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一线舒尼替尼对比帕唑帕尼治疗转移性肾细胞癌:国际转移性肾细胞癌数据库联盟研究结果。

First-line sunitinib versus pazopanib in metastatic renal cell carcinoma: Results from the International Metastatic Renal Cell Carcinoma Database Consortium.

机构信息

Tom Baker Cancer Center, University of Calgary, Calgary, AB, Canada; Hospital Medica Sur, Mexico City, Mexico.

Department of Oncology, Military Institute of Medicine, Warsaw, Poland.

出版信息

Eur J Cancer. 2016 Sep;65:102-8. doi: 10.1016/j.ejca.2016.06.016. Epub 2016 Jul 31.

Abstract

BACKGROUND

Sunitinib (SU) and pazopanib (PZ) are standards of care for first-line treatment of metastatic renal cell carcinoma (mRCC). However, how the efficacy of these drugs translates into effectiveness on a population-based level is unknown.

PATIENTS AND METHODS

We used the International mRCC Database Consortium (IMDC) to assess overall survival (OS), progression-free survival (PFS), response rate (RR) and performed proportional hazard regression adjusting for IMDC prognostic groups. Second-line OS (OS2) and second-line PFS (PFS2) were also evaluated.

RESULTS

We obtained data from 7438 patients with mRCC treated with either first-line SU (n = 6519) or PZ (n = 919) with an overall median follow-up of 40.4 months (95% confidence interval [CI] 39.2-42.1). There were no significant differences in IMDC prognostic groups (p = 0.36). There was no OS difference between SU and PZ (22.3 versus 22.6 months, respectively, p = 0.65). When adjusted for IMDC criteria, the hazard ratio (HR) of death for PZ versus SU was 1.03 (95% CI 0.92-1.17, p = 0.58). There was no PFS difference between SU and PZ (8.4 versus 8.3 months, respectively, p = 0.17). When adjusted for IMDC criteria, the HR for PFS for PZ versus SU was 1.08 (95% CI 0.981-1.19, p = 0.12). There was no difference in RR between SU and PZ (30% versus 28%, respectively, p = 0.15). We also found no difference in any second-line treatment between either post-SU or post-PZ groups for OS2 (13.1 versus 11 months, p = 0.27) and PFS2 (3.7 versus 5.0 months, p = 0.07).

CONCLUSIONS

We confirmed in real-world practice that SU and PZ have similar efficacy in the first-line setting for mRCC and do not affect outcomes with subsequent second-line treatment.

摘要

背景

舒尼替尼(SU)和帕唑帕尼(PZ)是转移性肾细胞癌(mRCC)一线治疗的标准治疗方法。然而,这些药物的疗效在基于人群的水平上如何转化为疗效尚不清楚。

患者和方法

我们使用国际 mRCC 数据库联盟(IMDC)评估总生存期(OS)、无进展生存期(PFS)、缓解率(RR),并进行比例风险回归,同时调整 IMDC 预后组。还评估了二线 OS(OS2)和二线 PFS(PFS2)。

结果

我们从接受一线 SU(n=6519)或 PZ(n=919)治疗的 7438 例 mRCC 患者中获得数据,中位随访时间为 40.4 个月(95%置信区间 [CI] 39.2-42.1)。IMDC 预后组之间无显著差异(p=0.36)。SU 和 PZ 之间的 OS 无差异(分别为 22.3 个月和 22.6 个月,p=0.65)。根据 IMDC 标准调整后,PZ 与 SU 相比死亡的风险比(HR)为 1.03(95%CI 0.92-1.17,p=0.58)。SU 和 PZ 之间的 PFS 无差异(分别为 8.4 个月和 8.3 个月,p=0.17)。根据 IMDC 标准调整后,PZ 与 SU 相比 PFS 的 HR 为 1.08(95%CI 0.981-1.19,p=0.12)。SU 和 PZ 之间 RR 无差异(分别为 30%和 28%,p=0.15)。我们还发现,SU 或 PZ 后组之间的任何二线治疗在 OS2(13.1 个月与 11 个月,p=0.27)和 PFS2(3.7 个月与 5.0 个月,p=0.07)方面均无差异。

结论

我们在真实世界的实践中证实,SU 和 PZ 在 mRCC 的一线治疗中具有相似的疗效,并且不会影响后续二线治疗的结果。

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