Amanda N. Fader, Johns Hopkins School of Medicine; Dana M. Roque, University of Maryland; Paul Celano, Greater Baltimore Medical Center, Baltimore; William Lowery, Walter Reed Medical Center, Bethesda, MD; Eric Siegel, University of Arkansas for Medical Sciences, Little Rock, AR; Natalia Buza, Pei Hui, Osama Abdelghany, Stefania Bellone, Masoud Azodi, Babak Litkouhi, Elena Ratner, Dan-Arin Silasi, Peter E. Schwartz, and Alessandro D. Santin, Yale University School of Medicine, New Haven, CT; Setsuko K. Chambers, University of Arizona, Tucson, AZ; Angeles Alvarez Secord and Laura Havrilesky, Duke University School of Medicine, Durham, NC; David M. O'Malley and Floor Backes, The Ohio State University School of Medicine, Columbus, OH; Nicole Nevadunsky, Montefiore Medical Center, Bronx, NY; Babak Edraki, John Muir Medical Center, Walnut Creek, CA; Dirk Pikaart, Penrose Cancer Center-St Francis, Colorado Springs, CO; and Karim S. ElSahwi, Meridian Health, Neptune, NJ.
J Clin Oncol. 2018 Jul 10;36(20):2044-2051. doi: 10.1200/JCO.2017.76.5966. Epub 2018 Mar 27.
Purpose Uterine serous carcinoma is a rare, aggressive variant of endometrial cancer. Trastuzumab is a humanized monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2)/neu, a receptor overexpressed in 30% of uterine serous carcinoma. This multicenter, randomized phase II trial compared carboplatin-paclitaxel with and without trastuzumab in patients with advanced or recurrent uterine serous carcinoma who overexpress HER2/neu. Methods Eligible patients had primary stage III or IV or recurrent HER2/neu-positive disease. Participants were randomly assigned to receive carboplatin-paclitaxel (control arm) for six cycles with or without intravenous trastuzumab (experimental arm) until progression or unacceptable toxicity. The primary end point was progression-free survival, which was assessed for differences between treatment arms via one-sided log-rank tests. Results From August 2011 to March 2017, 61 patients were randomly assigned. Forty progression-free survival-related events occurred among 58 evaluable participants. Among all patients, median progression-free survival was 8.0 months (control) versus 12.6 months (experimental; P = .005; hazard ratio [HR], 0.44; 90% CI, 0.26 to 0.76). Similarly, median progression-free survival was 9.3 (control) versus 17.9 (experimental) months among 41 patients with stage III or IV disease undergoing primary treatment ( P = .013; HR, 0.40; 90% CI, 0.20 to 0.80) and 6.0 (control) versus 9.2 months (experimental), respectively, among 17 patients with recurrent disease ( P = .003; HR, 0.14; 90% CI, 0.04 to 0.53). Toxicity was not different between treatment arms, and no unexpected safety signals emerged. Conclusion Addition of trastuzumab to carboplatin-paclitaxel was well tolerated and increased progression-free survival. These encouraging results deserve further investigation to determine their impact on overall survival in patients with advanced or recurrent uterine serous carcinoma who overexpress HER2/neu.
目的：子宫浆液性癌是一种罕见的、侵袭性的子宫内膜癌变体。曲妥珠单抗是一种针对人表皮生长因子受体 2（HER2/neu）的人源化单克隆抗体，HER2/neu 在 30%的子宫浆液性癌中过表达。这项多中心、随机的 II 期临床试验比较了卡铂-紫杉醇联合或不联合曲妥珠单抗治疗过表达 HER2/neu 的晚期或复发性子宫浆液性癌患者的疗效。
方法：符合条件的患者为原发性 III 期或 IV 期或复发性 HER2/neu 阳性疾病。参与者被随机分配接受卡铂-紫杉醇（对照组）治疗六个周期，加或不加静脉注射曲妥珠单抗（实验组），直到疾病进展或出现不可接受的毒性。主要终点是无进展生存期，通过单侧对数秩检验评估治疗组之间的差异。
结果：从 2011 年 8 月至 2017 年 3 月，共有 61 名患者被随机分配。在 58 名可评估的参与者中，有 40 例与无进展生存期相关的事件发生。在所有患者中，中位无进展生存期为 8.0 个月（对照组）与 12.6 个月（实验组）（ P =.005；风险比[HR]，0.44；90%CI，0.26 至 0.76）。同样，在接受初始治疗的 41 名 III 期或 IV 期疾病患者中，中位无进展生存期为 9.3 个月（对照组）与 17.9 个月（实验组）（ P =.013；HR，0.40；90%CI，0.20 至 0.80），在 17 名复发性疾病患者中，分别为 6.0 个月（对照组）与 9.2 个月（实验组）（ P =.003；HR，0.14；90%CI，0.04 至 0.53）。治疗组之间的毒性无差异，未出现意外的安全信号。
结论：卡铂-紫杉醇联合曲妥珠单抗耐受性良好，并提高了无进展生存期。这些令人鼓舞的结果值得进一步研究，以确定它们对过表达 HER2/neu 的晚期或复发性子宫浆液性癌患者总生存期的影响。
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