title: Phase I-II pilot study on the efficacy and tolerability of neoadjuvant chemotherapy (Rescue M-VEC) and preoperative radiation therapy for infiltrating bladder cancer: results of an 18-month follow-up.
abstract: In spite of the improvement of surgical techniques used alone or in combination with preoperative radiation therapy, more than 50% of the patients with infiltrating transitional cell carcinoma (TCC) of the bladder die of distant metastases. Systemic antiblastic polychemotherapy has been reported to achieve a complete remission rate of approximately 30% in patients with infiltrating bladder TCC, although there are still doubts relative to the duration of such complete remissions. This study investigated the efficacy and tolerability of a preoperative chemo- and radiotherapeutic treatment modality and the possibility of performing preservative surgery. Thirty-seven patients with bladder TCC stage T2-T4, N0, M0, have been subjected to neoadjuvant chemotherapy according to the "Rescue M-VEC" scheme of methotrexate 30 mg/m2 +folinic acid 15 mg. after 24 hours on days 1, 15, 22; vinblastine 3 mg/m2 on days 1, 15, 22; epidoxorubicin 30 mg/m2 on day 1 and cisplatin 70 mg/m2 on day 1. The course was repeated from day 29. After 2 "Rescue M-VEC" courses, the patients received pelvic cobalt tele-therapy (CTT) combined with cisplatin 24 mg/m2/week. The patients were then restaged. Those with complete remission (CR) received consolidation radiotherapeutic boost combined with cisplatin 24 mg/m2/week, avoiding radical cystectomy. Such treatment was also given to patients with significant partial remission (PR) who had undergone TUR or partial cystectomy. In all the remaining cases we carried out radical cystectomy. We obtained 45.7% CR, 31.4% PR and 22.8% were non-responders (NR), of 35 patients who were evaluable at restaging. Only 9 radical cystectomies were performed in this series. The overall survival rate was 80.6% at a mean follow-up of 18.1 months.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Division of Urology, Ospedale S. Maria delle Croci, Ravenna, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Voce
authors.forename: F
authors.initials: F
authors.lastname: Montanari
authors.forename: S
authors.initials: S
authors.lastname: Arnone
authors.forename: C
authors.initials: C
authors.lastname: Dal Pozzo
authors.forename: G
authors.initials: G
authors.lastname: Suprani
authors.forename: G
authors.initials: G
authors.lastname: Cerullo
authors.forename: V
authors.initials: V
authors.lastname: Fornarola
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002277:Carcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003037:Cobalt Radioisotopes / Q000627:therapeutic use; D003131:Combined Modality Therapy; D015653:Cystectomy; D015251:Epirubicin / Q000008:administration & dosage; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D010865:Pilot Projects; D011300:Preoperative Care; D011867:Radioisotope Teletherapy; D012074:Remission Induction; D001749:Urinary Bladder Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D014747:Vinblastine / Q000008:administration & dosage
chemical_list: D003037:Cobalt Radioisotopes; D015251:Epirubicin; D014747:Vinblastine; D002945:Cisplatin; D008727:Methotrexate