Chen Lili, Xi Ling, Jiang Jie, Yin Rutie, Qu Pengpeng, Li Xiuqin, Wan Xiaoyun, Chen Yaxia, Hu Dongxiao, Mao Yuyan, Pan Zimin, Cheng Xiaodong, Wang Xinyu, Li Qingli, Weng Danhui, Zhang Xi, Zhang Hong, Ping Quanhong, Liu Xiaomei, Xie Xing, Kong Beihua, Ma Ding, Lu Weiguo
Department of Gynecological Oncology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, 310006 s, China.
Department of Obstetrics and Gynecology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China.
Front Med. 2022 Apr;16(2):276-284. doi: 10.1007/s11684-021-0855-4. Epub 2021 Jun 28.
We aimed to evaluate the effectiveness and safety of single-course initial regimens in patients with low-risk gestational trophoblastic neoplasia (GTN). In this trial (NCT01823315), 276 patients were analyzed. Patients were allocated to three initiated regimens: single-course methotrexate (MTX), single-course MTX + dactinomycin (ACTD), and multi-course MTX (control arm). The primary endpoint was the complete remission (CR) rate by initial drug(s). The primary CR rate was 64.4% with multi-course MTX in the control arm. For the single-course MTX arm, the CR rate was 35.8% by one course; it increased to 59.3% after subsequent multi-course MTX, with non-inferiority to the control (difference -5.1%,95% confidence interval (CI) -19.4% to 9.2%, P = 0.014). After further treatment with multi-course ACTD, the CR rate (93.3%) was similar to that of the control (95.2%, P = 0.577). For the single-course MTX + ACTD arm, the CR rate was 46.7% by one course, which increased to 89.1% after subsequent multi-course, with non-inferiority (difference 24.7%, 95% CI 12.8%-36.6%, P < 0.001) to the control. It was similar to the CR rate by MTX and further ACTD in the control arm (89.1% vs. 95.2%, P =0.135). Four patients experienced recurrence, with no death, during the 2-year follow-up. We demonstrated that chemotherapy initiation with single-course MTX may be an alternative regimen for patients with low-risk GTN.
我们旨在评估单疗程初始方案治疗低危妊娠滋养细胞肿瘤（GTN）患者的有效性和安全性。在本试验（NCT01823315）中，对276例患者进行了分析。患者被分配到三种初始方案：单疗程甲氨蝶呤（MTX）、单疗程MTX + 放线菌素D（ACTD）和多疗程MTX（对照组）。主要终点是初始药物的完全缓解（CR）率。对照组多疗程MTX的主要CR率为64.4%。单疗程MTX组，一个疗程后的CR率为35.8%；后续多疗程MTX后增至59.3%，与对照组无差异（差异-5.1%，95%置信区间（CI）-19.4%至9.2%，P = 0.014）。多疗程ACTD进一步治疗后，CR率（93.3%）与对照组（95.2%，P = 0.577）相似。单疗程MTX + ACTD组，一个疗程后的CR率为46.7%，后续多疗程后增至89.1%，与对照组无差异（差异24.7%，95% CI 12.8%-36.6%，P < 0.001）。与对照组MTX及后续ACTD的CR率相似（89.1%对95.2%，P = 0.135）。在2年随访期间，4例患者复发，无死亡病例。我们证明，对于低危GTN患者，单疗程MTX起始化疗可能是一种替代方案。
