Abstract：
BACKGROUND: Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) combination therapy is a standard of care for advanced non-squamous non-small cell lung cancer (NSQ-NSCLC); however, the lack of safety data limits its clinical application in Japan.
METHODS: This study compared the safety of ABCP with that of bevacizumab, carboplatin, and paclitaxel (BCP) combination for the treatment of advanced NSQ-NSCLC in Japanese patients by evaluating the clinical background and incidence of adverse events (AEs) based on data extracted from the Diagnosis Procedure Combination (DPC) database. Incidence rates and restricted mean survival times (RMSTs) for up to 1 year were analyzed for 19 clinically important AEs. Covariates were adjusted using the inverse probability weighting method.
RESULTS: A search conducted using the International Statistical Classification of Diseases and Related Health Problems 10th Revision codes identified 350,987 patients, of whom 202 were included in the ABCP cohort and 232 in the BCP cohort. Among the 19 AEs, the incidence of skin disorder and febrile neutropenia (FN) was significantly higher in the ABCP cohort versus the BCP cohort. The adjusted incidence rate ratios were 2.65 [95% confidence interval (CI) 1.43-4.91] for skin disorder and 1.70 (95% CI 1.01-2.85) for FN. The adjusted RMST differences were - 64.2 days (95% CI - 93.0 to - 35.4 days) and - 46.0 days (95% CI - 73.5 to - 18.5 days) for skin disorder and FN, respectively. These results were comparable to those of other pivotal clinical trials.
CONCLUSIONS: The findings of this DPC database study highlight the safety of ABCP in Japanese clinical practice, and this methodology may facilitate more efficient research in real-world settings.
BACKGROUND: UMIN Clinical Trials Registry ID UMIN000041507.
METHODS: This study compared the safety of ABCP with that of bevacizumab, carboplatin, and paclitaxel (BCP) combination for the treatment of advanced NSQ-NSCLC in Japanese patients by evaluating the clinical background and incidence of adverse events (AEs) based on data extracted from the Diagnosis Procedure Combination (DPC) database. Incidence rates and restricted mean survival times (RMSTs) for up to 1 year were analyzed for 19 clinically important AEs. Covariates were adjusted using the inverse probability weighting method.
RESULTS: A search conducted using the International Statistical Classification of Diseases and Related Health Problems 10th Revision codes identified 350,987 patients, of whom 202 were included in the ABCP cohort and 232 in the BCP cohort. Among the 19 AEs, the incidence of skin disorder and febrile neutropenia (FN) was significantly higher in the ABCP cohort versus the BCP cohort. The adjusted incidence rate ratios were 2.65 [95% confidence interval (CI) 1.43-4.91] for skin disorder and 1.70 (95% CI 1.01-2.85) for FN. The adjusted RMST differences were - 64.2 days (95% CI - 93.0 to - 35.4 days) and - 46.0 days (95% CI - 73.5 to - 18.5 days) for skin disorder and FN, respectively. These results were comparable to those of other pivotal clinical trials.
CONCLUSIONS: The findings of this DPC database study highlight the safety of ABCP in Japanese clinical practice, and this methodology may facilitate more efficient research in real-world settings.
BACKGROUND: UMIN Clinical Trials Registry ID UMIN000041507.
摘要：
背景：阿替珠单抗，贝伐单抗,卡铂,和紫杉醇（ABCP）联合治疗是晚期非鳞状非小细胞肺癌（NSQ-NSCLC）的标准治疗；然而，缺乏安全性数据限制了其在日本的临床应用.
方法：本研究比较了ABCP与贝伐单抗的安全性，卡铂,和紫杉醇（BCP）联合用于治疗日本患者的晚期NSQ-NSCLC，方法是基于从诊断程序组合（DPC）数据库中提取的数据评估临床背景和不良事件（AE）的发生率。分析了长达1年的发病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次修订代码进行的搜索确定了350,987名患者，其中202人纳入ABCP队列，232人纳入BCP队列。在19个AE中，ABCP队列中皮肤病和发热性中性粒细胞减少症(FN)的发生率明显高于BCP队列.调整后的皮肤病发生率为2.65[95％置信区间（CI）1.43-4.91]，FN为1.70（95％CI1.01-2.85）。皮肤病和FN的调整后RMST差异为-64.2天（95％CI-93.0至-35.4天）和-46.0天（95％CI-73.5至-18.5天），分别。这些结果与其他关键临床试验的结果相当。
结论：这项DPC数据库研究的结果强调了ABCP在日本临床实践中的安全性，这种方法可以促进在现实世界中更有效的研究。
背景：UMIN临床试验注册IDUMIN000041507。
方法：本研究比较了ABCP与贝伐单抗的安全性，卡铂,和紫杉醇（BCP）联合用于治疗日本患者的晚期NSQ-NSCLC，方法是基于从诊断程序组合（DPC）数据库中提取的数据评估临床背景和不良事件（AE）的发生率。分析了长达1年的发病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次修订代码进行的搜索确定了350,987名患者，其中202人纳入ABCP队列，232人纳入BCP队列。在19个AE中，ABCP队列中皮肤病和发热性中性粒细胞减少症(FN)的发生率明显高于BCP队列.调整后的皮肤病发生率为2.65[95％置信区间（CI）1.43-4.91]，FN为1.70（95％CI1.01-2.85）。皮肤病和FN的调整后RMST差异为-64.2天（95％CI-93.0至-35.4天）和-46.0天（95％CI-73.5至-18.5天），分别。这些结果与其他关键临床试验的结果相当。
结论：这项DPC数据库研究的结果强调了ABCP在日本临床实践中的安全性，这种方法可以促进在现实世界中更有效的研究。
背景：UMIN临床试验注册IDUMIN000041507。
