TY - JOUR
T1 - Outcomes of phase I clinical trials for patients with advanced pancreatic cancer
T2 - Update of the MD Anderson Cancer Center experience
AU - Goldstein, Jennifer Brooke
AU - Tang, Chad
AU - Hess, Kenneth R
AU - Hong, David
AU - Subbiah, Vivek
AU - Janku, Filip
AU - Fu, Siqing
AU - Karp, Daniel D.
AU - Naing, Aung
AU - Tsimberidou, Apostolia Maria
AU - Wheler, Jennifer Jane
AU - Zinner, Ralph G
AU - Javle, Milind
AU - Varadhachary, Gauri R.
AU - Wolff, Robert A.
AU - Fogelman, David
AU - Meric-Bernstam, Funda
AU - Piha-Paul, Sarina A.
N1 - Publisher Copyright:
© Goldstein et al.
PY - 2017
Y1 - 2017
N2 - 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 Administrationapproved 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.
AB - 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 Administrationapproved 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.
KW - Biomarker
KW - Chemotherapy
KW - Pancreatic cancer
KW - Phase I trial
KW - Targeted therapy
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U2 - 10.18632/oncotarget.19897
DO - 10.18632/oncotarget.19897
M3 - Article
C2 - 29152071
AN - SCOPUS:85031714773
SN - 1949-2553
VL - 8
SP - 87163
EP - 87173
JO - Oncotarget
JF - Oncotarget
IS - 50
ER -