Long-Term Response to Sunitinib Treatment in Metastatic Renal Cell Carcinoma: A Pooled Analysis of Clinical Trials
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 |
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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 |
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