A phase II study of isoflavones erlotinib and ge

Authors: Bassel Fuad ElRayes Philip A Philip Fazlul H Sarkar Anthony F Shields Ann Marie Ferris Kenneth Hess Ahmad O Kaseb Milind M Javle Gauri R Varadhachary Robert A Wolff James L Abbruzzese

Publish Date: 2010/01/27

Volume: 29, Issue: 4, Pages: 694-699

PDF Link

Abstract

Background The EGFR/Akt/NFκB signalling pathway is frequently deregulated in pancreatic cancer and contributes to cell growth metastasis and chemoresistance An isoflavone genistein inactivates Akt and NFκB and enhances the antitumor activity of erlotinib and gemcitabine in experimental systems of pancreas cancer This phase II study was undertaken to determine the effects of adding isoflavone to a regimen of gemcitabine and erlotinib on survival in patients with advanced pancreatic cancer Methods Eligibility included previously untreated patients with advanced pancreatic adenocarcinoma Patients received gemcitabine 1000 mg/m2 on days 1 8 and 15 and erlotinib 150 mg once daily PO on day 1 to day 28 Soy isoflavones Novasoy® were administered at a dose of 531 mg twice daily PO starting day 7 until the end of study participation Results Twenty patients with advanced pancreas cancer were enrolled median age 579 years Sixteen patients had stage IV disease The median number of cycles was 2 per patient The median survival time was 52 months 95 CI 46—N/A months The probability of survival at 6 months was 50 95 CI 32–78 Conclusions The addition of soy isoflavones to gemcitabine and erlotinib did not appear to increase the survival of patients with advanced pancreatic cancer

Keywords: