Oncotarget

Research Papers:

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

Jennifer B. Goldstein _, Chad Tang, Kenneth R. Hess, David Hong, Vivek Subbiah, Filip Janku, Siqing Fu, Daniel D. Karp, Aung Naing, Apostolia Maria Tsimberidou, Jennifer Wheler, Ralph Zinner, Milind Javle, Gauri R. Varadhachary, Robert A. Wolff, David R. Fogelman, Funda Meric-Bernstam and Sarina A. Piha-Paul

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Oncotarget. 2017; 8:87163-87173. https://doi.org/10.18632/oncotarget.19897

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Abstract

Jennifer B. Goldstein1, Chad Tang2, Kenneth R. Hess3, David Hong4, Vivek Subbiah4, Filip Janku4, Siqing Fu4, Daniel D. Karp4, Aung Naing4, Apostolia Maria Tsimberidou4, Jennifer Wheler4, Ralph Zinner4, Milind Javle5, Gauri R. Varadhachary5, Robert A. Wolff5, David R. Fogelman5, Funda Meric-Bernstam4 and Sarina A. Piha-Paul4

1Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

2Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

3Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

4Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

5Department 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.


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