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Results of a Multicenter Phase II Study of Atezolizumab and Bevacizumab for Patients With Metastatic Renal Cell Carcinoma With Variant Histology and/or Sarcomatoid Features.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2020 Jan 01; Vol. 38 (1), pp. 63-70. Date of Electronic Publication: 2019 Nov 13. - Publication Year :
- 2020
-
Abstract
- Purpose: In this multicenter phase II trial, we evaluated atezolizumab combined with bevacizumab in patients with advanced renal cell carcinoma (RCC) with variant histology or any RCC histology with ≥ 20% sarcomatoid differentiation.<br />Patients and Methods: Eligible patients may have received previous systemic therapy, excluding prior bevacizumab or checkpoint inhibitors. Patients underwent a baseline biopsy and received atezolizumab 1,200 mg and bevacizumab 15 mg/kg intravenously every 3 weeks. The primary end point was overall response rate (ORR) by RECIST version 1.1. Additional end points were progression-free survival (PFS), toxicity, biomarkers of response as determined by programmed death-ligand 1 (PD-L1) status, and on-therapy quality-of-life (QOL) metrics using the Functional Assessment of Cancer Therapy Kidney Symptom Index-19 and the Brief Fatigue Inventory.<br />Results: Sixty patients received at least 1 dose of either study agent; the majority (65%) were treatment naïve. The ORR for the overall population was 33% and 50% in patients with clear cell RCC with sarcomatoid differentiation and 26% in patients with variant histology RCC. Median PFS was 8.3 months (95% CI, 5.7 to 10.9 months). PD-L1 status was available for 36 patients; 15 (42%) had ≥ 1% expression on tumor cells. ORR in PD-L1-positive patients was 60% (n = 9) v 19% (n = 4) in PD-L1-negative patients. Eight patients (13%) developed treatment-related grade 3 toxicities. There were no treatment-related grade 4-5 toxicities. QOL was maintained throughout therapy.<br />Conclusion: In this study, atezolizumab and bevacizumab demonstrated safety and resulted in objective responses in patients with variant histology RCC or RCC with ≥ 20% sarcomatoid differentiation. This regimen warrants additional exploration in patients with rare RCC, particularly those with PD-L1-positive tumors.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized administration & dosage
B7-H1 Antigen metabolism
Bevacizumab administration & dosage
Carcinoma, Renal Cell metabolism
Female
Humans
Immunohistochemistry
Kidney Neoplasms metabolism
Male
Middle Aged
Neoplasm Staging
Prospective Studies
Quality of Life
Sarcoma metabolism
Young Adult
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Carcinoma, Renal Cell drug therapy
Carcinoma, Renal Cell pathology
Kidney Neoplasms drug therapy
Kidney Neoplasms pathology
Sarcoma pathology
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 38
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 31721643
- Full Text :
- https://doi.org/10.1200/JCO.19.01882