口服布罗匹明联合膀胱内卡介苗治疗膀胱原位癌的II期临床试验：西南肿瘤学组研究

A phase II clinical trial of oral bropirimine in combination with intravesical bacillus Calmette-Guérin for carcinoma in situ of the bladder: a Southwest Oncology Group Study.

作者信息

Sarosdy Michael F, Tangen Catherine M, Weiss Geoffrey R, Nestok Blake R, Benson Mitchell C, Schellhammer Paul F, Sagalowsky Arthur I, Wood David P, Crawford E David

机构信息

South Texas Urology and Urologic Oncology, San Antonio, TX 78229, USA.

出版信息

Urol Oncol. 2005 Nov-Dec;23(6):386-9. doi: 10.1016/j.urolonc.2005.05.028.

DOI:10.1016/j.urolonc.2005.05.028

PMID:16301114

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3632328/

Abstract

OBJECTIVES

To estimate the probability of response when intravesical bacille Calmette-Guérin (BCG) is given in combination with oral bropirimine for bladder carcinoma in situ, and to evaluate toxicity when the 2 agents are combined.

METHODS

A total of 51 patients with histologic evidence of carcinoma in situ and no prior treatment with BCG or bropirimine were enrolled in a cooperative group multicenter phase II trial. Initial treatment included Tice BCG 50 mg weekly for 6 weeks and oral bropirimine 3.0 g/day for 3 consecutive days each week for 12 weeks. Response was assessed after 12 weeks by cystoscopy, biopsy, and barbotage cytology. Most patients received a second course followed by an identical assessment. Toxicity was recorded according to the Southwest Oncology Group toxicity criteria.

RESULTS

A total of 51 patients were enrolled and treated. There were 42 patients who were eligible and valuable for response and toxicity. There were 28 complete responders (67%, 50% to 80% 95% confidence interval). The 5-year progression-free survival estimate is 53%, and the 5-year survival estimate is 80%. There were no deaths, 2 patients had grade 4 toxicity, 14 grade 3 toxicity, 17 grade 2 toxicity, 6 grade 1 toxicity, and only 3 had no toxicity reported as their worst toxicity grade.

CONCLUSIONS

The combination failed to show an estimated response higher than 80%. It is not recommended that further evaluation of this combination be conducted.

摘要

目的

评估膀胱内灌注卡介苗（BCG）联合口服布罗匹明治疗原位膀胱癌的缓解概率，并评价两药联合使用时的毒性。

方法

51例经组织学证实为原位癌且既往未接受过卡介苗或布罗匹明治疗的患者参加了一个协作组多中心II期试验。初始治疗包括每周一次膀胱内灌注Tice BCG 50mg，共6周，以及每周连续3天口服布罗匹明3.0g/天，共12周。12周后通过膀胱镜检查、活检和灌洗细胞学评估缓解情况。大多数患者接受了第二个疗程并进行相同的评估。根据西南肿瘤协作组毒性标准记录毒性。

结果

共纳入51例患者并进行治疗。42例患者对缓解和毒性评估有效。有28例完全缓解者（67%，95%置信区间为50%至80%）。5年无进展生存率估计为53%，5年生存率估计为80%。无死亡病例，2例患者出现4级毒性，14例出现3级毒性，17例出现2级毒性，6例出现1级毒性，仅3例报告其最严重毒性等级为无毒性。