Kaufman Donald S, Winter Kathryn A, Shipley William U, Heney Niall M, Wallace H James, Toonkel Leonard M, Zietman Anthony L, Tanguay Simon, Sandler Howard M
Massachusetts General Hospital, Boston, Massachusetts 02114, USA.
Urology. 2009 Apr;73(4):833-7. doi: 10.1016/j.urology.2008.09.036. Epub 2008 Dec 18.
To evaluate the safety, tolerance, protocol completion rate, tumor response rate, and patient survival of chemoradiotherapy for patients with muscle-invasive operable bladder cancer.
After transurethral resection of the tumor in patients with Stage T2-T4a bladder cancer, twice-daily radiotherapy with paclitaxel and cisplatin chemotherapy induction (TCI) was administered. If repeat biopsy showed less than Stage T1 disease, consolidation with TCI was given. If repeat biopsy showed greater than Stage T1 disease, cystectomy was recommended. Adjuvant gemcitabine and cisplatin were given to all patients.
A total of 80 patients met protocol eligibility. TCI resulted in 26% developing grade 3-4 acute toxicity, mainly gastrointestinal (25%). During consolidation TCI, grade 3-4 acute toxicity, all transient, was reported in 8%. Four cycles of adjuvant chemotherapy were completed per protocol or with minor deviations in 70% of the patients. Adjuvant treatment was associated with grade 3 toxicity in 46% and grade 4 in 26%. One patient had a fatal hemorrhagic stroke. Late bladder radiation toxicity was evaluated in 53 patients with > or = 2 years of follow-up. Of these 53 patients, 3 experienced self-limited, late grade 3 bladder toxicity. The postinduction complete response rate was 81% (65/80), 36 of the 80 patients died (22 of bladder cancer). At a median follow-up of 49.4 months, the actuarial 5-year overall and disease-specific survival rate was 56% and 71%, respectively.
These favorable tumor response rates with possible increased bladder preservation rates suggest that this treatment regimen deserves further study.
评估肌肉浸润性可手术膀胱癌患者放化疗的安全性、耐受性、方案完成率、肿瘤缓解率及患者生存率。
对T2 - T4a期膀胱癌患者行经尿道肿瘤切除术后，给予每日两次放疗及紫杉醇和顺铂化疗诱导（TCI）。若重复活检显示疾病分期低于T1期，则给予TCI巩固治疗。若重复活检显示疾病分期高于T1期，则建议行膀胱切除术。所有患者均给予吉西他滨和顺铂辅助化疗。
共有80例患者符合方案入组标准。TCI导致26%的患者出现3 - 4级急性毒性反应，主要为胃肠道反应（25%）。在巩固性TCI治疗期间，8%的患者出现3 - 4级急性毒性反应，均为短暂性。70%的患者按方案或有轻微偏差完成了4个周期的辅助化疗。辅助治疗导致46%的患者出现3级毒性反应，26%的患者出现4级毒性反应。1例患者发生致命性出血性中风。对53例随访时间≥2年的患者评估了晚期膀胱放射毒性。在这53例患者中，3例出现自限性3级晚期膀胱毒性反应。诱导治疗后的完全缓解率为81%（65/80），80例患者中有36例死亡（22例死于膀胱癌）。中位随访49.4个月时，5年总生存率和疾病特异性生存率分别为56%和71%。
这些良好的肿瘤缓解率以及可能提高的膀胱保留率表明该治疗方案值得进一步研究。
