PMID- 26995224 OWN - NLM STAT- MEDLINE DCOM- 20161213 LR - 20240325 IS - 1559-131X (Electronic) IS - 1357-0560 (Print) IS - 1357-0560 (Linking) VI - 33 IP - 4 DP - 2016 Apr TI - Modified irinotecan and infusional 5-fluorouracil (mFOLFIRI) in patients with refractory advanced pancreas cancer (APC): a single-institution experience. PG - 37 LID - 10.1007/s12032-016-0753-9 [doi] AB - Pancreatic adenocarcinoma is the fourth leading cause of cancer death. Recently, MM-398 (nanoliposomal irinotecan) was shown to be associated with significant improvement in outcome measures with acceptable toxicities when combined with 5-fluorouracil (5-FU)/leucovorin (LV) compared to 5-FU/LV alone in patients failing one line of gemcitabine-based therapy. There is a paucity of data evaluating the role of irinotecan in combination with 5FU in advanced pancreas cancer (APC). We performed a retrospective analysis of all patients who received mFOLFIRI (minus bolus 5FU and LV). All patients with metastatic disease who had failed at least one line of gemcitabine-based therapy prior to receiving mFOLFIRI were included in this study. Descriptive statistics were used to assess the continuous variables and adverse events (AEs), and Kaplan-Meier methods were used to calculate the median progression-free survival (PFS) and overall survival (OS). Forty patients were included in this analysis. Patients received 1-5 lines of prior therapy (25 % with more than 3 lines of prior therapy). The mean age at diagnosis was 60, and 98 % had ECOG of 1. The mean CA 19-9 at the start of therapy was 33,169 U/ml. The median PFS was 2.59 months [95 % confidence interval (CI) (1.90, 3.54)], and OS was 4.75 months [95 % CI (3.14, 8.98)]. The most common AEs included fatigue (98 %), neuropathy (83 %), anorexia (68 %), nausea (60 %) and constipation (55 %). Grade 3 toxicities included fatigue (13 %) and rash (3 %). There were no observed grade 4 toxicities. In this single-institution retrospective analysis, mFOLFIRI was found to be both tolerable and relatively effective in a heavily pretreated patient population with APC. Future prospective studies should consider evaluating the role of mFOLFIRI in refractory APC. FAU - Bupathi, M AU - Bupathi M AD - Department of Medical Oncology, Richard Solove Research Institute and James Cancer Hospital, The Ohio State University Wexner Medical Center, A454 Startling Loving Hall, 320 West 10th Avenue, Columbus, OH, 43210, USA. FAU - Ahn, D H AU - Ahn DH AD - Department of Medical Oncology, Richard Solove Research Institute and James Cancer Hospital, The Ohio State University Wexner Medical Center, A454 Startling Loving Hall, 320 West 10th Avenue, Columbus, OH, 43210, USA. FAU - Wu, C AU - Wu C AD - Department of Medical Oncology, Richard Solove Research Institute and James Cancer Hospital, The Ohio State University Wexner Medical Center, A454 Startling Loving Hall, 320 West 10th Avenue, Columbus, OH, 43210, USA. FAU - Ciombor, K K AU - Ciombor KK AD - Department of Medical Oncology, Richard Solove Research Institute and James Cancer Hospital, The Ohio State University Wexner Medical Center, A454 Startling Loving Hall, 320 West 10th Avenue, Columbus, OH, 43210, USA. FAU - Stephens, J A AU - Stephens JA AD - Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University, Columbus, OH, USA. FAU - Reardon, J AU - Reardon J AD - Department of Pharmacy, Richard Solove Research Institute and James Cancer Hospital, The Ohio State University, Columbus, OH, USA. FAU - Goldstein, D A AU - Goldstein DA AD - Winship Cancer Institute, Emory University, 1365-C Clifton Rd NE, Atlanta, GA, USA. AD - Davidoff Cancer Center, Rabin Medical Center, Derech Ze'ev Jabotinsky 39, 4941492, Petach Tikva, Israel. FAU - Bekaii-Saab, T AU - Bekaii-Saab T AD - Department of Medical Oncology, Richard Solove Research Institute and James Cancer Hospital, The Ohio State University Wexner Medical Center, A454 Startling Loving Hall, 320 West 10th Avenue, Columbus, OH, 43210, USA. Tanios.Saab@osumc.edu. LA - eng GR - P30 CA016058/CA/NCI NIH HHS/United States GR - T32 CA165998/CA/NCI NIH HHS/United States PT - Clinical Trial PT - Journal Article DEP - 20160319 PL - United States TA - Med Oncol JT - Medical oncology (Northwood, London, England) JID - 9435512 RN - 7673326042 (Irinotecan) RN - Q573I9DVLP (Leucovorin) RN - U3P01618RT (Fluorouracil) RN - XT3Z54Z28A (Camptothecin) RN - IFL protocol SB - IM MH - Adenocarcinoma/*drug therapy/mortality/*pathology MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/administration & dosage/adverse effects/economics/*therapeutic use MH - Camptothecin/administration & dosage/adverse effects/*analogs & derivatives/economics/therapeutic use MH - Costs and Cost Analysis MH - Disease-Free Survival MH - Female MH - Fluorouracil/administration & dosage/adverse effects/economics/therapeutic use MH - Humans MH - Infusions, Intravenous MH - Irinotecan MH - Leucovorin/administration & dosage/adverse effects/economics/therapeutic use MH - Male MH - Middle Aged MH - Pancreatic Neoplasms/*drug therapy/mortality/*pathology MH - Retrospective Studies MH - Treatment Outcome PMC - PMC4976592 MID - NIHMS805083 OTO - NOTNLM OT - Adverse effects OT - Cancer OT - FOLFIRI OT - Gemcitabine OT - Pancreatic OT - Tolerability EDAT- 2016/03/21 06:00 MHDA- 2016/12/15 06:00 PMCR- 2016/08/08 CRDT- 2016/03/21 06:00 PHST- 2016/03/01 00:00 [received] PHST- 2016/03/04 00:00 [accepted] PHST- 2016/03/21 06:00 [entrez] PHST- 2016/03/21 06:00 [pubmed] PHST- 2016/12/15 06:00 [medline] PHST- 2016/08/08 00:00 [pmc-release] AID - 10.1007/s12032-016-0753-9 [pii] AID - 10.1007/s12032-016-0753-9 [doi] PST - ppublish SO - Med Oncol. 2016 Apr;33(4):37. doi: 10.1007/s12032-016-0753-9. Epub 2016 Mar 19.