PMID- 25615253 OWN - NLM STAT- MEDLINE DCOM- 20150615 LR - 20181202 IS - 1677-6119 (Electronic) IS - 1677-5538 (Linking) VI - 40 IP - 6 DP - 2014 Nov-Dec TI - Activity and safety of sunitinib in poor risk metastatic renal cell carcinoma patients. PG - 835-41 LID - 10.1590/S1677-5538.IBJU.2014.06.16 [doi] AB - PURPOSE: To assess the activity, safety and treatment patterns of sunitinib in patients with poor-risk metastatic renal cell carcinoma (mRCC). MATERIALS AND METHODS: We retrospectively reviewed the charts of poor risk patients treated with sunitinib from October 2006 to July 2013 who met the eligibility criteria. The primary endpoint was overall survival (OS). Tumor radiological response was measured according to RECIST 1.1 and adverse events (AEs) were assessed through standard criteria. RESULTS: Median OS was 8.16 months (95% CI, 5.73-10.59). Of the 53 patients included in this analysis, 9 (17.0%) achieved partial response, 12 (22.6%) had stable disease. Median treatment duration was 3.30 months (95% CI: 1.96-4.63) and 26.4% of patients discontinued treatment due to toxicity. Grade 3 or higher AEs occurred in 39.6% of patients, the most common being fatigue (15.1%), neutropenia (9.5%), nausea, vomiting and diarrhea (7.5% each). DISCUSSION: Sunitinib may benefit some unselected poor-risk patients, although the rates of AEs and drug discontinuation suggest a need for careful patient monitoring. FAU - Barroso-Sousa, Romualdo AU - Barroso-Sousa R AD - Instituto do Cancer do Estado de Sao Paulo, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil. FAU - Munhoz, Rodrigo R AU - Munhoz RR AD - Instituto do Cancer do Estado de Sao Paulo, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil and Centro de Oncologia, Hospital Sirio-Libanes, Sao Paulo, Brazil. FAU - Mak, Milena P AU - Mak MP AD - Instituto do Cancer do Estado de Sao Paulo, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil. FAU - Fonseca, Leonardo G AU - Fonseca LG AD - Instituto do Cancer do Estado de Sao Paulo, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil. FAU - Fede, Angelo B S AU - Fede AB AD - Instituto do Cancer do Estado de Sao Paulo, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil. FAU - Linck, Rudinei Diogo Marques AU - Linck RD AD - Centro de Oncologia, Hospital Sirio-Libanes, Sao Paulo, Brazil. FAU - Coelho, Clovis R AU - Coelho CR AD - Departament of Radiology and Oncology, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil. FAU - Moniz, Camila M V AU - Moniz CM AD - Instituto do Cancer do Estado de Sao Paulo, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil. FAU - Souza, Ciro E AU - Souza CE AD - Instituto do Cancer do Estado de Sao Paulo, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil and Centro de Oncologia, Hospital Sirio-Libanes, Sao Paulo, Brazil. FAU - Dzik, Carlos AU - Dzik C AD - Instituto do Cancer do Estado de Sao Paulo, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil and Centro de Oncologia, Hospital Sirio-Libanes, Sao Paulo, Brazil. LA - eng PT - Journal Article PL - Brazil TA - Int Braz J Urol JT - International braz j urol : official journal of the Brazilian Society of Urology JID - 101158091 RN - 0 (Antineoplastic Agents) RN - 0 (Indoles) RN - 0 (Pyrroles) RN - V99T50803M (Sunitinib) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Agents/*therapeutic use MH - Carcinoma, Renal Cell/*drug therapy/mortality/pathology/secondary MH - Drug-Related Side Effects and Adverse Reactions MH - Female MH - Humans MH - Indoles/*therapeutic use MH - Kaplan-Meier Estimate MH - Kidney Neoplasms/*drug therapy/mortality/pathology MH - Male MH - Middle Aged MH - Pyrroles/*therapeutic use MH - Retrospective Studies MH - Risk Assessment MH - Risk Factors MH - Sunitinib MH - Time Factors MH - Treatment Outcome EDAT- 2015/01/24 06:00 MHDA- 2015/06/16 06:00 CRDT- 2015/01/24 06:00 PHST- 2014/02/05 00:00 [received] PHST- 2014/05/03 00:00 [accepted] PHST- 2015/01/24 06:00 [entrez] PHST- 2015/01/24 06:00 [pubmed] PHST- 2015/06/16 06:00 [medline] AID - IBJUv40n6a16 [pii] AID - 10.1590/S1677-5538.IBJU.2014.06.16 [doi] PST - ppublish SO - Int Braz J Urol. 2014 Nov-Dec;40(6):835-41. doi: 10.1590/S1677-5538.IBJU.2014.06.16.