日本转移性及复发性食管鳞癌的真实世界治疗与结局：基于 Millennial Medical Record 数据库的回顾性分析
Real-world treatments and outcomes in metastatic and recurrent esophageal squamous cell carcinoma in Japan: a retrospective analysis using the Millennial Medical Record database.
作者
作者单位
- Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan. kenkato@ncc.go.jp.
- Health Economics and Outcomes Research, BeOne Medicines, Ltd., Singapore, Singapore.
- Medical Affairs, BeOne Medicines, Ltd., Tokyo, Japan.
- Real World Solutions, IQVIA Solutions Asia, Bangkok, Thailand.
- Real World Solutions, IQVIA Solutions Asia, Singapore, Singapore.
- Statistics, BeOne Medicines, Ltd., Beijing, China.
- Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.
摘要
中文
食管鳞癌（ESCC）在日本仍是重大临床挑战。关于治疗模式和结局的真实世界数据，尤其是针对不适合顺铂治疗的患者，仍然有限。本研究评估了初诊为转移性 ESCC（mESCC）或复发性 ESCC（rESCC）患者的特征、治疗和结局。利用 Millennial Medical Record 数据库（2021 年 12 月至 2024 年 6 月）进行回顾性队列分析，纳入 m/rESCC 患者。接受一线（1L）系统治疗的患者分为顺铂组和非顺铂组。主要结局包括治疗中断时间和总生存期（OS）。在 155 例患者中，52.3% 为 mESCC，47.7% 为 rESCC；31.0% 接受 1L 系统治疗，46.4% 行手术或放疗，22.6% 未接受任何治疗。在接受 1L 治疗的患者中，58.3% 接受免疫检查点抑制剂（ICI）治疗，包括联合化疗或单药治疗。非顺铂组患者年龄较大且合并症负担更重；约 33.3% 接受 ICI 单药治疗，27.8% 接受双 ICI 治疗。相比之下，顺铂组中 56.7% 的患者接受顺铂联合 ICI 治疗。顺铂组治疗中断发生率高于非顺铂组（73.3% vs. 55.6%），但中位治疗持续时间更长（75 天 vs. 47 天）。顺铂组 12 个月 OS 高于非顺铂组（92.1% vs. 75.0%）。在这项日本真实世界研究中，顺铂方案常用于 m/rESCC。许多未接受顺铂治疗的患者结局不同。这凸显了对不适合顺铂 ESCC 患者开发耐受性更佳替代方案的未满足需求。
English
Esophageal squamous cell carcinoma (ESCC) remains a significant clinical challenge in Japan. Real-world data on treatment patterns and outcomes, particularly for patients unfit for cisplatin, remain limited. This study evaluated characteristics, treatments, and outcomes of patients newly diagnosed with metastatic ESCC (mESCC) or recurrent ESCC (rESCC). A retrospective cohort analysis was conducted using the Millennial Medical Record database (December 2021-June 2024), including patients with m/rESCC. Patients receiving first-line (1 L) systemic therapy were categorized into cisplatin or non-cisplatin groups. Key outcomes included time-to-treatment discontinuation and overall survival (OS). Among 155 patients, 52.3% had mESCC and 47.7% had rESCC; 31.0% received 1 L systemic therapy, 46.4% underwent surgery or radiotherapy, and 22.6% received no treatment. Among those receiving 1 L therapy, 58.3% were treated with immune checkpoint inhibitors (ICIs), either in combination with chemotherapy or alone. Non-cisplatin patients were older with greater comorbidity burden; ~33.3% receiving ICI monotherapy and 27.8% dual ICI therapy. In contrast, 56.7% of patients in the cisplatin group received a cisplatin-ICI combination. Treatment discontinuation was more frequent with cisplatin than non-cisplatin therapy (73.3% vs. 55.6%), despite longer median treatment duration (75 vs. 47 days). Twelve-month OS was higher with cisplatin than non‑cisplatin regimens (92.1% vs. 75.0%). In this real-world Japanese study, cisplatin-based regimens were commonly used for m/rESCC. Many patients who did not receive cisplatin had differing outcomes. This highlights the unmet need for better-tolerated alternatives for cisplatin-unfit patients with ESCC in Japan.
分类与指标
- 研究类型
- 临床研究
- 病种
- 食管癌
- JCR 分区
- Q1
- 影响因子
- 5.8
- 新锐分区
- 4区