小细胞肺癌的一线化疗免疫疗法：一项双边真实世界研究的结果
First-Line Chemo-Immunotherapy in SCLC: Outcomes of a Binational Real-World Study.
作者信息
Moliner Laura, Zellweger Núria, Schmid Sabine, Bertschinger Martina, Waibel Christine, Cerciello Ferdinando, Froesch Patrizia, Mark Michael, Bettini Adrienne, Häuptle Pirmin, Blum Veronika, Holer Lisa, Hayoz Stefanie, Früh Martin, Ahmed Samreen, Bhagani Shradha, Steele Nicola, Gray Hannah-Leigh, Robinson Stephen D, Davidson Michael, Cox Samantha, Khalid Taha, Geldart Tom R, Nolan Luke, Scott Deborah C, Hennah Lindsay, Newsom-Davis Tom, Rathbone Emma, Handforth Catherine, Denton Arshi, Merchant Shairoz, Blackhall Fiona, Mauti Laetitia A, Califano Raffaele, Rothschild Sacha I
机构信息
Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom.
Department of Medical Oncology, University Hospital Basel, Basel, Switzerland.
出版信息
JTO Clin Res Rep. 2024 Oct 17;6(1):100744. doi: 10.1016/j.jtocrr.2024.100744. eCollection 2025 Jan.
INTRODUCTION
SCLC is characterized by aggressiveness and limited treatment options, especially in extensive-stage SCLC (ES-SCLC). Immunotherapy added to the platinum-etoposide combination has recently become standard in this setting. This retrospective study aims to evaluate the real-world effectiveness of chemo-immunotherapy in patients with ES-SCLC, focusing on subpopulations excluded from clinical trials.
METHODS
A retrospective binational multicenter study was conducted, involving consecutive patients with ES-SCLC from 10 British and 10 Swiss institutions. Patients received platinum-etoposide chemotherapy in combination with immunotherapy (atezolizumab or durvalumab). Patient, tumor, and treatment details were collected. Overall survival (OS), progression-free survival, objective response rate, and safety outcomes were analyzed.
RESULTS
A total of 436 patients were included. One hundred forty-two patients (32.6%) in our cohort would not have been eligible for the pivotal registrational trials owing to an Eastern Cooperative Oncology Group performance status of 2 or higher, autoimmune disease, active brain metastases, or steroid use. Most patients received carboplatin (96.8%) and atezolizumab (97.9%). The median progression-free survival was 5.5 months and the median OS was 9.3 months. The two-year OS was 14%. Patients with liver or bone metastases or an Eastern Cooperative Oncology Group performance status of 2 or higher had worse survival outcomes. Treatment-related adverse events were reported in 222 patients (51%) whereas immune-related adverse events occurred in 95 patients (22%). Three out of five grade 5 immune-related adverse events were caused by pneumonitis.
CONCLUSIONS
To our knowledge, this is the largest real-world cohort of patients treated with chemo-immunotherapy for ES-SCLC. Although one-third of patients would not have been eligible for pivotal trials, the survival outcomes in our cohort are similar to those in registrational trials. In particular, the number of long-term survivors and the safety data are comparable, supporting the use of chemo-immunotherapy as first-line treatment for ES-SCLC in daily clinical practice.
引言
小细胞肺癌（SCLC）具有侵袭性且治疗选择有限，尤其是在广泛期小细胞肺癌（ES-SCLC）中。在铂类-依托泊苷联合方案基础上加用免疫疗法最近已成为这种情况下的标准治疗方法。这项回顾性研究旨在评估化疗联合免疫疗法在ES-SCLC患者中的真实疗效，重点关注被排除在临床试验之外的亚组人群。
方法
开展了一项回顾性双边多中心研究，纳入了来自10家英国机构和10家瑞士机构的连续ES-SCLC患者。患者接受铂类-依托泊苷化疗联合免疫疗法（阿替利珠单抗或度伐利尤单抗）。收集患者、肿瘤及治疗细节。分析总生存期（OS）、无进展生存期、客观缓解率及安全性结果。
结果
共纳入436例患者。由于东部肿瘤协作组（ECOG）体能状态评分为2分或更高、自身免疫性疾病、有症状的脑转移或使用类固醇，我们队列中的142例患者（32.6%）不符合关键注册试验的入选标准。大多数患者接受了卡铂（96.8%）和阿替利珠单抗（97.9%）治疗。中位无进展生存期为5.5个月，中位总生存期为9.3个月。两年总生存率为14%。有肝转移或骨转移或ECOG体能状态评分为2分或更高的患者生存结果较差。222例患者（51%）报告了与治疗相关的不良事件，而95例患者（22%）发生了与免疫相关的不良事件。5例5级与免疫相关的不良事件中有3例由肺炎引起。
结论
据我们所知，这是接受化疗联合免疫疗法治疗ES-SCLC的最大规模真实世界队列。尽管三分之一的患者不符合关键试验的入选标准，但我们队列中的生存结果与注册试验中的结果相似。特别是，长期生存者数量和安全性数据具有可比性，支持化疗联合免疫疗法在日常临床实践中作为ES-SCLC的一线治疗方法使用。
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