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Pharmacoepidemiol Drug Saf. 2017 Dec;26(12):1561-1569. doi: 10.1002/pds.4228. Epub 2017 Jun 1.

Real-life patterns of use, safety and effectiveness of sunitinib in first-line therapy of metastatic renal cell carcinoma: the SANTORIN cohort study.

Author information

1
Bordeaux PharmacoEpi, Inserm CIC1401, Bordeaux, France.
2
CHU Bordeaux, Bordeaux, France.
3
Bordeaux Population Health Research Centre, Pharmacoepidemiology team, Inserm U1219, Bordeaux, France.
4
CHU Clermont-Ferrand, Site Estaing et Centre Jean Perrin, Clermont-Ferrand, France.
5
Institut Claudius Regaud, Toulouse, France.
6
Hôpital Saint-Louis, Paris, France.
7
University Bordeaux, Bordeaux, France.

Abstract

PURPOSE:

To investigate sunitinib in the real-life first-line treatment of metastatic renal cell carcinoma (mRCC).

METHODS:

SANTORIN is a French observational multicentre cohort. Patients initiating sunitinib in first-line mRCC therapy were included (January 2008 to April 2010) and followed for 24 months. Data were collected from medical files. The outcomes were 24-month overall survival (OS) and progression-free survival (PFS), response and safety.

RESULTS:

Three hundred two patients were included: median age, 64.8 years; male, 73.2%; clear cell mRCC, 83.1%; prior nephrectomy, 85.4%; >1 metastatic sites, 64.2%; brain metastases, 6.3%; ECOG-PS ≥ 2, 9.9%. Median duration of first-line therapy with sunitinib was 10.7 months. Initial sunitinib dose was 50 mg/day for 83.4% of patients; dose reduction occurred in 65.2%. Sunitinib was discontinued in 73.2% of the patients: for progression (61.1%), death (31.2%) or adverse events (6.8%). More than half (58.3%) had grade ≥3 adverse events, mainly hypertension (12.6%) and hand-foot syndrome (12.3%). The 24-month OS and PFS rates [95%CI] were 49.5% [43.7;55.0] and 16.4% [12.5;20.9], respectively. Median OS was 23.6 months [20.2;-] and median PFS 8.4 months [7.6;9.9]. Overall best response rate was 31.1%.

CONCLUSIONS:

Results from this large observational study suggest that effectiveness of sunitinib in first-line mRCC as predicted by clinical trials is maintained in real-life clinical practice. The expected benefit in poor-prognosis patients that were not evaluated in the pivotal clinical trial remains; however, questionable and long-term safety monitoring is still warranted. Copyright © 2017 John Wiley & Sons, Ltd.

KEYWORDS:

clear cell metastatic renal cell carcinoma; cohort studies; molecular targeted therapy; pharmacoepidemiology; sunitinib

PMID:
28573786
DOI:
10.1002/pds.4228
[Indexed for MEDLINE]

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