中国晚期黑色素瘤患者抗癌治疗的真实世界临床结果:回顾性观察性研究

C. Cui, Xieqiao Yan, Shusen Liu, A. Deitz, L. Si, Z. Chi, X. Sheng, B. Lian, Jian-fang Li, J. Ge, Xuan Wang, L. Mao, B. Tang, Li Zhou, X. Bai, Si-ming Li, Ben Li, Haiyan Wu, Jun Guo
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Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Results: Of 248 eligible patients, 221 and 116 were treated with anticancer therapies in first-line and second-line settings, respectively (89 received both at BCH). Approximately 95% of patients had stage IV melanoma; 40.7% had acral melanoma, and 30.6% had mucosal histology. By data cutoff, 195 of 248 (78.6%) patients had died. Median OS for all patients was 10.5 months; 12-month OS rate was 43.9%. In the first-line setting, the objective response rate was 6.3% (95% confidence interval, 3.5%–10.4%) and the median duration of response was 9.1 months. Median PFS was 3.5 months and 12-month PFS rate was 10.6%; median OS was 10.5 months and 12-month OS rate was 43.5%. In the second-line setting, objective response rate was 3.4% (95% confidence interval, 0.9%–8.6%) and median duration of response was 7.5 months. 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引用次数: 3

摘要

在中国,晚期黑色素瘤的治疗方案缺乏,特别是二线治疗。这项回顾性观察性研究的目的是描述中国局部晚期/转移性黑色素瘤患者可用抗癌疗法的实际有效性。方法:纳入2014年1月1日至2015年12月31日在北京肿瘤医院(BCH)接受治疗的无法切除的III期或IV期黑色素瘤成年患者(数据截止日期:2017年12月31日)。数据来自患者的电子病历。应答者根据实体瘤应答评价标准(1.1版)进行判定。使用Kaplan-Meier法估计无进展生存期(PFS)和总生存期(OS)。结果:在248例符合条件的患者中,221例和116例分别在一线和二线环境中接受了抗癌治疗(89例在BCH接受了两种治疗)。大约95%的患者患有IV期黑色素瘤;40.7%有肢端黑色素瘤,30.6%有粘膜组织学。截至数据截止,248例患者中有195例(78.6%)死亡。所有患者的中位OS为10.5个月;12个月OS率为43.9%。在一线治疗中,客观缓解率为6.3%(95%可信区间为3.5%-10.4%),中位缓解持续时间为9.1个月。中位PFS为3.5个月,12个月PFS率为10.6%;中位OS为10.5个月,12个月OS率为43.5%。在二线治疗中,客观缓解率为3.4%(95%可信区间,0.9%-8.6%),中位缓解持续时间为7.5个月。中位PFS为2.3个月,12个月PFS率为5.2%;中位OS为7.5个月,12个月OS率为30.5%。结论:在中国,一线和二线抗癌治疗似乎与晚期黑色素瘤不理想的临床结果相关,表明需要有效的治疗方法。
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Real-world clinical outcomes of anticancer treatments in patients with advanced melanoma in China: retrospective, observational study
Introduction: Treatment options for advanced melanoma in China are lacking, particularly second-line therapies. The aim of this retrospective observational study was to describe the real-world effectiveness of available anticancer therapies in patients with locally advanced/metastatic melanoma in China. Methods: Adult patients with unresectable stage III or IV melanoma treated between January 1, 2014, and December 31, 2015, at the Beijing Cancer Hospital (BCH) were eligible (data cutoff: December 31, 2017). Data were obtained from patient electronic medical records. Responders were adjudicated per Response Evaluation Criteria in Solid Tumors, version 1.1. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Results: Of 248 eligible patients, 221 and 116 were treated with anticancer therapies in first-line and second-line settings, respectively (89 received both at BCH). Approximately 95% of patients had stage IV melanoma; 40.7% had acral melanoma, and 30.6% had mucosal histology. By data cutoff, 195 of 248 (78.6%) patients had died. Median OS for all patients was 10.5 months; 12-month OS rate was 43.9%. In the first-line setting, the objective response rate was 6.3% (95% confidence interval, 3.5%–10.4%) and the median duration of response was 9.1 months. Median PFS was 3.5 months and 12-month PFS rate was 10.6%; median OS was 10.5 months and 12-month OS rate was 43.5%. In the second-line setting, objective response rate was 3.4% (95% confidence interval, 0.9%–8.6%) and median duration of response was 7.5 months. Median PFS was 2.3 months and 12-month PFS rate was 5.2%; median OS was 7.5 months and 12-month OS rate was 30.5%. Conclusion: In China, first-line and second-line anticancer therapy seems to be associated with suboptimal clinical outcomes in advanced melanoma, indicating a need for effective therapies.
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