Real‐life patterns of use, safety and effectiveness of sunitinib in first‐line therapy of metastatic renal cell carcinoma: the SANTORIN cohort study. Issue 12 (1st June 2017)

• Record Type: Journal Article
• Authors: Noize, Pernelle; Grelaud, Angela; Bay, Jacques‐Olivier; Chevreau, Christine; Gross‐Goupil, Marine; Culine, Stéphane; Ferrière, Jean‐Marie; Moulin, Flore; Robinson, Philip; Balestra, Aurelie; Lamarque, Stéphanie; Bernard, Marie‐Agnès; Lassalle, Régis; Rouyer, Magali; Droz‐Perroteau, Cécile; Moore, Nicholas; Fourrier‐Réglat, Annie; Ravaud, Alain
• Is Part Of: Pharmacoepidemiology and drug safety. Volume 26:Issue 12(2017)
• Page Start: 1561
• Page End: 1569
• Publication Date: 2017-06-01
• Subjects: molecular targeted therapy -- sunitinib -- clear cell metastatic renal cell carcinoma -- cohort studies -- pharmacoepidemiology; Pharmacoepidemiology -- Periodicals; Chemotherapy -- Periodicals; Epidemiology -- Periodicals; 615.705
• DOI: 10.1002/pds.4228
• Languages: English
• ISSNs: 1053-8569

Abstract

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.