title: Neoadjuvant treatment of cancer of the bladder with M-VAC/M-VEC, and bladder-sparing policy: preliminary report of a non-randomized study.
abstract: The life expectancy of patients with invasive bladder cancer is limited by the age of incidence and by the natural history of the cancer. Careful selection of patients, independent of age but linked to a neoadjuvant chemotherapy, should be useful for a bladder-sparing policy. Between January 1991 and December 1994, we selected 36 patients with invasive, transitional bladder cancer, but showing good performance status, after a transurethral resection biopsy performed with cytoreductive intention, and after a complete staging. Patients (median age, 65 years) were treated with neoadjuvant M-VAC/M-VEC and then selected for conservative surgery if the downstaging, topography, absence of in situ carcinoma, and residual bladder capacity allowed. At restaging, nine patients (27%) were in complete pathological response; 13 (39%) were in partial pathological response, with a total rate of 67%; and 11 patients (33%) were non-responders, i.e. non-downstaged. Thirty nine percent were treated with radical cystectomy and 60% with limited surgery. Thirteen patients relapsed and seven died of disease during a median follow-up period of 23.5 months. At the end of the study, 68% of patients were alive, with a progression-free survival of 49.8% and a median survival of 32.9 months. Twenty one patients were alive at 31 December 1995, 14 with their bladder. No statistical differences were observed for overall survival and progression-free survival between the two surgery groups. Results were independent of age. A statistically significant difference was found (p = 0.0001) only between non-responders and all the downstaged patients, independent of surgery. These results confirm the feasibility of conservative treatment after a careful selection of patients, even in patients over 65 years, compared with standard available treatments.
authors.affiliation: Department of Oncology, Azienda ospedaliera San Giovanni Addolorata, Rome, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Galante
authors.forename: C
authors.initials: C
authors.lastname: Ferroni
authors.forename: S
authors.initials: S
authors.lastname: Bianchi
authors.forename: C
authors.initials: C
authors.lastname: Megale
authors.forename: S
authors.initials: S
authors.lastname: Molinaro
authors.forename: S
authors.initials: S
authors.lastname: Maymone
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use; D003131:Combined Modality Therapy; D018450:Disease Progression; D004317:Doxorubicin / Q000009:adverse effects / Q000627:therapeutic use; D015251:Epirubicin / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D016019:Survival Analysis; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D014747:Vinblastine / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D015251:Epirubicin; D014747:Vinblastine; D004317:Doxorubicin; D002945:Cisplatin; D008727:Methotrexate