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2019-12-25 农历十一月二十八 每天精选一篇文献，陪你度过2019的365天 知识城邦，从临床医生视角，让你了解最前沿的胸部肿瘤研究进展 （总第364篇）    璀璨的星光闪耀着吉祥，平安的钟声传递着和谐，愿圣诞之光照亮您的每一天。 知识城邦祝您圣诞节快乐! 奥希替尼治疗含有少见EGFR突变的非小细胞患者肺癌：多中心，开放标签的II期试验（KCSG-LU15-09） — 结论— 奥希替尼在少见的EGFR突变的非小细胞肺癌患者中显示出良好的治疗活性和可控的毒副作用。 Osimertinib demonstrated favorable activity with manageable toxicity in patients with NSCLC harboring uncommon EGFR mutations. — 背景— 大约10%的EGFR突变阳性的非小细胞肺癌患者具有罕见的突变类型。在这里，我们报告了奥希替尼治疗具有这些少见EGFR突变的NSCLC患者的疗效和安全性。 Approximately 10% of patients with epidermal growth factor receptor (EGFR) mutation–positive non–small-cell lung cancer (NSCLC) harbor uncommon mutations. Here, we report the efficacy and safety of osimertinib in patients with NSCLC harboring uncommon EGFR mutations. — 方法— 这是一项在韩国开展的多中心、单臂、开放标签的II期研究。经组织学确诊为转移性或复发性NSCLC患者，除19号外显子缺失、L858R和T790M突变以及20号外显子插入以外的EGFR突变类型患者均符合研究入组条件。以客观缓解率为主要研究终点，根据1.1版的实体瘤疗效评价标准（RECIST）每6周评估一次。次要研究终点是无进展生存时间、总生存时间、反应持续时间和安全性。 This was a multicenter, single-arm, open-label, phase II study in Korea. Patients with histologically confirmed metastatic or recurrent NSCLC harboring EGFR mutations other than the exon 19 deletion, L858R and T790M mutations, and exon 20 insertion were eligible for the study. The primary end point of objective response rate was assessed every 6 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary end points were progression-free survival, overall survival, duration of response, and safety. —结果— 在2016年3月至2017年10月期间，共入组了37名患者。除一名患者在开始治疗后撤回同意外，其余患者均可进行评估。 患者中位年龄为60岁，男性22人（61%）。在这些患者中，61%的人接受奥希替尼作为一线治疗。 所鉴定的突变类型最常见的为G719X（n=19；53%），其次是L861Q（n=9；25%），S768I（n=8；22%）和其他类型（n=4；11%）。 客观缓解率为50%（18/36，95%CI，33%-67%）。中位无进展生存时间为8.2个月（95%可信区间为5.9-10.5个月），未达到中位总生存时间。中位缓解时间为11.2个月（95%可信区间为7.7-14.7个月）。 各级别的不良事件包括皮疹（n=11；31%）、瘙痒（n=9；25%）、食欲下降（n=9；25%）、腹泻（n=8；22%）和呼吸困难（n=8；22%），但所有不良事件都在可控范围内。 Between March 2016 and October 2017, 37 patients were enrolled. All were evaluable except one patient who withdrew consent after starting treatment. Median age was 60 years, and 22 (61%) were male. Among patients, 61% received osimertinib as first-line therapy. The mutations identified were G719X (n = 19; 53%), followed by L861Q (n = 9; 25%), S768I (n = 8; 22%), and others (n = 4; 11%). Objective response rate was 50% (18 of 36 patients; 95% CI, 33% to 67%). Median progression-free survival was 8.2 months (95% CI, 5.9 to 10.5 months), and median overall survival was not reached. Median duration of response was 11.2 months (95% CI, 7.7 to 14.7 months). Adverse events of any grade were rash (n = 11; 31%), pruritus (n = 9; 25%), decreased appetite (n = 9; 25%), diarrhea (n = 8; 22%), and dyspnea (n = 8; 22%), but all adverse events were manageable. —附图— TABLE 1. Activity of Osimertinib in Specific Uncommon Mutations. TABLE 2. All Adverse Events Regardless of Relationship with Osimertinib. 编辑：SOA 美术设计：SOA ?知识城邦 苟日新，日日新 |
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