2023年，第59届美国临床肿瘤学会（ASCO）年会将于美国芝加哥当地时间6月2日至6日举行。作为肿瘤界首屈一指的交流盛会，ASCO年会汇聚全球专家学者，重磅前沿进展令人目不暇接。ASCO官网现已公布了本次会议部分的摘要内容，【肿瘤资讯】就NEJ057研究的结果进行报道，该研究旨在探索免疫检查点抑制剂单药或联合化疗一线治疗真实世界中的晚期非小细胞肺癌老年患者的疗效和安全性。
摘要号：9012
原文标题：First-line immune checkpoint inhibitors alone or in combination with chemotherapy in real-life elderly patients with advanced non-small cell lung cancer (NEJ057).
作者信息：
Mao Uematsu, Yoko Tsukita, Takehiro Tozuka, Kohei Kushiro, Shinobu Hosokawa, Toshiyuki Sumi, Osamu Honjo, Ou Yamaguchi, Tetsuhiko Asao, Jun Sugisaka, Go Saito, Jun Shiihara, Ryo Morita, Seigo Katakura, Takehiro Yasuda, Kakeru Hisakane, Eisaku Miyauchi, Satoshi Morita, Kunihiko Kobayashi, Hajime Asahina; Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan; Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan;Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan; Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan; Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama-Shi Kita-Ku, Japan; Department of Respiratory Medicine, Hakodate Goryoukaku Hospital, Hakodate, Japan; Department of Respiratory Medicine, Sapporo Minami-Sanjo Hospital, Sapporo, Japan; Department of Respiratory Medicine, Saiatama Medical University International Medical Center, Hidaka-Shi, Japan; Department of Respiratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan; Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan; Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan; Department of Respiratory Medicine, Jichi Medical University Saitama Medical Center, Saitama, Japan; Department of Respiratory Medicine, Akita Kousei Medical Center, Akita, Japan; Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan; Department of Respieatory Medicine, Yokosuka Kyosai Hospital, Yokosuka, Japan;Department of Pulmonary Medicine and Medical Oncology, Nippon Medical School Tamanagayama Hospital, Tama, Japan; Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan; Department of Pulmonary Medicine, Saitama Medical University International Medical Center, Hidaka, Japan; Department of Respiratory Medicine, Hokkaido University Graduate School of Medicine, Sapporo, Japan
临床试验信息：UMIN000046700
背景
免疫检查点抑制剂（ICI）联合化疗目前是无靶向癌基因改变的非小细胞肺癌（NSCLC）的标准治疗方法。然而，ICI+化疗在75岁或以上患者中的疗效和安全性尚未阐明。本研究的目的是揭示老年患者一线药物的真实选择，并评估ICI+化疗的疗效和安全性。
方法
研究者对2018年12月至2021年3月期间开始一线全身治疗的临床分期为IIIB、IIIC、IV期、术后或放疗复发性NSCLC的连续75岁或以上患者进行了一项多中心（日本58家中心）回顾性队列研究。排除了EGFR突变、ALK重排或一线全身治疗为分子靶向治疗的患者。
结果
共入组1245例患者：中位（范围）年龄78（75-95）岁；女性278例（22%）；367例（29%）ECOG PS 0，680例（55%）PS 1和171例（14%）PS 2；腺癌678例（54%）；PD-L1肿瘤比例评分268例（22%）<1%，387例（31%）1%-49%和410例（34%）≥50%；354例（28%）接受ICI+化疗，425例（34%）接受ICI单药治疗，311例（25%）接受铂类药物双联化疗，155例（12%）接受单药化疗。中位总生存期（OS）在ICI+化疗组中为20.0个月（95%CI，17.1-23.6），在ICI单药组中为19.8个月（95%CI，16.5-23.8），在铂双联化疗组中为12.8个月（95%CI，10.7-15.6），在单药化疗组中为9.5个月（95%CI，7.4-13.4）。倾向评分匹配后，在PD-L1 ≥1%的患者中，ICI+化疗组（n=96）和单药ICI组（n=95）的OS和无进展生存期（PFS）无差异（OS：HR，0.98; 95% CI，0.67-1.42，PFS：HR，0.92; 95%CI，0.67-1.25）。无论PD-L1亚组（1-49%或≥50%）如何，均未观察到OS和PFS的显著差异。关于安全性，ICI+化疗组86例患者（24.3%）和ICI单药组76例患者（17.9%）发生3级或以上免疫相关不良事件（irAE）（p=0.03）。ICI+化疗组需要类固醇治疗irAE的患者数量为115例（32.5%），ICI单药治疗组为105例（24.7%）（p=0.02）。ICI+化疗组83例患者（23.4%）和ICI单药组66例患者（15.6%）报告了肺炎（p=0.006）。
结论
在75岁或以上患者的真实数据中，与ICI单药治疗相比，ICI+化疗未改善生存率，并增加了3级或3级以上irAE的发生率。 据此结果，对于PD-L1阳性NSCLC老年患者，建议单用ICI。
Mao Uematsu, Yoko Tsukita, Takehiro Tozuka,et al.First-line immune checkpoint inhibitors alone or in combination with chemotherapy in real-life elderly patients with advanced non-small cell lung cancer (NEJ057).2023 ASCO abstract.9012.
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