Treatment options for muscle-invasive urothelial cancer for patients who were not eligible for cystectomy or neoadjuvant chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin: report of Southwest Oncology Group Trial 8733.
Treatment options for muscle-invasive urothelial cancer for patients who were not eligible for cystectomy or neoadjuvant chemotherapy with methotrexate, vinblastine, doxorubicin, and cisplatin: report of Southwest Oncology Group Trial 8733.
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对于不适合接受膀胱切除术或甲氨蝶呤、长春碱、阿霉素和顺铂新辅助化疗的患者的肌层浸润性尿路上皮癌的治疗选择：西南肿瘤组试验 8733 的报告。
DOI：
10.1002/cncr.23420
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发表时间：
2008
期刊：
影响因子：
6.2
通讯作者：
SouthwestOncologyGroupTrial8733
中科院分区：
文献类型：
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作者：
Higano,CelestiaS;Tangen,CatherineM;Sakr,WaelA;Faulkner,James;Rivkin,SaulE;Meyers,FrederickJ;Hussain,Maha;Baker,LaurenceH;Russell,KennethJ;Crawford,EDavid;SouthwestOncologyGroupTrial8733
背景：许多侵袭性尿路上皮细胞癌患者不适合顺铂为基础的化疗，许多患者有膀胱切除术的高风险。西南肿瘤组试验8733旨在解决这类患者的治疗问题。方法入选患者为原发性或复发性肌肉侵袭性疾病，组织学为移行细胞或鳞状细胞，运动能力评分0 ~ 2分，无盆腔外疾病，预期寿命0 ~ 3个月，血液学功能正常。治疗临床医生将患者分为可手术组和不可手术组。所有患者均接受2个周期的5 -氟尿嘧啶（5 - FU）治疗，剂量为1000mg/m2 /天× 4，同时开始放疗，剂量为200centigrays /天× 10 /周期。2周期后，活检阳性可手术患者行膀胱切除术，活检阴性患者行第三周期放化疗。不手术组患者接受3个周期，未进行中期活检。结果可手术组24例患者中有18例可评价疗效。5例完全缓解（CR）， 9例病情稳定，1例病情进展，3例无法评估。中位无进展生存期为10个月（95%置信区间[95% CI]， 4-14个月），中位总生存期为18个月（95% CI， 7-28个月）。在不手术组，37例符合条件的患者中有35例可评估缓解，CRs为17 （49%;95% CI, 31%-66%）。中位无进展生存期为13个月（95% CI， 10-17个月），中位总生存期为20个月（95% CI， 11-53个月）。没有4级毒性发作。结论：在目前的研究中，5 - FU联合放疗被发现对许多合并症患者具有良好的耐受性，这些患者不能耐受顺铂治疗或膀胱切除术。2008年癌症。©2008美国癌症协会。
BACKGROUNDMany patients with invasive urothelial cell cancer are poor candidates for cisplatin‐based chemotherapy, and many are high risk for cystectomy. Southwest Oncology Group Trial 8733 was designed to address treatment for such patients.METHODSEligible patients had primary or recurrent muscle‐invasive disease with transitional cell or squamous cell histology, a performance status from 0 to 2, no extrapelvic disease, a life expectancy >3 months, and adequate hematologic function. The treating clinician assigned patients to operable or inoperable groups. All patients received 2 cycles of 5‐fluorouracil (5‐FU) at a dose of 1000mg/m2per day × 4 starting concurrently with radiation at a dose of 200 centigrays per day × 10 each cycle. After 2 cycles, operable patients with positive biopsies underwent cystectomy, and patients with negative biopsies received a third cycle of chemoradiotherapy. Patients in the inoperable group received 3 cycles without interim biopsy.RESULTSEighteen of 24 eligible patients in the operable group were evaluable for response. Five patients had a complete response (CR), 9 patients had stable disease, 1 patient had progressive disease, and 3 patients were not assessable. The median progression‐free survival was 10 months (95% confidence interval [95% CI], 4–14 months), and the median overall survival was 18 months (95% CI, 7–28 months). In the inoperable group, 35 of 37 eligible patients were evaluable for response with 17 CRs (49%; 95% CI, 31%–66%). The median progression‐free survival was 13 months (95% CI, 10–17 months), and the median overall survival was 20 months (95% CI, 11–53 months). There were no episodes of grade 4 toxicity.CONCLUSIONSIn the current study, the combination of 5‐FU and radiation was found to be tolerated well by patients with numerous comorbidities who could not tolerate cisplatin‐based therapy or cystectomy. Cancer 2008. © 2008 American Cancer Society.