Durvalumab with etoposide and carboplatin for patients with extensive-stage small cell lung cancer and interstitial lung disease: A multicenter, open-label prospective trial

IF 4.5 2区医学 Q1 ONCOLOGY

Lung Cancer Pub Date : 2024-09-19 DOI:10.1016/j.lungcan.2024.107958

Ryota Shibaki , Daichi Fujimoto , Eisaku Miyauchi , Yoko Tsukita , Ichiro Nakachi , Daisuke Arai , Yoshihiko Sakata , Naoki Shingu , Toshio Shimokawa , Takashi Kijima , Motohiro Tamiya , Sachiko Kawana , Satoshi Hara , Go Saito , Yuki Sato , Toshihide Yokoyama , Shinya Sakata , Yoshihiko Taniguchi , Akito Hata , Hirotaka Matsumoto , Nobuyuki Yamamoto

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引用次数: 0

Abstract

Objectives

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).

Methods

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.

Results

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).

Conclusions

Chemoimmunotherapy is a feasible treatment approach for patients with ES-SCLC and mild IIP.

查看原文本刊更多论文

Durvalumab与依托泊苷和卡铂联合治疗广泛期小细胞肺癌和间质性肺病患者：一项多中心、开放标签前瞻性试验。

目的：由于抗癌疗法诱发肺炎的发生率很高，因此某些指南建议已患间质性肺病（ILD）的患者在使用免疫疗法时应谨慎。有必要开展一项前瞻性临床试验，评估化疗免疫疗法对患有小细胞肺癌（SCLC）和原有间质性肺病的患者的安全性。因此，本研究评估了化疗免疫疗法在广泛期（ES）-SCLC和轻度特发性间质性肺炎（IIP）患者中的安全性和有效性：在这项多中心前瞻性试验中，招募了ES-SCLC患者和原有轻度慢性纤维化IIP患者。轻度 IIP 的定义是排除肺功能不佳、明确的寻常间质性肺炎（UIP）模式以及血液检测中自身抗体阳性。患者每三周接受一次杜伐单抗、依托泊苷和卡铂治疗（诱导期），之后每四周接受一次1500毫克杜伐单抗治疗（维持期）。主要终点是无严重肺炎率：21名患者被纳入分析。其中，13 名患者表现为可能的 UIP 模式，8 名患者表现为不确定的 UIP 模式。两名患者（9.5%）在诱导阶段出现任何程度的肺炎，其中一名患者为一级肺炎，另一名患者为五级肺炎。在维持治疗阶段，没有其他患者出现肺炎。无严重肺炎率为 95.2%（95% 置信区间 (CI)：77.3-99.2%）。无进展生存期中位数为 5.5 个月（95 % 置信区间：3.6-6.4 个月）。中位总生存期为10.7个月（95 % CI：6.0个月至未达到）：化疗免疫疗法是ES-SCLC和轻度IIP患者的可行治疗方法。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Lung Cancer 医学-呼吸系统

CiteScore

9.40

自引率

3.80%

发文量

407

审稿时长

25 days

期刊介绍： Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.