Health-related quality of life scores of metastatic pancreatic cancer patients responsive to first line chemotherapy compared to newly derived EORTC QLQ-C30 reference values

Suvina Amin, Seongjung Joo, Sandra Nolte, Hyun Kyoo Yoo, Nikunj Patel, Hilary F Byrnes, Sara Costa-Cabral, Colin D Johnson, Suvina Amin, Seongjung Joo, Sandra Nolte, Hyun Kyoo Yoo, Nikunj Patel, Hilary F Byrnes, Sara Costa-Cabral, Colin D Johnson

Abstract

Background: Metastatic pancreatic cancer (mPC) and its treatments significantly impact health-related quality of life (HRQoL). POLO, a randomized, double-blind, placebo-controlled phase 3 trial evaluated the efficacy of olaparib as maintenance therapy in germline BRCA mutated mPC patients who had not progressed during ≥16 weeks of first-line platinum-based chemotherapy. HRQoL was assessed using the EORTC QLQ-C30. To enhance score interpretation, we derived reference values for treatment-naïve mPC patients from the literature.

Methods: A targeted literature review identified EORTC QLQ-C30 baseline values in treatment-naïve mPC patients. Reference values were calculated by deriving means from studies meeting inclusion criteria, with scores from 0 to 100 (higher scores indicate better QoL/functioning but worse symptoms). For POLO patients, means were calculated using pooled baseline data across study arms.

Results: Four studies met inclusion criteria. Depending on the specific scale, sample sizes ranged from n = 466 to n = 639. Compared to newly derived reference values, POLO patients reported markedly better HRQoL scores at baseline across most scales, with eight scales showing differences of ≥10 points. POLO patients' HRQoL scores were often close to or better than general population norm data.

Conclusions: This is the first study to systematically derive EORTC QLQ-C30 reference values for mPC. POLO patients had better HRQoL scores than those in the literature and similar to general population data. Comparatively high HRQoL of POLO patients are likely due to effects of prior first-line treatment and resolution of chemotherapy-related symptoms, response shift, or a combination. Newly derived reference values can enhance interpretation of mPC patients' HRQoL.

Trial registration: The POLO trial was registered on 9 July 2014 with ClinicalTrials.gov as NCT02184195.

Keywords: EORTC QLQ-C30; Health-related quality of life; Pancreatic carcinoma; Patient-reported outcome; Reference values.

Conflict of interest statement

CJ (University of Southampton), HB (ICON plc), SC (Mapi Research Trust), and SN (ICON Clinical Research GmbH) received consultancy fees from AstraZeneca and Merck & Co, Inc. SA, HKY, and NP are employees of AstraZeneca; SJ is an employee of Merck & Co, Inc. All other authors report no conflict of interest.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
PRISMA Flow Diagram
Fig. 2
Fig. 2
a EORTC QLQ-C30 scale scores, reference values, and general population scores versus POLO mean baseline scores, Global health status/QoL and functional scales. Clinically meaningful difference:10 points [14]. b EORTC QLQ-C30 scale scores, reference values, and general population scores versus POLO mean baseline scores, symptom scales Clinically meaningful difference:10 points [14]

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