title: Neoadjuvant treatment of stages T2 to T4 bladder cancer with cis-platinum, cyclophosphamide and doxorubicin.
abstract: In an ongoing phase II study 17 patients with potentially operable transitional cell carcinoma of the bladder (stages T2 to T4, Nx, Mo) have been treated with intravenous cis-platinum (50 mg.per m.2), cyclophosphamide (400 mg.per m.2) and doxorubicin (40 mg.per m.2). They were to receive 3 treatments at 3-week intervals before cystectomy and 2 treatments at 3-week intervals commencing 5 weeks after cystectomy. Of 17 patients 14 (82 per cent) completed all 3 preoperative treatments but only 7 (41 per cent) continued on to complete the entire 5 treatments. In most cases incomplete therapy was due to patient refusal. Toxicity was low as measured by World Health Organization standards. Of the 17 patients 9 (53 per cent) exhibited objective tumor response (pathological downstaging or greater than 50 per cent reduction of tumor volume determined by either computerized tomography scan and/or endoscopic examination. When the determination was made by endoscopy the changes were dramatic and not borderline.) No patient demonstrated a pathological complete response. All 9 of the responders (100 per cent) remain clinically free of disease at a median follow-up of 19 months (range 4 to 30 months). The 8 nonresponders have done poorly with 5 dead of disease, 1 alive with pelvic recurrence and 2 free of disease at 4 and 12 months. These tumor response rates compare favorably with other cis-platinum-based combination regimens. The response to the chemotherapy appears to be an important prognostic indicator. Phase III trials must be conducted to determine whether this neoadjuvant chemotherapy regimen has a significant effect on long-term patient survival.
authors.affiliation: Department of Surgery, Bowman Gray School of Medicine, Winston-Salem, North Carolina.
authors.forename: D L
authors.initials: DL
authors.lastname: McCullough
authors.forename: R M
authors.initials: RM
authors.lastname: Cooper
authors.forename: L D
authors.initials: LD
authors.lastname: Yeaman
authors.forename: L
authors.initials: L
authors.lastname: Loomer
authors.forename: R D
authors.initials: RD
authors.lastname: Woodruff
authors.forename: W H
authors.initials: WH
authors.lastname: Boyce
authors.forename: L H
authors.initials: LH
authors.lastname: Harrison
authors.forename: D G
authors.initials: DG
authors.lastname: Assimos
authors.forename: D F
authors.initials: DF
authors.lastname: Lynch
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D001743:Urinary Bladder / Q000601:surgery; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000601:surgery
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide; D002945:Cisplatin