J Korean Med Sci.  2016 Dec;31(12):1983-1988. 10.3346/jkms.2016.31.12.1983.

A Prospective Multicenter Trial of the Efficacy and Tolerability of Neoadjuvant Sunitinib for Inoperable Metastatic Renal Cell Carcinoma

• Kim SH
• Seo SI
• Lee HM
• Choi HY
• Jeon SH
• Lee HL
• Kwon TG
• Kim YJ
• Kim WJ
• Chung J

• KMID: 2355629
• DOI: http://doi.org/10.3346/jkms.2016.31.12.1983

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).

Keyword

Targeted Molecular Therapy; Neoadjuvant Therapy; Carcinoma, Renal Cell; Metastasis; Neoplasm

MeSH Terms

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

Figure

• 

  Fig. 1 Waterfall plot for size changes (%) in (A) the primary lesion and (B) the metastatic lesions.

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