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Background: For moderately emetogenic chemotherapy, palonosetron (PALO) is reported to provide complete control of chemotherapy-induced nausea and vomiting (CINV) in 69% of patients. Prior to August 2009, our gastrointestinal (GI) cancer patients receiving the moderately emetogenic compounds oxaliplatin or irinotecan plus a fluoropyrimidine regimen received ondansetron and dexamethasone orally on day 1 of chemotherapy for CINV prevention. Beginning in August of 2009, ondansetron was replaced by PALO 0.25 mg (intravenous push). Methods: This is a single-institution retrospective study of GI cancer patients who received oxaliplatin or irinotecan plus a fluoropyrimidine. Failure of an antiemetic regimen was defined as grade ≥1 vomiting or grade ≥2 nausea (Common Terminology Criteria for Adverse Events, version 3) on days 1 through 5 following chemotherapy. Patients were divided for analysis into pre-PALO and post-PALO cohorts. Fisher’s exact test compared cohort differences. Results: A total of 305 patients were included in the study, with 157 patients in the pre-PALO cohort and 148 in the post-PALO cohort. For all patients, the risk of antiemetic failure was reduced from 50.3% [95% confidence interval (CI) 42.2–58.4%] to 28.4% (95% CI 21.3–36.4%) with PALO. This reduction in the relative risk of antiemetic failure was observed in all subgroups. Conclusion: The addition of PALO may provide increased control of CINV for the moderately emetogenic regimens of oxaliplatin or irinotecan plus a fluoropyrimidine in GI cancer patients.

275 Background: FOLFIRINOX exhibits a meaningful improvement in outcome measures in metastatic pancreatic cancer, making it an interesting regimen for BRPC and LAURPC. However, its use remains prohibitive due to toxicity. In this study, we examine the outcomes of mFOLFIRINOX as a neoadjuvant strategy for patients with BRPC and LAURPC. Methods: This is a retrospective analysis of a prospectively maintained database of patients who received mFOLFIRINOX for BRPC or LAURPC at Ohio State University. mFOLFIRINOX is as follows: irinotecan at 165 mg/m2; oxaliplatin at 85 mg/m2; 5-fluorouracil (5FU) at 2,400 mg/m2 over 46 hours and pegfilgrastim on day 4 of each 2-week cycle. Cases were thoroughly reviewed by a multidisciplinary team prior to initiation of therapy and at each restaging scan. The primary outcomes of this analysis were resection rate and grade 3/4 (G3/4) toxicities. Results: Since 1/1/2011, 43 patients (20 BRPC; 23 LAURPC) have received mFOLFIRINOX. Patients received gemcitabine-based chemoradiation (36 Gy in 15 fractions) only if their best response was stable disease after 4 months of mFOLFIRINOX. At the time of this abstract, 39 patients are evaluable for primary outcome. Overall resection rate was 53.8% including 45% of patients with initially unresectable disease. R0 resection was achieved in 85.7% of the surgeries. See table for more results. The rate of G3/4 toxicity was remarkably low with no episodes of febrile neutropenia, G3/4 neutropenia or thrombocytopenia. Toxicities lead to dose reductions in 46% of patients. Conclusions: Neoadjuvant mFOLFIRINOX is an effective, well-tolerated regimen as part of an integrated, multimodality strategy in BRPC and LAURPC leading to high resection rates and high R0 resection frequency. [Table: see text]

9079 Background: In moderately emetogenic regimens, palonosetron provides complete control of chemotherapy-induced nausea/vomiting (CINV) in 69.3% of patients [Grall, et al. Ann Oncol.14:2003, 1570-77]. Given this promising outcome, we hypothesized that adding palonosetron to our first-line prevention anti-emetic regimen will significantly increase complete control rate of CINV. Methods: Beginning August 2009, all patients starting a fluoropyrimidine-based regimen containing irinotecan (FOLFIRI or XELIRI) or oxaliplatin (FOLFOX or XELOX) received palonosetron at 0.25 mg and dexamethasone 12 mg prior to chemotherapy on day #1. Prior to August 2009, our standard consisted of ondansetron 16 mg and dexamethasone 12 mg prior to chemotherapy on day#1. Failure was defined as grade ≥ 1 vomiting or grade ≥ 2 nausea on days 1 to 5 post chemotherapy. In the event of failure, patients received Aprepitant (125 mg on day 1 and 80 mg on days 2 and 3) plus dexamethasone at 8 mg on days 2 through 4. In this retrospective ...