durvalumab具有依托泊苷和卡泊素的杜瓦卢姆布，用于大型小细胞肺癌和间质性肺部疾病的患者：多中心，开放标签的前瞻性试验
Durvalumab with etoposide and carboplatin for patients with extensive-stage small cell lung cancer and interstitial lung disease: A multicenter, open-label prospective trial
影响因子:4.40000
分区:医学2区 / 肿瘤学3区 呼吸系统3区
发表日期:2024 Oct
作者:
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, Teppei Yamaguchi, Nobuyuki Yamamoto
摘要
某些指南建议在患有抗癌治疗引起的肺炎高发病率的高发病率的患者中进行免疫疗法时要谨慎。一项评估化学免疫疗法在小细胞肺癌（SCLC）和先前存在的ILD患者中的前瞻性临床试验是有必要的。因此，这项研究评估了化学免疫疗法在广泛的（ES）-SCLC和轻度特发性间质性肺炎（IIP）的患者中的安全性和功效。在这项多中心前瞻性试验中，ES-SCLC患者患有ES-SCLC和预先存在的轻度纤维纤维IIP患者。温和的IIP被定义为排除较差的肺功能，确定的常规间质性肺炎（UIP）模式，并且在血液检查中自身抗体的阳性。患者每三周（诱导阶段）接受每三周1,500毫克杜瓦卢马布（维持阶段），然后接受每三周1,500 mg杜瓦卢马布（维持阶段）接受杜瓦卢马布，依托泊苷和卡泊汀。主要终点是严重的无肺炎率。二十一名患者被包括在分析中。其中，有13名患者表现出可能的UIP模式，而有8例患者表现出不确定的UIP模式。在诱导阶段，有两名患者（9.5％）患有任何年级的肺炎；一个患有1级，另一个患有5级肺炎。在维持阶段，没有其他患者患有肺炎。严重的无肺炎率为95.2％（95％置信区间（CI）：77.3-99.2％）。无进展生存期的中位数为5.5个月（95％CI：3.6-6.4个月）。总体生存期中位数为10.7个月（95％CI：6.0个月未达到）。ChemoMuntherapy是ES-SCLC和轻度IIP患者的可行治疗方法。
Abstract
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.