Oxaliplatin and irinotecan plus granulocyte-colony stimulating factor as third-line treatment in relapsed or cisplatin-refractory germ-cell tumor patients: a phase II study.
OBJECTIVE
To investigate the efficacy and tolerability of the combination of oxaliplatin and irinotecan in patients with relapsed or cisplatin-refractory germ cell tumors (GCT).


METHODS
Eighteen patients with relapsed or cisplatin-refractory GCT were treated with oxaliplatin 85 mg/m(2) on days 1 and 15, followed by irinotecan 80 mg/m(2) on days 1, 8 and 15, every four weeks for a maximum of six cycles.


RESULTS
All patients were assessable for response and toxicity. Overall, 7 patients (40%) achieved a favorable response (4 complete and 3 partial responses). One of the complete responders relapsed after 2.5 months and despite further treatment with high dose chemotherapy, he died two months later. The remaining 3 patients are continuously disease free for 11+, 14+ and 19+ months. The partial responders subsequently progressed and died after 2, 3 and 4.5 months, respectively. None of the patients with extragonadal mediastinal GCT responded to oxaliplatin and irinotecan chemotherapy. The investigated combination has a good tolerance. Neutropenia related toxicity (grade 3/4, 17%), neutropenic infections and sepsis were not common probably due to prophylactic use of hematopoietic colony stimulating factor (G-CSF). Thrombocytopenia and anemia were not a serious problem. Gastrointestinal side effects, specifically grade 3/4 diarrhea and nausea/vomiting were noted in 22% and 28% of patients, respectively. Oxaliplatin-associated neurotoxicity was rather low; grade 3 peripheral sensory neuropathy was recorded in 11% of patients.


CONCLUSIONS
The combination of oxaliplatin and irinotecan is feasible and associated with significant clinical antitumor activity, mild and manageable toxicity and easy outpatient administration in patients with relapsed or cisplatin-refractory germ cell cancer. This combination seems to offer a possibility for long-term disease-free status (17%), despite the poor prognostic features of the study patient group.
Pectasides
Dimitrios
D
Second Department of Internal Medicine-Propaedeutic, Athens University Medical School, Attikon University Hospital, Athens, Greece. pectasid@otenet.gr
Pectasides
Melina
M
Farmakis
Dimitrios
D
Aravantinos
Gerasimos
G
Nikolaou
Maria
M
Koumpou
Maria
M
Gaglia
Asimina
A
Kostopoulou
Vasiliki
V
Mylonakis
Nikolaos
N
Economopoulos
Theofanis
T
Raptis
Sotirios A
SA
D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002945:Cisplatin / Q000627:therapeutic use; D018237:Germinoma / Q000188:drug therapy*; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D013736:Testicular Neoplasms / Q000188:drug therapy*; D017211:Treatment Failure
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D016179:Granulocyte Colony-Stimulating Factor; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin