对于不符合膀胱切除术或使用甲氨蝶呤、长春花碱、阿霉素和顺铂进行新辅助化疗条件的肌肉浸润性尿路上皮癌患者的治疗选择：西南肿瘤协作组8733试验报告

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.

作者信息

Higano Celestia S, Tangen Catherine M, Sakr Wael A, Faulkner James, Rivkin Saul E, Meyers Frederick J, Hussain Maha, Baker Laurence H, Russell Kenneth J, Crawford E David

机构信息

Department of Medicine, Division of Oncology, University of Washington, Seattle, Washington, USA.

出版信息

Cancer. 2008 May 15;112(10):2181-7. doi: 10.1002/cncr.23420.

DOI:10.1002/cncr.23420

PMID:18404692

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8211356/

Abstract

BACKGROUND

Many 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.

METHODS

Eligible 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 1000 mg/m(2) per day x 4 starting concurrently with radiation at a dose of 200 centigrays per day x 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.

RESULTS

Eighteen 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.

CONCLUSIONS

In 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.

摘要

背景

许多浸润性尿路上皮癌患者不适合接受以顺铂为基础的化疗，且许多患者进行膀胱切除术的风险较高。西南肿瘤协作组试验8733旨在针对此类患者进行治疗。

方法

符合条件的患者患有原发性或复发性肌肉浸润性疾病，组织学类型为移行细胞或鳞状细胞，体能状态为0至2，无盆腔外疾病，预期寿命>3个月，且血液学功能良好。主治医生将患者分为可手术组或不可手术组。所有患者均接受2个周期的5-氟尿嘧啶（5-FU）治疗，剂量为每天1000mg/m²×4天，每个周期同时开始接受剂量为每天200厘戈瑞×10天的放疗。2个周期后，活检阳性的可手术患者接受膀胱切除术，活检阴性的患者接受第3个周期的放化疗。不可手术组的患者接受3个周期的治疗，期间不进行活检。

结果

可手术组24例符合条件的患者中有18例可评估疗效。5例患者完全缓解（CR），9例患者疾病稳定，1例患者疾病进展，3例患者无法评估。无进展生存期的中位数为10个月（95%置信区间[95%CI]，4 - 14个月），总生存期的中位数为18个月（95%CI，7 - 28个月）。在不可手术组中，37例符合条件的患者中有35例可评估疗效，其中17例完全缓解（49%；95%CI，31% - 66%）。无进展生存期的中位数为13个月（95%CI，10 - 17个月），总生存期的中位数为20个月（95%CI，11 - 53个月）。未出现4级毒性反应。