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依托泊苷联合洛铂或依托泊苷联合顺铂同步胸部放疗治疗局限期小细胞肺癌的随机II期研究初步结果

Preliminary results of randomized phase II study of etoposide plus lobaplatin or etoposide plus cisplatin with concurrent thoracic radiotherapy in the treatment of limited-stage small cell lung cancer.

作者信息

Wang Mengfan, Ma Zhu, Li Qingsong, Yang Wengang, Chen Xiaxia, Geng Yichao, Luo Daxian, Hu Yinxiang, Wu Bibo, Jiang Wei, Su Shengfa, Ouyang Weiwei, Lu Bing

机构信息

Department of Oncology, The Affiliated Hospital of Guizhou Medical University.

Department of Oncology, The Affiliated Cancer Hospital of Guizhou Medical University.

出版信息

Anticancer Drugs. 2023 Nov 1;34(10):1183-1189. doi: 10.1097/CAD.0000000000001501. Epub 2023 Jan 24.

DOI:10.1097/CAD.0000000000001501
PMID:36727741
Abstract

The purpose is to compare the clinical efficacy and toxicity of etoposide plus lobaplatin (EL) or etoposide plus cisplatin (EP) with concurrent thoracic radiotherapy during the treatment of limited-stage small cell lung cancer (LS-SCLC). Forty-two patients with LS-SCLC were randomly divided into EL ( n = 19) or EP ( n = 23) regimens combined with thoracic intensity-modulated radiotherapy. The primary endpoint was 1-year progression-free survival (PFS) rate. The 1-, 2-, and 3-year PFS rates in the EL and EP cohorts were 50.8, 38.1, and 12.7%; and 56.5, 43.5, and 29.0%, respectively ( P = 0.527), whereas the 1-, 2-, and 3-year overall survival (OS) rates were 72.2, 52.5, and 43.8%; and 73.9, 48.4, and 48.4%, respectively ( P = 0.923). The hematological toxicities were similar in two cohorts. However, gastrointestinal reactions were more severe in the EP group. The incidence of nausea and vomiting in EL and EP cohorts were 31.6% vs. 73.9% ( P = 0.006) and 20.1% vs. 60.9% ( P = 0.009), respectively. The two cohorts did not show ≥grade 4 radiation esophagitis and ≥grade 3 radiation pneumonitis. The incidence of acute radiation esophagitis in EL group was lower ( P = 0.038), both groups showed a similar incidence of radiation pneumonitis ( P = 1.000). EL or EP chemotherapy with concurrent thoracic radiotherapy showed similar PFS and OS. The EL group showed milder gastrointestinal toxicity and radiation esophagitis. Radiation pneumonitis and hematological toxicity were similar in the two regimens, which can be tolerated by patients.

摘要

目的是比较依托泊苷联合洛铂(EL)或依托泊苷联合顺铂(EP)同步胸部放疗在局限期小细胞肺癌(LS-SCLC)治疗中的临床疗效和毒性。42例LS-SCLC患者被随机分为EL方案组(n = 19)或EP方案组(n = 23),并联合胸部调强放疗。主要终点是1年无进展生存期(PFS)率。EL组和EP组的1年、2年和3年PFS率分别为50.8%、38.1%和12.7%;以及56.5%、43.5%和29.0%(P = 0.527),而1年、2年和3年总生存期(OS)率分别为72.2%、52.5%和43.8%;以及73.9%、48.4%和48.4%(P = 0.923)。两组的血液学毒性相似。然而,EP组的胃肠道反应更严重。EL组和EP组恶心和呕吐的发生率分别为31.6%对73.9%(P = 0.006)和20.1%对60.9%(P = 0.009)。两组均未出现≥4级放射性食管炎和≥3级放射性肺炎。EL组急性放射性食管炎的发生率较低(P = 0.038),两组放射性肺炎的发生率相似(P = 1.000)。EL或EP化疗同步胸部放疗显示出相似的PFS和OS。EL组的胃肠道毒性和放射性食管炎较轻。两种方案的放射性肺炎和血液学毒性相似,患者可以耐受。

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