Safety and efficacy of modified dose-attenuated FOLFIRINOX chemotherapy in patients over 65 years with advanced pancreatic adenocarcinoma.

Abstract

e15176 Background: Few data regard efficacy and safety of FOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, fluorouracil bolus of 400 mg/m2 and continuous infusion of 2400 mg/m2 over 46 hours and leucovorin 400 mg/m2) in patients over 65 years with advanced pancreatic adenocarcinoma. Methods: After Ethical Committee approval, consecutive patients age over 65 with biopsy proven pancreatic adenocarcinoma that received at least one cycle of modified dose-attenuated FOLFIRINOX (no bolus FU and reduced dose of at least one agent since first cycle) were selected (São José Hospital database) for a retrospective review for safety, response, and survival. Results: Nineteen consecutive patients were selected from our database. Patients characteristics included 12 (63,1%) males, 7 (36,9 %) females, median age 72,7 (range 66-79). Tumor location was 11 (57,8 %) head of the pancreas, 6 (31,57 %) body and 2 (11 %) in other sites. Grade 3/4 toxicities were reported in 10 patients (52,6 %): nausea/vomiting 1 (5,2 %), diarrhea 1 (5,2 %), fatigue 3 (15,7%), neutropenia 4 (21 %), thrombocytopenia 1 (5,2%) and febrile neutropenia 3 (15,6 %). Elevations in AST and ALT above the upper limit of normality were identified in 5 (26,31%). No deaths reported due to toxicity. Prophylactic granulocyte colony stimulator factor (G-CSF) was given to 14 (73 %). Seventeen patients completed at least four cycles; disease control was obtained in 15 (83, 3 %) with 1 complete response, 5 partial response and 9 stable diseases. Median reductions in doses in the first cycle of chemotherapy by drugs were: oxaliplatin 23,3 % (10%-30%), irinotecan 24,6 % (0%-60%), fluorouracil 20,6% (0%-40%). Median reductions in doses in the fourth cycle of chemotherapy by drugs were: oxaliplatin 20,8 % (0%-42%), irinotecan 24,9 % (0%-75%), fluorouracil 17,6% (0%-40%).With a median follow up of 4.5 months, median overall or progression free survival is not reached. Conclusions: Modified dose-attenuated FOLFIRINOX is a therapeutic option to elderly with advanced pancreatic adenocarcinoma. Although grade 3 and 4 toxicities were reported, they were manageable. Modified attenuated-dose of FOLFIRINOX needs further investigated.