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DDMODEL00000137: Executable_Tate_mBC_TGI_PACGEM

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Short description:
One of three models comprising the tumour growth / overall survival modelling framework for first-line metastatic breast cancer developed using gemcitabine clinical trial data. The model within describes drug-induced tumour growth inhibition as a result of paclitaxel alone or in combination with gemcitabine in first-line metastatic breast cancer.
Original code
  • Early change in tumour size predicts overall survival in patients with first-line metastatic breast cancer.
  • Tate SC, Andre V, Enas N, Ribba B, Gueorguieva I
  • European journal of cancer (Oxford, England : 1990), 10/2016, Volume 66, pages: 95-103
  • PK/PD, Eli Lilly and Company, Erl Wood Manor, Windlesham, GU20 6PH, UK. Electronic address: tate_sonya@network.lilly.com.
  • Clinical trials using change in tumour size (CTS) as a primary end-point benefit from earlier evaluation of treatment effect and increased study power over progression-free survival, ultimately resulting in more timely regulatory approvals for cancer patients. In this work, a modelling framework was established to further characterise the relationship between CTS and overall survival (OS) in first-line metastatic breast cancer (mBC).Data from three randomised phase III trials designed to evaluate the clinical benefit of gemcitabine combination therapy in mBC patients were collated. Two drug-dependent models were developed to describe tumour growth dynamics: the first for paclitaxel/gemcitabine treatment and the second for docetaxel/gemcitabine treatment. A parametric survival model was used to characterise survival as a function of CTS and baseline patient demographics.While the paclitaxel/gemcitabine model incorporated tumour shrinkage by both paclitaxel and gemcitabine with resistance to paclitaxel, the docetaxel/gemcitabine model incorporated shrinkage and resistance to docetaxel alone. Predictors for OS were CTS at week 8, baseline tumour size and ECOG performance status. Model predictions reveal that for an asymptomatic mBC patient with a 6-cm tumour burden, first-line paclitaxel/gemcitabine treatment offers a median OS of 28.6 months, compared to 26.0 months for paclitaxel alone.A modelling framework was established, quantitatively describing the tumour growth inhibitory effects of various gemcitabine combotherapies and the effect of the resulting CTS on survival in first-line mBC. This work further supports the use of early CTS as a go/no-go decision point during phase II clinical evaluation of treatments for mBC.
Sonya Tate
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  • Model owner: Sonya Tate
  • Submitted: Oct 16, 2016 12:36:35 PM
  • Last Modified: Oct 16, 2016 12:41:35 PM
Revisions
  • Version: 7 public model Download this version
    • Submitted on: Oct 16, 2016 12:41:35 PM
    • Submitted by: Sonya Tate
    • With comment: Edited model metadata online.
  • Version: 5 public model Download this version
    • Submitted on: Oct 16, 2016 12:36:35 PM
    • Submitted by: Sonya Tate
    • With comment: Model revised without commit message
 
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