Purpose

The aim of this study was to investigate the impact of acid suppressive therapy on clinical efficacy and safety of pazopanib in patients with metastatic renal cell carcinoma (mRCC).

Methods

A single-center retrospective study was carried out. Charts of mRCC patients who received pazopanib as first-line treatment were reviewed and concomitant use of proton pump inhibitors (PPI) and histamine 2 receptor antagonists (H2RA) was studied. Two groups of patients were identified, namely patients receiving PPI/H2RA and patients without acid suppressive therapy. Both groups were compared with regard to progression free survival (PFS), overall survival (OS), tumor response, and time to dose reduction of pazopanib.

Results

Ninety-one patients were included. Median PFS was 8 months in the PPI/H2RA group vs. 7 months in the no PPI/H2RA group (hazard ratio (HR) 0.76 (95% confidence interval (CI) 0.42–1.35)), p = 0.35. Median OS was 27 months in the PPI/H2RA group vs. 23 months in the no PPI/H2RA group (HR 0.87 (95% CI 0.46–1.66)), p = 0.68. Mean tumor response was 17% (95% CI 8–25%) in the PPI/H2RA group vs. 11% (95% CI 0–21%) in the no PPI/H2RA group, p = 0.52. Median time to first dose reduction was 9 months in both subgroups (HR 1.25 (95% CI 0.65–2.39)), p = 0.51. Median time to second dose (< 600 mg) reduction was 17 months in the PPI/H2RA group vs. 7 months in the no PPI/H2RA group (HR 0.26 (95% CI 0.07–0.89)), p = 0.03.

Conclusion

In this limited patient series, no evidence of a negative impact of PPI/H2RA on clinical outcome and time to first dose reduction was observed. These results suggest that PPI/H2RA might be considered, when there is a clinical need, in patients treated with pazopanib for mRCC. However, a prospective study is warranted to confirm these results.

中文翻译：

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伴有酸抑制疗法对转移性肾细胞癌患者帕唑帕尼疗效和剂量降低的影响。

目的

这项研究的目的是调查酸抑制疗法对帕唑帕尼在转移性肾细胞癌（mRCC）患者中的临床疗效和安全性的影响。

方法

进行了单中心回顾性研究。回顾了接受帕唑帕尼作为一线治疗的mRCC患者图表，并研究了质子泵抑制剂（PPI）和组胺2受体拮抗剂（H2RA）的同时使用。确定了两组患者，即接受PPI / H2RA的患者和未使用酸抑制疗法的患者。比较了两组的无进展生存期（PFS），总生存期（OS），肿瘤反应以及帕唑帕尼剂量减少的时间。

结果

包括九十一名患者。PPI / H2RA组的中位PFS为8个月，而无PPI / H2RA组的中位PFS为7个月（危险比（HR）0.76（95％置信区间（CI）0.42-1.35）），p = 0.35。PPI / H2RA组的中位OS为27个月，而无PPI / H2RA组的中位OS为23个月（HR 0.87（95％CI 0.46-1.66）），p = 0.68。PPI / H2RA组的平均肿瘤应答率为17％（95％CI 8–25％），而无PPI / H2RA组的平均肿瘤应答为11％（95％CI 0-21％），p = 0.52。两个亚组中首次减量的中位时间均为9个月（HR 1.25（95％CI 0.65–2.39）），p = 0.51。PPI / H2RA组中至第二剂（<600 mg）减少的中位时间为17个月，而无PPI / H2RA组中为7个月（HR 0.26（95％CI 0.07-0.89）），p = 0.03。

结论

在这一有限的患者系列中，没有观察到PPI / H2RA对临床结局和首次剂量减少时间有负面影响的证据。这些结果表明，在有临床需要时，帕唑帕尼治疗mRCC的患者可以考虑使用PPI / H2RA。但是，有必要进行前瞻性研究来证实这些结果。