title: The role of adjuvant chemotherapy following cystectomy for invasive bladder cancer: a prospective comparative trial.
abstract: We assigned 91 patients with deeply invasive, pathological stage P3, P4 or N+ and Mo transitional cell carcinoma of the bladder (with or without squamous or glandular differentiation) to adjuvant chemotherapy or to observation after radical cystectomy and pelvic lymph node dissection. For most patients chemotherapy was planned as 4 courses at 28-day intervals of 100 mg./M.2 cisplatin, 60 mg./M.2 doxorubicin and 600 mg./M.2 cyclophosphamide. A significant delay was shown in the time to progression (p = 0.0010) with 70% of the patients assigned to chemotherapy free of disease at 3 years compared to 46% in the observation group. Median survival time for patients in the chemotherapy group was 4.3 years compared to 2.4 years in the observation group (p = 0.0062). In addition to treatment groups, important prognostic factors included age, gender and lymph node status. The number of involved lymph nodes was the single most important variable. We recommend adjuvant chemotherapy for patients with invasive transitional cell carcinoma after definitive surgical resection.
authors.affiliation: Department of Urology, University of Southern California School of Medicine, Kenneth Norris, Jr. Cancer Hospital, Los Angeles.
authors.forename: D G
authors.initials: DG
authors.lastname: Skinner
authors.forename: J R
authors.initials: JR
authors.lastname: Daniels
authors.forename: C A
authors.initials: CA
authors.lastname: Russell
authors.forename: G
authors.initials: G
authors.lastname: Lieskovsky
authors.forename: S D
authors.initials: SD
authors.lastname: Boyd
authors.forename: P
authors.initials: P
authors.lastname: Nichols
authors.forename: W
authors.initials: W
authors.lastname: Kern
authors.forename: J
authors.initials: J
authors.lastname: Sakamoto
authors.forename: M
authors.initials: M
authors.lastname: Krailo
authors.forename: S
authors.initials: S
authors.lastname: Groshen
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000401:mortality / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D015653:Cystectomy; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D016019:Survival Analysis; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000628:therapy*
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide; D002945:Cisplatin