A Prospective Multicenter Trial of the Efficacy and Tolerability of Neoadjuvant Sunitinib for Inoperable Metastatic Renal Cell Carcinoma.
10.3346/jkms.2016.31.12.1983
- Author:
Sung Han KIM
1
;
Seong Il SEO
;
Hyun Moo LEE
;
Han Yong CHOI
;
Seung Hyun JEON
;
Hyung Lae LEE
;
Tae Gyun KWON
;
Yong June KIM
;
Wun Jae KIM
;
Jinsoo CHUNG
Author Information
1. Department of Urology, Center for Prostate Cancer, Research Institute and Hospital of National Cancer Center, Goyang, Korea. cjs5225@ncc.re.kr
- Publication Type:Multicenter Study ; Original Article
- Keywords:
Targeted Molecular Therapy;
Neoadjuvant Therapy;
Carcinoma, Renal Cell;
Metastasis;
Neoplasm
- MeSH:
Carcinoma, Renal Cell*;
Disease Progression;
Fatigue;
Humans;
Molecular Targeted Therapy;
Multicenter Studies as Topic*;
Nausea;
Neoadjuvant Therapy;
Neoplasm Metastasis;
Prospective Studies*;
Quality of Life;
Response Evaluation Criteria in Solid Tumors;
Vomiting
- From:Journal of Korean Medical Science
2016;31(12):1983-1988
- CountryRepublic of Korea
- Language:English
-
Abstract:
This study aimed to evaluate the efficacy, safety, and tolerability of 2-cycled neoadjuvant sunitinib therapy (NST) in patients with inoperable metastatic renal cell carcinoma (mRCC). Between 2009 and 2012, 14 patients with inoperable mRCC from 5 Korean academic centers were prospectively enrolled after collecting their clinicopathological data and completing health-related questionnaires. The best overall response (BOR), safety profile, and changes in quality of life during NST were assessed using the RECIST criteria (version 1.0), CTCAE criteria (version 4.0), and the Cancer Quality of Life Questionnaire (QLQ-C30). Among the 14 patients, 9 patients (64.3%) experienced partial response or stable disease state, and 5 patients (35.7%) did not complete treatment, with 1 case of disease progression (7.1%), 3 grade 3 adverse events (21.4%), and 1 voluntary withdrawal (7.1%). Four patients (28.6%) were successfully converted to an operable state and underwent surgery after NST. The BOR for the primary renal lesions was 22.2%, with a median 1.3-cm diameter reduction (range: 0–2.8 cm) from a baseline diameter of 10.3 cm (range: 6.6–15.8 cm). The other 18 measurable metastatic lesions exhibited a BOR of 55.6%. The QLQ-C30 questionnaire results revealed significant improvements in the quality of life domain, although we observed significant increases in the scores for fatigue, nausea and vomiting, and the financial effects of NST (P < 0.05). Two-cycle NST provided limited efficacy for resectability of inoperable mRCC, despite mild improvements in the BOR of the primary lesion and quality of life (Clinical Trial Registry 1041140-1).
