Durvalumab联合铂依托泊苷一线治疗广泛期小细胞肺癌（CANTABRICO）：单臂临床试验

IF 4.4 2区医学 Q1 ONCOLOGY

Lung Cancer Pub Date : 2025-09-24 DOI:10.1016/j.lungcan.2025.108763

Dolores Isla , Jon Zugazagoitia , Edurne Arriola , Rosario García-Campelo , Cristina Martí Blanco , María Pilar Diz-Taín , Marta López-Brea , Alberto Luis Moreno-Vega , Luis León-Mateos , Juana Oramás , Vanesa Gutiérrez-Calderón , Margarita Majem , Alfredo Sánchez-Hernández , Carlos Aguado , Ruth Alvarez-Cabellos , Bartomeu Massutí , Amaia Moreno , José-Luis Fírvida-Pérez , Javier Valdivia , Marta González-Cordero , Luis Paz-Ares

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引用次数: 0

摘要

背景：需要从现实世界的临床实践中对广泛期小细胞肺癌（ES-SCLC）患者进行免疫治疗试验。我们的目的是评估杜伐单抗加铂依托泊苷作为ES-SCLC患者一线治疗的安全性和有效性。患者和方法：一项前瞻性单臂研究在组织学或细胞学证实的ES-SCLC和who /ECOG PS为0-2的成年患者中进行（PS为2的患者最多允许30%）。患者接受杜伐单抗加依托泊苷铂治疗长达6个周期，随后每4周接受杜伐单抗单药治疗。主要结局包括≥3级不良事件（ae）和免疫介导的不良事件（imae）的发生率。结果：在2020年12月至2021年4月期间，101名患者被纳入该试验。3级及以上不良事件发生在77例（76.2%）患者中，58例（57.4%）患者被认为与治疗相关。38例患者（37.6%）报告了至少一次影像学反应，所有这些都被认为与治疗有关。在研究期间报告的82例图像中，68例（82.9%）为1-2级。中位总生存期为9.6个月（95% CI, 7.8 ~ 11.3）， 12个月和24个月的总生存率分别为40.7%（31.1% ~ 50.3%）和25.4% （95% CI, 16.8% ~ 34.0%）。结论：这项3B期临床试验表明，ES-SCLC患者的一线治疗方案是可行的，初始方案为杜伐单抗加依托泊苷铂，然后维持杜伐单抗，最多可达6个周期，根据患者的特点，在日常临床实践中为这些患者的管理提供了更多的选择。

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Durvalumab plus platinum-etoposide in the first-line treatment of extensive-stage small cell lung cancer (CANTABRICO): A single-arm clinical trial

Background

Immunotherapy trials involving patients with extensive-stage small cell lung cancer (ES-SCLC) from real-world clinical practice are needed. We aimed to evaluate the safety and effectiveness of durvalumab plus platinum-etoposide as a first-line treatment in a real-world population of patients with ES-SCLC.

Patients and methods

A prospective, single-arm study was conducted in adult patients who had histologically or cytologically confirmed ES-SCLC and a WHO/ECOG PS of 0–2 (a maximum of 30 % of patients with a PS of 2 were allowed). Patients received durvalumab plus platinum-etoposide for up to 6 cycles, followed by durvalumab every 4 weeks as a single agent. The primary outcomes included the incidence of grade ≥ 3 adverse events (AEs) and immune-mediated AEs (imAEs).

Results

Between December 2020 and April 2021, 101 patients were included in this trial. Grade 3 or higher AEs occurred in 77 patients (76.2 %) and were considered treatment-related in 58 patients (57.4 %). Thirty-eight patients (37.6 %) reported at least one imAE, all of which were considered treatment related. Among the 82 imAEs reported during the study, 68 (82.9 %) were grade 1–2. The median overall survival was 9.6 months (95 % CI, 7.8 to 11.3), and the 12-month and 24-month overall survival rates were 40.7 % (31.1 % to 50.3 %) and 25.4 % (95 % CI, 16.8 % to 34.0 %), respectively.

Conclusions

This phase 3B trial suggests that first-line treatment of patients with ES-SCLC with an initial regimen of up to six cycles of durvalumab plus platinum-etoposide followed by maintenance with durvalumab is feasible providing more options in daily clinical practice for the management of these patients depending on their characteristics..

Trial registration: NCT04712903.

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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.