Sakai Kosuke, Ishii Shigeru, Yokosuka Shin, Takahashi Tomoyuki, Kawano Yuichiro, Nishimura Hiroaki, Kuwabara Yoshiki, Sasaki-Toda Maiko, Ogawa-Kobayashi Yumiko, Kikuchi Satoshi, Hirata Yusuke, Kyoyama Hiroyuki, Moriyama Gaku, Koyama Nobuyuki, Uematsu Kazutsugu
Department of Pulmonary Medicine, Saitama Medical Center, Saitama Medical University, Saitama, Japan.
Cancer Med. 2025 Sep;14(17):e71136. doi: 10.1002/cam4.71136.
The prognosis of small-cell lung cancer (SCLC) remains poor, particularly in patients with extensive-stage SCLC. The IMpower133 and CASPIAN trials revealed the efficacy of immune checkpoint inhibitors (ICIs) in extensive-stage SCLC patients with good performance status (PS). The aim of this study was to investigate the efficacy of ICIs in patients with poor PS.
Patients with extensive-stage SCLC who visited Saitama Medical Center, Saitama Medical University (Kawagoe, Japan) (September 2019-December 2022) were enrolled and followed up until February 2024. Objective response rate (ORR) and overall survival (OS) were compared between patients who received platinum-based doublet chemotherapy with an ICI (atezolizumab or durvalumab; ICI group) and those treated with platinum-based doublet chemotherapy alone (non-ICI group). Results were stratified by the Eastern Cooperative Oncology Group performance status (ECOG-PS) (i.e., 0-1 and 2-3).
A total of 74 patients were included in the study (median OS: 327 days). In patients with ECOG-PS 0-1, ORR was 76.5% and 56.5% in the ICI group (n = 17) and non-ICI group (n = 23), respectively; OS was 406 and 379 days, respectively. In patients with ECOG-PS 2-3, ORR was 93.3% and 56.3% in the ICI group (n = 15) and non-ICI group (n = 16), respectively; OS was 446 days and 169 days, respectively. This evidence indicates that the addition of an ICI significantly improved OS (p = 0.00661) and enhanced ORR.
In patients with extensive-stage SCLC and ECOG-PS 2-3, the addition of atezolizumab or durvalumab to platinum-doublet chemotherapies improved the ORR, resulting in a better prognosis. These findings suggest that chemoimmunotherapy may be a feasible treatment option beyond the ideal clinical trial populations, addressing an unmet clinical need.
小细胞肺癌（SCLC）的预后仍然很差，尤其是广泛期SCLC患者。IMpower133和CASPIAN试验揭示了免疫检查点抑制剂（ICI）在体能状态（PS）良好的广泛期SCLC患者中的疗效。本研究的目的是调查ICI在PS较差患者中的疗效。
纳入2019年9月至2022年12月期间就诊于日本埼玉医科大学埼玉医疗中心（川越）的广泛期SCLC患者，并随访至2024年2月。比较接受含ICI的铂类双联化疗（阿替利珠单抗或度伐利尤单抗；ICI组）的患者与仅接受铂类双联化疗的患者（非ICI组）的客观缓解率（ORR）和总生存期（OS）。结果按东部肿瘤协作组体能状态（ECOG-PS）分层（即0-1和2-3）。
本研究共纳入74例患者（中位OS：327天）。在ECOG-PS为0-1的患者中，ICI组（n = 17）和非ICI组（n = 23）的ORR分别为76.5%和56.5%；OS分别为406天和379天。在ECOG-PS为2-3的患者中，ICI组（n = 15）和非ICI组（n = 16）的ORR分别为93.3%和56.3%；OS分别为446天和169天。这一证据表明，添加ICI显著改善了OS（p = 0.00661）并提高了ORR。
在广泛期SCLC和ECOG-PS为2-3的患者中，在铂类双联化疗中添加阿替利珠单抗或度伐利尤单抗可提高ORR，从而改善预后。这些发现表明，化疗免疫疗法可能是理想临床试验人群之外的一种可行治疗选择，满足了未满足的临床需求。
