Quality of life (QoL)-based end-points for patients with advanced pancreatic ductal adenocarcinoma (aPDAC): Results from the PanDA prospective observational study
Lamarca, Angela Carnie, Lindsay E Shah, Dinakshi Vaughan, K. Kapacee, Zainul Abedin McCallum, L. Abraham, Marc Backen, Alison C Gillespie, Loraine McNamara, Mairead G
Lamarca, Angela
Carnie, Lindsay E
Shah, Dinakshi
Vaughan, K.
Kapacee, Zainul Abedin
McCallum, L.
Abraham, Marc
Backen, Alison C
Gillespie, Loraine
McNamara, Mairead G
Citations
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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.
Description
Date
2022
Publisher
Collections
Keywords
Type
Meetings and Proceedings
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.