A randomized trial of radical cystectomy versus radical cystectomy plus cisplatin, vinblastine and methotrexate chemotherapy for muscle invasive bladder cancer
A randomized trial of radical cystectomy versus radical cystectomy plus cisplatin, vinblastine and methotrexate chemotherapy for muscle invasive bladder cancer
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DOI：
10.1016/s0022-5347(01)66430-9
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发表时间：
1996-02-01
影响因子：
6.6
通讯作者：
Torti, FM
中科院分区：
文献类型：
--
作者：
Freiha, F;Reese, J;Torti, FM
目的：膀胱肌肉侵袭性移行细胞癌的标准治疗是根治性膀胱切除术。尽管有仔细的分期，大多数累及局部淋巴结和/或侵犯邻近器官的癌症最终会复发。我们研究了根治性膀胱切除术后顺铂、甲氨蝶呤和长春花碱（CMV）化疗的获益。材料和方法：一项前瞻性试验，患者在膀胱切除术后随机接受4个周期的巨细胞病毒化疗或观察。在复发时，患者在我们的机构接受标准的CMV转移性化疗。结果：在进入该试验的55例患者中，1例不符合条件，4例尚为时过早，无法评估。在50例可评估的患者中，25例随机接受辅助CMV化疗，25例观察。CMV组12例（48%），观察组5例（25%）从未复发。中位随访62个月，无患者随访时间小于2年，辅助化疗组无进展自由优于观察组（中位37个月vs中位12个月，p = 0.01）。辅助治疗组的中位生存期为63个月，而观察组为36个月。令人惊讶的是，一些复发的病例可以通过CMV化疗来挽救，这可能是总生存率缺乏差异的原因（p = 0.32）。结论：对于p3b期、p4NO期或N1期膀胱移行细胞癌患者，根治性膀胱切除术后CMV化疗是一种可接受的治疗方法。必须进行进一步的研究，以确定这些结果是否可以外推到目前正在接受根治性膀胱切除术或最终照射治疗的更有限的疾病（p2期和p3a期）患者。
Purpose: Standard treatment for muscle invasive transitional cell cancer of the bladder is radical cystectomy. Despite careful staging, the majority of cancers with regional lymph node involvement and/or invasion to adjacent organs eventually recur. We investigated the benefit of chemotherapy with cisplatin, methotrexate and vinblastine (CMV) after radical cystectomy.Materials and Methods: A prospective trial was done in which patients were randomized after cystectomy to receive either 4 cycles of CMV chemotherapy or observation. At relapse, patients were treated with standard CMV chemotherapy for metastatic disease at our institution.Results: Of 55 patients who entered this trial 1 was ineligible and in 4 it is too soon to be evaluated. Of the 50 evaluable patients 25 were randomized to receive adjuvant CMV chemotherapy and 25 were observed. In the CMV arm 12 (48%) and in the observation arm 5 (25%) never had recurrence. With a median followup of 62 months and no patient with less than 2 years of followup, the freedom from progression in the adjuvant chemotherapy group was superior to that in the observation group (median 37 versus 12 months, respectively, p = 0.01). Median survival in the adjuvant group was 63 months compared to 36 months for the observation group. Surprisingly, some cases with relapse could be salvaged with CMV chemotherapy, perhaps contributing to this lack of difference in overall survival (p = 0.32).Conclusions: Treatment with CMV chemotherapy after radical cystectomy is an acceptable approach in patients with stages p3b and p4NO or N1 transitional cell carcinoma of the bladder. Further studies must be performed to determine whether these results can be extrapolated to patients with more limited disease (stages p2 and p3a) who are currently treated with radical cystectomy or definitive irradiation.