title: Geriatric factors predict chemotherapy feasibility: ancillary results of FFCD 2001-02 phase III study in first-line chemotherapy for metastatic colorectal cancer in elderly patients.
abstract: OBJECTIVE
  Elderly patients form a heterogeneous population. Evaluation of geriatric factors may help evaluate a patient's health status to better adapt treatment.
  
  
  METHODS
  Elderly patients with previously untreated metastatic colorectal cancer (mCRC) were randomly assigned to receive fluorouracil (FU) -based chemotherapy either alone or in combination with irinotecan (IRI) in the Fédération Francophone de Cancérologie Digestive (FFCD) 2001-02 study. Sites participating in the geriatric substudy completed geriatric screening tools to perform prognostic factor analyses for treatment safety during the first 4 months after treatment initiation.
  
  
  RESULTS
  The geriatric score was calculated in 123 patients (44%). Median age was 80 years (range, 75 to 91 years). The Charlson comorbidity index was ≤ 1 in 75%, Mini-Mental State Examination (MMSE) score was ≤ 27/30 in 31%, and Instrumental Activities of Daily Living (IADL) showed impairment in 34% of the patients. Seventy-one patients (58%) had grade 3 to 4 toxicity, 41 (33%) had a dose-intensity reduction of more than 33%, and 54 (44%) had at least one unexpected hospitalization during the first 4 months after starting treatment. In multivariate analysis, significant predictive factors for grade 3-4 toxicity were IRI arm (odds ratio [OR], 5.03), MMSE ≤ 27/30 (OR, 3.84), and impaired IADL (OR, 4.67); for dose-intensity reduction of > 33%, the significant predictive factors were alkaline phosphates > 2 × upper limit of normal (OR, 4.16) and IRI arm (OR, 6.85); and for unexpected hospitalization, significant predictive factors were MMSE ≤ 27/30 (OR, 4.56) and Geriatric Depression Scale ≤ 2 (OR, 5.52).
  
  
  CONCLUSIONS
  Geriatric factors (MMSE and IADL) are predictive of severe toxicity or unexpected hospitalization (MMSE) in a randomized prospective phase III study in mCRC. These results suggest that cognitive function and autonomy impairment should be taken into account when choosing a regimen for chemotherapy.
authors: Gastroenterology, Avicenne Hospital, AP-HP, Université Paris 13, Sorbonne Paris Cité, 125 rue de Stalingrad, 93000 Bobigny, France. thomas.aparicio@avc.aphp.fr
authors: Thomas
authors: T
authors: Aparicio
authors: Jean-Louis
authors: JL
authors: Jouve
authors: Laurent
authors: L
authors: Teillet
authors: Dany
authors: D
authors: Gargot
authors: Fabien
authors: F
authors: Subtil
authors: Valérie
authors: V
authors: Le Brun-Ly
authors: Jacques
authors: J
authors: Cretin
authors: Christophe
authors: C
authors: Locher
authors: Olivier
authors: O
authors: Bouché
authors: Gilles
authors: G
authors: Breysacher
authors: Jacky
authors: J
authors: Charneau
authors: Jean-François
authors: JF
authors: Seitz
authors: Mohamed
authors: M
authors: Gasmi
authors: Laetitia
authors: L
authors: Stefani
authors: Mohamed
authors: M
authors: Ramdani
authors: Thierry
authors: T
authors: Lecomte
authors: Emmanuel
authors: E
authors: Mitry
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D003072:Cognition Disorders / Q000139:chemically induced; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D015577:Geriatric Assessment / Q000706:statistics & numerical data*; D006299:Health Services for the Aged / Q000706:statistics & numerical data*; D006801:Humans; D000077146:Irinotecan; D016015:Logistic Models; D008297:Male; D015999:Multivariate Analysis; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin