研究动态
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胰腺癌手术后早期与晚期开始辅助化疗对生存的影响:目标试验模拟。

Impact on Survival of Early Versus Late Initiation of Adjuvant Chemotherapy After Pancreatic Adenocarcinoma Surgery: A Target Trial Emulation.

发表日期:2023 Nov 01
作者: Jakob Kirkegård, Morten Ladekarl, Andrea Lund, Frank Mortensen
来源: ANNALS OF SURGICAL ONCOLOGY

摘要:

我们研究了早期(出院后 0-4 周)与晚期(出院后 > 4-8 周)开始辅助化疗对胰腺腺癌生存的影响。我们使用丹麦基于人群的医疗保健登记处来模拟一项假设的目标试验,该试验使用克隆审查权重方法。所有符合条件的患者都被克隆,其中一个克隆被指定为“早期启动”,一个克隆被指定为“晚期启动”。当指定的治疗不再与实际治疗兼容时,克隆就会被审查。使用审查权重的逆概率来解决信息审查问题。我们在一项假设目标试验中纳入了 1491 名患者,其中 32.3% 的患者在胰腺腺癌手术出院后 0-4 周内开始化疗,38.3% 的患者在出院后 4 至 8 周内开始化疗; 206 人 (13.8%) 在超过 8 周后开始化疗,232 人 (15.6%) 没有开始化疗。晚期和早期启动者的中位总生存期分别为 30.4 个月和 29.9 个月。与早期启动者相比,OS 的绝对差异为 3.2%(95% 置信区间 [CI] - 1.5%, 7.9%)、- 0.7%(95% CI - 7.2%、5.8%)和 3.2%( 1 年、3 年和 5 年分别为 95% CI - 2.8%、9.3%)。晚期启动者的白蛋白水平增加较多,治疗前白蛋白值也较高。将辅助化疗推迟至胰腺腺癌手术出院后 8 周是安全的,并且可能允许更多患者因恢复得更好而接受辅助治疗。© 2023。作者。
We examined the impact of early (0-4 weeks after discharge) versus late (> 4-8 weeks after discharge) initiation of adjuvant chemotherapy on pancreatic adenocarcinoma survival.We used Danish population-based healthcare registries to emulate a hypothetical target trial using the clone-censor-weight approach. All eligible patients were cloned with one clone assigned to 'early initiation' and one clone assigned to 'late initiation'. Clones were censored when the assigned treatment was no longer compatible with the actual treatment. Informative censoring was addressed using inverse probability of censoring weighting.We included 1491 patients in a hypothetical target trial, of whom 32.3% initiated chemotherapy within 0-4 weeks and 38.3% between > 4 and 8 weeks after discharge for pancreatic adenocarcinoma surgery; 206 (13.8%) initiated chemotherapy after > 8 weeks, and 232 (15.6%) did not initiate chemotherapy. Median overall survival was 30.4 and 29.9 months in late and early initiators, respectively. The absolute differences in OS, comparing late with early initiators, were 3.2% (95% confidence interval [CI] - 1.5%, 7.9%), - 0.7% (95% CI - 7.2%, 5.8%), and 3.2% (95% CI - 2.8%, 9.3%) at 1, 3, and 5 years, respectively. Late initiators had a higher increase in albumin levels as well as higher pretreatment albumin values.Postponement of adjuvant chemotherapy up to 8 weeks after discharge from pancreatic adenocarcinoma surgery is safe and may allow more patients to receive adjuvant therapy due to better recovery.© 2023. The Author(s).