PMID- 29103187 OWN - NLM STAT- MEDLINE DCOM- 20180625 LR - 20181202 IS - 1559-131X (Electronic) IS - 1357-0560 (Print) IS - 1357-0560 (Linking) VI - 34 IP - 12 DP - 2017 Nov 4 TI - Real-world treatment patterns and effectiveness among patients with metastatic colorectal cancer treated with ziv-aflibercept in community oncology practices in the USA. PG - 193 LID - 10.1007/s12032-017-1049-4 [doi] LID - 193 AB - Routine clinical practice data often differ from clinical trials. This study describes real-world treatment patterns and effectiveness among patients with metastatic colorectal cancer (mCRC) receiving ziv-aflibercept in non-academic, community oncology practices in the USA. De-identified electronic medical records from Vector Oncology and Altos Solutions databases were analysed. We identified 218 patients diagnosed with mCRC who had received prior oxaliplatin therapy and initiated ziv-aflibercept as part of second-line or later-line therapy. Overall survival (OS) and progression-free survival (PFS) were estimated using Kaplan-Meier analysis. Mean age was 62.8 years at ziv-aflibercept initiation. Most patients (91.7%) received bevacizumab before ziv-aflibercept, 95.4% initiated ziv-aflibercept with FOLFIRI or another irinotecan-based regimen, and 59.6% had received prior irinotecan. Overall, 24.8% of patients initiated ziv-aflibercept in second line, 31.7% in third line, 21.6% in fourth line and 22.0% in later lines of therapy. Mean duration of ziv-aflibercept treatment was 5.3 months. For patients initiating ziv-aflibercept in second-, third- and fourth-line therapy, median OS was 11.9 (95% confidence interval 5.1-16.2), 11.1 (6.9-16.7) and 8.1 (5.2-11.4) months, respectively, and median PFS was 4.4 (2.8-6.5), 4.3 (2.9-6.3) and 3.4 (2.2-5.2) months, respectively. Common adverse events (AEs) (any grade) included gastrointestinal disorders (64.7%) and asthenia/fatigue (63.3%). In routine clinical practice, ziv-aflibercept was frequently initiated in third line or later lines of therapy. Although patients receiving ziv-aflibercept were more heavily pretreated and potentially less robust compared with the VELOUR trial, median OS for patients receiving second-line ziv-aflibercept was comparable. AE rates were similar to or lower than the VELOUR trial. FAU - Ivanova, Jasmina I AU - Ivanova JI AUID- ORCID: 0000-0001-7213-1841 AD - Analysis Group, Inc., 10 Rockefeller Plaza, 15th Floor, New York, NY, 10020, USA. jasmina.ivanova@analysisgroup.com. FAU - Saverno, Kimberly R AU - Saverno KR AD - Vector Oncology, Memphis, TN, USA. FAU - Sung, Jennifer AU - Sung J AD - Sanofi US, Bridgewater, NJ, USA. FAU - Duh, Mei Sheng AU - Duh MS AD - Analysis Group, Inc., Boston, MA, USA. FAU - Zhao, Chen AU - Zhao C AD - Analysis Group, Inc., 10 Rockefeller Plaza, 15th Floor, New York, NY, 10020, USA. FAU - Cai, Sean AU - Cai S AD - Analysis Group, Inc., 10 Rockefeller Plaza, 15th Floor, New York, NY, 10020, USA. FAU - Vekeman, Francis AU - Vekeman F AD - Analysis Group, Inc., Montreal, QC, Canada. FAU - Peevyhouse, Aaron AU - Peevyhouse A AD - Vector Oncology, Memphis, TN, USA. FAU - Dhawan, Ravinder AU - Dhawan R AD - Sanofi US, Bridgewater, NJ, USA. FAU - Fuchs, Charles S AU - Fuchs CS AD - Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA. LA - eng GR - R01 CA169141/CA/NCI NIH HHS/United States GR - UL1 TR001863/TR/NCATS NIH HHS/United States PT - Journal Article DEP - 20171104 PL - United States TA - Med Oncol JT - Medical oncology (Northwood, London, England) JID - 9435512 RN - 0 (Recombinant Fusion Proteins) RN - 15C2VL427D (aflibercept) RN - EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor) SB - IM MH - Adolescent MH - Adult MH - Aged MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Cohort Studies MH - Colorectal Neoplasms/*drug therapy/mortality/pathology MH - Community Health Services/statistics & numerical data MH - Disease-Free Survival MH - Female MH - Humans MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Receptors, Vascular Endothelial Growth Factor/*therapeutic use MH - Recombinant Fusion Proteins/adverse effects/*therapeutic use MH - Retrospective Studies MH - Treatment Outcome MH - United States MH - Young Adult PMC - PMC5671551 OTO - NOTNLM OT - Clinical practice OT - Colorectal cancer OT - Experience OT - Outcomes OT - Post-oxaliplatin OT - Second line OT - Ziv-aflibercept OT - mCRC COIS- Sean Cai is a former employee of Analysis Group, Inc., which received research funding from Sanofi. Ravinder Dhawan was previously an employee of Sanofi, is currently an employee of Merck&Co, and owns stock in Sanofi. Mei Sheng Duh is an employee of Analysis Group, Inc., which received research funding from Sanofi, and has provided expert testimony for AbbVie. Charles Fuchs has provided a consultancy/advisory for Sanofi, Genentech, Pfizer, Merck&Co, Dicerna Pharmaceuticals Inc., Entrinsic Health Solutions, Amgen and MacroGenics. Jasmina Ivanova is an employee of Analysis Group, Inc., which has received research funding from Sanofi, and has an immediate family member employed by Boehringer Ingelheim. Aaron Peevyhouse has no conflicts of interest to disclose. Jennifer Sung was previously an employee of Sanofi and owns stock in Sanofi. Kimberly Saverno was previously an employee of Comprehensive Health Insights Inc., a wholly owned subsidiary of Humana, and has received research funding from Sanofi. Francis Vekeman is a former employee of Analysis Group, Inc., which received research funding from Sanofi, and owns stocks in Valeant Pharmaceuticals. Chen Zhao is a former employee of Analysis Group, Inc., which received research funding from Sanofi. EDAT- 2017/11/06 06:00 MHDA- 2018/06/26 06:00 PMCR- 2017/11/04 CRDT- 2017/11/06 06:00 PHST- 2017/09/08 00:00 [received] PHST- 2017/10/16 00:00 [accepted] PHST- 2017/11/06 06:00 [entrez] PHST- 2017/11/06 06:00 [pubmed] PHST- 2018/06/26 06:00 [medline] PHST- 2017/11/04 00:00 [pmc-release] AID - 10.1007/s12032-017-1049-4 [pii] AID - 1049 [pii] AID - 10.1007/s12032-017-1049-4 [doi] PST - epublish SO - Med Oncol. 2017 Nov 4;34(12):193. doi: 10.1007/s12032-017-1049-4.