PMID- 31174493 OWN - NLM STAT- MEDLINE DCOM- 20191120 LR - 20200225 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 19 IP - 1 DP - 2019 Jun 7 TI - Real-world treatment patterns and adverse events in metastatic renal cell carcinoma from a large US claims database. PG - 548 LID - 10.1186/s12885-019-5716-z [doi] LID - 548 AB - BACKGROUND: Vascular endothelial growth factor (VEGF), tyrosine kinase (TK) and mechanistic target of rapamycin kinase (mTOR) inhibitors are common first-line (1 L) treatments for metastatic renal cell carcinoma (mRCC). Despite treatment availability, the 5-year survival rate in patients diagnosed at the metastatic stage is only approximately 10%. To gain contemporary insights into RCC treatment trends that may inform clinical, scientific and payer considerations, treatment patterns and adverse events (AEs) associated with 1 L therapy were examined in a retrospective, longitudinal, population-based, observational study of patients with mRCC. METHODS: US administrative claims data (Truven Health MarketScan Commercial Databases) were used to assess trends in 1 L treatment initiation in mRCC (2006-2015) and characterize patterns of individual 1 L treatments, baseline characteristics, comorbidities and treatment-related AEs from 2011 through 2015. Outcomes were evaluated by drug class and route of administration. RESULTS: Ten-year trend analysis (n = 4270) showed that TK/VEGF-directed therapy rapidly became more common than mTOR-directed therapy, and oral treatments were favored over intravenous (IV) treatments. Overall, 1992 eligible patients initiated 1 L treatment for mRCC from 2011 through 2015: 1752 (88%) received TK/VEGF-directed agents and 233 (12%) received mTOR-directed agents; 1674 (84%) received oral treatments, and 318 (16%) received IV treatments. The most common 1 L treatment was sunitinib (n = 849), followed by pazopanib (n = 631), temsirolimus (n = 157) and bevacizumab (n = 154). Patient characteristics and comorbidities, including age, diabetes and congestive heart failure, were independent predictors of 1 L mRCC treatment choice. The three most common potentially 1 L treatment-related AEs were nausea/vomiting (128.2 per 100 patient-years [PY]), hypertension (69 per 100 PY) and renal insufficiency (44.6 per 100 PY). A wide variety of agents were used as second-line (2 L) therapy. Substantial latency of onset was observed for several potentially treatment-related toxicities in patients treated with TK/VEGF- or mTOR-directed agents. CONCLUSIONS: In the US, 1 L TK/VEGF inhibitor uptake in recent years appears largely in line with national approvals and guidelines, with varied 2 L agent use. Although retrospective evaluation of claims data cannot assess underlying causality, insights from these real-world RCC treatment and AE patterns will be useful in informing medical and payer decisions. FAU - Pal, Sumanta AU - Pal S AD - Department of Medical Oncology and Experimental Therapeutics, City of Hope National Medical Center, 1500 East Duarte Road, Duarte, CA, 91010, USA. spal@coh.org. FAU - Gong, Jun AU - Gong J AD - Department of Hematology/Oncology, City of Hope National Medical Center, 1500 East Duarte Road, Duarte, CA, 91010, USA. FAU - Mhatre, Shivani K AU - Mhatre SK AD - Real World Data Science (Oncology), Genentech, Inc, 1 DNA Way, MS 352B, South San Francisco, CA, 94080, USA. FAU - Lin, Shih-Wen AU - Lin SW AD - Real World Data Science (Oncology), Genentech, Inc, 1 DNA Way, MS 352B, South San Francisco, CA, 94080, USA. FAU - Surinach, Andy AU - Surinach A AD - Genesis Research, 5 Marine View Plaza, Hoboken, NJ, 07030, USA. FAU - Ogale, Sarika AU - Ogale S AD - US Medical Affairs, Genentech, Inc, 1 DNA Way, MS 352B, South San Francisco, CA, 94080, USA. FAU - Vohra, Rini AU - Vohra R AD - School of Pharmacy, West Virginia University, P.O. Box 9500, Morgantown, WV, 26506, USA. FAU - Wallen, Herschel AU - Wallen H AD - Oncology and Hematology Care Clinic, Providence Cancer Center, 4805 NE Glisan Street, Suite 6N40, Portland, OR, 97213, USA. FAU - George, Daniel AU - George D AD - Department of Medicine, Medical Oncology, Duke University School of Medicine, Box 103861, Durham, NC, 27710, USA. LA - eng PT - Journal Article DEP - 20190607 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 SB - IM CIN - Ann Transl Med. 2019 Dec;7(Suppl 8):S349. PMID: 32016067 MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/*adverse effects/therapeutic use MH - Carcinoma, Renal Cell/drug therapy/*epidemiology/pathology MH - Cross-Sectional Studies MH - Databases, Factual MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology MH - Female MH - Health Care Surveys MH - Humans MH - Kidney Neoplasms/drug therapy/*epidemiology/pathology MH - Longitudinal Studies MH - Male MH - Middle Aged MH - Molecular Targeted Therapy MH - *Practice Patterns, Physicians' MH - United States/epidemiology PMC - PMC6555983 OTO - NOTNLM OT - Administrative claims OT - Adverse events OT - Renal cell carcinoma OT - Targeted therapy OT - Treatment patterns COIS- SP reports honoraria and a consulting/advisory role with Novartis, Astellas, Aveo, Bristol-Myers Squibb, Eisai, Exelixis, Ipsen, Myriad Pharmaceuticals, Pfizer and Roche/Genentech and honoraria and research funding from Medivation. AS is employed by Genesis Research and reports a consulting/advisory role with Roche/Genentech. SKM, SW and SO are employees of Genentech, Inc. and own Roche stock. DG reports consulting/advisory roles with Astellas, AstraZeneca, Bayer, Bristol-Myers Squibb, Clovis, Exelixis, Genentech/Roche, Innocrin, Janssen, Myovant, Pfizer and Sanofi and received research funding from Astellas, Bayer, Innocrin, Janssen, Novartis and Pfizer. HW is a former employee of Roche/Genentech. RV was a paid intern at Roche/Genentech at the time of the study. JG declares that he has no competing interests. EDAT- 2019/06/09 06:00 MHDA- 2019/11/21 06:00 PMCR- 2019/06/07 CRDT- 2019/06/09 06:00 PHST- 2018/01/23 00:00 [received] PHST- 2019/05/14 00:00 [accepted] PHST- 2019/06/09 06:00 [entrez] PHST- 2019/06/09 06:00 [pubmed] PHST- 2019/11/21 06:00 [medline] PHST- 2019/06/07 00:00 [pmc-release] AID - 10.1186/s12885-019-5716-z [pii] AID - 5716 [pii] AID - 10.1186/s12885-019-5716-z [doi] PST - epublish SO - BMC Cancer. 2019 Jun 7;19(1):548. doi: 10.1186/s12885-019-5716-z.