OBJECTIVES

Metastatic renal cell carcinoma (mRCC) is frequently diagnosed in late phases. In 2017, CONITEC (Brazilian HTA Agency) incorporated sunitinib and pazopanib (SUNI/PAZO) for the public setting as treatment options for mRCC. Despite the importance of providing access to patients, real-world data has not been used so far to assess whether these two drugs provide better outcomes. The objective of this study is to explore real-world driven information about SUNI/PAZO effectiveness.

METHODS

Retrospective cohort study in public administrative database. Inclusion criteria consisted in patients with diagnosis of mRCC (ICD-10 code C34), between Jan 1^st 2011 to December 31^st 2015. Two cohort of treated patients were compared: G1 (SUNI/PAZO) versus G2 (systemic intravenous chemotherapies/non-monoclonal antibodies) for mRCC. The primary outcome of the study was 5-year mortality, which was reported as survival curve (Kaplan Meier method) and compared with log-rank test.

RESULTS

Of 3,675 patients with mRCC, 67% were males with 65 years old (median). A total of 2682 (73%) patients were on systemic intravenous chemotherapy (G2), while 992 mRCC individuals used SUNI/PAZO. The overall 5-year mortality in G1 was consistently lower than G2: SUN and PAZO had respectively 9 and 11 months of median survival from diagnosis, while systemic intravenous chemotherapy had 27 months of median survival (log-rank p-value=0.0001).

CONCLUSIONS

Sunitinib and pazopanib were associated with lower survival rates than intravenous systemic chemotherapy. The present real-world findings are exploratory and should be confirmed with prospective studies, aiming to assess whether recent incorporations of SUNI/PAZO by CONITEC are effective or not for mRCC. Forthcoming studies should also be able to assess the impact of risk factors for worse prognosis, including sex, age, time from nephrectomy and time from diagnosis to outcome.