title: 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.
abstract: 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.
authors.affiliation: Second Department of Internal Medicine-Propaedeutic, Athens University Medical School, Attikon University Hospital, Athens, Greece. pectasid@otenet.gr
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Pectasides
authors.forename: Melina
authors.initials: M
authors.lastname: Pectasides
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Farmakis
authors.forename: Gerasimos
authors.initials: G
authors.lastname: Aravantinos
authors.forename: Maria
authors.initials: M
authors.lastname: Nikolaou
authors.forename: Maria
authors.initials: M
authors.lastname: Koumpou
authors.forename: Asimina
authors.initials: A
authors.lastname: Gaglia
authors.forename: Vasiliki
authors.initials: V
authors.lastname: Kostopoulou
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Mylonakis
authors.forename: Theofanis
authors.initials: T
authors.lastname: Economopoulos
authors.forename: Sotirios A
authors.initials: SA
authors.lastname: Raptis
mesh_terms: 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
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D016179:Granulocyte Colony-Stimulating Factor; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin