Ma Yijie, Zhao Weijie, Deng Wenying, Wei Chen, Bie Liangyu, Zhang Chi, Li Ning, Luo Suxia
Department of Medical Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
Department of General Surgery, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
Ann Transl Med. 2022 Oct;10(20):1124. doi: 10.21037/atm-22-4809.
A reasonable and effective control of chemotherapy-induced nausea and vomiting (CINV) plays an important role in the comprehensive treatment of cancer. Megestrol belongs to the 17α-hydroxyprogesterone derivative and is a highly effective synthetic progesterone. Recorded in the instructions may improve appetite and cachexia in patients with advanced tumors. In recent years, clinical practice and small sample studies have shown that megestrol combined with chemotherapy can improve CINV. This randomized controlled trial aimed to evaluate the clinical efficacy and safety of megestrol acetate combined with a 5-Hydroxytryptamine (5-HT3) receptor antagonist and dexamethasone in patients with CINV.
Patients with malignant tumors who were treated with cisplatin-containing chemotherapy in our hospital from September 2018 to December 2019 were enrolled. A total of 120 patients were selected and randomly assigned to receive either megestrol acetate dispersible tablets with a 5-HT3 receptor antagonist and dexamethasone (megestrol group) or a 5-HT3 receptor antagonist plus dexamethasone (control group). Megestrol acetate dispersible tablets: 160 mg orally every morning from the day of chemotherapy until it lasts for ten days. Abstract IV of the quality-of-life scale for cancer patients in China was used to assess the quality of life (QOL) of the participants. All adverse reactions during chemotherapy were assessed according to the CTCAE 4.03 evaluation standard issued by the National Cancer Institute and divided into five grades according to severity.
For the control of nausea, the rates of complete prevention were significantly higher in the megestrol group than in the control patients during the delayed [53.3% (31/60) 30.0% (18/60), P=0.012] and overall [40.0% (24/60) 15.0% (9/60), P=0.002] observation periods. Moreover, the megestrol combination treatment group also achieved markedly higher rates of complete remission of vomiting than the control group during the delayed observation period [76.7% (46/60) 51.7% (31/60), P=0.001], achieving an overall higher proportion of remission during the study period [68.3% (41/60) 46.6% (28/60), P=0.0016].
The triple antiemetic protocol using megestrol acetate with a 5-HT3 receptor antagonist plus dexamethasone can improve CINV symptoms caused by highly emetogenic chemotherapy (HEC) with cisplatin, with an excellent control effect and few adverse reactions, especially for delayed CINV.
Chinese Clinical Trial Registry ChiCTR1800017953.
合理有效地控制化疗所致恶心和呕吐（CINV）在癌症综合治疗中具有重要作用。甲地孕酮属于17α-羟孕酮衍生物，是一种高效合成孕激素。药品说明书记载其可改善晚期肿瘤患者的食欲和恶病质。近年来，临床实践及小样本研究表明，甲地孕酮联合化疗可改善CINV。本随机对照试验旨在评估醋酸甲地孕酮联合5-羟色胺（5-HT3）受体拮抗剂及地塞米松治疗CINV患者的临床疗效及安全性。
选取2018年9月至2019年12月在我院接受含顺铂化疗的恶性肿瘤患者。共入选120例患者，随机分为醋酸甲地孕酮分散片联合5-HT3受体拮抗剂及地塞米松组（甲地孕酮组）和5-HT3受体拮抗剂加地塞米松组（对照组）。醋酸甲地孕酮分散片：化疗当日起每天早晨口服160mg，持续10天。采用中国癌症患者生活质量量表第四部分评估参与者生活质量（QOL）。化疗期间所有不良反应均按照美国国立癌症研究所发布的CTCAE 4.03评估标准进行评估，并根据严重程度分为5级。
在延迟观察期[53.3%（31/60）对30.0%（18/60），P = 0.012]和总观察期[40.0%（24/60）对15.0%（9/60），P = 0.002]，甲地孕酮组恶心完全预防率显著高于对照组。此外，在延迟观察期，甲地孕酮联合治疗组呕吐完全缓解率也显著高于对照组[76.7%（46/60）对51.7%（31/60），P = 0.001]，在研究期间总体缓解比例更高[68.3%（41/60）对46.6%（28/60），P = 0.0016]。
醋酸甲地孕酮联合5-HT3受体拮抗剂及地塞米松的三联止吐方案可改善顺铂所致高致吐性化疗（HEC）引起的CINV症状，控制效果良好且不良反应少，尤其对延迟性CINV。
中国临床试验注册中心ChiCTR180,001,
