由于抗癌治疗诱发肺炎的发生率很高，某些指南建议对已有间质性肺病 (ILD) 的患者进行免疫治疗时要谨慎。有必要进行一项前瞻性临床试验，评估化学免疫疗法对小细胞肺癌 (SCLC) 和既往 ILD 患者的安全性。因此，本研究评估了化学免疫治疗对广泛期 (ES)-SCLC 和轻度特发性间质性肺炎 (IIP) 患者的安全性和有效性。在这项多中心前瞻性试验中，ES-SCLC 和既往患有轻度慢性纤维化 IIP 的患者被招募了。轻度 IIP 被定义为排除肺功能不良、明确的常见间质性肺炎 (UIP) 模式以及血液检查中自身抗体阳性。患者每三周接受一次 durvalumab、依托泊苷和卡铂（诱导期），然后每四周接受 1,500 mg durvalumab（维持阶段）。主要终点是重症肺炎的无发生率。分析包括 21 名患者。其中，13 名患者表现出可能的 UIP 模式，而 8 名患者表现出不确定的 UIP 模式。两名患者 (9.5%) 在诱导阶段患有任何级别的肺炎；一名患者患有 1 级肺炎，另一名患者患有 5 级肺炎。在维持阶段没有其他患者出现肺炎。无重症肺炎率为 95.2%（95% 置信区间 (CI)：77.3-99.2%）。中位无进展生存期为 5.5 个月（95% CI：3.6-6.4 个月）。中位总生存期为 10.7 个月（95% CI：6.0 个月未达到）。对于 ES-SCLC 和轻度 IIP 患者，化学免疫疗法是一种可行的治疗方法。版权所有 © 2024 Elsevier B.V。保留所有权利。

Certain guidelines recommend caution when administering immunotherapy in patients with pre-existing interstitial lung disease (ILD) owing to the high incidence of pneumonitis induced by anti-cancer therapy. A prospective clinical trial assessing the safety of chemoimmunotherapy in patients with small-cell lung cancer (SCLC) and pre-existing ILD is warranted. Therefore, this study evaluated the safety and efficacy of chemoimmunotherapy in patients with extensive-stage (ES)-SCLC and mild idiopathic interstitial pneumonia (IIP).In this multicenter prospective trial, patients with ES-SCLC and pre-existing mild chronic fibrosing IIP were recruited. Mild IIP was defined as the exclusion of poor pulmonary function, a definite usual interstitial pneumonia (UIP) pattern, and positivity for autoantibodies in blood tests. The patients received durvalumab, etoposide, and carboplatin every three weeks (induction phase), followed by 1,500 mg durvalumab every four weeks (maintenance phase). The primary endpoint was severe pneumonitis-free rate.Twenty-one patients were included in the analysis. Among them, 13 patients displayed a probable UIP pattern, whereas eight patients exhibited an indeterminate for UIP pattern. Two patients (9.5 %) had pneumonitis of any grade during the induction phase; one had Grade 1 and the other had Grade 5 pneumonitis. No other patient developed pneumonitis during the maintenance phase. The severe pneumonitis-free rate was 95.2 % (95 % confidence interval (CI): 77.3-99.2 %). The median progression-free survival was 5.5 months (95 % CI: 3.6-6.4 months). Median overall survival was 10.7 months (95 % CI: 6.0 months to not reached).Chemoimmunotherapy is a feasible treatment approach for patients with ES-SCLC and mild IIP.Copyright © 2024 Elsevier B.V. All rights reserved.