Abstract
Limited data exist on the clinical effectiveness of second-line (2L) vascular endothelial growth factor (receptor) targeted inhibitor (VEGF(R)i) sunitinib after first-line (1L) immuno-oncology (IO) therapy for patients with metastatic renal cell carcinoma (mRCC) in real-world settings. A retrospective cohort study among adult patients with mRCC treated with 2L sunitinib following 1L IO was conducted from select International mRCC Database Consortium (IMDC) centers. All analyses were performed overall and by 1L ipilimumab + nivolumab (IPI+NIVO) or 1L IO+VEGF(R)i. Median overall survival (mOS) and time-to-treatment discontinuation (mTTD) in 2L were estimated using Kaplan-Meier analysis. The 2L objective response rate (ORR) (complete/partial response) was reported. Among 102 patients on 2L sunitinib, mean age was 61.3 years. IMDC risk scores at 2L initiation was available for 83 patients: 8 (9.6%) were favorable, 45 (54.2%) were intermediate, and 30 (36.1%) were poor risk. The 1L consisted of IPI+NIVO in 62 (60.8%), IO+VEGF(R)i therapy in 27 (26.5%), and IO monotherapy in 13 (12.7%) patients. Among all patients, mOS was 15.6 months (95% confidence interval [CI], 9.8-21.7), with a 1-year OS rate of 57.5% (95% CI, 45.2-68.0). mTTD was 5.4 months (95% CI, 4.2-7.2) and ORR was 22.5%. Despite availability of effective 1L therapies in recent years, 2L sunitinib continues to have clinical activity after failure of 1L IO. Further studies on optimal treatment sequencing after 1L IO progression are needed.
Highlights
Renal cell carcinoma (RCC) accounts for more than 90% of all kidney cancers
Among the 102 patients included in the study, 8 (7.8%) were classified in the favorable International mRCC Database Consortium (IMDC) risk group at the time of 2L sunitinib initiation, 45 (44.1%) in the intermediate-risk group, and 30 (29.4%) in the poor-risk group; 19 (18.6%) patients could not be classified
The current study is among the first to report real-world clinical outcomes associated with 2L sunitinib following 1L IO-based therapy
Summary
Renal cell carcinoma (RCC) accounts for more than 90% of all kidney cancers. Partial or radical nephrectomy is the standard of care for patients with stage I-III RCC,[1,2] but approximately one-third of these patients develop metastatic RCC (mRCC) post-surgery.[3,4,5,6] Further, up to 30% of patients diagnosed with RCC have metastases at initial presentation.[7]. Several new therapies have contributed to improving outcomes of patients with mRCC These include a number of vascular endothelial growth factor inhibitors (VEGFi) or VEGF receptor tyrosine kinase inhibitors (VEGFR TKI), including sorafenib, sunitinib, bevacizumab, pazopanib, axitinib, lenvatinib, and cabozantinib.[9,10] More recently, immuno-oncology (IO) drugs emerged as the new first-line (1L) standard of care in many countries for patients with intermediate- or poor-risk disease.[1,2] The CheckMate 214 and KEYNOTE-426 trials showed significant overall survival (OS) benefits of ipilimumab + nivolumab (IPI+NIVO) and pembrolizumab + axitinib, respectively, relative to sunitinib alone.[11,12] JAVELIN (avelumab + axitinib vs sunitinib) and IMmotion[151] trial (atezolizumab + bevacizumab vs sunitinib) trials showed that IO therapy in combination with a VEGF(R)i (IO+VEGF(R)i) significantly improved progression-free survival (PFS) relative to VEGF(R)i alone.[12,13,14]
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