Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update
Autor: | Darren R. Feldman, Milan Mangeshkar, M. Dror Michaelson, Shaker R. Dakhil, Ben L. Sanford, Daniel J. George, Meghara K. Walsh, Thomas Olencki, Joel Picus, Susan Halabi, Colin Hessel, Toni K. Choueiri, Olwen Hahn, Michael J. Morris, Christian Scheffold, Eric J. Small |
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Rok vydání: | 2017 |
Předmět: |
0301 basic medicine
Oncology Male Cancer Research medicine.medical_specialty Cabozantinib Pyridines Population Antineoplastic Agents Kaplan-Meier Estimate Advanced renal cell carcinoma urologic and male genital diseases Article 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Renal cell carcinoma Internal medicine Sunitinib Medicine Humans Anilides Progression-free survival Adverse effect education Carcinoma Renal Cell Aged Proportional Hazards Models education.field_of_study business.industry Hazard ratio First-line Middle Aged medicine.disease female genital diseases and pregnancy complications Confidence interval Kidney Neoplasms Progression-Free Survival 3. Good health 030104 developmental biology chemistry 030220 oncology & carcinogenesis Female business IMDC risk groups medicine.drug |
Zdroj: | European journal of cancer (Oxford, England : 1990) |
ISSN: | 1879-0852 |
Popis: | Background The randomised phase 2 CABOSUN trial comparing cabozantinib with sunitinib as initial therapy for advanced renal cell carcinoma (RCC) of intermediate or poor risk met the primary end-point of improving progression-free survival (PFS) as assessed by investigator. We report PFS by independent radiology review committee (IRC) assessment, ORR per IRC and updated overall survival (OS). Patients and methods Previously untreated patients with advanced RCC of intermediate or poor risk by IMDC criteria were randomised 1:1 to cabozantinib 60 mg daily or sunitinib 50 mg daily (4 weeks on/2 weeks off). Stratification was by risk group and presence of bone metastases. Results A total of 157 patients were randomised 1:1 to cabozantinib (n = 79) or sunitinib (n = 78). Median PFS per IRC was 8.6 months (95% confidence interval [CI] 6.8–14.0) versus 5.3 months (95% CI 3.0–8.2) for cabozantinib versus sunitinib (hazard ratio [HR] 0.48 [95% CI 0.31–0.74]; two-sided p = 0.0008), and ORR per IRC was 20% (95% CI 12.0–30.8) versus 9% (95% CI 3.7–17.6), respectively. Subgroup analyses of PFS by stratification factors and MET tumour expression were consistent with results for the overall population. With a median follow-up of 34.5 months, median OS was 26.6 months (95% CI 14.6–not estimable) with cabozantinib and 21.2 months (95% CI 16.3–27.4) with sunitinib (HR 0.80 [95% CI 0.53–1.21]. The incidence of grade 3 or 4 adverse events was 68% for cabozantinib and 65% for sunitinib. Conclusions In this phase 2 trial, cabozantinib treatment significantly prolonged PFS per IRC compared with sunitinib as initial systemic therapy for advanced RCC of poor or intermediate risk. Trial Registration Number NCT01835158 . |
Databáze: | OpenAIRE |
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