title: Survey of modalities of toxicity assessment and reporting in noncomparative prospective studies of chemotherapy in breast cancer.
abstract: OBJECTIVE
  To review how toxicity, a main end point of phase II studies, is assessed and reported in published phase II chemotherapy trials in breast cancer.
  
  
  METHODS
  A survey was performed by hand-searching studies published in seven distinguished journals between 1995 and 1999. All selected articles were independently evaluated by two investigators using an ad hoc study report form. Descriptive statistics, contingency tables, and the chi(2) test were applied.
  
  
  RESULTS
  Overall, 122 articles were found; 65.6% lacked a statistical study design. Planned modalities for assessment of toxicity were inadequately reported in 20.5% of the studies. The scheduling of assessment of hematologic toxicity varied greatly. Toxicity was predominantly summarized per patient (69.7%). Although overall the World Health Organization scale was adopted more frequently (45.9%), the Common Toxicity Criteria (in different versions) were used more frequently in studies published in journals with a high impact factor (P =.001), in more recently initiated studies (P =.03), in sponsored studies (P =.0006), and in studies with an identifiable statistical design (P =.006).
  
  
  CONCLUSIONS
  The wide diversity in modalities of toxicity assessment and reporting observed in this study suggests that the reliability of the body of published data on the toxicity of chemotherapy in breast cancer may be questionable. Current standards should be revised and harmonized to improve the reliability of such data. A checklist is proposed to help editorial evaluation of assessment and reporting of toxicity in phase II studies.
authors.affiliation: Clinical Trials Office, National Cancer Institute, I-80131 Naples, Italy. fr.perrone@agora.it
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.forename: Ermelinda
authors.initials: E
authors.lastname: De Maio
authors.forename: Paolo
authors.initials: P
authors.lastname: Maione
authors.forename: Massimo
authors.initials: M
authors.lastname: Di Maio
authors.forename: Alessandro
authors.initials: A
authors.lastname: Ottaiano
authors.forename: Matilde
authors.initials: M
authors.lastname: Pensabene
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Lorenzo
authors.forename: Alessandra
authors.initials: A
authors.lastname: Vernaglia Lombardi
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
mesh_terms: D000970:Antineoplastic Agents / Q000506:poisoning*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D006801:Humans; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D000970:Antineoplastic Agents