Sugisaka Jun, Fujimoto Daichi, Tamiya Motohiro, Hata Akito, Matsumoto Hirotaka, Yokoyama Toshihide, Taniguchi Yoshihiko, Uchida Junji, Sato Yuki, Kijima Takashi, Tanaka Hisashi, Furuya Naoki, Masuda Takeshi, Sakata Yoshihiko, Miyauchi Eisaku, Saito Go, Miura Satoru, Yamaguchi Teppei, Daga Haruko, Sakata Shinya, Yamamoto Nobuyuki, Akamatsu Hiroaki
Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
Department of Respiratory Medicine and Hematology, Hyogo Medical University, Nishinomiya, Japan; Internal Medicine III, Wakayama Medical University, Wakayama, Japan.
Lung Cancer. 2025 Jan;199:108056. doi: 10.1016/j.lungcan.2024.108056. Epub 2024 Dec 9.
Chemoimmunotherapy is the standard first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC); however, its real-world long-term outcomes associated with patient backgrounds are still unclear. We explored this association using an updated large real-world prospective cohort with a minimum follow-up of 3 years.
This prospective cohort study, conducted across 32 hospitals, enrolled patients with ES-SCLC receiving carboplatin, etoposide, and atezolizumab between September 1, 2019 and September 30, 2020. Updated data with a minimum 3-year follow-up period were analyzed. Patients who met eligibility criteria for pivotal phase 3 clinical trials were considered "trial-eligible."
The median (range) time from the treatment initiation to data cutoff (September 30, 2023) was 42.2 (35.8-48.2) months for the enrolled 207 patients. Most patients (89 %) had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients fulfilling the inclusion criteria (132 [64 %]) were categorized as trial-eligible. The 3-year progression-free survival (PFS) probability and overall survival (OS) were 6.1 % and 20.9 %, respectively. The 3-year OS probabilities for trial-eligible and trial-ineligible patients were 26.7 and 9.5 %, respectively. The trial-eligible cohort had a larger percentage of patients achieving a 3-year OS (30/132, 22.7 %) than the trial-ineligible cohort (5/75, 6.7 %) (P = 0.003) CONCLUSIONS: Our study provides the first documentation of the long-term outcomes following chemoimmunotherapy in a large prospective real-world cohort of patients with ES-SCLC. Key eligibility criteria significantly influenced the long-term effectiveness. These findings provide valuable insights into the practical effectiveness of chemoimmunotherapy and clinical decision-making for patients with ES-SCLC.
化疗免疫疗法是广泛期小细胞肺癌（ES-SCLC）的标准一线治疗方法；然而，其与患者背景相关的真实世界长期疗效仍不明确。我们使用了一个更新的大型真实世界前瞻性队列进行研究，该队列的最短随访时间为3年。
这项前瞻性队列研究在32家医院开展，纳入了在2019年9月1日至2020年9月30日期间接受卡铂、依托泊苷和阿替利珠单抗治疗的ES-SCLC患者。对最短随访期为3年的更新数据进行了分析。符合关键3期临床试验资格标准的患者被视为“符合试验条件”。
纳入的207例患者从治疗开始到数据截止（2023年9月30日）的中位（范围）时间为42.2（35.8 - 48.2）个月。大多数患者（89%）东部肿瘤协作组体能状态为0或1。符合纳入标准的患者（132例[64%]）被归类为符合试验条件。3年无进展生存期（PFS）概率和总生存期（OS）分别为6.1%和20.9%。符合试验条件和不符合试验条件的患者3年OS概率分别为26.7%和9.5%。符合试验条件的队列中达到3年OS的患者比例（30/132，22.7%）高于不符合试验条件的队列（5/75，6.7%）（P = 0.003）。结论：我们的研究首次记录了在一个大型前瞻性真实世界ES-SCLC患者队列中化疗免疫疗法后的长期疗效。关键资格标准显著影响长期疗效。这些发现为化疗免疫疗法的实际疗效以及ES-SCLC患者的临床决策提供了有价值的见解。
