospital, Athens, Greece

Received 10 July 2003; revised 3 November 2003; accepted 19 December 2003

^*Correspondence to: Dr D. Pectasides, Second Department of Medical Oncology, Metaxas Memorial Cancer Hospital, 51 Botassi Street, 18537 Piraeus, Greece. Tel: +32-10-428-5015; Fax: +32-10-428-5025; E-mail: [email protected]

Annals of Oncology 15(3):p 493-497, March 2004.

Background

To investigate the efficacy and toxicity of the combination of gemcitabine and oxaliplatin (GEMOX) in patients with relapsed or cisplatin-refractory non-seminomatous germ cell tumors (NSGCT).

Patients and methods

Twenty-nine patients with relapsed or cisplatin-refractory NSGCT were treated with gemcitabine 1000 mg/m² on days 1 and 8 followed by oxaliplatin 130 mg/m² on day 1 every 3 weeks for a maximum of six cycles. Twenty-four patients (83%) were considered refractory and five (17%) absolutely refractory to cisplatin.

Results

Twenty-eight patients were assessable for response. Overall, nine patients (32%) achieved a favourable response (complete response, four; partial response, five). One of the complete responders relapsed after 7 months and went into disease-free status lasting for 11+ months after resection of lung metastases. The rest of the complete responders are continuously disease-free at 14+, 19+ and 28+ months with the study regimen plus or minus surgery. One of the complete responders had absolutely cisplatin-refractory disease and another one presented with a late relapse. Toxicity was primarily hematological and generally manageable: 62% of patients experienced grade 3/4 neutropenia, 10% neutropenic fever and 41% grade 3/4 thrombocytopenia. Non-hematological toxicity consisted mainly of nausea/vomiting. Three patients (10%) developed grade 3 neurotoxicity and discontinued treatment.

Conclusions

The combination of GEMOX is an active, moderately toxic and easily administered regimen in patients with relapsed or cisplatin-refractory NSGCT. The 14% long-term disease-free status accomplished in this heavily pretreated patient population is quite encouraging.