Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, 410013, China.
Graduate Collaborative Training Base of Hunan Cancer Hospital, Hengyang Medical School, University of South China, Hengyang, 421001, Hunan, China.
Cancer Immunol Immunother. 2024 Mar 7;73(4):74. doi: 10.1007/s00262-024-03660-2.
Pembrolizumab has been indicated in the treatment of solid tumors with high frequency microsatellite instability (MSI-H) or high tumor mutational burden (TMB-H); however, real-world data on the effectiveness of pembrolizumab with or without chemotherapy in this molecular subset remain limited. Our retrospective study evaluated the clinical efficacy and safety of pembrolizumab in treating advanced solid tumors with either MSI-H or TMB-H.
This retrospective study analyzed data from 116 patients with MSI-H or TMB-H advanced solid cancers who received pembrolizumab with or without chemotherapy regardless of treatment setting. We analyzed objective response rate (ORR) and progression-free survival (PFS).
The top three cancer types were colorectal (48.6% MSI-H, 6.5% TMB-H), lung (15.4% MSI-H, 84.4% TMB-H), and gastric (15.4% MSI-H, 5.1% TMB-H). The ORR with pembrolizumab was 52.6%, including complete response (CR) observed in 8.6% (n = 10) of cases and partial responses (PR) in 43.9% (n = 51). Of the 93 patients who received first-line pembrolizumab, 52 patients achieved objective response (10 CR, 42 PR), with a median PFS of 14.0 months (95% confidence intervals [CI] 6.6-21.4). Of the 23 who received subsequent-line pembrolizumab, the ORR was 39.1%, disease control rate was 91.3%, and median PFS was 5.7 months (95% CI 3.9-7.5). Treatment-related adverse events were observed in 32 patients (27.6%), with no reported treatment-related fatal adverse events.
Our study provides real-world evidence on the clinical effectiveness of pembrolizumab with or without chemotherapy in the treatment of patients with MSI-H and TMB-H advanced solid cancers.
帕博利珠单抗已被批准用于治疗高频微卫星不稳定（MSI-H）或高肿瘤突变负荷（TMB-H）的实体肿瘤；然而，在这种分子亚群中，关于帕博利珠单抗联合或不联合化疗的有效性的真实世界数据仍然有限。我们的回顾性研究评估了帕博利珠单抗在治疗 MSI-H 或 TMB-H 晚期实体瘤中的临床疗效和安全性。
本回顾性研究分析了 116 例接受帕博利珠单抗联合或不联合化疗治疗的 MSI-H 或 TMB-H 晚期实体癌患者的数据，无论治疗环境如何。我们分析了客观缓解率（ORR）和无进展生存期（PFS）。
前三种癌症类型是结直肠癌（48.6% MSI-H，6.5% TMB-H）、肺癌（15.4% MSI-H，84.4% TMB-H）和胃癌（15.4% MSI-H，5.1% TMB-H）。帕博利珠单抗的 ORR 为 52.6%，包括 8.6%（n=10）的完全缓解（CR）和 43.9%（n=51）的部分缓解（PR）。在 93 例接受一线帕博利珠单抗治疗的患者中，52 例患者获得客观缓解（10 例 CR，42 例 PR），中位 PFS 为 14.0 个月（95%置信区间 [CI] 6.6-21.4）。在 23 例接受后续线帕博利珠单抗治疗的患者中，ORR 为 39.1%，疾病控制率为 91.3%，中位 PFS 为 5.7 个月（95%CI 3.9-7.5）。32 例患者（27.6%）出现治疗相关不良事件，无报道与治疗相关的致命不良事件。
本研究提供了帕博利珠单抗联合或不联合化疗治疗 MSI-H 和 TMB-H 晚期实体癌患者的临床疗效的真实世界证据。
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