title: Paclitaxel plus ifosfamide and cisplatin in second-line treatment of germ cell tumors: a phase II study.
abstract: The aim of this study was to determine efficacy and toxicity of TIP combination (paclitaxel, ifosfamid, cisplatin) as first salvage treatment in patients with relapsed germ cell tumours (GCTs). Excellent results were achieved from TIP combination with a dose 250 mg/m(2) of paclitaxel [5]. Our hypothesis was that comparable efficacy with less toxicity could be achieved even with a lower dose of 175 mg/m(2) paclitaxel in TIP. In 17 consecutive patients with failed standard 1st line treatment, we used four to six courses of paclitaxel 175 mg/m(2) on day 1 and ifosfamide 1,200 mg/m(2) plus cisplatin 20 mg/m(2), both on day 1 through 5, every 3 weeks. Eleven patients achieved favorable response (65%; 95% confidence interval, 42 to 87%) with 7 complete responses (41%). Estimated 2-year disease free survival is 47% (95% CI, 23-71%). Treatment combination was well tolerated and myelosupression was major toxicity. Granulocytopenia Gr3-4 was observed in 8% and febrile neutropenia in 7% of the courses. No case of severe neurotoxicity or treatment-related death was observed. In our study, TIP combination had good toxicity profile. The results however, did not show expected treatment efficacy and we raise the idea of paclitaxel dosage relevance in TIP.
authors.affiliation: Department of Medical Oncology, National Cancer Institute, 833 10 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; D018237:Germinoma / Q000188:drug therapy* / Q000556:secondary; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008297:Male; D020714:Maximum Tolerated Dose; D008479:Mediastinal Neoplasms / Q000188:drug therapy / Q000473:pathology; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D018309:Neoplasms, Gonadal Tissue / Q000188:drug therapy / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D012186:Retroperitoneal Neoplasms / Q000188:drug therapy / Q000473:pathology; D016879:Salvage Therapy; D013736:Testicular Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D002945:Cisplatin; D007069:Ifosfamide