University of Lille, Lille, France.
Medical Oncology Department, Lille University Hospital, Lille, France.
J Gastrointest Cancer. 2023 Jun;54(2):545-553. doi: 10.1007/s12029-022-00825-z. Epub 2022 May 14.
Proton pump inhibitors (PPIs) are one of the most widely used drugs worldwide and are involved in several drug interactions. Recently, several studies have suggested that PPIs may interfere with the efficacy of capecitabine. This study primarily aimed to investigate the effects of PPI intake on the pathologic response rate of patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy with capecitabine.
A retrospective study was conducted at a French Comprehensive Cancer Center. Patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy followed by surgery were included in the study. Demographic parameters, treatment characteristics, survival data, and PPI intake data were collected. Frequencies and percentages were reported for categorical variables and medians and interquartile ranges for continuous variables. Distribution of variables was compared according to PPI treatment using the chi-square test or Fisher's exact test for categorical data and nonparametric Wilcoxon tests for continuous variables. Survival data were estimated using the Kaplan-Meier method and compared using the log-rank test.
In total, 215 patients were included, of whom 135 (62.8%) were men. The PPI intake frequency was 16.1%. The rate of complete pathological response was not significantly lower in patients on PPIs than in those not on PPIs (8.7% vs. 19%, p = 0.36). PPI intake was not associated with a statistically significant decrease in recurrence-free survival (hazard ratio [HR] = 1.26, 95% confidence interval [CI] 0.61-2.60, p = 0.54) or overall survival (HR = 0.95, 95% CI 0.33-2.76, p = 0.93).
No significant association was observed between PPI co-medication and complete pathological response or survival in patients treated for locally advanced rectal cancer. However, the safety of PPIs could not be confirmed. Further ancillary studies of prospective clinical trials or studies using the Health Data Hub are necessary to explore the effects of PPIs on rectal cancer more accurately.
质子泵抑制剂(PPIs)是全球应用最广泛的药物之一,涉及多种药物相互作用。最近,多项研究表明,PPIs 可能会干扰卡培他滨的疗效。本研究主要旨在探讨 PPI 联合应用对接受卡培他滨新辅助放化疗的局部晚期直肠癌患者病理缓解率的影响。
本研究在法国综合癌症中心进行了一项回顾性研究。纳入接受新辅助放化疗后手术治疗的局部晚期直肠癌患者。收集人口统计学参数、治疗特征、生存数据和 PPI 摄入数据。分类变量用频率和百分比表示,连续变量用中位数和四分位间距表示。根据 PPI 治疗情况比较变量分布,分类数据采用卡方检验或 Fisher 确切检验,连续变量采用非参数 Wilcoxon 检验。使用 Kaplan-Meier 方法估计生存数据,并使用对数秩检验进行比较。
共纳入 215 例患者,其中 135 例(62.8%)为男性。PPI 摄入频率为 16.1%。接受 PPI 治疗的患者完全病理缓解率与未接受 PPI 治疗的患者无显著差异(8.7%比 19%,p=0.36)。PPI 摄入与无复发生存率(风险比 [HR]1.26,95%置信区间 [CI]0.61-2.60,p=0.54)或总生存率(HR 0.95,95%CI 0.33-2.76,p=0.93)无统计学显著相关性。
在接受局部晚期直肠癌治疗的患者中,PPI 联合用药与完全病理缓解或生存之间未观察到显著相关性。然而,PPI 的安全性无法得到确认。需要进一步进行前瞻性临床试验的辅助研究或使用健康数据中心的研究,以更准确地探讨 PPI 对直肠癌的影响。