PMID- 26774206 OWN - NLM STAT- MEDLINE DCOM- 20171016 LR - 20181202 IS - 1938-0682 (Electronic) IS - 1558-7673 (Linking) VI - 14 IP - 4 DP - 2016 Aug TI - Synergistic Survival: A New Phenomenon Connected to Adverse Events of First-Line Sunitinib Treatment in Advanced Renal Cell Carcinoma. PG - 314-22 LID - S1558-7673(15)00315-8 [pii] LID - 10.1016/j.clgc.2015.11.016 [doi] AB - BACKGROUND: The aim was to assess the relationship between treatment efficacy and adverse events (AEs) for patients with advanced renal cell carcinoma treated with first-line sunitinib. PATIENTS AND METHODS: 274 patients were treated with sunitinib (50 mg/d, 4-weeks-on and 2-weeks-off schedule). Physical and laboratory evaluations were done every sixth week. AEs were diagnosed at every visit. Clinical response was assessed every 3 months. The objective response rate (ORR), median progression-free (mPFS) and median overall survival (mOS) and AEs were evaluated. Besides chi(2) and log rank tests, multivariate Cox regression analysis and for synergism 1-sided t tests were used. RESULTS: The ORR was 25%. After a median follow-up of 32 months, the mPFS and mOS were 9 and 19 months, respectively. Hypertension, diarrhea, hypothyroidism, mucositis, hand-foot syndrome (HFS), skin toxicity, and leukopenia were the most frequent treatment-associated AEs. Significantly longer (P < .01) mPFS and mOS were observed when hypertension, diarrhea, HFS, hypothyroidism, skin toxicity, or leukopenia occurred. A statistically significant synergistic effect of the listed AEs was observed for progression-free survival (P < .001) and overall survival (P < .001). Multivariate analysis revealed that besides the prognostic category, the higher number of AEs (3-6 vs. 0-2) was an independent marker of longer mPFS (24 vs. 5 months, respectively; P < .001) and mOS (51 vs. 9 months, respectively; P < .001). CONCLUSION: Results of this study provide evidence for the synergistically enhanced efficacy of sunitinib treatment in patients who present multiple AEs. These AEs are diagnosed routinely and their coexistence can help physicians to predict which group of patients would benefit the most from first-line sunitinib treatment. CI - Copyright (c) 2015 Elsevier Inc. All rights reserved. FAU - Nagyivanyi, Krisztian AU - Nagyivanyi K AD - National Institute of Oncology, Budapest, Hungary. FAU - Budai, Barna AU - Budai B AD - National Institute of Oncology, Budapest, Hungary. Electronic address: budai@oncol.hu. FAU - Biro, Krisztina AU - Biro K AD - National Institute of Oncology, Budapest, Hungary. FAU - Gyergyay, Fruzsina AU - Gyergyay F AD - National Institute of Oncology, Budapest, Hungary. FAU - Noszek, Laszlo AU - Noszek L AD - Semmelweis University, Budapest, Hungary. FAU - Kuronya, Zsofia AU - Kuronya Z AD - National Institute of Oncology, Budapest, Hungary. FAU - Nemeth, Hajnalka AU - Nemeth H AD - National Institute of Oncology, Budapest, Hungary. FAU - Nagy, Peter AU - Nagy P AD - National Institute of Oncology, Budapest, Hungary. FAU - Geczi, Lajos AU - Geczi L AD - National Institute of Oncology, Budapest, Hungary. LA - eng PT - Journal Article DEP - 20151207 PL - United States TA - Clin Genitourin Cancer JT - Clinical genitourinary cancer JID - 101260955 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/*administration & dosage/adverse effects MH - Carcinoma, Renal Cell/*drug therapy MH - Disease-Free Survival MH - Dose-Response Relationship, Drug MH - Female MH - Humans MH - Indoles/*administration & dosage/adverse effects MH - Kaplan-Meier Estimate MH - Kidney Neoplasms/*drug therapy MH - Male MH - Middle Aged MH - Prognosis MH - Pyrroles/*administration & dosage/adverse effects MH - Sunitinib MH - Survival Analysis MH - Treatment Outcome OTO - NOTNLM OT - Advanced renal cell carcinoma OT - Adverse events OT - First-line sunitinib OT - Predictive marker OT - Synergistic survival EDAT- 2016/01/18 06:00 MHDA- 2017/10/17 06:00 CRDT- 2016/01/18 06:00 PHST- 2015/09/30 00:00 [received] PHST- 2015/11/30 00:00 [accepted] PHST- 2016/01/18 06:00 [entrez] PHST- 2016/01/18 06:00 [pubmed] PHST- 2017/10/17 06:00 [medline] AID - S1558-7673(15)00315-8 [pii] AID - 10.1016/j.clgc.2015.11.016 [doi] PST - ppublish SO - Clin Genitourin Cancer. 2016 Aug;14(4):314-22. doi: 10.1016/j.clgc.2015.11.016. Epub 2015 Dec 7.