According to a recent article in the New York Times, one of the world’s top breast cancer doctors failed to disclose millions of dollars in payments from drug and health care companies in recent years, omitting his financial ties from dozens of research articles in prestigious publications like The New England Journal of Medicine and The Lancet. One of the articles published in The Lancet (Lancet Oncol. 2017 Jun; 18(6): 732–742) is entitled, “Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial”. The article states that:
“EMILIA was a randomised, international, open-label, phase 3 study of men and women aged 18 years or older with HER2-positive unresectable, locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane. Between Feb 23, 2009, and Oct 13, 2011, 991 eligible patients were enrolled and randomly assigned to either trastuzumab emtansine (n=495) or capecitabine and lapatinib (control; n=496). On May 30, 2012, the study protocol was amended to allow crossover from control to trastuzumab emtansine after the second interim overall survival analysis crossed the prespecified overall survival efficacy boundary. Approval of trastuzumab emtansine was based on the phase 3 EMILIA study, which showed that trastuzumab emtansine significantly improved progression-free survival and overall survival compared with capecitabine plus lapatinib in patients with HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane.”
The study was first posted on Clinicaltrials.gov on January 26, 2009. The researcher resigns after failing to disclose industry ties. A link to the article can be found here.