Work

Outcomes of phase I clinical trials for patients with advanced pancreatic cancer: update of the MD Anderson Cancer Center experience

Year: 2017

Type: article

Abstract: // Jennifer B. Goldstein 1 , Chad Tang 2 , Kenneth R. Hess 3 , David Hong 4 , Vivek Subbiah 4 , Filip Janku 4 , Siqing Fu 4 , Daniel D. Karp 4 , Aung Naing 4 , Apostolia Maria Tsimberidou 4 , Jennifer Wheler 4 , Ralph Zinner 4 , Milind Javle 5 , Gauri R. Varadhachary 5 , Robert A. Wolff 5 , David R. Fogelman 5 , Funda Meric-Bernstam 4 and Sarina A. Piha-Paul 4 1 Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA 2 Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA 3 Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA 4 Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA 5 Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA Correspondence to: Jennifer B. Goldstein, email: [email protected] Keywords: pancreatic cancer, phase I trial, biomarker, chemotherapy, targeted therapy Received: November 02, 2016 Accepted: July 17, 2017 Published: August 03, 2017 ABSTRACT Background: In 2011, we reported the outcomes of pancreatic cancer (PC) patients enrolled in phase I trials at our institution from 2004 through 2009. At the time, gemcitabine and erlotinib were the only Food and Drug Administration-approved drugs for PC and median overall survival (OS) from consultation in the phase I clinic was 5 months. We sought to determine the impact of novel therapeutics on PC patients in phase I trials. Methods: We reviewed records of PC patients treated in phase I trials at our institution from January 2009 through December 2014. Survival was analyzed using the Kaplan-Meier method. Results: Ninety-five patients were identified. The median age was 61 years (range, 40-84), 59% were men, and 41% had stage IV disease. The median OS from consultation in the phase I clinic was 5.8 months (95% confidence interval [CI], 4.5-6.8), and the 1-year OS rate was 9% (95% CI, 4%-17%). Three patients had partial responses and 18 had stable disease ≥ 4 months. Conclusion: We observed no improvement in OS between PC patients enrolled in phase I trials in 2004-2009 and 2009-2015. To substantially improve OS in this challenging disease, improved patient selection and science-driven, innovative trial designs will be key.

Source: Oncotarget

DOI: 10.18632/oncotarget.19897