Statistical analysis in cancer clinical trials.
Evidence suggests that over the long term (>5 years), tamoxifen should be replaced with an agent such as an aromatase inhibitor. Recent decisions to terminate several large clinical trials, in view of emerging efficacy data with the aromatase inhibitors, indicate that there is a need for guidelines that determine when trials should be discontinued. As a result of the interim efficacy analysis and subsequent discontinuation of the NCIC MA.17 trial, the National Surgical Adjuvant Breast and Bowel Project B-33 study was unblinded after a median of 10 months of treatment. The B-33 trial, nevertheless, demonstrated a statistically significant improvement in relapse-free survival indicating that exemestane is likely to be a valuable treatment option in postmenopausal women with early breast cancer who remain disease-free following 5 years of tamoxifen therapy.
Jeong
Jong-Hyeon
JH
National Surgical Adjuvant Breast and Bowel Project Biostatistical Center, Department of Biostatistics, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.
D000730:Androstadienes / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D047072:Aromatase Inhibitors / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D003627:Data Interpretation, Statistical; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D017698:Postmenopause; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*; D013629:Tamoxifen / Q000627:therapeutic use*
D000730:Androstadienes; D000970:Antineoplastic Agents; D047072:Aromatase Inhibitors; D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen; C056516:exemestane