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    Quality of life (QoL)-based end-points for patients with advanced pancreatic ductal adenocarcinoma (aPDAC): Results from the PanDA prospective observational study

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    Authors
    Lamarca, Angela
    Carnie, Lindsay E
    Shah, Dinakshi
    Vaughan, K.
    Kapacee, Zainul Abedin
    McCallum, L.
    Abraham, Marc
    Backen, Alison C
    Gillespie, Loraine
    McNamara, Mairead G
    Hubner, Richard A
    Valle, Juan W
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    Affiliation
    The Christie National Health Service Foundation Trust, Manchester,
    Issue Date
    2022
    
    Metadata
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    Abstract
    Background: Adequate design of clinical trials using QoL-based primary-end points to assess benefit derived from supportive interventions such as exercise, nutrition or complementary therapies is challenging in PDAC due to a lack of available data describing baseline QoL and changes over time for this patient population. Methods: PanDA was a prospective observational study of prevalence, assessment and treatment of pancreatic exocrine insufficiency in patients with aPDAC (NCT03616431). QoL data using the EORTC QlQ-C30 and QLQ-PAN26 questionnaires were collected for the follow-up cohort at baseline (BSL), week6 (W6) and month3 (M3). This post-hoc analysis included patients with aPDAC and explored the mean and standard deviation (SD) of the Physical Functioning Scale (PhFS) at BSL, W6, M3) and mean (SD) intra-patient changes over time (W6-BSL and M3-BSL). Subgroup analysis by stage (locally-advanced vs metastatic) was also performed. Percentage of patients evaluable at each time point was reported. Descriptive statistical analysis was per- formed (Stata v.17). Results: Of 37 patients recruited into the follow-up cohort, 32 met eligibility criteria for this post hoc analysis. Thirty (93.8%), 17 (53.1%; all had paired BSL data) and 13 (40.6%; all had paired BSL data) patients were evaluable with PhFS data available at BSL, W6 and M3, respectively. PhFS (mean (SD); number of observations) did not vary over time when all patients were analysed together (BSL: 76.17(26.46);30) (W6: 79.18(12.74);17) (M3: 74.46(16.76);13). Intra-patient mean changes at W6 (-6.59(15.13);17) or M3 (-5.46(24.82);13). Subgroup analysis identified that changes in W6 were more marked in patients with metastatic disease (-12.14(15.54);7) compared to locally advanced (-2.70(14.32);10). Conclusions: Changes on PhFS over time were likely impacted by selection bias. Intra- patient mean changes at W6 or M3 seemed more reliable to be utilised as primary- end point and sample size calculation in future clinical trials. Subgroup analysis identified that changes in W6 were more marked in patients with metastatic Intra- patient changes rather than pooled results may be more reliable when designing clinical trials with QoL-based primary end-points in aPDAC. W6 assessment may be most informative, as waiting until M3 may compromise the power of the study due to significant drop out.
    Citation
    Lamarca A, Carnie L, Shah D, Vaughan K, Kapacee Z, McCallum L, et al. Quality of life (QoL)-based end-points for patients with advanced pancreatic ductal adenocarcinoma (aPDAC): Results from the PanDA prospective observational study. Annals of Oncology. 2022 Jun;33:S281-S. PubMed PMID: WOS:000823826500104.
    Journal
    Annals of Oncology
    URI
    http://hdl.handle.net/10541/625591
    Type
    Meetings and Proceedings
    Language
    en
    Collections
    All Christie Publications

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