title: Effect of a novel bladder preservation therapy, BOAI-CDDP-radiation (OMC-regimen).
abstract: We have developed a novel form of bladder preservation therapy [OMC (Osaka Medical College)-regimen] involving balloon-occluded-arterial-infusion (BOAI) of an anticancer agent (cisplatin/gemcitabine), used concomitantly with hemodialysis, which delivers an extremely high concentration of anticancer agent to the site of a tumor without systemic adverse effects, along with concurrent radiation. We previously reported that the OMC-regimen elicited a complete response (CR) in >90% of patients with organ confined tumors, while LN(+), T4 tumors and a non-UC histological type were statistically significant risk factors for treatment failure and patient survival. In this study, we investigated the effects of the OMC-regimen in patients with organ confined urothelial cancer tumors and the outcomes were compared to those with total cystectomy. Three hundred and one patients were assigned to receive either the OMC-regimen (n=162) or total cystectomy (n=139). Patients in the OMC-regimen group who failed to achieve CR underwent cystectomy, or secondary BOAI with an increased amount of CDDP or gemcitabine (1600 mg). The OMC-regimen yielded 98.1% of clinical response; CR in 93.8% (152/162) of patients; PR in 4.3% (7/162). More than 96% of the CR patients (146/152) were alive with no evidence of recurrence after a mean follow-up of 166 (range 23-960) weeks. No patients suffered grade III toxicity; all patients successfully completed this therapy. The patient survival was significantly better compared to the cystectomy group; the overall 5-, 10- and 15-year survival rates were 87.3, 79.6 and 59.7%, respectively. Moreover, the 5-, 10- and 15-year bladder intact survival rates, the most important issue for bladder preservation therapy, were 85.7, 78.4 and 58.8%, respectively. In conclusion, the OMC-regimen is a useful bladder-preservation strategy, not only in those for whom cystectomy is indicated, but also in patients whose condition is not amenable to curative treatment and for whom palliation would otherwise seem the only option.
authors.affiliation: Department of Urology, Osaka Medical College, Takatsuki city, Osaka 569-8686, Japan. uro004@poh.osaka-med.ac.jp
authors.forename: Haruhito
authors.initials: H
authors.lastname: Azuma
authors.forename: Teruo
authors.initials: T
authors.lastname: Inamoto
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Takahara
authors.forename: Hayahito
authors.initials: H
authors.lastname: Nomi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Uehara
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Komura
authors.forename: Koichiro
authors.initials: K
authors.lastname: Minami
authors.forename: Junko
authors.initials: J
authors.lastname: Kouno
authors.forename: Yatsugu
authors.initials: Y
authors.lastname: Kotake
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Abe
authors.forename: Shizuko
authors.initials: S
authors.lastname: Takagi
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Yoshihumi
authors.initials: Y
authors.lastname: Narumi
authors.forename: Satoshi
authors.initials: S
authors.lastname: Kiyama
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D021721:Balloon Occlusion; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D015653:Cystectomy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007261:Infusions, Intra-Arterial; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D009367:Neoplasm Staging; D001743:Urinary Bladder / Q000187:drug effects / Q000473:pathology / Q000601:surgery; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine