Phase II trial of second-line everolimus in patients with metastatic renal cell carcinoma (RECORD-4)

Motzer, Robert J.; Alyasova, Anna; Ye, Dingwei; Karpenko, Andrey; Li, H.; Alekseev, Boris; Xie, Liping; Kurteva, G.; Kowalyszyn, Rubén Dario; Karyakin, O. B.; Neron, Yeni Verónica; Cosgriff, Thomas M.; Collins, LaTonya; Brechenmacher, Thomas; Lin, Chinjune; Morgan, Liza; Yang, Lin

doi:10.1093/annonc/mdv612

Cited by 38 publications

(43 citation statements)

References 9 publications

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“…RECORD-4 study in purely second-line setting using everolimus after the failure of one prior VEGF-directed therapy showed median PFS of 7.8 months and OS of 23.8 months. [39] This can be explained on the basis of change in the mechanism of action of mTOR inhibition which will target downstream activation, translating to efficacy, and differentiated safety profile as compared to cumulative toxicity with may occur with sequential use of TKI. [40]…”

Section: Defining Clinical Cohort and Practice Of Expert Group Panel mentioning

confidence: 99%

Oncology Gold StandardTM practical consensus recommendations 2016 for treatment of advanced clear cell renal cell carcinoma

Batra

Parikh

Prabhash

et al. 2016

South Asian J Cancer

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The Oncology Gold Standard (OGS) Expert Group on renal cell carcinoma (RCC) developed the consensus statement to provide community oncologists practical guidelines on the management of advanced clear cell (cc) RCC using published evidence, practical experience of experts in real life management, and results of a nationwide survey involving 144 health-care professionals. Six broad question categories containing 33 unique questions cover major situations in the routine management of RCC. This document serves as a ready guide for the standard of care to optimize outcome. The table of “Take Home Messages” at the end is a convenient tool for busy practitioners.

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Section: Defining Clinical Cohort and Practice Of Expert Group Panel mentioning

confidence: 99%

Oncology Gold StandardTM practical consensus recommendations 2016 for treatment of advanced clear cell renal cell carcinoma

Batra

Parikh

Prabhash

et al. 2016

South Asian J Cancer

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“…Since limited prospective clinical data are available on second-line everolimus following only 1 VEGFR-TKI [11,12], and data on second-line everolimus following first-line pazopanib are lacking, the SUNPAZ study evaluated the efficacy and safety of everolimus following firstline sunitinib or pazopanib in mRCC patients experiencing disease progression.…”

Section: Introductionmentioning

confidence: 99%

A Phase 4 Study of Everolimus to Evaluate Efficacy and Safety in Patients with Metastatic Renal-Cell Carcinoma after Failure of First-Line Sunitinib or Pazopanib (SUNPAZ)

et al. 2019

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Introduction: Sunitinib and pazopanib are both standard first-line therapies for clear-cell metastatic renal-cell carcinoma (mRCC). Everolimus is a well-established second-line treatment. Objective: To estimate the efficacy and safety of second-line everolimus following pazopanib or sunitinib. Methods: SUNPAZ was an open-label, phase 4 clinical trial of everolimus in patients with clear-cell mRCC progressing after first-line sunitinib or pazopanib. The primary end point was the number of patients without progression 6 months after starting everolimus. Secondary end points included progression-free survival (PFS), overall survival (OS), and overall response rate. Enrollment was terminated early due to slow recruitment; all analyses are descriptive. Results: Patients who received prior sunitinib (n = 16) or pazopanib (n = 13) were enrolled. One of 12 patients in the sunitinib group and 6/13 patients in the pazopanib group were progressionfree by month 6 in the full analysis set. Median PFS in the sunitinib and pazopanib groups was 2.8 and 8.0 months, and median OS was 14.8 months and 20.4 months, respectively. Fifteen patients in the sunitinib group and 13 in the pazopanib group experienced adverse events. Conclusions: Safety and efficacy results confirm the second-line everolimus profile. However, baseline differences in patient populations should be taken into consideration.

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Section: Introductionmentioning

confidence: 99%

“…6,7 Adverse events were more frequent in the everolimus group, but were mostly of mild or moderate severity. 6,7 Everolimus was the first mTOR inhibitor to be approved for sequential use after a prior targeted therapy, and it is one of the most commonly used treatments in this setting. [8][9][10] For the second-line treatment of mRCC, several targeted agents have been introduced, including TKIs and mTOR inhibitors; however, in Korea, everolimus is the only available drug for VEGF-refractory patients with mRCC.…”

Section: Introductionmentioning

confidence: 99%

Clinical outcomes of the sequential use of pazopanib followed by everolimus for the treatment of metastatic renal cell carcinoma: A multicentre study in Korea

Kim

Lee

Kim

et al. 2017

CUAJ

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Introduction: The aim of this study was to investigate the real-world clinical outcomes of first-line pazopanib and second-line everolimus in Korean patients with metastatic renal cell carcinoma (mRCC). Methods: Data of patients who had mRCC with clear-cell component between 2001 and 2015 at multiple institutions were collected retrospectively. To be included in the analysis, patients had to meet the following criteria: age≥18 years; received first-line targeted therapy with pazopanib; and received second-line targeted therapy with everolimus. The primary outcomes included overall survival (OS), progression-free survival (PFS), and adverse events (AEs). Results: A total of 36 patients were included in the analysis. The median followup period was 33.5 months (range 17-49.5). The median PFS was eight months (95% confidence interval [CI] 6.4-9.6) after treatment with pazopanib and three months (95% CI 1.9-4.1) with everolimus. The median OS was 27 months (95% CI 16.6-37.4). The median treatment duration was seven months (range 4.3-10.8) after treatment with pazopanib and 3.5 months (range 3-4) with everolimus. Multivariate analysis revealed that the Heng risk criteria were independently associated with OS (p<0.001). Almost every patient experienced some form of AE, the majority of which were mostly mild or moderate in severity. The most common AEs were diarrhea (50%), hypertension (44.4%), and fatigue (41.7%) after treatment with pazopanib, and anemia (47.2%), stomatitis (41.7%), and fatigue (38.9%) with everolimus. Conclusions: The outcomes for the patients treated with pazopanib followed by everolimus in Korea as observed by us were consistent with those reported by previous studies. The Heng risk criteria were significantly associated with the prognosis of patients with mRCC. AEs were mainly mild to moderate and readily managed.

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Phase II trial of second-line everolimus in patients with metastatic renal cell carcinoma (RECORD-4)

Abstract: Everolimus as Second-line Therapy in Metastatic Renal Cell Carcinoma (RECORD-4), ClinicalTrials.gov identifier, NCT01491672.

Cited by 38 publications

References 9 publications

Oncology Gold StandardTM practical consensus recommendations 2016 for treatment of advanced clear cell renal cell carcinoma

Oncology Gold StandardTM practical consensus recommendations 2016 for treatment of advanced clear cell renal cell carcinoma

A Phase 4 Study of Everolimus to Evaluate Efficacy and Safety in Patients with Metastatic Renal-Cell Carcinoma after Failure of First-Line Sunitinib or Pazopanib (SUNPAZ)

Clinical outcomes of the sequential use of pazopanib followed by everolimus for the treatment of metastatic renal cell carcinoma: A multicentre study in Korea

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