Tannir, N. M., Figlin, R. A., Gore, M. E., Michaelson, M. D., Motzer, R. J., Porta, C., Rini, B. I., Hoang, C., Lin, X., Escudier, B. (2018) Long-Term Response to Sunitinib Treatment in Metastatic Renal Cell Carcinoma: A Pooled Analysis of Clinical Trials. CLINICAL GENITOURINARY CANCER, 16 (1). pp. 6-12. ISSN 1558-7673

Full text not available from this repository.

Abstract

A subset of patients with metastatic renal cell carcinoma treated with sunitinib achieved long-term response (ie, progression-free survival [PFS] > 18 months). Long-term responders had improved objective response rate, PFS, and overall survival versus others. Patient baseline characteristics predictive of long-term response to sunitinib were identified. Background: We characterized clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) treated with sunitinib who were long-term responders (LTRs), defined as patients having progression-free survival (PFS) > 18 months. Patients and Methods: A retrospective analysis of data from 5714 patients with mRCC treated with sunitinib in 8 phase II/III clinical trials and the expanded access program. Duration on-study and objective response rate (ORR) were compared between LTRs and patients with PFS < 18 months ("others"). PFS and overall survival (OS) were summarized using Kaplan-Meier methodology. Results: Overall, 898 (15.7%) patients achieved a long-term response and 4816 (84.3%) patients did not achieve long-term response. The median (range) duration on-study was 28.6 (16.8-70.7) months in LTRs and 5.5 (0-68.8) months in others. ORR was 51% in LTRs versus 14% in others (P < .0001). Median PFS in LTRs was 32.11 months and median OS was not reached. LTRs had higher percentage of early tumor shrinkage >= 10% at the first scan (67.1% vs. 51.2%; P = .0018) and greater median maximum on-study tumor shrinkage from baseline (-56.9 vs. -27.1; P < .0001) versus others. White race, Eastern Cooperative Oncology Group performance status 0, time from diagnosis to treatment >= 1 year, clear cell histology, no liver metastasis, lactate dehydrogenase <= 1.5 upper limit of normal (ULN), corrected calcium <= 10 mg/dL, hemoglobin greater than the lower limit of normal, platelets less than or equal to ULN, body mass index >= 25 kg/m(2), and low neutrophil-to-lymphocyte ratio were associated with LTR. Conclusion: A subset of patients with mRCC treated with sunitinib achieved long-term response. LTRs had improved ORR, PFS, and OS.

Item Type:	Article
Authors (ICR Faculty only):	Gore, Martin
All Authors:	Tannir, N. M., Figlin, R. A., Gore, M. E., Michaelson, M. D., Motzer, R. J., Porta, C., Rini, B. I., Hoang, C., Lin, X., Escudier, B.
Additional Information:	ISI Document Delivery No.: FW3EW Times Cited: 0 Cited Reference Count: 37 Tannir, Nizar M. Figlin, Robert A. Gore, Martin E. Michaelson, M. Dror Motzer, Robert J. Porta, Camillo Rini, Brian I. Hoang, Caroline Lin, Xun Escudier, Bernard Pfizer; Pfizer Inc. This study was sponsored by Pfizer. Medical writing support was provided by Vardit Dror, PhD, of Engage Scientific Solutions and was funded by Pfizer Inc. 0 Cig media group, lp Dallas 1938-0682
Uncontrolled Keywords:	Long-term response Metastatic Objective response rate Predictors Progression-free survival phase-iii trial expanded-access trial interferon-alpha japanese patients prognostic-factor double-blind follow-up survival efficacy therapy Oncology Urology & Nephrology
Research teams:	Clinical Units > Gynaecology Unit Clinical Units > Renal & Melanoma Unit
Depositing User:	Barry Jenkins
Date Deposited:	12 Mar 2018 14:01
Last Modified:	12 Mar 2018 14:01
URI:	http://publications.icr.ac.uk/id/eprint/16669

Actions (login required)

View Item