Patients with metastatic renal cell carcinoma ( mRCC ) received Sunitinib ( Sutent ) in a global expanded-access program ( EAP ).
Efficacy and safety results for the EAP subpopulation in Italy were reported.
Patients greater than or equal to 18 years old with previously treated or treatment-naïve metastatic renal cell carcinoma received oral Sunitinib 50 mg/day on a 4-weeks-on/2-weeks-off schedule.
Tumor measurements were scheduled per local practice ( using Response Evaluation Criteria in Solid Tumors ). Safety was regularly assessed.
A total of 521 patients participated, including 40% aged greater than or equal to 65 years, 11% with an Eastern Cooperative Oncology Group ( ECOG ) performance status greater than or equal to 2, 14% with non-clear cell RCC, and 11% with brain metastases.
The median treatment duration and post-treatment follow-up were 7.4 and 12.3 months, respectively.
The objective response rate ( ORR ) was 12%, and the median progression-free and overall survival was 9.1 and 27.2 months, respectively.
514 patients ( 99% ) discontinued treatment; reasons included death ( 17% ), non-response ( 46% ), or adverse events ( 13% ).
The most common any-grade treatment-related adverse effects were asthenia ( 44%, plus 15% reporting fatigue ), thrombocytopenia and stomatitis ( both 37% ), diarrhea ( 36% ), mucosal inflammation ( 29% ), hypertension ( 26% ), and dysgeusia ( 25% ).
The most common grade 3/4 treatment-related adverse effects were thrombocytopenia ( 10% ), asthenia ( 9%, plus 3% reporting fatigue ), neutropenia, stomatitis ( both 6% ), and hypertension ( 5% ).
In conclusion, in a large population of Italian patients with metastatic renal cell carcinoma, Sunitinib had a manageable safety profile and encouraging efficacy. ( Xagena )
Sternberg CN et al, Oncology 2015; 88:273-280