Side-effect analysis of sunitinib (S) in patients treated with metastatic renal cell cancer (mRCC): Single center experience in the National Institute of Oncology, Hungary—Influence of dose reduction/modification and application schedule on the efficacy of S.

Abstract

e15530 Background: S, an active and relatively well tolerated treatment for mRCC, based on the result of a global phase III study. Methods: Retrospectively, 383 patient’s data with clear cell mRCC were collected, who were treated with S in our department between 01/nov/2005 and 31/dec/2012. S was used in 1st or 2 nd line setting. The first few dozen subjects were involved in a clinal trial after progression on first line INF therapy. In Hungary S became reimbursed by the public health insurence from 01/jan/2008 in second line, and from 01/feb/2010 in first line. All patients had definitely favorable or intermediate risk based on MSKCC risk group criteria. The starting dose of S was mostly 50 mg (schedule 4 weeks on followed by 2 weeks off). Results: We investigated the prevalence of necessity of dose reduction/modification or pretence to follow an out of ordinary application form. We registered the frequency and modality of the different types of side effects, we also studied the outcome of patients. Incidence of grade 3+4 side effects was nearly 60%. The most common side effects were fatigue (63%), mucositis/stomatitis (40,2%), hand-foot syndome (16,1%), diarrhea (34%), hypertension (34%), nausea (2%), anaemia (8,6%), leukopenia (4,6%), thrombopenia (20%) and hypothyreosis (20%). Objective response rate based on RECIST and progression-free survival (PFS) were also recorded. The efficacy of treatment was nearly similar to the global clinical trial results. CR was rare (4,2%), most of our patients had PR (31,1%) or SD (51,2%) as best response. In first line setting the results were even better (CR 10,5%, PR 44% and SD 57,5). Conclusions: S is effective and safe agent to treat patients with mRCC. Due to side effects, dose reduction / modification is often needed but rarely requires treatment discontinuation. The early detection and right management of side effects is crucial to maintain the patients on the treatment. Unfortunately the deviation from the standard care may bias the efficacy.