Choi Dae-Ho, Kim Miso, Kim Young Saing, Park Keon Uk, Cho Jang Ho, Kim Hongsik, Lee Ki Hyeong, Ahn Heejoon, Kim Il-Hwan, Lee Kyung-Hee, Lee Gyeong-Won, Yi Seong Yoon, Ahn Beung Chul, Lee Min-Young, Jung Hyun Ae, Park Sehhoon, Sun Jong-Mu, Ahn Jin Seok, Lee Se-Hoon, Ahn Myung-Ju
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
JTO Clin Res Rep. 2024 Oct 16;5(12):100734. doi: 10.1016/j.jtocrr.2024.100734. eCollection 2024 Dec.
The role of maintenance durvalumab after definitive concurrent chemoradiotherapy (CCRT) in unresectable locally advanced NSCLC with mutation or translocation remains unclear. We compared the effectiveness of durvalumab maintenance therapy in groups with and wild-type versus those with or mutations.
In this retrospective multicenter observational study, patients with locally advanced NSCLC without progression after CCRT followed by maintenance durvalumab and available molecular test results ( and ) were eligible. The primary objective was to compare progression-free survival (PFS) between and wild-type and or mutant NSCLC. Secondary objectives include overall survival according to or mutation and programmed death-ligand 1 (PD-L1) expression.
Among 339 patients, 279 had wild-type , 41 had mutations and 19 had translocations. The median age was 68 years with 276 male individuals (81.4%) and 63 female individuals (18.6%), 165 (49.3%) had adenocarcinoma, 149 (44.5%) had squamous cell carcinoma, and 21 (6.3%) had other histologic types, 120 (35.4%) had stage IIIA, 168 (49.6%) stage IIIB, and 51 (15.0%) had stage IIIC. Most of the patients (n = 288, 85%) achieved partial response to CCRT, two (0.6%) had a complete response, and 49 patients (14.4%) had stable disease. Excluding four patients with unknown PD-L1 tumor proportion score (TPS), 16 (4.8%) had a PD-L1 TPS of 0, 168 (50.1%) had 1 to 49, and 151 (45.1%) had 50 or higher. The median PFS was 21.4 months (95% confidence interval [CI]: 17.3-25.3) for the EGFR/ALK wild-type group and 21.0 months (95% CI: 15.7-not available [NA]) for the or mutant group with no difference ( 0.74). Significant differences occurred in PFS on the basis of PD-L1 expression with values of 13.6 (95% CI: 10.5-NA), 18.7 (95% CI: 15.1-26.9), and 24.7 (95% CI: 20.7-NA) months for TPS of 0, 1-49, and 50 or higher, respectively ( 0.02).
Durvalumab maintenance therapy after definitive CCRT in unresectable locally advanced NSCLC patients with or mutation demonstrates comparable clinical outcomes to those with wild-type when PD-L1 expression is present.
对于伴有 突变或 易位的不可切除局部晚期非小细胞肺癌（NSCLC）患者，在根治性同步放化疗（CCRT）后使用度伐利尤单抗进行维持治疗的作用仍不明确。我们比较了度伐利尤单抗维持治疗在 和 野生型组与 或 突变组中的疗效。
在这项回顾性多中心观察性研究中，CCRT后无进展且接受度伐利尤单抗维持治疗并具备可用分子检测结果（ 和 ）的局部晚期NSCLC患者符合条件。主要目标是比较 和 野生型与 或 突变型NSCLC之间的无进展生存期（PFS）。次要目标包括根据 或 突变以及程序性死亡配体1（PD-L1）表达情况的总生存期。
在339例患者中，279例为 野生型，41例有 突变，19例有 易位。中位年龄为68岁，男性276例（81.4%），女性63例（18.6%），165例（49.3%）为腺癌，149例（44.5%）为鳞状细胞癌，21例（6.3%）为其他组织学类型，120例（35.4%）为IIIA期，168例（49.6%）为IIIB期，51例（15.0%）为IIIC期。大多数患者（n = 288，85%）对CCRT达到部分缓解，2例（0.6%）完全缓解，49例患者（14.4%）病情稳定。排除4例PD-L1肿瘤比例评分（TPS）未知的患者后，16例（4.8%）的PD-L1 TPS为0，168例（50.1%）为1至49，151例（45.1%）为50或更高。 野生型组的中位PFS为21.4个月（95%置信区间[CI]：17.3 - 25.3）， 或 突变组为21.0个月（95% CI：15.7 - 不可用[NA]），无差异（ = 0.74）。基于PD-L1表达的PFS存在显著差异，TPS为0、1 - 49和50或更高时，PFS分别为13.6（95% CI：10.5 - NA）、18.7（95% CI：15.1 - 26.9）和24.7（95% CI：20.7 - NA）个月（ = 0.02）。
对于伴有 或 突变的不可切除局部晚期NSCLC患者，在根治性CCRT后使用度伐利尤单抗进行维持治疗，当存在PD-L1表达时，其临床结局与 野生型患者相当。
