Meeting
2014 Genitourinary Cancers Symposium
Multicenter phase II clinical trial of everolimus in Japanese patients with unresectable or metastatic renal cell carcinoma (mRCC) after failure of treatment with first-line tyrosine kinase inhibitor (TKI) therapy.
Authors
Seiichiro Ozono
Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan
Seiichiro Ozono , Masafumi Oyama , Masahiro Nozawa , Kiyohide Fujimoto , Ken Kishida , Noriaki Tokuda , Go Kimura , Kazuo Nishimura , Akio Matsubara , Hideyasu Matsuyama , Takayuki Sugiyama , Tomomi Kamba , Haruki Kume , Naoya Masumori , Mototsugu Oya , Hiro-Omi Kanayama , Seiji Naito , Shiro Hinotsu , Kojiro Shimozuma , Hideyuki Akaza
Organizations
Department of Urology, Hamamatsu University School of Medicine, Hamamatsu, Japan, Saitama Medical University International Medical Center, Saitama, Japan, Department of Urology, Kinki University Faculty of Medicine, Osaka-Sayama, Japan, Department of Urology, Nara Medical University, Kashihara, Japan, Department of Urology, Kanagawa Cancer Center Hospital, Yokohama, Japan, Department of Urology, Saga-ken Medical Centre Koseikan, Saga, Japan, Department of Urology, Nippon Medical School Hospital, Tokyo, Japan, Department of Urology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan, Department of Urology, Institute of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan, Department of Urology, Graduate School of Medicine, Yamaguchi University, Ube, Japan, Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan, Department of Urology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan, Department of Urologic Surgery and Andrology, Sapporo Medical University School of Medicine, Sapporo, Japan, Department of Urology, Keio University School of Medicine, Tokyo, Japan, Department of Urology, Institute of Health Biosciences, The University of Tokushima Graduate School, Tokushima, Japan, Department of Urology, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan, Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan, Division of Health Services Research, Department of Biomedical Sciences, College of Life Science, Ritsumeikan University, Shiga, Japan, Research Center for Advanced Science and Technology, University of Tokyo, Tokyo, Japan
Research Funding
Other Foundation
Background: Everolimus has shown the efficacy and the safety in the phase III trial (RECORD-1) in patients with mRCC after failure of Vascular Endothelial Growth Factor Receptor-TKI. However, 26% of patients received two TKIs (sunitinib and sorafenib) as previous therapy in RECORD-1. In addition, as pre-treatment before TKI, 65% of patients received cytokine therapy and 13% of patients received chemotherapy. Therefore, there is still no clear evidence of everolimus as second line setting after failure of 1st-line TKI therapy. Methods: This study is an open-label, multi-center, single-arm, phase II trial. Primary endpoint is progression-free survival (PFS), and secondary endpoints are overall survival, objective response rate, time-to-treatment-failure, safety and quality of life (EORTC QLQ-C30, FKSI-DRS, EQ-5D). Key eligibility criteria are RCC with clear cell component, patients who received one TKI as first line therapy, patients who did not receive cytokine and chemotherapy and ECOG performance status 0-1. Results: 57 patients were enrolled from 02/11 to 12/12. Median age was 63 years, common sites of metastasis were lung (32.7%) and bone (12.2%), 79.6% had previous nephrectomy, previous TKI therapy were sunitinib (69.4%), sorafenib (22.4%) and axitinib (8.2%). Median PFS was 4.4 months (95% confidence interval: 3.7-6.0). 8.2% had partial response and 57.1% had stable disease according to RECIST v.1.0. The incidence of adverse events (AEs) of all grades was 95.9%. Major AEs were stomatitis (49.0%), hypertriglyceridemia (26.5%) and hypercholesterolemia (24.5%). Serious AEs were stomatitis (10.2%), interstitial lung disease (6.1%) and rash (6.1%). There were no treatment related deaths. All QOL scores were not changed at 2 months, while dyspnea and global health scores of EORTC QLQ-C30 and FKSI-DRS score were worsened at 4 months. Conclusions: This study is a first report of everolimus as second line setting after failure of 1st-line TKI. Further study and long-term follow-up would be warranted. Clinical trial information: UMIN000004742.
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Abstract Details
Session Type
Poster Session
Session Title
General Poster Session C: Renal Cancer
Track
Renal Cell Cancer
Sub Track
Renal Cell Cancer
Clinical Trial Registration Number
UMIN000004742
Citation
J Clin Oncol 32, 2014 (suppl 4; abstr 455)
DOI
10.1200/jco.2014.32.4_suppl.455
Abstract #
455
Poster Bd #
E6
Abstract Disclosures
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