Sternberg C N, Arena M G, Calabresi F, De Carli P, Platania A, Zeuli M, Giannarelli D, Cancrini A, Pansadoro V
Department of Medical Oncology, Regina Elena Cancer Institute, Rome, Italy.
Cancer. 1993 Sep 15;72(6):1975-82. doi: 10.1002/1097-0142(19930915)72:6<1975::aid-cncr2820720631>3.0.co;2-i.
Based on the excellent results with combination chemotherapy such as M-VAC (methotrexate, vinblastine, doxorubicin, and cisplatin) in patients with advanced disease, neoadjuvant chemotherapy has been advocated to improve survival and in some cases to permit bladder conservation.
A Phase II study of neoadjuvant M-VAC chemotherapy was performed in patients with T2-T4N0M0 bladder tumors. After clinical staging, three cycles of M-VAC were given. After patients underwent postchemotherapy clinical restaging, pathologic restaging (partial or radical cystectomy) was planned.
Forty-six patients are evaluable. A clinical response was attained in 78%. Six patients (13%) had stable disease, and four (9%) had progression. After chemotherapy, 17 patients underwent radical cystectomy, none of whom were pTO. In this group, 10 of the 17 (59%) are alive at a median follow-up of 37+ months (range, 8-62+ months). Eleven patients had a partial cystectomy; 7 of the 11 (64%) are alive, 6 (55%) with a preserved bladder. Eighteen patients had clinical restaging only, and did not have pathologic staging. Median follow-up for this group is 36+ months (11-65+ months). Twenty-one of the 29 (72%) patients managed with conservative surgery or transurethral resection of the bladder alone are alive with a functional bladder. Median survival for all patients has not yet been reached. Two-year survival is 82%, and 3-year survival is 70%.
The current study is of interest in terms of bladder conservation. Assessment of the true success of any bladder-preserving treatment will require longer follow-up.
基于诸如M-VAC(甲氨蝶呤、长春花碱、阿霉素和顺铂)等联合化疗方案在晚期疾病患者中取得的优异疗效,新辅助化疗已被提倡用于提高生存率,并且在某些情况下允许保留膀胱。
对T2-T4N0M0膀胱肿瘤患者进行了新辅助M-VAC化疗的II期研究。临床分期后,给予三个周期的M-VAC化疗。患者接受化疗后临床重新分期后,计划进行病理重新分期(部分或根治性膀胱切除术)。
46例患者可评估。78%的患者获得了临床缓解。6例患者(13%)病情稳定,4例(9%)病情进展。化疗后,17例患者接受了根治性膀胱切除术,其中无一例为pTO。在该组中,17例患者中有10例(59%)在中位随访37+个月(范围8-62+个月)时存活。11例患者进行了部分膀胱切除术;11例中有7例(64%)存活,6例(55%)保留了膀胱。18例患者仅进行了临床重新分期,未进行病理分期。该组的中位随访时间为36+个月(11-65+个月)。29例仅接受保守手术或经尿道膀胱切除术治疗的患者中有21例(72%)存活且膀胱功能正常。所有患者的中位生存期尚未达到。两年生存率为82%,三年生存率为70%。
就保留膀胱而言,当前的研究具有一定意义。对任何保留膀胱治疗的真正成功评估都需要更长时间的随访。