title: Filling in the gaps: reporting of concurrent supportive care therapies in breast cancer chemotherapy trials.
abstract: BACKGROUND
  Supportive care interventions can have a substantial impact on side effects of chemotherapy. Consequently, accurate reporting of such interventions is essential when interpreting clinical trial results. This study determined the prevalence and quality of reporting of supportive care treatment for common chemotherapy-induced toxicities in phase III, breast cancer chemotherapy trials.
  
  
  METHODS
  A systematic review of phase III trials of breast cancer trials incorporating chemotherapy published in the last 5 years was undertaken. Trials were identified through MEDLINE, EMBASE, BIOSIS, and the Cochrane Library. Supportive treatments evaluated were use of antiemetics, colony-stimulating growth factors, and antibiotics. Reporting quality was rated as "good", "fair", "poor", or "absent" using predetermined criteria.
  
  
  RESULTS
  Sixty-two trials met inclusion criteria. In 41 studies (66%), details regarding prophylactic antiemetic treatment were not provided. Growth factor use was not reported in 20 trials (32%). Instructions for the use of prophylactic antibiotics were absent in 45 trials (72%).
  
  
  CONCLUSIONS
  There are significant deficiencies in reporting of use of prophylactic supportive care agents in breast cancer trials. Omission of supportive care instructions may impact substantially on patient management and health care system expenditure. Recommendations for the type, dose, and frequency of supportive care drugs should be provided and reported on in trials.
authors.affiliation: Department of Medicine, University of Toronto, Toronto, Canada.
authors.forename: Orit
authors.initials: O
authors.lastname: Freedman
authors.forename: Eitan
authors.initials: E
authors.lastname: Amir
authors.forename: Camilla
authors.initials: C
authors.lastname: Zimmermann
authors.forename: Mark
authors.initials: M
authors.lastname: Clemons
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000932:Antiemetics / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D017326:Clinical Trials, Phase III as Topic / Q000592:standards*; D003115:Colony-Stimulating Factors / Q000627:therapeutic use; D003625:Data Collection / Q000592:standards; D005260:Female; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000592:standards
chemical_list: D000900:Anti-Bacterial Agents; D000932:Antiemetics; D000970:Antineoplastic Agents; D003115:Colony-Stimulating Factors