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

• Published in: Annals of oncology Vol. 15; no. 3; pp. 493 - 497
• Main Authors: Pectasides, D., Pectasides, M., Farmakis, D., Aravantinos, G., Nikolaou, M., Koumpou, M., Gaglia, A., Kostopoulou, V., Mylonakis, N., Skarlos, D.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.03.2004
• Subjects: Adolescent; Adult; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Bone Neoplasms - drug therapy; Bone Neoplasms - secondary; Brain Neoplasms - drug therapy; Brain Neoplasms - secondary; Cisplatin - administration & dosage; cisplatin-refractory disease; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Female; gemcitabine; germ cell tumors; Germinoma - drug therapy; Germinoma - pathology; Humans; Liver Neoplasms - drug therapy; Liver Neoplasms - secondary; Lung Neoplasms - drug therapy; Lung Neoplasms - secondary; Lymphatic Metastasis; Male; Mediastinal Neoplasms - drug therapy; Mediastinal Neoplasms - pathology; Medical sciences; Middle Aged; Neoplasm Recurrence, Local - drug therapy; Neoplasm Recurrence, Local - pathology; Neoplasms, Gonadal Tissue - drug therapy; Neoplasms, Gonadal Tissue - pathology; Organoplatinum Compounds - administration & dosage; Oxaliplatin; Pharmacology. Drug treatments; Remission Induction; Salvage Therapy; testicular cancer; Treatment Outcome; Tumors; Human; Treatment resistance; Gemcitabine; Cisplatin; Germ cell tumor; testicular cancer; Alkylating agent; germ cell tumors; Oxaliplatin; Antimetabolic; Phase II trial; this heavily pretreated patient population is quite encouraging. cisplatin-refractory disease; Fluorine Organic compounds; salvage therapy; Pyrimidine nucleoside; Platinum II Complexes
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdh103

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.