title: Chemotherapy with cisplatin, epirubicin, methotrexate in the treatment of locally advanced or metastatic transitional cell cancer of the bladder (TCC).
abstract: Forty patients with advanced transitional cell cancer (TCC) of the bladder were treated with cisplatin, epirubicin, methotrexate (PEM, every 3-4 weeks). If creatinine clearance was reduced to 40 ml/min, the usual full doses of cisplatin and methotrexate, 50 mg/m2, were proportionally reduced. 23 patients had full-dose (FD) therapy, 17 had reduced dose (RD) (40-20 mg/m2). Two patients achieved complete response and 17 partial response. The overall response rate was 19/40 (47.5%), 11/23 (48%) for FD and 8/17 (47%) for RD (p = 1.000). 17/40 pts (42.5%) had no-change and 4/40 (10%) had disease progression. The median duration of CR and PR was 32 weeks, range 4-82 (22 weeks, range 12-52 for FD; 32 weeks, range 4-82 for RD, cisplatin p = .7362). The main side effect was vomiting (35/40 pts, 87.5%, 20/23 = 87% for FD, 15/17 = 90% for RD, p = 1.000). Leukopenia was observed in 12 patients (30%, nadir 3,240 range 900-3,800, 6/23 = 26% for FD, 6/17 = 35% for RD, p = .7285), alopecia in 18 patients (45%, 15/23 = 65% for FD, 3/17 = 18% for RD, p = .004). The results of this study show that a dose escalation to 50 mg/m2 for cisplatin, epirubicin and methotrexate in the PEM regimen results in an increase in overall response (OR) (19/40 = 47.5%) with respect to a historical control using the same drugs at doses of 40 mg/m2 (12/35 = 34%). In patients with normal renal function the escalated dose was tolerated without a corresponding increase in toxicity.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Oncology Dept., S. Orsola-Malpighi Hosp., Bologna, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Lelli
authors.forename: B
authors.initials: B
authors.lastname: Melotti
authors.forename: F
authors.initials: F
authors.lastname: Pannuti
authors.forename: A P
authors.initials: AP
authors.lastname: Rossi
authors.forename: P
authors.initials: P
authors.lastname: Maver
authors.forename: D
authors.initials: D
authors.lastname: Mannini
authors.forename: G
authors.initials: G
authors.lastname: Corrado
authors.forename: G
authors.initials: G
authors.lastname: Severini
authors.forename: E
authors.initials: E
authors.lastname: Bercovich
authors.forename: R
authors.initials: R
authors.lastname: Beghelli
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003404:Creatinine / Q000097:blood / Q000652:urine; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate / Q000187:drug effects; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D015251:Epirubicin; D003404:Creatinine; D002945:Cisplatin; D008727:Methotrexate