Methotrexate-paclitaxel-epirubicin-carboplatin as second-line chemotherapy in patients with metastatic transitional cell carcinoma of the bladder pretreated with cisplatin-gemcitabine: a phase II study.
OBJECTIVE
To assess the efficacy and toxicity of methotrexate-paclitaxel-epirubicin-carboplatin combination as second-line chemotherapy in patients with metastatic transitional cell carcinoma (TCC) of the bladder pretreated with cisplatin-gemcitabine.


METHODS
In this prospective phase II study, patients with metastatic TCC of the bladder pretreated with first-line cisplatin-gemcitabine received on progression paclitaxel 175 mg/m(2)  i.v. and carboplatin (area under curve of 5) on day 1, and methotrexate 40 mg/m(2)  and epirubicin 40 mg/m(2)  on day 15. The whole course was repeated every 28 days. The end-points included clinical tumor response, treatment toxicity, quality of life and survival.


RESULTS
A total of 40, predominantly male, patients were enrolled (median age 62 years [range 46-69]). Efficacy and survival were assessed in 38 patients only, as two patients refused treatment after the first cycle. Grade 3 neutropenia was the commonest acute severe toxicity (12/40 patients; 30%). The overall response rate was 39% (15/38 patients). The median follow up was 14 months (range 3-45). The median progression-free and overall survival were 12 and 12.5 months, respectively. The 1-year progression-free and overall survival were 24 and 35%, respectively.


CONCLUSIONS
Methotrexate-paclitaxel-epirubicin-carboplatin combination as second-line chemotherapy in patients with metastatic TCC of the bladder results in a modest response rate with acceptable toxicity.
Department of Clinical Oncology and Nuclear Medicine, Faculty of Medicine, Mansoura University, Mansoura, Egypt. amalsalahm@yahoo.com
Amal
A
Halim
Niveen
N
Abotouk
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D011446:Prospective Studies; D016879:Salvage Therapy; D015996:Survival Rate; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000093542:Gemcitabine
D003841:Deoxycytidine; D015251:Epirubicin; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin; D008727:Methotrexate; D000093542:Gemcitabine