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Models for change in tumour size, appearance of new lesions and survival probability in patients with advanced epithelial ovarian cancer
Eli Lilly & Co, Global PK PD & Pharmacometr, Sunninghill Rd, Windlesham GU20 6PH, Surrey, England..
Eli Lilly & Co, Global PK PD & Pharmacometr, Sunninghill Rd, Windlesham GU20 6PH, Surrey, England..
Eli Lilly & Co, Res Advisor Stat Oncol, Indianapolis, IN 46285 USA..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
2016 (English)In: British Journal of Clinical Pharmacology, ISSN 0306-5251, E-ISSN 1365-2125, Vol. 82, no 3, 717-727 p.Article in journal (Refereed) Published
Abstract [en]

AimsThe aims of this study were (i) to develop a modelling framework linking change in tumour size during treatment to survival probability in metastatic ovarian cancer; and (ii) to model the appearance of new lesions and investigate their relationship with survival and disease characteristics. MethodsData from a randomized Phase III clinical trial comparing carboplatin monotherapy to gemcitabine plus carboplatin combotherapy in 336 patients with metastatic ovarian cancer were used. A population model describing change in tumour size based on drug treatment information was established and its relationship with time to appearance of new lesions and survival were investigated with time to event models. ResultsThe tumour size profiles were well characterized as evaluated by visual predictive checks. Metastasis in the liver at enrolment and change in tumour size up to week 12 were predictors of time to appearance of new lesions. Survival was predicted based on the patient tumour size and ECOG performance status at enrolment and on appearance of new lesions during treatment and change in tumour size up to week 12. Tumour size and survival data from a separate study were adequately predicted. ConclusionsThe proposed models simulate tumour dynamics following treatment and provide a link to the probability of developing new lesions as well as to survival. The models have potential to be used for optimizing the design of late phase clinical trials in metastatic ovarian cancer based on early phase clinical study results and simulation.

Place, publisher, year, edition, pages
2016. Vol. 82, no 3, 717-727 p.
Keyword [en]
carboplatin, gemcitabine, metastasis, Phase III
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-304164DOI: 10.1111/bcp.12994ISI: 000382509900011PubMedID: 27136318OAI: oai:DiVA.org:uu-304164DiVA: diva2:1014866
Funder
EU, FP7, Seventh Framework ProgrammeSwedish Cancer Society
Available from: 2016-10-03 Created: 2016-10-03 Last updated: 2017-11-30Bibliographically approved

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