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A pharmacometric an...
A pharmacometric analysis of patient-reported outcomes in breast cancer patients through item response theory
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- Schindler, Emilie (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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- Friberg, Lena (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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- Lum, Bertram L. (författare)
- Genentech Inc, South San Francisco, CA USA
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- Wang, Bei (författare)
- Genentech Inc, South San Francisco, CA USA
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- Quartino, Angelica (författare)
- Genentech Inc, South San Francisco, CA USA
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- Li, Chunze (författare)
- Genentech Inc, South San Francisco, CA USA
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- Girish, Sandhya (författare)
- Genentech Inc, South San Francisco, CA USA
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- Jin, Jin Y. (författare)
- Genentech Inc, South San Francisco, CA USA
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- Karlsson, Mats O. (författare)
- Uppsala universitet,Institutionen för farmaceutisk biovetenskap
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(creator_code:org_t)
- 2018-04-19
- 2018
- Engelska.
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Ingår i: Pharmaceutical research. - : Springer Science and Business Media LLC. - 0724-8741 .- 1573-904X. ; 35:6
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://europepmc.or...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- PurposeAn item response theory (IRT) pharmacometric framework is presented to characterize Functional Assessment of Cancer Therapy-Breast (FACT-B) data in locally-advanced or metastatic breast cancer patients treated with ado-trastuzumab emtansine (T-DM1) or capecitabine-plus-lapatinib.MethodsIn the IRT model, four latent well-being variables, based on FACT-B general subscales, were used to describe the physical, social/family, emotional and functional well-being. Each breast cancer subscale item was reassigned to one of the other subscales. Longitudinal changes in FACT-B responses and covariate effects were investigated.ResultsThe IRT model could describe both item-level and subscale-level FACT-B data. Non-Asian patients showed better baseline social/family and functional well-being than Asian patients. Moreover, patients with Eastern Cooperative Oncology Group performance status of 0 had better baseline physical and functional well-being. Well-being was described as initially increasing or decreasing before reaching a steady-state, which varied substantially between patients and subscales. T-DM1 exposure was not related to any of the latent variables. Physical well-being worsening was identified in capecitabine-plus-lapatinib-treated patients, whereas T-DM1-treated patients typically stayed stable.ConclusionThe developed framework provides a thorough description of FACT-B longitudinal data. It acknowledges the multi-dimensional nature of the questionnaire and allows covariate and exposure effects to be evaluated on responses.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Farmaceutiska vetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Pharmaceutical Sciences (hsv//eng)
Nyckelord
- ado-trastuzumab emtansine
- capecitabine
- kadcyla
- lapatinib
- nonlinear mixed effects
- NONMEM
- T-DM1
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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