Randomized trial of neoadjuvant cisplatin, vincristine, bleomycin, and radical hysterectomy versus radiation therapy for bulky stage IB and IIA cervical cancer
Randomized trial of neoadjuvant cisplatin, vincristine, bleomycin, and radical hysterectomy versus radiation therapy for bulky stage IB and IIA cervical cancer
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DOI：
10.1200/jco.2000.18.8.1740
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发表时间：
2000-04-01
影响因子：
45.3
通讯作者：
Soong, YK
中科院分区：
文献类型：
--
作者：
Chang, TC;Lai, CH;Soong, YK
目的：比较新辅助化疗（NAC）加根治性子宫切除术与放疗（R/T）治疗体积较大的早期宫颈癌的疗效。先前未经治疗的大体积（原发肿瘤大于或等于4cm） IB或IIA期非小细胞宫颈癌妇女被随机分配接受顺铂50mg /m(2)和长春新碱1mg /m(2)治疗1天，博来霉素25mg /m(2)治疗3天，共3个周期，随后进行根治性子宫切除术（NAC组）或仅接受原发性盆腔放疗（R/T组）。NAC组和R/T组的患者分配比例为6:4。除非细胞学或组织学检查结果为阴性，否则影像学检查显示主动脉旁淋巴结肿大的妇女不适合。结果：124例符合条件的患者中，NAC组有68例，R/T组有52例可以评估。中位随访时间为39个月。NAC组31%的患者和R/T组27%的患者在治疗后出现复发或持续性疾病，每组21%的患者死于疾病。NAC组估计2年累积生存率为81%，R/T组为84%；5年生存率分别为70%和61%。结论：NAC +根治性子宫切除术和原发性R/T治疗体积较大的IB期和IIA期宫颈癌的疗效相似。进一步研究确定更适合任何一种治疗方式的患者亚组，并评估顺铂和放疗同时使用而不进行常规子宫切除术是必要的。[J]中华临床杂志，18(6):1740-1747。(C)美国临床肿瘤学会，2000。
Purpose: To compare the efficacy of neoadjuvant chemotherapy (NAC) followed by radical hysterectomy with that of radiotherapy (R/T) for bulky early-stage cervical cancer,Patients and Methods: Women with previously untreated bulky (primary tumor greater than or equal to 4 cm) stage IB or IIA non-small-cell carcinoma of the uterine cervix were randomly assigned to receive either cisplatin 50 mg/m(2) and vincristine 1 mg/m(2) for 1 day and bleomycin 25 mg/m(2) for 3 days for three cycles followed by radical hysterectomy (NAC arm) or receive primary pelvic radiotherapy only (R/T arm). The ratio of patient allocation was 6:4 for the NAC and R/T arms. Women with enlarged para-aortic lymph nodes on image study were ineligible unless results of cytologic or histologic studies were negative.Results: Of the 124 eligible patients, 68 in the NAC arm and 52 in the R/T arm could be evaluated. The median duration of follow-up was 39 months. Thirty-one percent of patients in the NAC arm and 27% in the R/T arm had relapse or persistent diseases after treatment, and 21% in each group died of disease. Estimated cumulative survival rates at 2 years were 81% for the NAC arm and 84% for the R/T arm; the 5-year rates were 70% and 61%, respectively. There were no significant differences in disease-free survival and overall survival,Conclusion: NAC followed by radical hysterectomy and primary R/T showed similar efficacy for bulky stage IB or IIA cervical cancer. Further study to identify patient subgroups better suited for either treatment modality and to evaluate the concurrent use of cisplatin and radiation without routine hysterectomy is necessary.J Clin Oncol 18:1740-1747. (C), 2000 by American Society of Clinical Oncology.