Abstract：
BACKGROUND: Atezolizumab, carboplatin, and etoposide (ACE) therapy is a standard of care for extensive-disease small cell lung cancer (SCLC); however, its safety data are scarce, limiting generalization to the Japanese population.
METHODS: This study aimed to compare the safety of ACE versus carboplatin and etoposide (CE) therapies in Japanese patients using the Diagnosis Procedure Combination (DPC) database by comparing the incidence of adverse events (AEs). Retrospective data on clinical background and AEs were extracted from the DPC database. Incidence rates and restricted mean survival times (RMSTs) up to 6 months were analyzed for 19 clinically important AEs. Covariates were adjusted using the inverse probability weighting method.
RESULTS: A total of 330,774 patients were identified using the International Statistical Classification of Diseases and Related Health Problems 10th Revision codes, of whom 277 were included in the ACE cohort and 478 in the CE cohort. Among the 19 AEs, the incidence of skin disorder and thyroid dysfunction was significantly higher in the ACE cohort compared with the CE cohort. The adjusted incidence rate ratios were 2.38 (95% confidence interval [CI] 1.04-5.43) for skin disorder and 6.92 (95% CI 2.00-23.89) for thyroid dysfunction. The adjusted RMST differences were - 8.2 days (95% CI - 16.0 to - 0.4 days) for skin disorder and - 8.8 days (95% CI - 15.7 to - 1.9 days) for thyroid dysfunction.
CONCLUSIONS: This study provides evidence regarding the safety of ACE combination therapy in Japanese clinical practice using the DPC database, with results comparable to those reported in pivotal clinical trials.
BACKGROUND: UMIN Clinical Trials Registry ID UMIN000041508.
METHODS: This study aimed to compare the safety of ACE versus carboplatin and etoposide (CE) therapies in Japanese patients using the Diagnosis Procedure Combination (DPC) database by comparing the incidence of adverse events (AEs). Retrospective data on clinical background and AEs were extracted from the DPC database. Incidence rates and restricted mean survival times (RMSTs) up to 6 months were analyzed for 19 clinically important AEs. Covariates were adjusted using the inverse probability weighting method.
RESULTS: A total of 330,774 patients were identified using the International Statistical Classification of Diseases and Related Health Problems 10th Revision codes, of whom 277 were included in the ACE cohort and 478 in the CE cohort. Among the 19 AEs, the incidence of skin disorder and thyroid dysfunction was significantly higher in the ACE cohort compared with the CE cohort. The adjusted incidence rate ratios were 2.38 (95% confidence interval [CI] 1.04-5.43) for skin disorder and 6.92 (95% CI 2.00-23.89) for thyroid dysfunction. The adjusted RMST differences were - 8.2 days (95% CI - 16.0 to - 0.4 days) for skin disorder and - 8.8 days (95% CI - 15.7 to - 1.9 days) for thyroid dysfunction.
CONCLUSIONS: This study provides evidence regarding the safety of ACE combination therapy in Japanese clinical practice using the DPC database, with results comparable to those reported in pivotal clinical trials.
BACKGROUND: UMIN Clinical Trials Registry ID UMIN000041508.
摘要：
背景：阿替珠单抗，卡铂,和依托泊苷（ACE）治疗是广泛疾病小细胞肺癌（SCLC）的标准治疗；然而，它的安全数据很少，限制对日本人口的推广。
方法：本研究旨在使用诊断程序组合（DPC）数据库，通过比较不良事件（AE）的发生率，比较ACE与卡铂和依托泊苷（CE）疗法在日本患者中的安全性。从DPC数据库中提取临床背景和AE的回顾性数据。分析了长达6个月的发生率和受限平均生存时间（RMST）的19种临床重要的AE。使用逆概率加权方法调整协变量。
结果：使用国际疾病和相关健康问题统计分类第10次修订代码确定了330,774名患者，其中277人纳入ACE队列，478人纳入CE队列。在19个AE中，ACE队列中皮肤病和甲状腺功能异常的发生率明显高于CE队列.调整后的皮肤病发生率为2.38（95％置信区间[CI]1.04-5.43），甲状腺功能障碍为6.92（95％CI2.00-23.89）。调整后的RMST差异为皮肤疾病-8.2天（95％CI-16.0至-0.4天），甲状腺功能障碍-8.8天（95％CI-15.7至-1.9天）。
结论：本研究使用DPC数据库提供了有关日本临床实践中ACE联合治疗安全性的证据，结果与关键临床试验报告的结果相当。
背景：UMIN临床试验注册IDUMIN000041508。
方法：本研究旨在使用诊断程序组合（DPC）数据库，通过比较不良事件（AE）的发生率，比较ACE与卡铂和依托泊苷（CE）疗法在日本患者中的安全性。从DPC数据库中提取临床背景和AE的回顾性数据。分析了长达6个月的发生率和受限平均生存时间（RMST）的19种临床重要的AE。使用逆概率加权方法调整协变量。
结果：使用国际疾病和相关健康问题统计分类第10次修订代码确定了330,774名患者，其中277人纳入ACE队列，478人纳入CE队列。在19个AE中，ACE队列中皮肤病和甲状腺功能异常的发生率明显高于CE队列.调整后的皮肤病发生率为2.38（95％置信区间[CI]1.04-5.43），甲状腺功能障碍为6.92（95％CI2.00-23.89）。调整后的RMST差异为皮肤疾病-8.2天（95％CI-16.0至-0.4天），甲状腺功能障碍-8.8天（95％CI-15.7至-1.9天）。
结论：本研究使用DPC数据库提供了有关日本临床实践中ACE联合治疗安全性的证据，结果与关键临床试验报告的结果相当。
背景：UMIN临床试验注册IDUMIN000041508。
