J-TAIL-2：一项日本广泛期SCLC患者Atezolizumab联合卡铂和依托泊苷的前瞻性观察性研究

IF 3 Q2 ONCOLOGY

JTO Clinical and Research Reports Pub Date : 2024-12-18 DOI:10.1016/j.jtocrr.2024.100783

Eisaku Miyauchi MD, PhD , Makoto Nishio MD, PhD , Kadoaki Ohashi MD, PhD , Atsushi Osoegawa MD, PhD , Eiki Kikuchi MD, PhD , Hideharu Kimura MD, PhD , Yasushi Goto MD, PhD , Junichi Shimizu MD, PhD , Hiroshige Yoshioka MD, PhD , Ichiro Yoshino MD, PhD , Toshihiro Misumi PhD , Nobuyuki Katakami MD, PhD , Masahide Oki MD, PhD , Takashi Kijima MD, PhD , Kenichi Chikamori MD, PhD , Kazumi Nishino MD, PhD , Yuki Kobayashi MS , Asako Miwa BA , Misa Tanaka MS , Akihiko Gemma PhD

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引用次数: 0

摘要

在IMpower133试验的基础上，atezolizumab联合卡铂和依托泊苷（CE）被批准作为大分期(ES)-SCLC的一线治疗。J-TAIL-2研究在常规临床实践环境中评估了atezolizumab加CE。方法j - tail -2是一项来自日本的前瞻性、多中心观察性研究。ES-SCLC患者在临床实践中接受atezolizumab加CE治疗。主要终点为12个月的OS率。次要终点包括选择亚组的总生存期（OS）、无进展生存期（PFS）和安全性，包括impower133不像组（即东部肿瘤合作组表现状态2或以上、间质性肺疾病、自身免疫性疾病）与impower133样组。结果共纳入403例患者；中位年龄为71岁，16.6% （n = 67）有东部肿瘤合作组2级及以上的表现，26.8% （n = 108）有脑转移，6.9% （n = 28）有间质性肺疾病，4.0% （n = 16）有自身免疫性疾病，72.7% （n = 293）有impower133不像。在有效人群（n = 399）中，12个月的OS率为63.7%，中位OS为16.5个月，中位PFS为5.1个月。在impower133不同亚组和impower133相似亚组中，12个月的OS率分别为58.5%和77.5%，中位OS为15.5和19.1个月(风险比，1.32；95%可信区间：0.98-1.77)，中位PFS为4.8个月vs 5.4个月(风险比，1.14；95%置信区间：0.90-1.45)。未观察到新的安全信号（安全人群，n = 400）；impower133 - different和IMpower133-like亚组的安全性结果相似。结论在J-TAIL-2中，atezolizumab联合CE在临床实践中对ES-SCLC患者的疗效与IMpower133一致。结合可接受的安全性，这些数据支持在日本ES-SCLC患者中使用atezolizumab加CE，包括那些不符合IMpower133的患者。

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J-TAIL-2: A Prospective, Observational Study of Atezolizumab Combined With Carboplatin and Etoposide in Patients With Extensive-Stage SCLC in Japan

Introduction

On the basis of the IMpower133 trial, atezolizumab plus carboplatin and etoposide (CE) is approved as first-line treatment for extensive-stage (ES)-SCLC. The J-TAIL-2 study evaluated atezolizumab plus CE in routine clinical practice settings.

Methods

J-TAIL-2 was a prospective, multicenter observational study in Japan. Patients with ES-SCLC received atezolizumab plus CE in clinical practice. The primary end point was 12-month OS rate. Secondary end points included overall survival (OS), progression-free survival (PFS), and safety in select subgroups, including the IMpower133-unlike (i.e., Eastern Cooperative Oncology Group performance status 2 or more, interstitial lung disease, autoimmune disease) versus IMpower133-like groups.

Results

Overall, 403 patients were included; the median age was 71 years, 16.6% (n = 67) had an Eastern Cooperative Oncology Group performance status 2 or more, 26.8% (n = 108) had brain metastasis, 6.9% (n = 28) had interstitial lung disease, 4.0% (n = 16) had autoimmune disease, and 72.7% (n = 293) were IMpower133-unlike. In the efficacy population (n = 399), the 12-month OS rate was 63.7%, median OS was 16.5 months, and median PFS was 5.1 months. In IMpower133-unlike versus IMpower133-like subgroups, the 12-month OS rate was 58.5% versus 77.5%, median OS was 15.5 versus 19.1 months (hazard ratio, 1.32; 95% confidence interval: 0.98–1.77), and median PFS was 4.8 versus 5.4 months (hazard ratio, 1.14; 95% confidence interval: 0.90–1.45). No new safety signals were observed (safety population, n = 400); safety outcomes in the IMpower133-unlike and IMpower133-like subgroups were similar.

Conclusions

In J-TAIL-2, atezolizumab plus CE had efficacy in patients with ES-SCLC in clinical practice that was consistent with that in IMpower133. Taken together with the acceptable safety profile, these data support the use of atezolizumab plus CE in patients with ES-SCLC in Japan, including those who would have been ineligible for IMpower133.

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