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

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).

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“…Chang et al9 suggested that among patients with RCC, the genotype of cyclooxygenase 2 (COX2) could be used as a novel marker for the diagnosis of RCC. In 14 patients with inoperable mRCC, neoadjuvant sunitinib therapy showed a satisfactory response rate although a small number are operable after treatment 10. It has been indicated that among Chinese patients with mRCC, both sorafenib and sunitinib are effective agents.…”

“…In 14 patients with inoperable mRCC, neoadjuvant sunitinib therapy showed a satisfactory response rate although a small number are operable after treatment. 10 It has been indicated that among Chinese patients with mRCC, both sorafenib and sunitinib are effective agents. The median OS of patients treated with the two agents is similar (24.0 vs 24.0 months; P = 0.298), while the mPFS with sorafenib is higher compared with sunitinib (11.1 vs 10.0 months; P = 0.028).…”