Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102).
Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102).
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DOI：
10.1038/bjc.2013.179
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发表时间：
2013-05-28
影响因子：
8.8
通讯作者：
Japan Clinical Oncology Group
中科院分区：
文献类型：
--
作者：
Katsumata N;Yoshikawa H;Kobayashi H;Saito T;Kuzuya K;Nakanishi T;Yasugi T;Yaegashi N;Yokota H;Kodama S;Mizunoe T;Hiura M;Kasamatsu T;Shibata T;Kamura T;Japan Clinical Oncology Group
进行了一项III期试验，以确定根治性手术（RS）前新辅助化疗（NACT）是否能提高总生存率。IB2、IIA2或IIB期宫颈鳞状细胞癌患者被随机分配接受BOMP（博来霉素7 mg天- 1-5，新碱0.7 mg m - 2天- 5，丝裂霉素7 mg m - 2天- 5，顺铂14 mg m - 2天- 1-5，每3周，2至4个周期）加RS （NACT组）或单独RS （RS组）。有病理性高危因素的患者行术后放疗。主要终点为总生存期。共有134名患者被随机分配到治疗组。这项研究在第一次计划的中期分析中过早终止，因为NACT组的总生存率低于RS组。术后接受RT的患者NACT组（58%）明显低于RS组（80% P=0.015）。NACT组5年总生存率为70.0%，RS组为74.4% （P=0.85）。RS前BOMP方案的新辅助化疗没有提高总生存率，但减少了术后接受RT的患者数量。
A phase III trial was conducted to determine whether neoadjuvant chemotherapy (NACT) before radical surgery (RS) improves overall survival. Patients with stage IB2, IIA2, or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7 mg days 1–5, vincristine 0.7 mg m−2 day 5, mitomycin 7 mg m−2 day 5, cisplatin 14 mg m−2 days 1–5, every 3 weeks for 2 to 4 cycles) plus RS (NACT group) or RS alone (RS group). Patients with pathological high-risk factors received postoperative radiotherapy (RT). The primary end point was overall survival. A total of 134 patients were randomly assigned to treatment. This study was prematurely terminated at the first planned interim analysis because overall survival in the NACT group was inferior to that in the RS group. Patients who received postoperative RT were significantly lower in the NACT group (58%) than in the RS group (80% P=0.015). The 5-year overall survival was 70.0% in the NACT group and 74.4% in the RS group (P=0.85). Neoadjuvant chemotherapy with BOMP regimen before RS did not improve overall survival, but reduced the number of patients who received postoperative RT.
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