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

• Published in: Pharmacoepidemiology and drug safety 2017-12, Vol.26 (12), p.1561-1569
• Main 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
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Carcinoma, Renal Cell - drug therapy; Carcinoma, Renal Cell - epidemiology; clear cell metastatic renal cell carcinoma; Clear cell-type renal cell carcinoma; Clinical trials; Cohort analysis; Cohort Studies; Disease-Free Survival; Drug Administration Schedule; Female; France; Hematology; Human health and pathology; Humans; Indoles - administration & dosage; Indoles - adverse effects; Indoles - therapeutic use; Kidney cancer; Kidney Neoplasms - drug therapy; Kidney Neoplasms - epidemiology; Kidney transplantation; Life Sciences; Male; Medical prognosis; Metastases; Metastasis; Middle Aged; molecular targeted therapy; Nephrectomy; pharmacoepidemiology; Pyrroles - administration & dosage; Pyrroles - adverse effects; Pyrroles - therapeutic use; Safety; sunitinib; Targeted cancer therapy; Young Adult
• ISSN: 1053-8569; 1099-1557
• DOI: 10.1002/pds.4228

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.