title: Factors related to biopsy willingness in patients with advanced cancer in a phase 1 clinic for molecularly targeted therapy.
abstract: OBJECTIVE
  Tumor biopsies are critical for delineating pharmacodynamic effects of drugs and for optimal patient selection during oncology clinical trials of molecular targeted therapies. The purpose of this study was to identify factors related to patients' willingness to provide study-related tumor biopsies in phase 1 clinical trials of molecularly targeted therapy.
  
  
  METHODS
  An investigator-designed survey, that assessed biopsy willingness, demographic and clinical factors, was completed anonymously by patients with advanced cancer in a phase 1 clinic for targeted therapy. Data were analyzed using multivariate logistic regression models with odds ratios (OR) and 95 % confidence intervals (CI).
  
  
  RESULTS
  Three hundred and sixty-two patients with advanced cancer (50 % male, 56 % aged ≤ 60 years) participated. In univariate analyses, willingness to provide study-related biopsy was associated with male gender, white race, higher income, using the Internet for cancer-related information, and having had a biopsy previously (p < 0.05). In multivariate analyses, male gender (OR 2.41, 95 % CI 1.54, 3.78) and having had a biopsy (OR 3.71, 95 % CI 1.68, 8.15) were associated with willingness to have one biopsy; male gender (OR 1.97, 95 % CI 1.30, 3.00) and relying on the Internet as a source of information (OR 1.87, 95 % CI 1.21, 2.89) were associated with willingness to have more than one biopsy.
  
  
  CONCLUSIONS
  The results suggest that male gender is associated with greater stated willingness to undergo biopsy. Also, the Internet is an important source of information for patients with cancer and may strongly influence their decisions about whether to consent to biopsies in early clinical trials.
authors: Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. dshong@mdanderson.org
authors: David S
authors: DS
authors: Hong
authors: Goldy C
authors: GC
authors: George
authors: Eucharia C
authors: EC
authors: Iwuanyanwu
authors: Bahareh
authors: B
authors: Tavana
authors: Gerald S
authors: GS
authors: Falchook
authors: Sarina A
authors: SA
authors: Piha-Paul
authors: Jennifer J
authors: JJ
authors: Wheler
authors: Reena H
authors: RH
authors: Mistry
authors: Xiudong
authors: X
authors: Lei
authors: Razelle
authors: R
authors: Kurzrock
mesh_terms: D001706:Biopsy / Q000523:psychology*; D017321:Clinical Trials, Phase I as Topic / Q000523:psychology*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009369:Neoplasms / Q000473:pathology / Q000523:psychology* / Q000628:therapy*; D016017:Odds Ratio; D010358:Patient Participation / Q000523:psychology*; D018579:Patient Selection; D011795:Surveys and Questionnaires