Literature DB >> 9430477

Pharmacokinetic modeling and absorbed dose estimation for chimeric anti-CEA antibody in humans.

T L Odom-Maryon1, L E Williams, A Chai, G Lopatin, A Liu, Y C Wong, J Chou, K G Clarke, A A Raubitschek.   

Abstract

UNLABELLED: The objective of this article was to model pharmacokinetic data from clinical diagnostic studies involving the 111In-labeled monoclonal antibody (MAb) chimeric T84.66, against carcinoembryonic antigen. Model-derived results based on the 111In-MAb blood, urine and digital imaging data were used to predict 90Y-MAb absorbed radiation doses and to guide treatment planning for future therapy trials. Fifteen patients with at least one carcinoembryonic antigen-positive lesion were evaluated. We report the kinetic parameter estimates and absorbed 111In-MAb dose and projected 90Y-MAb doses for each patient as well as describe our approach and rationale for modeling an extensive set of pharmacokinetic data.
METHODS: The ADAPT II software package was used to create three- and five-compartment models of uptake against time in the patient population. The "best-fit" model was identified using ordinary least squares. Areas under the curve were calculated using the modeled curves and input into MIRDOSE3 to estimate absorbed radiation doses for each patient.
RESULTS: A five-compartment model best described the liver, whole body, blood and urine data for a subcohort of nine patients with digital imaging data. A three-compartment model best described the blood and urine data for all 15 clinical patients accrued in the clinical trial. For the subcohort, the largest projected 90Y-MAb doses were delivered to the liver (mean, 24.78 rad/mCi; range, 15.02-37.07 rad/mCi), with red marrow estimates on the order of 3.32 rad/mCi (range, 1.24-5.55) of 90Y. Corresponding estimates for the 111In-MAb were 3.18 (range, 2.09-4.43) and 0.55 (range, 0.34-0.74), respectively.
CONCLUSION: The three- and five-compartment models presented here were successfully used to represent the blood, urine and imaging data. This was evidenced by the small standard errors for the kinetic parameter estimates and R2 values close to 1. As planned future therapeutic trials will involve stem cell support to alleviate hematological toxicities, the development of an approach for estimating doses to other major organs is crucial.

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Year:  1997        PMID: 9430477

Source DB:  PubMed          Journal:  J Nucl Med        ISSN: 0161-5505            Impact factor:   10.057


  6 in total

1.  Dosimetric effectiveness of targeted radionuclide therapy based on a pharmacokinetic landscape.

Authors:  Joseph J Grudzinski; Ronald R Burnette; Jamey P Weichert; Robert Jeraj
Journal:  Cancer Biother Radiopharm       Date:  2010-08       Impact factor: 3.099

2.  A pretherapy biodistribution and dosimetry study of indium-111-radiolabeled trastuzumab in patients with human epidermal growth factor receptor 2-overexpressing breast cancer.

Authors:  Jeffrey Y C Wong; Andrew Raubitschek; Dave Yamauchi; Lawrence E Williams; Anna M Wu; Paul Yazaki; John E Shively; David Colcher; George Somlo
Journal:  Cancer Biother Radiopharm       Date:  2010-08       Impact factor: 3.099

3.  Target mediated disposition of T84.66, a monoclonal anti-CEA antibody: application in the detection of colorectal cancer xenografts.

Authors:  Shweta R Urva; Joseph P Balthasar
Journal:  MAbs       Date:  2010-01-26       Impact factor: 5.857

4.  A phase I study of a combination of yttrium-90-labeled anti-carcinoembryonic antigen (CEA) antibody and gemcitabine in patients with CEA-producing advanced malignancies.

Authors:  Stephen Shibata; Andrew Raubitschek; Lucille Leong; Marianna Koczywas; Lawrence Williams; Jiping Zhan; Jeffrey Y C Wong
Journal:  Clin Cancer Res       Date:  2009-04-07       Impact factor: 12.531

Review 5.  Review: update on selection of optimal radiopharmaceuticals for clinical trials.

Authors:  Lawrence E Williams; George Lopatin; Daniel D Kaplan; An Liu; Jeffrey Y C Wong
Journal:  Cancer Biother Radiopharm       Date:  2008-12       Impact factor: 3.099

6.  Safety and biodistribution of 111In-amatuximab in patients with mesothelin expressing cancers using single photon emission computed tomography-computed tomography (SPECT-CT) imaging.

Authors:  Liza Lindenberg; Anish Thomas; Stephen Adler; Esther Mena; Karen Kurdziel; Julia Maltzman; Bruce Wallin; Kimberly Hoffman; Ira Pastan; Chang Hum Paik; Peter Choyke; Raffit Hassan
Journal:  Oncotarget       Date:  2015-02-28
  6 in total

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