Sunitinib treatment in patients with advanced renal cell cancer: the Brazilian National Cancer Institute (INCA) experience

Coelho, Rafael Corrêa; Reinert, Tomás; Campos, Franz; Peixoto, Fábio Affonso; Andrade, Carlos Augusto de; Castro, Thalita; Herchenhorn, Daniel

doi:10.1590/S1677-5538.IBJU.2015.0226

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Original Article • IBJUInt. braz j urol 42 (04) • Jul-Aug 2016 • https://doi.org/10.1590/S1677-5538.IBJU.2015.0226 copy

Sunitinib treatment in patients with advanced renal cell cancer: the Brazilian National Cancer Institute (INCA) experience

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Purpose:

The aim of this study was to assess the impact of sunitinib treatment in a non-screened group of patients with metastatic renal cell cancer (mRCC) treated by the Brazilian Unified Health System (SUS) at a single reference institution.

Material and Methods:

Retrospective cohort study, which evaluated patients with mRCC who received sunitinib between May 2010 and December 2013.

Results:

Fifty-eight patients were eligible. Most patients were male 41 (71%), with a median age of 58 years. Nephrectomy was performed in 41 (71%) patients with a median interval of 16 months between the surgery and initiation of sunitinib. The most prevalent histological subtype was clear cell carcinoma, present in 52 (91.2%) patients. In 50 patients (86%), sunitinib was the first line of systemic treatment. The main adverse effects were fatigue (57%), hypothyroidism (43%), mucositis (33%) and diarrhea (29%). Grade 3 and 4 adverse effects were infrequent: fatigue (12%), hypertension (12%), thrombocytopenia (7%), neutropenia (5%) and hand-foot syndrome (5%). Forty percent of patients achieved a partial response and 35% stable disease, with a disease control rate of 75%. Median progression free survival was 7.6 months and median overall survival was 14.1 months.

Conclusion:

Sunitinib treatment was active in the majority of patients, especially those with low and intermediate risk by MSKCC score, with manageable toxicity. Survival rates were inferior in this non-screened population with mRCC treated in the SUS.

Keywords:
Neoplasm Metastasis; Kidney Neoplasms; sunitinib [Supplementary Concept]; Retrospective Studies

		n	%
Age, years
	Median	58.0
	Range	18−80
ECOG PS
	0-1	37	64
	2	12	20
Histology
	Clear cell	52	91
	Non-clear cell	6	9
Previous nephrectomy		41	71
Metastatic sites
	Lung	42	72
	Bone	26	45
	Lymph nodes	21	36
	Liver	9	15
	Adrenal glands	5	9
	Pancreas	4	7
	Locoregional	4	7
	Pleura	3	5
	Brain	2	3
Previous systemic therapy^a a Includes 3 (7%) patients that participated in clinical trials ,*
	No previous systemic therapy	50	86
	Antiangiogenic ^b b Include sorafenib and bevacizumab.	3	5
	Cytokine	7	12
	mTOR inhibitor ^c c Include everolimus and temsirolimus.	2	3
Risk group according MSKCC criteria ^d d The MSKCC modified risk factors are PS ECOG ≥2, anemia, hypercalcemia, increased lactate dehydrogenase and time between nephrectomy and treatment shorter than 12 months [5]. MSKCC: Memorial Sloan-Kettering Cancer Center.
	Low risk	19	33
	Intermediate risk	23	38
	High risk	16	28
Total		58 patients

Adverse effect	Grade
Adverse effect	All	1	2	3
Fatigue	57	21	24	12
Diarrhea	29	9	17	3
Skin changes	29	11	16	2
Mucositis	33	17	16	NA
Hand-foot syndrome	29	19	5	5
Hypertension	24	3	9	12
Nausea	24	15	9	NA
Anemia	19	3.5	12	3.5
Thrombocytopenia	15	3	5	7
Epistaxis	9	3.5	3.5	2
Neutropenia	10	2	3	5
Edema	5	2	3	NA
Neuropathy	5	3	2	NA
Change in Taste	5	3	2	NA
Constipation	5	2	3	NA
Bleeding	5	2	3	NA

			Response
			Total	PR	SD	PD
MSKCC criteria	Favorable risk	Number of patients	16	10	5	1
	Favorable risk	(%)	35.6%	55.6%	31.3%	9.1%
	Intermediate risk	Number of patients	16	6	7	3
	Intermediate risk	(%)	35.6%	33.3%	43.8%	27.3%
	High risk	Number of patients	13	2	4	7
	High risk	(%)	28.9%	11.1%	25.0%	63.6%
Total		Number of patients	45	18	16	11
Total		(%)	100%	40%	35.6%	24.4%

Site	N	Prognostic factors	G3-4 Toxicities	Response Rate	PFS (m)	OS (m)
Coelho et al.	58	28.9% MSKCC high risk, 36% PS≥2, 27% ≥ 65 years old, 29 % without nephrectomy	12% fatigue, 12% hypertension, 7% thrombocytopenia, 5% neutropenia, 5% hand-foot syndrome.	Assessed in 45 patients: 40% partial response, 35.6% stable disease	7.6	14.1
Motzer et al. (¹¹11. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol.2009;27:3584-90., ¹²12. Motzer RJ, Bacik J, Schwartz LH, Reuter V, Russo P, Marion S, et al. Prognostic factors for survival in previously treated patients with metastatic renal cell carcinoma. J Clin Oncol.2004;22:454-63.)	375	10% without nephrectomy, 6% MSKCC high risk, PS 0-1, median age of 62 years	12% hypertension, 11% fatigue, 9% hand-foot syndrome and 9% diarrhea.	47%	11	26.4
Gore et al. (¹⁶16. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) [Internet]. August 9, 2006. Available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed January 20,2015. http://ctep.cancer.gov/protocolDevelopme... )	4564	11% without nephrectomy, 9% MSKCC high risk, 14% PS≥ 2, 32% age ≥ 65 years	8% fatigue, 8% thrombocytopenia, 6% neutropenia, 6% asthenia, 6 % HFS, 5 % diarrhea	1% complete response, 16% partial response, 59% stable disease	10.9	18.4
Ansari et al. (¹⁷17. Gore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S, et al. Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol.2009;10:757-63.)	56	14 % without nephrectomy, 18% PS≥2, median age of 61 years, 50% received interferon alpha as previous treatment	21 % mucositis, 14% leucopenia, 13% neutropenia, 9% thrombocytopenia, 7% increased creatinine, 5% diarrhea, 5% hypertension, 5% HFS	Assessed in 49 patients: 41% partial response, 37% stable disease	12.2 no difference between patients receiving and not receiving immunotherapy	18.2 no difference between patients receiving and not receiving immunotherapy
Hong et al. (¹⁸18. Ansari J, Fatima A, Fernando K, Collins S, James ND, Porfiri E. Sunitinib in patients with metastatic renal cell carcinoma: Birmingham experience. Oncol Rep.2010;24:507-10.)	76	Median age of 57.5 years, 10.5% PS =2, 10% MSKCC high risk, 4.3% without nephrectomy	38.2% thrombocytopenia, 10.5 % fatigue, 10.5% mucositis, 9.2 % HFS	27.6% objective response and 84.2% with controlled disease	7.2	22.8

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[1] Correspondence address: Rafael Correa Coelho, MD, Departamento de Oncologia Clínica, Inst. Nac. do Câncer José de Alencar Gomes da Silva (INCA), Praça da Cruz Vermelha, 23, Centro, Rio de Janeiro, 20230-130, Brasil, Telefone: + 55 21 99638942, E-mail: rccmed@gmail.com