Mochizuki Eisuke, Matsuura Shun, Koshimizu Naoki, Kojima Suguru, Sakurai Shogo, Kishimoto Satoshi, Niwa Mitsuru, Watanuki Masayuki, Inaba Ryunosuke, Takuma Sho, Inoue Yusuke, Karayama Masato, Inui Naoki, Suda Takafumi
Department of Respiratory Medicine, Fujieda Municipal General Hospital, 4-1-11 Surugadai, Fujieda, Shizuoka, Japan.
Department of Respiratory Medicine, Fujieda Municipal General Hospital, 4-1-11 Surugadai, Fujieda, Shizuoka, Japan.
Cancer Treat Res Commun. 2025;44:100972. doi: 10.1016/j.ctarc.2025.100972. Epub 2025 Jul 26.
Platinum-based chemotherapy combined with immune checkpoint inhibitor therapy has recently been introduced for treating extensive-stage small-cell lung cancer (ES-SCLC). In the Phase III CASPIAN study, first-line etoposide (Etoposide) with cisplatin / carboplatin (EP) plus durvalumab significantly improved survival in patients with ES-SCLC. However, it included few Japanese patients, underscoring the need for evaluating the efficacy and safety of this treatment specifically in the Japanese population.
Patients with treatment-naïve ES-SCLC were retrospectively investigated at eight hospitals in Japan, between August 1, 2020 and December 31, 2023. They received EP plus durvalumab (four cycles) every 3 weeks, followed by maintenance durvalumab every 4 weeks until disease progression. The primary endpoint was safety, while the secondary endpoints were overall survival, progression-free survival, objective response rate, and disease control rate.
Sixty-nine patients aged 48-91 years (median: 72 years) were included. Most had an Eastern Cooperative Oncology Group performance status of 0 or 1. Grade ≥3 adverse events occurred in 72.5 % of patients and immune-related adverse events in 21.7 %. The median overall survival was 15.0 months (95 % confidence interval: 11.6-20.0), while the median progression-free survival was 5.0 months (95 % confidence interval: 4.3-5.8). Objective response and disease control rates were 75.4 % and 92.8 %, respectively.
First-line EP plus durvalumab was effective and well tolerated in Japanese patients with ES-SCLC in a real-world setting aligning with findings of global studies. This regimen should be considered the standard of care for Japanese patients with ES-SCLC.
基于铂类的化疗联合免疫检查点抑制剂疗法最近已被用于治疗广泛期小细胞肺癌（ES-SCLC）。在III期CASPIAN研究中，一线依托泊苷联合顺铂/卡铂（EP）加度伐利尤单抗显著改善了ES-SCLC患者的生存率。然而，该研究纳入的日本患者较少，这凸显了专门评估这种治疗在日本人群中的疗效和安全性的必要性。
对2020年8月1日至2023年12月31日期间在日本8家医院接受治疗的初治ES-SCLC患者进行回顾性研究。他们每3周接受一次EP加度伐利尤单抗（4个周期）治疗，随后每4周接受一次度伐利尤单抗维持治疗，直至疾病进展。主要终点是安全性，次要终点是总生存期、无进展生存期、客观缓解率和疾病控制率。
纳入了69例年龄在48 - 91岁（中位数：72岁）的患者。大多数患者的东部肿瘤协作组体能状态为0或1。72.5%的患者发生了≥3级不良事件，21.7%的患者发生了免疫相关不良事件。中位总生存期为15.0个月（95%置信区间：11.6 - 20.0），而中位无进展生存期为5.0个月（95%置信区间：4.3 - 5.8）。客观缓解率和疾病控制率分别为75.4%和92.8%。
在真实世界环境中，一线EP加度伐利尤单抗对日本ES-SCLC患者有效且耐受性良好，这与全球研究结果一致。该方案应被视为日本ES-SCLC患者的标准治疗方案。
