When an interim analysis of randomized trial changes the practice in oncology: The lesson of adjuvant trastuzumab and the HERA trial.
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.
De Rossi
Costanza
C
Instituto Oncologic. Veneto IRCCS, Padua, Italy. jirillo@libero.it
Brunello
Antonella
A
Jirillo
Giuseppe
G
Jirillo
Antonio
A
D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use; D015982:Bias; D001943:Breast Neoplasms / Q000188:drug therapy; D017024:Chemotherapy, Adjuvant; D026661:Clinical Trials Data Monitoring Committees; D032984:Ethics, Research; D005260:Female; D006801:Humans; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D000068878:Trastuzumab; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000068878:Trastuzumab