title: FOLFOX in patients aged between 76 and 80 years with metastatic colorectal cancer: an exploratory cohort of the OPTIMOX1 study.
abstract: BACKGROUND
  Patients older than 75 years of age are usually excluded from metastatic colorectal cancer randomized studies. The OPTIMOX1 study evaluated FOLFOX7, a simplified (s) leucovorin (LV) and 5-fluorouracil (5FU) regimen (sLV5FU2) with high-dose oxaliplatin, in a new oxaliplatin stop-and-go strategy. An exploratory cohort of patients aged 76 to 80 years was included in the study.
  
  
  METHODS
  In all, 620 previously untreated patients were randomized between FOLFOX4 until progression (arm A), or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7 (arm B).
  
  
  RESULTS
  A total of 37 patients aged 76 to 80 years were included, 20 in arm A and 17 in arm B. The overall response rate (ORR) was 59.4%, comparable to younger patients (59%). Median progression-free survival (PFS) was 9.0 months and median overall survival (OS) was 20.7 months. These results did not differ from that in younger patients < or =75 years in the OPTIMOX1 study with PFS 9.0 months (P = .63) and OS 20.2 months (P = .57). They experienced slightly more grade 3 of 4 toxicity than younger patients: 65% versus 48% (P = .06), mainly with more neutropenia (41% vs 24%, P = .03) and neurotoxicity (22% vs 11%, P = .06). Tolerability, however, was manageable and no toxic death occurred in this elderly population.
  
  
  CONCLUSIONS
  The efficacy of FOLFOX-based treatment was maintained in patients >75 years with both FOLFOX regimens. The oxaliplatin stop-and-go management strategy performed well in this population.
authors.affiliation: Beth Sourasky Medical Center Tel Aviv, Israel.
authors.forename: Arié
authors.initials: A
authors.lastname: Figer
authors.forename: Nathalie
authors.initials: N
authors.lastname: Perez-Staub
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Carola
authors.forename: Christophe
authors.initials: C
authors.lastname: Tournigand
authors.forename: Gerard
authors.initials: G
authors.lastname: Lledo
authors.forename: Michel
authors.initials: M
authors.lastname: Flesch
authors.forename: Ramon
authors.initials: R
authors.lastname: Barcelo
authors.forename: Andre
authors.initials: A
authors.lastname: Cervantes
authors.forename: Thierry
authors.initials: T
authors.lastname: André
authors.forename: Philippe
authors.initials: P
authors.lastname: Colin
authors.forename: Christophe
authors.initials: C
authors.lastname: Louvet
authors.forename: Aimery
authors.initials: A
authors.lastname: de Gramont
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015996:Survival Rate
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil