 子宫内膜癌的初期治疗是手术，包括全子宫切除术。复发的危险因素包括深部肌层浸润、宫颈间质浸润、淋巴血管浸润、肿瘤组织学、宫外进展和远处转移。对于有危险因素的患者，建议术后辅助治疗以降低复发风险。紫杉醇联合铂治疗晚期或复发性子宫内膜癌的疗效已得到证实; 然而，还没有对其在子宫内膜癌的术后辅助化疗中的疗效进行评估的研究。 1.最新发现 今年3月JAMA oncology发表了一项由日本庆应大学医学院领头完成的随机临床试验，为评价紫杉烷联合铂与标准阿霉素联合顺铂作为子宫内膜癌术后辅助化疗的临床疗效差异。在这个多中心、非盲、3期随机临床试验中，两种患者被纳入研究：子宫内膜癌高危阶段I或II或III或IV期且肿瘤没有超出腹腔范围的，以及生长有2厘米或更大的残余肿瘤的。患者数据来自118个日本机构，数据时间从2006年11月24日到2011年1月7日。数据分析时间为2017年3月15日至2017年6月30日。 符合条件的患者被随机分配到各组(1:1:1)，分别于第1天接受6个周期的阿霉素(60 mg/m2)联合顺铂(50 mg/m2)治疗; 或多西他赛70 mg/m2，加顺铂60 mg/m2; 或紫杉醇180 mg/m2，加卡铂(曲线下面积，6.0 mg/mL×min)，每3周1次。疗效评价的主要标准是无进展生存时间。次要标准为总生存率、不良事件发生率、耐受性和淋巴结清扫情况。  共788例符合条件的患者，中位年龄(SD)为59岁(22-74岁); 其中263例患者给予阿霉素加顺铂治疗，263例给予多西紫杉醇加顺铂治疗，262例给予紫杉醇加卡铂治疗。未完成6个周期的患者中，阿霉素联合顺铂组53例(20.1%)，多西他赛联合顺铂组45例(17.1%)，紫杉醇联合卡铂组63例(24.0%)。这些方案的耐受性无统计学差异。中位随访7年后，无进展生存期的差别没有统计学意义(阿霉素联合顺铂，191; 多西他赛加顺铂，208; 紫杉醇加卡铂，187; P = .12)总生存率的结果亦然(阿霉素加顺铂，217; 多西他赛加顺铂，223; 紫杉醇加卡铂，215; 3组中P = .67)。阿霉素联合顺铂组5年无进展生存率为73.3%，多西他赛联合顺铂组为79.0%，紫杉醇联合卡铂组为73.9%，5年总生存率分别为82.7%、88.1%和86.1%。  子宫内膜癌术后辅助化疗阿霉素联合顺铂、多西他赛联合顺铂、紫杉醇联合卡铂患者生存率无显著差异。阿霉素联合顺铂依然可作为子宫内膜癌术后标准辅助化疗方案。研究涉及的每个方案都显示出足够的耐受性，但存在不同的毒性作用，因此在特定情况下，紫杉醇联合铂方案可能会是一个合理的替代治疗方案。 2.摘要原文 Importance The efficacy of taxane plus platinum regimens has been demonstrated for advanced or recurrent endometrial cancer; however, it has not been assessed in postoperative adjuvant chemotherapy for endometrial cancer. Objective To evaluate the clinical benefit of taxane plus platinum compared with standard doxorubicin plus cisplatin as postoperative adjuvant chemotherapy in endometrial cancer. Design, Setting, and Participants In this multicenter, open-label, phase 3 randomized clinical trial, patients with endometrial cancer at high-risk stage I or II or stage III or IV that did not extend beyond the abdominal cavity and had 2 cm or greater residual tumor were included from 118 institutions in Japan from November 24, 2006, to January 7, 2011. Data was analyzed from March 15, 2017, to June 30, 2017. Interventions Eligible patients were randomly assigned (1:1:1) to receive 6 cycles of doxorubicin, 60 mg/m2, plus cisplatin, 50 mg/m2, on day 1; docetaxel, 70 mg/m2, plus cisplatin, 60 mg/m2, on day 1; or paclitaxel, 180 mg/m2, plus carboplatin (area under the curve, 6.0 mg/mL × min) on day 1 every 3 weeks. Main Outcomes and Measures The primary end point was progression-free survival. Secondary end points were overall survival, occurrence of adverse events, tolerability, and status of lymph node dissection. Results Among 788 eligible patients, the median (SD) age was 59 (22-74) years; 263 patients were assigned to doxorubicin plus cisplatin treatment, 263 patients to docetaxel plus cisplatin treatment, and 262 patients to paclitaxel plus carboplatin treatment. The number of patients who did not complete 6 cycles was 53 (20.1%) for the doxorubicin plus cisplatin group, 45 (17.1%) for the docetaxel plus cisplatin group, and 63 (24.0%) for the paclitaxel plus carboplatin group. Tolerability of these regimens were not statistically different. After a median follow-up period of 7 years, there was no statistical difference of progression-free survival (doxorubicin plus cisplatin, 191; docetaxel plus cisplatin, 208; paclitaxel plus carboplatin, 187; P = .12) or overall survival (doxorubicin plus cisplatin, 217; docetaxel plus cisplatin, 223; paclitaxel plus carboplatin, 215; P = .67) among the 3 groups. The 5-year progression-free survival rate was 73.3% for the doxorubicin plus cisplatin group, 79.0% for the docetaxel plus cisplatin group, and 73.9% for the paclitaxel plus carboplatin group, while the 5-year overall survival rates were 82.7%, 88.1%, and 86.1%, respectively. Conclusions and Relevance There was no significant difference of survival among patients receiving doxorubicin plus cisplatin, docetaxel plus cisplatin, or paclitaxel plus carboplatin as postoperative adjuvant chemotherapy for endometrial cancer. Because each regimen showed adequate tolerability but different toxic effects, taxane plus platinum regimens may be a reasonable alternative to treatment with doxorubicin plus cisplatin. 3.参考文献 NOMURA H, AOKI D, MICHIMAE H, et al. Effect of Taxane Plus Platinum Regimens vs Doxorubicin Plus Cisplatin as Adjuvant Chemotherapy for Endometrial Cancer at a High Risk of Progression[J]. JAMA Oncology, 2019,5(6):833. 编辑：Terrell 文字：Janine |
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