A Prospective Multicenter Trial of the Efficacy and Tolerability of Neoadjuvant Sunitinib for Inoperable Metastatic Renal Cell Carcinoma.
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).
Department of Urology, Center for Prostate Cancer, Research Institute and Hospital of National Cancer Center, Goyang, Korea.
Sung Han
http://orcid.org/0000-0002-1689-5203
SH
Kim
Department of Urology, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.
Seong Il
http://orcid.org/0000-0002-9792-7798
SI
Seo
Department of Urology, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.
Hyun Moo
http://orcid.org/0000-0003-3969-4540
HM
Lee
Department of Urology, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.
Han Yong
http://orcid.org/0000-0002-1980-4899
HY
Choi
Department of Urology, Kyung Hee University Hospital, Seoul, Korea.
Seung Hyun
http://orcid.org/0000-0003-0915-8106
SH
Jeon
Department of Urology, Kyung Hee University Hospital, Seoul, Korea.
Hyung Lae
http://orcid.org/0000-0002-4338-7423
HL
Lee
Department of Urology, Kyungpook National University Hospital, Deagu, Korea.
Tae Gyun
http://orcid.org/0000-0002-4390-0952
TG
Kwon
Department of Urology, Chungbuk National University Hospital, Cheongju, Korea.
Yong June
http://orcid.org/0000-0002-7021-2450
YJ
Kim
Department of Urology, Chungbuk National University Hospital, Cheongju, Korea.
Wun Jae
http://orcid.org/0000-0002-8060-8926
WJ
Kim
Department of Urology, Center for Prostate Cancer, Research Institute and Hospital of National Cancer Center, Goyang, Korea. cjs5225@ncc.re.kr.
Jinsoo
http://orcid.org/0000-0003-2251-5331
J
Chung
D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D005221:Fatigue / Q000209:etiology; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000209:etiology; D020360:Neoadjuvant Therapy; D011446:Prospective Studies; D011758:Pyrroles / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D000077210:Sunitinib; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib
Carcinoma, Renal Cell; Metastasis; Neoadjuvant Therapy; Neoplasm; Targeted Molecular Therapy