文章：

度伐利尤单抗可延长总生存期，而放疗剂量提升至66 Gy以上或可改善不可切除III期非小细胞肺癌的长期局部控制：奥地利放射肿瘤学肺癌研究协会注册库（ALLSTAR）的更新分析

Durvalumab Prolongs Overall Survival, Whereas Radiation Dose Escalation > 66 Gy Might Improve Long-Term Local Control in Unresectable NSCLC Stage III: Updated Analysis of the Austrian Radio-Oncological Lung Cancer Study Association Registry (ALLSTAR)

原文发布日期：25 April 2025

DOI: 10.3390/cancers17091443

类型: Article

开放获取: 是

英文摘要：

Introduction: Long-term analysis of PACIFIC revealed the clinical benefit of chemoradiotherapy combined with Durvalumab for unresectable non-small-cell lung cancer (NSCLC) stage III. ALLSTAR is a prospective registry aimed at validating the PACIFIC regimen in daily practice in Austria. Patients and Methods: Patients were eligible if they had pathologically confirmed unresectable NSCLC III with a curative treatment option. The endpoints for this analysis were overall survival (OS), updated local control (LC), and progression-free survival (PFS). Results: The 2- and 3-year LC rates in patients who received total radiation doses > 66 Gy were 80% and 75%, respectively, which were superior to the standard treatment (65% and 54%;p-value 0.085). This benefit was even more pronounced in Durvalumab patients with 2- and 3-year LC rates of 82% and 79% with >66 Gy (p-value 0.068). The 2- and 3-year OS with Durvalumab was 71% and 63%, respectively, compared to 58% and 44% without Durvalumab (HR 0.552; 95%-CI 0.347–0.881;p-value 0.011). Patients who were treated with Durvalumab also had a significantly longer 2- and 3-year PFS (56% and 48%) than those without (35% and 20%; HR 0.469; 95%-CI 0.312–0.707;p-value < 0.001). Pulmonary side effects were observed in 66/188 (35%) patients, with one case of grades 4 and 5 each. Oesophageal toxicity grade 1–3 occurred in 93/188 (49%) cases. Conclusion: The updated ALLSTAR analysis demonstrated sustained benefit of Durvalumab for OS and PFS, as well as a possible long-term benefit of radiation dose escalation > 66 Gy on LC.

摘要翻译： 

引言：PACIFIC研究的长期分析证实了放化疗联合度伐利尤单抗治疗不可切除III期非小细胞肺癌（NSCLC）的临床获益。ALLSTAR是一项前瞻性注册研究，旨在验证PACIFIC方案在奥地利日常临床实践中的应用效果。患者与方法：经病理确诊不可切除III期NSCLC且具备根治性治疗指征的患者符合入组条件。本次分析的主要终点为总生存期（OS）、更新的局部控制率（LC）和无进展生存期（PFS）。结果：接受总放射剂量>66 Gy治疗的患者2年与3年LC率分别为80%和75%，显著优于标准治疗组（65%和54%；p值0.085）。在度伐利尤单抗治疗亚组中，>66 Gy剂量组的2年与3年LC获益更为显著（82%和79%；p值0.068）。度伐利尤单抗组的2年与3年OS率分别为71%和63%，显著优于非度伐利尤单抗组的58%和44%（HR 0.552；95%CI 0.347–0.881；p值0.011）。度伐利尤单抗治疗患者的2年与3年PFS率（56%和48%）亦显著优于对照组（35%和20%；HR 0.469；95%CI 0.312–0.707；p值<0.001）。188例患者中66例（35%）出现肺部不良反应，其中4级和5级毒性各1例；93例（49%）发生1-3级食管毒性。结论：本次更新的ALLSTAR分析证实度伐利尤单抗在OS和PFS方面具有持续获益，同时提示>66 Gy的放疗剂量提升可能为LC带来长期获益。

原文链接：

Durvalumab Prolongs Overall Survival, Whereas Radiation Dose Escalation > 66 Gy Might Improve Long-Term Local Control in Unresectable NSCLC Stage III: Updated Analysis of the Austrian Radio-Oncological Lung Cancer Study Association Registry (ALLSTAR)