title: Risk and outcomes of chemotherapy-induced diarrhea (CID) among patients with colorectal cancer receiving multi-cycle chemotherapy.
abstract: BACKGROUND
  Diarrhea is a common toxicity of chemotherapy, but the practice of reporting only severe grades (≥ 3) in clinical trials results in misleading conclusions of significance. Epidemiology remains poorly described, and effects of multi-cycle regimens have not been investigated. To better understand the risks, symptom burden and consequences of CID, we studied patients receiving chemotherapy for colorectal cancer (CRC).
  
  
  METHODS
  One hundred and fourteen patients receiving FOLFOX (95 patients, 530 cycles), FOLFOX + monoclonal antibodies (10 patients, 49 cycles) or FOLFIRI (9 patients, 50 cycles) were enrolled. CID was identified from diaries at baseline and daily during up to 8 chemotherapy cycles using supplemental questions on the Oral Mucositis Daily Questionnaire, a valid tool for collecting patient-reported outcomes of regimen-related mucosal injury. Patients scored CID severity from 0 "none" to 10 "worst possible," and quantity from "little" to "severe" on a 5-point scale. Quality of life was measured using the FACT-G, and fatigue using the FACIT fatigue scale.
  
  
  RESULTS
  CID occurred in 89% of patients on FOLFIRI, 50% on FOLFOX + monoclonal antibodies and 56% on FOLFOX alone. The risk of a first episode was highest during Cycle 1 (35 %) and dropped to <10% during Cycles 3-5. Patients with CID reported poorer quality of life scores than those without CID (77.1 vs 80.7).
  
  
  CONCLUSIONS
  Diarrhea occurs more commonly than typically appreciated during chemotherapy for CRC. Risk is highest during first exposure, suggesting variable susceptibility. Identification of this high-risk subgroup for prophylaxis could improve the quality of life.
authors: University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia, dorothy.keefe@health.sa.gov.au.
authors: Dorothy M
authors: DM
authors: Keefe
authors: Linda S
authors: LS
authors: Elting
authors: Hoang T
authors: HT
authors: Nguyen
authors: Steven M
authors: SM
authors: Grunberg
authors: Giuseppe
authors: G
authors: Aprile
authors: Antony
authors: A
authors: Bonaventura
authors: Sudarsha
authors: S
authors: Selva-Nayagam
authors: Andrea
authors: A
authors: Barsevick
authors: Bogda
authors: B
authors: Koczwara
authors: Stephen T
authors: ST
authors: Sonis
mesh_terms: D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D001315:Australia / Q000453:epidemiology; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002170:Canada / Q000453:epidemiology; D015179:Colorectal Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000523:psychology; D003967:Diarrhea / Q000139:chemically induced / Q000175:diagnosis / Q000453:epidemiology / Q000503:physiopathology / Q000517:prevention & control; D004354:Drug Screening Assays, Antitumor; D005060:Europe / Q000453:epidemiology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D015995:Prevalence; D011788:Quality of Life; D018570:Risk Assessment; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D007155:Immunologic Factors; D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin