Zehentmayr Franz, Feurstein Petra, Ruznic Elvis, Langer Brigitte, Grambozov Brane, Klebermass Marisa, Hochreiter Alexandra, Purevdorj Ayurzana, Gruber Georg, Minasch Danijela, Breitfelder Barbara, Steffal Claudia, Kirchhammer Karoline, Stranzl Heidi, Röder Falk, Dieckmann Karin
Department of Radiation Oncology, Paracelsus Medical University, 5020 Salzburg, Austria.
Department of Radiation Oncology, Klinikum Ottakring, 1160 Vienna, Austria.
Cancers (Basel). 2025 Apr 25;17(9):1443. doi: 10.3390/cancers17091443.
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 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).
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%; -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 (-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; -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; -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.
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.
PACIFIC的长期分析揭示了放化疗联合度伐利尤单抗治疗不可切除的III期非小细胞肺癌(NSCLC)的临床益处。ALLSTAR是一项前瞻性登记研究,旨在验证奥地利日常实践中的PACIFIC方案。
患者若经病理确诊为不可切除的III期NSCLC且有治愈性治疗选择,则符合入选标准。该分析的终点为总生存期(OS)、更新后的局部控制率(LC)和无进展生存期(PFS)。
接受总辐射剂量>66 Gy的患者的2年和3年LC率分别为80%和75%,优于标准治疗(65%和54%;P值0.085)。在度伐利尤单抗治疗的患者中,这种益处更为明显,总辐射剂量>66 Gy时2年和3年LC率分别为82%和79%(P值0.068)。度伐利尤单抗治疗的患者2年和3年OS分别为71%和63%,未使用度伐利尤单抗的患者为58%和44%(风险比0.552;95%置信区间0.347 - 0.881;P值0.011)。接受度伐利尤单抗治疗的患者2年和3年PFS(56%和48%)也显著长于未接受治疗的患者(35%和20%;风险比0.469;95%置信区间0.312 - 0.707;P值<0.001)。188例患者中有66例(35%)出现肺部副作用,各有1例4级和5级病例。93/188(49%)例出现1 - 3级食管毒性。
ALLSTAR的更新分析表明度伐利尤单抗对OS和PFS有持续益处,以及辐射剂量增加>66 Gy对LC可能有长期益处。