When an interim analysis of randomized trial changes the practice in oncology: the lesson of adjuvant Trastuzumab and the HERA trial

Immunopharmacol Immunotoxicol. 2009 Mar;31(1):30-1. doi: 10.1080/08923970802340332.

Abstract

About 30% of the randomized clinical trials are stopped early because of appearance of clear clinical benefit. Though interim analyses protect patients in case of significant imbalance between two treatment arms, conclusions drawn from truncated studies can be premature and should be viewed with caution. We report the lesson learnt from the Herceptin adjuvant (HERA) trial.

Publication types

  • Review

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adjuvants, Immunologic / therapeutic use*
  • Anthracyclines / administration & dosage
  • Anthracyclines / therapeutic use
  • Antibodies, Monoclonal / administration & dosage
  • Antibodies, Monoclonal / therapeutic use*
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Bias
  • Breast Neoplasms / drug therapy*
  • Bridged-Ring Compounds / administration & dosage
  • Bridged-Ring Compounds / therapeutic use
  • Chemotherapy, Adjuvant
  • Disease-Free Survival
  • Female
  • Humans
  • Randomized Controlled Trials as Topic
  • Taxoids / administration & dosage
  • Taxoids / therapeutic use
  • Trastuzumab

Substances

  • Adjuvants, Immunologic
  • Anthracyclines
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents
  • Bridged-Ring Compounds
  • Taxoids
  • taxane
  • Trastuzumab