Outcomes of patients with metastatic clear-cell renal cell carcinoma treated with second-line VEGFR-TKI after first-line immune checkpoint inhibitors
Immune checkpoint inhibitors (ICIs) are being increasingly utilised in the front-line (1L) setting of metastatic clear-cell renal cell carcinoma (mccRCC). Limited data exist on responses and survival on second-line (2L) vascular endothelial growth factor–receptor tyrosine kinase inhibitor (VEGFR-TKI...
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| Published in | European journal of cancer (1990) Vol. 114; pp. 67 - 75 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
England
Elsevier Ltd
01.06.2019
Elsevier Science Ltd |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0959-8049 1879-0852 1879-0852 |
| DOI | 10.1016/j.ejca.2019.04.003 |
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| Abstract | Immune checkpoint inhibitors (ICIs) are being increasingly utilised in the front-line (1L) setting of metastatic clear-cell renal cell carcinoma (mccRCC). Limited data exist on responses and survival on second-line (2L) vascular endothelial growth factor–receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy after 1L ICI therapy.
This is a retrospective study of mccRCC patients treated with 2L VEGFR-TKI after progressive disease (PD) with 1L ICI. Patients were treated at MD Anderson Cancer Center or Memorial Sloan Kettering Cancer Center between December 2015 and February 2018. Objective response was assessed by blinded radiologists' review using Response Evaluation Criteria in Solid Tumours v1.1. Descriptive statistics and Kaplan–Meier method were used.
Seventy patients were included in the analysis. Median age at mccRCC diagnosis was 59 years; 8 patients (11%) had international metastatic database consortium favourable-risk disease, 48 (69%) had intermediate-risk disease and 14 (20%) had poor-risk disease. As 1L therapy, 12 patients (17%) received anti–programmed death ligand-1 (PD-(L)1) monotherapy with nivolumab or atezolizumab, 33 (47%) received nivolumab plus ipilimumab and 25 (36%) received combination anti–PD-(L)1 plus bevacizumab. 2L TKI therapies included pazopanib, sunitinib, axitinib and cabozantinib. On 2L TKI therapy, one patient (1.5%) achieved a complete response, 27 patients (39.7%) a partial response and 36 patients (52.9%) stable disease. Median progression-free survival (mPFS) was 13.2 months (95% confidence interval: 10.1, NA). Forty-five percent of subjects required a dose reduction, and twenty-seven percent of patients discontinued treatment because of toxicity.
In this retrospective study of patients with mccRCC receiving 2L TKI monotherapy after 1L ICI, we observed 2L antitumour activity and tolerance comparable to historical data for 1L TKI.
•Immunotherapy (ICI) is moving to front-line treatment in metastatic RCC for intermediate- and poor-risk patients.•Little data exists on responses to second-line (2L) TKI after front-line (1L) ICI.•Our data showed that 2L VEGFR-TKI have ORR 41% and DCR 94% after 1L ICI–containing regimen.•Median PFS on 2L VEGFR-TKI after 1L ICI in metastatic clear-cell RCC was 13.2 mo.•Safety and tolerability of 2L VEGFR-TKI after 1L ICI is typical of class effects. |
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| AbstractList | Immune checkpoint inhibitors (ICIs) are being increasingly utilised in the front-line (1L) setting of metastatic clear-cell renal cell carcinoma (mccRCC). Limited data exist on responses and survival on second-line (2L) vascular endothelial growth factor-receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy after 1L ICI therapy.BACKGROUNDImmune checkpoint inhibitors (ICIs) are being increasingly utilised in the front-line (1L) setting of metastatic clear-cell renal cell carcinoma (mccRCC). Limited data exist on responses and survival on second-line (2L) vascular endothelial growth factor-receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy after 1L ICI therapy.This is a retrospective study of mccRCC patients treated with 2L VEGFR-TKI after progressive disease (PD) with 1L ICI. Patients were treated at MD Anderson Cancer Center or Memorial Sloan Kettering Cancer Center between December 2015 and February 2018. Objective response was assessed by blinded radiologists' review using Response Evaluation Criteria in Solid Tumours v1.1. Descriptive statistics and Kaplan-Meier method were used.PATIENTS AND METHODSThis is a retrospective study of mccRCC patients treated with 2L VEGFR-TKI after progressive disease (PD) with 1L ICI. Patients were treated at MD Anderson Cancer Center or Memorial Sloan Kettering Cancer Center between December 2015 and February 2018. Objective response was assessed by blinded radiologists' review using Response Evaluation Criteria in Solid Tumours v1.1. Descriptive statistics and Kaplan-Meier method were used.Seventy patients were included in the analysis. Median age at mccRCC diagnosis was 59 years; 8 patients (11%) had international metastatic database consortium favourable-risk disease, 48 (69%) had intermediate-risk disease and 14 (20%) had poor-risk disease. As 1L therapy, 12 patients (17%) received anti-programmed death ligand-1 (PD-(L)1) monotherapy with nivolumab or atezolizumab, 33 (47%) received nivolumab plus ipilimumab and 25 (36%) received combination anti-PD-(L)1 plus bevacizumab. 2L TKI therapies included pazopanib, sunitinib, axitinib and cabozantinib. On 2L TKI therapy, one patient (1.5%) achieved a complete response, 27 patients (39.7%) a partial response and 36 patients (52.9%) stable disease. Median progression-free survival (mPFS) was 13.2 months (95% confidence interval: 10.1, NA). Forty-five percent of subjects required a dose reduction, and twenty-seven percent of patients discontinued treatment because of toxicity.RESULTSSeventy patients were included in the analysis. Median age at mccRCC diagnosis was 59 years; 8 patients (11%) had international metastatic database consortium favourable-risk disease, 48 (69%) had intermediate-risk disease and 14 (20%) had poor-risk disease. As 1L therapy, 12 patients (17%) received anti-programmed death ligand-1 (PD-(L)1) monotherapy with nivolumab or atezolizumab, 33 (47%) received nivolumab plus ipilimumab and 25 (36%) received combination anti-PD-(L)1 plus bevacizumab. 2L TKI therapies included pazopanib, sunitinib, axitinib and cabozantinib. On 2L TKI therapy, one patient (1.5%) achieved a complete response, 27 patients (39.7%) a partial response and 36 patients (52.9%) stable disease. Median progression-free survival (mPFS) was 13.2 months (95% confidence interval: 10.1, NA). Forty-five percent of subjects required a dose reduction, and twenty-seven percent of patients discontinued treatment because of toxicity.In this retrospective study of patients with mccRCC receiving 2L TKI monotherapy after 1L ICI, we observed 2L antitumour activity and tolerance comparable to historical data for 1L TKI.CONCLUSIONSIn this retrospective study of patients with mccRCC receiving 2L TKI monotherapy after 1L ICI, we observed 2L antitumour activity and tolerance comparable to historical data for 1L TKI. Background Immune checkpoint inhibitors (ICIs) are being increasingly utilised in the front-line (1L) setting of metastatic clear-cell renal cell carcinoma (mccRCC). Limited data exist on responses and survival on second-line (2L) vascular endothelial growth factor–receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy after 1L ICI therapy. Patients and methods This is a retrospective study of mccRCC patients treated with 2L VEGFR-TKI after progressive disease (PD) with 1L ICI. Patients were treated at MD Anderson Cancer Center or Memorial Sloan Kettering Cancer Center between December 2015 and February 2018. Objective response was assessed by blinded radiologists' review using Response Evaluation Criteria in Solid Tumours v1.1. Descriptive statistics and Kaplan–Meier method were used. Results Seventy patients were included in the analysis. Median age at mccRCC diagnosis was 59 years; 8 patients (11%) had international metastatic database consortium favourable-risk disease, 48 (69%) had intermediate-risk disease and 14 (20%) had poor-risk disease. As 1L therapy, 12 patients (17%) received anti–programmed death ligand-1 (PD-(L)1) monotherapy with nivolumab or atezolizumab, 33 (47%) received nivolumab plus ipilimumab and 25 (36%) received combination anti–PD-(L)1 plus bevacizumab. 2L TKI therapies included pazopanib, sunitinib, axitinib and cabozantinib. On 2L TKI therapy, one patient (1.5%) achieved a complete response, 27 patients (39.7%) a partial response and 36 patients (52.9%) stable disease. Median progression-free survival (mPFS) was 13.2 months (95% confidence interval: 10.1, NA). Forty-five percent of subjects required a dose reduction, and twenty-seven percent of patients discontinued treatment because of toxicity. Conclusions In this retrospective study of patients with mccRCC receiving 2L TKI monotherapy after 1L ICI, we observed 2L antitumour activity and tolerance comparable to historical data for 1L TKI. Immune checkpoint inhibitors (ICIs) are being increasingly utilised in the front-line (1L) setting of metastatic clear-cell renal cell carcinoma (mccRCC). Limited data exist on responses and survival on second-line (2L) vascular endothelial growth factor–receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy after 1L ICI therapy. This is a retrospective study of mccRCC patients treated with 2L VEGFR-TKI after progressive disease (PD) with 1L ICI. Patients were treated at MD Anderson Cancer Center or Memorial Sloan Kettering Cancer Center between December 2015 and February 2018. Objective response was assessed by blinded radiologists' review using Response Evaluation Criteria in Solid Tumours v1.1. Descriptive statistics and Kaplan–Meier method were used. Seventy patients were included in the analysis. Median age at mccRCC diagnosis was 59 years; 8 patients (11%) had international metastatic database consortium favourable-risk disease, 48 (69%) had intermediate-risk disease and 14 (20%) had poor-risk disease. As 1L therapy, 12 patients (17%) received anti–programmed death ligand-1 (PD-(L)1) monotherapy with nivolumab or atezolizumab, 33 (47%) received nivolumab plus ipilimumab and 25 (36%) received combination anti–PD-(L)1 plus bevacizumab. 2L TKI therapies included pazopanib, sunitinib, axitinib and cabozantinib. On 2L TKI therapy, one patient (1.5%) achieved a complete response, 27 patients (39.7%) a partial response and 36 patients (52.9%) stable disease. Median progression-free survival (mPFS) was 13.2 months (95% confidence interval: 10.1, NA). Forty-five percent of subjects required a dose reduction, and twenty-seven percent of patients discontinued treatment because of toxicity. In this retrospective study of patients with mccRCC receiving 2L TKI monotherapy after 1L ICI, we observed 2L antitumour activity and tolerance comparable to historical data for 1L TKI. •Immunotherapy (ICI) is moving to front-line treatment in metastatic RCC for intermediate- and poor-risk patients.•Little data exists on responses to second-line (2L) TKI after front-line (1L) ICI.•Our data showed that 2L VEGFR-TKI have ORR 41% and DCR 94% after 1L ICI–containing regimen.•Median PFS on 2L VEGFR-TKI after 1L ICI in metastatic clear-cell RCC was 13.2 mo.•Safety and tolerability of 2L VEGFR-TKI after 1L ICI is typical of class effects. Immune checkpoint inhibitors (ICIs) are being increasingly utilised in the front-line (1L) setting of metastatic clear-cell renal cell carcinoma (mccRCC). Limited data exist on responses and survival on second-line (2L) vascular endothelial growth factor-receptor tyrosine kinase inhibitor (VEGFR-TKI) therapy after 1L ICI therapy. This is a retrospective study of mccRCC patients treated with 2L VEGFR-TKI after progressive disease (PD) with 1L ICI. Patients were treated at MD Anderson Cancer Center or Memorial Sloan Kettering Cancer Center between December 2015 and February 2018. Objective response was assessed by blinded radiologists' review using Response Evaluation Criteria in Solid Tumours v1.1. Descriptive statistics and Kaplan-Meier method were used. Seventy patients were included in the analysis. Median age at mccRCC diagnosis was 59 years; 8 patients (11%) had international metastatic database consortium favourable-risk disease, 48 (69%) had intermediate-risk disease and 14 (20%) had poor-risk disease. As 1L therapy, 12 patients (17%) received anti-programmed death ligand-1 (PD-(L)1) monotherapy with nivolumab or atezolizumab, 33 (47%) received nivolumab plus ipilimumab and 25 (36%) received combination anti-PD-(L)1 plus bevacizumab. 2L TKI therapies included pazopanib, sunitinib, axitinib and cabozantinib. On 2L TKI therapy, one patient (1.5%) achieved a complete response, 27 patients (39.7%) a partial response and 36 patients (52.9%) stable disease. Median progression-free survival (mPFS) was 13.2 months (95% confidence interval: 10.1, NA). Forty-five percent of subjects required a dose reduction, and twenty-seven percent of patients discontinued treatment because of toxicity. In this retrospective study of patients with mccRCC receiving 2L TKI monotherapy after 1L ICI, we observed 2L antitumour activity and tolerance comparable to historical data for 1L TKI. |
| Author | Chaim, J.L. Kotecha, R.R. Campbell, M.T. Jonasch, E. Msaouel, P. Wang, J. Sharma, P. Tannir, N.M. Voss, M.H. Corn, P.G. Lemke, E.A. Xiao, L. Gao, J. Zurita, A.J. Motzer, R.J. Shah, A.Y. Chandramohan, A. |
| AuthorAffiliation | 5 Department of Biostatistics, MD Anderson Cancer Center, Houston, TX, USA 6 Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA 1 Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA 3 Department of Diagnostic Radiology, MD Anderson Cancer Center, Houston, TX, USA 2 Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA 4 Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA |
| AuthorAffiliation_xml | – name: 1 Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – name: 6 Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA – name: 2 Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA – name: 3 Department of Diagnostic Radiology, MD Anderson Cancer Center, Houston, TX, USA – name: 4 Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA – name: 5 Department of Biostatistics, MD Anderson Cancer Center, Houston, TX, USA |
| Author_xml | – sequence: 1 givenname: A.Y. surname: Shah fullname: Shah, A.Y. email: ayshah@mdanderson.org organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 2 givenname: R.R. surname: Kotecha fullname: Kotecha, R.R. organization: Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA – sequence: 3 givenname: E.A. surname: Lemke fullname: Lemke, E.A. organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 4 givenname: A. surname: Chandramohan fullname: Chandramohan, A. organization: Department of Diagnostic Radiology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 5 givenname: J.L. surname: Chaim fullname: Chaim, J.L. organization: Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA – sequence: 6 givenname: P. surname: Msaouel fullname: Msaouel, P. organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 7 givenname: L. surname: Xiao fullname: Xiao, L. organization: Department of Biostatistics, MD Anderson Cancer Center, Houston, TX, USA – sequence: 8 givenname: J. surname: Gao fullname: Gao, J. organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 9 givenname: M.T. surname: Campbell fullname: Campbell, M.T. organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 10 givenname: A.J. surname: Zurita fullname: Zurita, A.J. organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 11 givenname: J. surname: Wang fullname: Wang, J. organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 12 givenname: P.G. surname: Corn fullname: Corn, P.G. organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 13 givenname: E. surname: Jonasch fullname: Jonasch, E. organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 14 givenname: R.J. surname: Motzer fullname: Motzer, R.J. organization: Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA – sequence: 15 givenname: P. surname: Sharma fullname: Sharma, P. organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA – sequence: 16 givenname: M.H. surname: Voss fullname: Voss, M.H. organization: Genitourinary Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA – sequence: 17 givenname: N.M. surname: Tannir fullname: Tannir, N.M. organization: Department of Genitourinary Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31075726$$D View this record in MEDLINE/PubMed |
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| Copyright | 2019 Elsevier Ltd Copyright © 2019 Elsevier Ltd. All rights reserved. Copyright Elsevier Science Ltd. Jun 2019 |
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| Keywords | RCC ccRCC Therapy sequence Immune checkpoint inhibitor Renal cell carcinoma Immunotherapy Clear cell renal cell carcinoma Immunotherapy refractory VEGFR-TKI Metastatic kidney cancer |
| Language | English |
| License | Copyright © 2019 Elsevier Ltd. All rights reserved. |
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| Snippet | Immune checkpoint inhibitors (ICIs) are being increasingly utilised in the front-line (1L) setting of metastatic clear-cell renal cell carcinoma (mccRCC).... Background Immune checkpoint inhibitors (ICIs) are being increasingly utilised in the front-line (1L) setting of metastatic clear-cell renal cell carcinoma... |
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| SubjectTerms | Anticancer properties Apoptosis Bevacizumab Cancer Carcinoma, Renal Cell - drug therapy Carcinoma, Renal Cell - mortality Carcinoma, Renal Cell - pathology ccRCC Clear cell renal cell carcinoma Clear cell-type renal cell carcinoma Confidence intervals Consortia Enzyme inhibitors Female Growth factors Health risks Humans Immune checkpoint inhibitor Immune checkpoint inhibitors Immunological tolerance Immunotherapy Immunotherapy - methods Immunotherapy refractory Inhibitors Kidney cancer Kidney Neoplasms - drug therapy Kidney Neoplasms - mortality Kidney Neoplasms - pathology Kinases Male Median (statistics) Metastases Metastasis Metastatic kidney cancer Middle Aged Monoclonal antibodies Protein Kinase Inhibitors - pharmacology Protein Kinase Inhibitors - therapeutic use Protein-tyrosine kinase receptors RCC Renal cell carcinoma Retrospective Studies Risk Solid tumors Statistical analysis Survival Survival Analysis Targeted cancer therapy Therapy Therapy sequence Toxicity Treatment Outcome Tumors Tyrosine Vascular endothelial growth factor Vascular Endothelial Growth Factor A - antagonists & inhibitors Vascular endothelial growth factor receptors VEGFR-TKI |
| Title | Outcomes of patients with metastatic clear-cell renal cell carcinoma treated with second-line VEGFR-TKI after first-line immune checkpoint inhibitors |
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