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帕唑帕尼治疗失败后依维莫司作为转移性肾细胞癌二线治疗的真实世界经验。

Real-world experience of everolimus as second-line treatment in metastatic renal cell cancer after failure of pazopanib.

作者信息

Koutsoukos Konstantinos, Bamias Aristotelis, Tzannis Kimon, Espinosa Montaño Marta, Bozionelou Vasiliki, Christodoulou Christos, Stefanou Dimitra, Kalofonos Haralabos, Duran Ignacio, Papazisis Konstantinos

机构信息

Hellenic Genito-Urinary Cancer Group.

Oncology Unit, Department of Clinical Therapeutics, Alexandra Hospital, National and Kapodistrian University of Athens, Athens, Greece.

出版信息

Onco Targets Ther. 2017 Oct 6;10:4885-4893. doi: 10.2147/OTT.S141260. eCollection 2017.

Abstract

AIM

We aimed to provide real-life data on the outcomes of metastatic renal cell carcinoma (mRCC) patients treated with everolimus as second-line treatment after failure of first-line pazopanib.

PATIENTS AND METHODS

Data from the medical charts of mRCC patients from 8 centers in Greece and Spain were reviewed. All patients had received or were continuing to receive second-line everolimus treatment after failure of first-line treatment with pazopanib. No other previous therapies were allowed. The primary end point was the determination of progression-free survival (PFS).

RESULTS

In total, 31 patients were enrolled. Of these, 26% had performance status (PS) >0, 88% were of intermediate/poor Memorial Sloan-Kettering Cancer Center (MSKCC) risk group, and only 61% had undergone prior nephrectomy. Median PFS was 3.48 months (95% CI: 2.37-5.06 months). Median overall survival (OS) from everolimus initiation was 8.9 months (95% CI: 6.47-13.14 months). Median OS from pazopanib initiation was 14.78 months (95% CI: 10.54-19.08 months). Furthermore, 32% of patients temporarily discontinued everolimus due to adverse events (AEs), and 22% of patients discontinued everolimus permanently due to toxicity. Most common toxicities were anemia (29%), stomatitis (26%), pneumonitis (19%), and fatigue (10%). Moreover, 14 AEs (27%) were graded as 3 or 4 and were reported by 13 patients (42%).

CONCLUSION

This study provides data exclusively on the sequence pazopanib-everolimus in mRCC. Everolimus has a favorable safety profile and is active. The short PFS and OS could be attributed to the fact that the pazopanib-everolimus sequence was mainly offered to patients with adverse prognostic features, resulting in a modest increase in the combined OS of our population.

摘要

目的

我们旨在提供关于转移性肾细胞癌(mRCC)患者在一线帕唑帕尼治疗失败后接受依维莫司二线治疗的真实数据。

患者与方法

回顾了来自希腊和西班牙8个中心的mRCC患者病历数据。所有患者在一线帕唑帕尼治疗失败后已接受或正在接受二线依维莫司治疗。不允许有其他既往治疗。主要终点是无进展生存期(PFS)的测定。

结果

共纳入31例患者。其中,26%的患者体能状态(PS)>0,88%属于纪念斯隆凯特琳癌症中心(MSKCC)中/低风险组,仅有61%曾接受过肾切除术。中位PFS为3.48个月(95%置信区间:2.37 - 5.06个月)。从开始使用依维莫司起的中位总生存期(OS)为8.9个月(95%置信区间:6.47 - 13.14个月)。从开始使用帕唑帕尼起的中位OS为14.78个月(95%置信区间:10.54 - 19.08个月)。此外,32%的患者因不良事件(AE)暂时停用依维莫司,22%的患者因毒性反应永久停用依维莫司。最常见的毒性反应为贫血(29%)、口腔炎(26%)、肺炎(19%)和疲劳(10%)。此外,14例AE(27%)为3级或4级,由13例患者(42%)报告。

结论

本研究仅提供了mRCC患者中帕唑帕尼 - 依维莫司序贯治疗的数据。依维莫司具有良好的安全性且有活性。PFS和OS较短可能归因于帕唑帕尼 - 依维莫司序贯治疗主要应用于预后不良特征的患者,导致我们研究人群的联合OS仅有适度增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d0fc/5640393/616ef3e6ed80/ott-10-4885Fig1.jpg

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