title: Gemcitabine plus cisplatine and paclitaxel (GCP) in second-line treatment of germ cell tumors (GCT): a phase II study.
abstract: The aim of the study was to determine the efficacy and toxicity of gemcitabine, cisplatin and paclitaxel (GCP) combination as a first salvage treatment of patients with relapsed GCT. Four courses of paclitaxel 175 mg/m(2) and cisplatin 50 mg/m(2), both on day 1, and gemcitabine 1000 mg/m(2), on days 1 and 8, every 3 weeks, were given to 12 consecutive patients who had failed standard 1st line treatment. Six patients (50%; 95% CI 21-79%) achieved favourable response and two of them are maintained 38+ and 29+ months. Median survival time was 16 months (range, 0.77-38+). All, but two patients had hematological toxicity Gr3-4 with infectious complication seen only in 6 courses of therapy. GCP is an active second-line combination regimen for relapsed GCTs with acceptable toxicity profile. However the results of this study did not show expected treatment efficacy and we raise the idea of cisplatin dosage relevance in this combination.
authors.affiliation: Department of Medical Oncology, National Cancer Institute, 83310 Bratislava, Slovak Republic. jozef.mardiak@nou.sk
authors.forename: J
authors.initials: J
authors.lastname: Mardiak
authors.forename: T
authors.initials: T
authors.lastname: Sálek
authors.forename: Z
authors.initials: Z
authors.lastname: Sycová-Milá
authors.forename: J
authors.initials: J
authors.lastname: Obertová
authors.forename: Z
authors.initials: Z
authors.lastname: Hlavatá
authors.forename: M
authors.initials: M
authors.lastname: Mego
authors.forename: M
authors.initials: M
authors.lastname: Recková
authors.forename: I
authors.initials: I
authors.lastname: Koza
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D018237:Germinoma / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000097:blood; D017239:Paclitaxel / Q000008:administration & dosage; D013736:Testicular Neoplasms / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine