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.
Operative Unit Medical Oncology 2, Instituto Oncologi Veneto IRCCS, Via Gattamelata 64, 35128 Padua, Italy.
Costanza
C
De Rossi
Antonella
A
Brunello
Giuseppe
G
Jirillo
Antonio
A
Jirillo
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000627:therapeutic use*; D018943:Anthracyclines / Q000008:administration & dosage / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use; D015982:Bias; D001943:Breast Neoplasms / Q000188:drug therapy*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use; D000068878:Trastuzumab
D000276:Adjuvants, Immunologic; D018943:Anthracyclines; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane; D000068878:Trastuzumab