title: Modified FOLFIRINOX regimen with improved safety and maintained efficacy in pancreatic adenocarcinoma.
abstract: OBJECTIVE
  FOLFIRINOX (5-fluorouracil [5-FU], oxaliplatin, and irinotecan) as compared with gemcitabine in pancreatic cancer (PC) has superior activity and increased toxicity. The bolus 5-FU contributes to the toxicity. We hypothesized that the elimination of bolus 5-FU and use of hematopoietic growth factor will improve the safety profile without compromising the activity of FOLFIRINOX.
  
  
  METHODS
  Sixty patients with PC treated with modified FOLFIRINOX (no bolus 5-FU) were reviewed. Patients were divided into metastatic or nonmetastatic (locally advanced or borderline resectable) disease. Toxicity, response rate, progression-free survival, and overall survival were evaluated.
  
  
  RESULTS
  Nonmetastatic and metastatic disease were present in 24 (40%) and 36 (60%) patients, respectively. The incidence of grade 4 neutropenia, grade 3/4 diarrhea, and fatigue were 3%, 13%, and 13%, respectively. Response rate was 30%. The median progression-free survival for nonmetastatic disease was 13.7 months (95% confidence interval [CI], 9.6-24.6 months), and that for metastatic disease was 8.5 months (95% CI, 3.7-11.0 months), respectively. The median overall survival for nonmetastatic disease was 17.8 months (95% CI, 9.9 months to not estimable), and that for metastatic disease was and 9.0 months (95% CI, 7.1 months to not estimable), respectively.
  
  
  CONCLUSIONS
  Modified FOLFIRINOX has an improved safety profile with maintained efficacy in metastatic PC. Modified FOLFIRINOX has promising activity in nonmetastatic disease.
authors.affiliation: From the *Department of Hematology and Medical Oncology, †Biostatistics and Bioinformatics Shared Resource at Winship Cancer Institute, ‡Department of Biostatistics, §Division of Surgical Oncology, Department of Surgery, and ∥Department of Radiation Oncology, Emory University, Atlanta, GA.
authors.forename: Hemchandra
authors.initials: H
authors.lastname: Mahaseth
authors.forename: Edith
authors.initials: E
authors.lastname: Brutcher
authors.forename: John
authors.initials: J
authors.lastname: Kauh
authors.forename: Natalyn
authors.initials: N
authors.lastname: Hawk
authors.forename: Sungjin
authors.initials: S
authors.lastname: Kim
authors.forename: Zhengjia
authors.initials: Z
authors.lastname: Chen
authors.forename: David A
authors.initials: DA
authors.lastname: Kooby
authors.forename: Shishir K
authors.initials: SK
authors.lastname: Maithel
authors.forename: Jerome
authors.initials: J
authors.lastname: Landry
authors.forename: Bassel F
authors.initials: BF
authors.lastname: El-Rayes
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000378:metabolism; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018395:CA-19-9 Antigen / Q000378:metabolism; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D000069585:Filgrastim; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D018395:CA-19-9 Antigen; D009944:Organoplatinum Compounds; D011994:Recombinant Proteins; D000077150:Oxaliplatin; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000077146:Irinotecan; D000069585:Filgrastim; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin