Systemic therapy for advanced clear cell renal cell carcinoma after discontinuation of immune-oncology and VEGF targeted therapy combinations View Full Text


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Article Info

DATE

2020-07-02

AUTHORS

Yasser Ged, Ruby Gupta, Cihan Duzgol, Andrea Knezevic, Natalie Shapnik, Ritesh Kotecha, Martin H. Voss, Darren R. Feldman, Oguz Akin, Sujata Patil, Robert J. Motzer, Brian I. Rini, Chung-Han Lee

ABSTRACT

BackgroundSeveral phase 3 studies reported positive results for combinations of Immune-Oncology (IO) and Vascular Endothelial Growth Factor (VEGF) targeted therapies in patients with metastatic clear cell Renal Cell Carcinoma (ccRCC). However, there are limited data on outcomes to systemic therapy after IO-VEGF combinations.MethodsA retrospective analysis was performed on patients with metastatic ccRCC treated at the Memorial Sloan Kettering Cancer Center and Cleveland Clinic who initiated systemic therapy post IO-VEGF including combinations with VEGF receptor (VEGFR) tyrosine kinase inhibitors (IO-TKI) and combinations with the anti-VEGF monoclonal antibody bevacizumab (IO-Bev). The study objectives were to evaluate the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) on systemic therapy post IO-VEGF. RECIST v1.1 criteria were used to determine radiological responses and progression. Survival estimates were evaluated with the Kaplan-Meier methods and the log-rank test from the start of systemic therapy post IO-VEGF to the event of interest.ResultsA total of fifty-nine patients were treated post discontinuation of IO-VEGF regimens which included IO-Bev (n = 35; 59%) and IO-TKI (n = 24; 41%). Fifty-eight patients (98%) received IO-VEGF regimens as part of a clinical trial. Subsequent therapies included cabozantinib (n = 22; 37%), axitinib (n = 18; 31%), pazopanib (n = 4; 7%), lenvatinib and everolimus (n = 4; 7%), mTOR inhibitor monotherapy (n = 3; 5%), axitinib and dalantercept (n = 2; 3%), sunitinib (n = 1; 2%), sorafenib (n = 1; 2%), and treatment with agents on unreported clinical trials (n = 4; 7%). Patients treated on unreported clinical trials were excluded from the efficacy analysis. Post IO-VEGF, the ORR was 25% and median PFS was 12.0 months (95% CI, 8.2–24.5). Median OS was 24.5 months (95% CI, 12–NE) and 12 months OS rate was 63.3% (95% CI, 48.6–74.9). We observed no differences post IO-VEGF OS when comparing IO- TKI vs IO-Bev (Log-rank p = 0.73).ConclusionsPost IO-VEGF, most patients received VEGFR-TKIs. In this setting, VEGFR-TKIs demonstrated clinical activity and remain a viable option for salvage therapy after progression on IO-VEGF. More... »

PAGES

84

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s12894-020-00647-w

DOI

http://dx.doi.org/10.1186/s12894-020-00647-w

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1128939618

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/32616076


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    "description": "BackgroundSeveral phase 3 studies reported positive results for combinations of Immune-Oncology (IO) and Vascular Endothelial Growth Factor (VEGF) targeted therapies in patients with metastatic clear cell Renal Cell Carcinoma (ccRCC). However, there are limited data on outcomes to systemic therapy after IO-VEGF combinations.MethodsA retrospective analysis was performed on patients with metastatic ccRCC treated at the Memorial Sloan Kettering Cancer Center and Cleveland Clinic who initiated systemic therapy post IO-VEGF including combinations with VEGF receptor (VEGFR) tyrosine kinase inhibitors (IO-TKI) and combinations with the anti-VEGF monoclonal antibody bevacizumab (IO-Bev). The study objectives were to evaluate the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) on systemic therapy post IO-VEGF. RECIST v1.1 criteria were used to determine radiological responses and progression. Survival estimates were evaluated with the Kaplan-Meier methods and the log-rank test from the start of systemic therapy post IO-VEGF to the event of interest.ResultsA total of fifty-nine patients were treated post discontinuation of IO-VEGF regimens which included IO-Bev (n\u2009=\u200935; 59%) and IO-TKI (n\u2009=\u200924; 41%). Fifty-eight patients (98%) received IO-VEGF regimens as part of a clinical trial. Subsequent therapies included cabozantinib (n\u2009=\u200922; 37%), axitinib (n\u2009=\u200918; 31%), pazopanib (n\u2009=\u20094; 7%), lenvatinib and everolimus (n\u2009=\u20094; 7%), mTOR inhibitor monotherapy (n\u2009=\u20093; 5%), axitinib and dalantercept (n\u2009=\u20092; 3%), sunitinib (n\u2009=\u20091; 2%), sorafenib (n\u2009=\u20091; 2%), and treatment with agents on unreported clinical trials (n\u2009=\u20094; 7%). Patients treated on unreported clinical trials were excluded from the efficacy analysis. Post IO-VEGF, the ORR was 25% and median PFS was 12.0\u2009months (95% CI, 8.2\u201324.5). Median OS was 24.5\u2009months (95% CI, 12\u2013NE) and 12\u2009months OS rate was 63.3% (95% CI, 48.6\u201374.9). We observed no differences post IO-VEGF OS when comparing IO- TKI vs IO-Bev (Log-rank p\u2009=\u20090.73).ConclusionsPost IO-VEGF, most patients received VEGFR-TKIs. In this setting, VEGFR-TKIs demonstrated clinical activity and remain a viable option for salvage therapy after progression on IO-VEGF.", 
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22 schema:description BackgroundSeveral phase 3 studies reported positive results for combinations of Immune-Oncology (IO) and Vascular Endothelial Growth Factor (VEGF) targeted therapies in patients with metastatic clear cell Renal Cell Carcinoma (ccRCC). However, there are limited data on outcomes to systemic therapy after IO-VEGF combinations.MethodsA retrospective analysis was performed on patients with metastatic ccRCC treated at the Memorial Sloan Kettering Cancer Center and Cleveland Clinic who initiated systemic therapy post IO-VEGF including combinations with VEGF receptor (VEGFR) tyrosine kinase inhibitors (IO-TKI) and combinations with the anti-VEGF monoclonal antibody bevacizumab (IO-Bev). The study objectives were to evaluate the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) on systemic therapy post IO-VEGF. RECIST v1.1 criteria were used to determine radiological responses and progression. Survival estimates were evaluated with the Kaplan-Meier methods and the log-rank test from the start of systemic therapy post IO-VEGF to the event of interest.ResultsA total of fifty-nine patients were treated post discontinuation of IO-VEGF regimens which included IO-Bev (n = 35; 59%) and IO-TKI (n = 24; 41%). Fifty-eight patients (98%) received IO-VEGF regimens as part of a clinical trial. Subsequent therapies included cabozantinib (n = 22; 37%), axitinib (n = 18; 31%), pazopanib (n = 4; 7%), lenvatinib and everolimus (n = 4; 7%), mTOR inhibitor monotherapy (n = 3; 5%), axitinib and dalantercept (n = 2; 3%), sunitinib (n = 1; 2%), sorafenib (n = 1; 2%), and treatment with agents on unreported clinical trials (n = 4; 7%). Patients treated on unreported clinical trials were excluded from the efficacy analysis. Post IO-VEGF, the ORR was 25% and median PFS was 12.0 months (95% CI, 8.2–24.5). Median OS was 24.5 months (95% CI, 12–NE) and 12 months OS rate was 63.3% (95% CI, 48.6–74.9). We observed no differences post IO-VEGF OS when comparing IO- TKI vs IO-Bev (Log-rank p = 0.73).ConclusionsPost IO-VEGF, most patients received VEGFR-TKIs. In this setting, VEGFR-TKIs demonstrated clinical activity and remain a viable option for salvage therapy after progression on IO-VEGF.
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29 Cleveland Clinic
30 Kaplan-Meier method
31 Memorial Sloan-Kettering Cancer Center
32 OS rates
33 RECIST v1.1 criteria
34 ResultsA total
35 VEGF monoclonal antibody bevacizumab
36 VEGF receptor tyrosine kinase inhibitor
37 activity
38 advanced clear cell renal cell carcinoma
39 agents
40 analysis
41 antibody bevacizumab
42 axitinib
43 bevacizumab
44 cabozantinib
45 carcinoma
46 cell carcinoma
47 cell renal cell carcinoma
48 center
49 clear cell renal cell carcinoma
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55 data
56 differences
57 discontinuation
58 efficacy analysis
59 endothelial growth factor
60 estimates
61 event of interest
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63 everolimus
64 factors
65 growth factor
66 immune oncology
67 inhibitor monotherapy
68 inhibitors
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70 kinase inhibitors
71 lenvatinib
72 log-rank test
73 mTOR inhibitor monotherapy
74 median overall survival
75 median progression-free survival
76 metastatic clear cell renal cell carcinoma
77 method
78 monoclonal antibody bevacizumab
79 monotherapy
80 months
81 months OS rate
82 most patients
83 objective
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85 options
86 outcomes
87 overall survival
88 part
89 patients
90 pazopanib
91 phase 3 study
92 positive results
93 post discontinuation
94 progression
95 progression-free survival
96 radiological response
97 rate
98 receptor tyrosine kinase inhibitors
99 regimens
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101 response
102 response rate
103 results
104 retrospective analysis
105 salvage therapy
106 setting
107 sorafenib
108 start
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111 subsequent therapy
112 sunitinib
113 survival
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115 systemic therapy
116 test
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