Department of Medical Oncology, Faculty of Medicine, Ankara University, 06590, Ankara, Turkey.
Cancer Research Institute, Ankara University, Ankara, Turkey.
Eur J Clin Pharmacol. 2022 Dec;78(12):1973-1979. doi: 10.1007/s00228-022-03403-1. Epub 2022 Oct 21.
To compare survival outcomes, response rates, and adverse events (AEs) in proton pump inhibitor (PPI) user and non-user patients with metastatic colorectal cancer (mCRC) treated with regorafenib.
We included 272 patients with mCRC treated with regorafenib in this study. Patients were divided into two categories according to their status of PPI use. The primary endpoint was overall survival (OS). The secondary endpoints were time to treatment failure (TTF), response rates, and safety. To exclude immortal time bias in survival analyses, we compared PPI non-user patients and all patients.
There were 141 and 131 patients in the PPI non-user and user groups. Baseline characteristics were similar in each group. Pantoprazole was the most used PPI. At the median 35.2 (95% confidence interval (CI): 32.6-37.9) months follow-up, the median OS was similar in PPI non-user and all patients (6.9 months (95% CI: 5.3-8.5) and 7.7 months (95% CI:6.6-8.8), p = 0.913). TTF was also similar in PPI non-user and all patients (3.3 months (95% CI: 2.7-3.9) and 3.5 months (95% CI: 3.0-4.0), p = 0.661). In multivariable analysis, no statistically significant difference was observed between PPI user and non-user groups in OS and TTF (hazard ratio (HR), 0.99; 95% CI, 0.77-1.28; p = 0.963 for OS; HR, 0.93; 0.77-1.20, p = 0.598 for TTF). The objective response rates (ORR) were similar in the PPI non-user and user groups (19.8% and 16.8%, p = 0.455). The rates of any grade AEs were also similar in each group.
This study found no worse outcome in the combined use of PPI and regorafenib among patients with mCRC.
比较质子泵抑制剂（PPI）使用者和非使用者转移性结直肠癌（mCRC）患者接受regorafenib 治疗的生存结局、缓解率和不良事件（AE）。
本研究纳入了 272 例接受regorafenib 治疗的 mCRC 患者。根据 PPI 使用情况将患者分为两组。主要终点为总生存期（OS）。次要终点为治疗失败时间（TTF）、缓解率和安全性。为了排除生存分析中的不朽时间偏倚，我们比较了 PPI 非使用者和所有患者。
PPI 非使用者和使用者组各有 141 例和 131 例患者。两组的基线特征相似。泮托拉唑是最常用的 PPI。在中位 35.2（95%置信区间（CI）：32.6-37.9）个月的随访中，PPI 非使用者和所有患者的中位 OS 相似（6.9 个月（95%CI：5.3-8.5）和 7.7 个月（95%CI：6.6-8.8），p=0.913）。TTF 也在 PPI 非使用者和所有患者中相似（3.3 个月（95%CI：2.7-3.9）和 3.5 个月（95%CI：3.0-4.0），p=0.661）。在多变量分析中，OS 和 TTF 方面，PPI 使用者和非使用者组之间无统计学显著差异（风险比（HR），0.99；95%CI，0.77-1.28；p=0.963 用于 OS；HR，0.93；95%CI，0.77-1.20，p=0.598 用于 TTF）。PPI 非使用者和使用者组的客观缓解率（ORR）相似（19.8%和 16.8%，p=0.455）。每组的任何等级 AE 发生率也相似。
本研究发现，在 mCRC 患者中，PPI 联合使用regorafenib 并没有导致更差的结局。
