Article, 2024

Patient-reported outcomes after personalised dose-escalation for stage II-III non-small-cell lung cancer patients: Results from the randomised ARTFORCE PET-Boost trial

Radiotherapy and Oncology, ISSN 1879-0887, 0167-8140, Volume 196, Page 110312, 10.1016/j.radonc.2024.110312

Contributors

Cooke, Saskia A 0000-0002-9549-5397 (Corresponding author) [1] Belderbos, José S A (Corresponding author) [1] Reymen, Bart [2] Lambrecht, Maarten L F 0000-0002-8746-2691 [3] [4] Fredberg Persson, Gitte [5] [6] [7] Faivre-Finn, Corinne 0000-0001-5617-9781 [8] Dieleman, Edith M T 0000-0002-9133-7877 [9] van Diessen, Judi N A [1] Sonke, Jan-Jakob 0000-0001-5155-5274 [1] De Ruysscher, Dirk Karel Maria [2]

Affiliations

  1. [1] Antoni van Leeuwenhoek Hospital
    2. [NORA names: Netherlands; Europe, EU; OECD];
  2. [2] Maastricht University Medical Centre
    3. [NORA names: Netherlands; Europe, EU; OECD];
  3. [3] KU Leuven
    4. [NORA names: Belgium; Europe, EU; OECD];
  4. [4] Universitair Ziekenhuis Leuven
    5. [NORA names: Belgium; Europe, EU; OECD];
  5. [5] Copenhagen University Hospital
    6. [NORA names: Capital Region of Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];

Abstract

BACKGROUND AND PURPOSE: The ultimate challenge in dose-escalation trials lies in finding the balance between benefit and toxicity. We examined patient-reported outcomes (PROs), including health-related quality of life (HRQoL) in patients with locally advanced non-small cell lung cancer (LA-NSCLC), treated with dose-escalated radiotherapy. MATERIALS AND METHODS: The international, randomised, phase 2 ARTFORCE PET-Boost study (NCT01024829) aimed to improve 1-year freedom from local failure rates in patients with stage II-III NSCLC, with a ≥ 4 cm primary tumour. Treatment consisted of an individualised, escalated fraction dose, either to the primary tumour as a whole or to its most FDG-avid subvolume (24 x 3.0-5.4 Gy). Patients received sequential or concurrent chemoradiotherapy, or radiotherapy only. Patients were asked to complete the EORTC QLQ-C30, QLQ-LC13, and the EuroQol-5D at eight timepoints. We assessed the effect of dose-escalation on C30 sum score through mixed-modelling and evaluated clinically meaningful changes for all outcomes. RESULTS: Between Apr-2010 and Sep-2017, 107 patients were randomised; 102 were included in the current analysis. Compliance rates: baseline 86.3%, 3-months 85.3%, 12-months 80.3%; lowest during radiation treatment 35.0%. A linear mixed-effect (LME) model revealed no significant change in overall HRQoL over time, and no significant difference between the two treatment groups. Physical functioning showed a gradual decline in both groups during treatment and at 18-months follow-up, while clinically meaningful worsening of dyspnoea was seen mainly at 3- and 6-months. CONCLUSION: In patients with LA-NSCLC treated with two dose-escalation strategies, the average patient-reported HRQoL remained stable in both groups, despite frequent patient-reported symptoms, including dyspnoea, dysphagia, and fatigue.

Keywords

C30, EORTC, EORTC QLQ-C30, EuroQol-5D, HRQoL, LA-NSCLC, Mixed-effects, NSCLC, No significant changes, QLQ-C30, QLQ-LC13, Subvolume, advanced non-small cell lung cancer, analysis, balance, baseline, benefits, cancer, cancer patients, cell lung cancer, changes, chemoradiotherapy, clinic, clinically meaningful change, clinically meaningful worsening, concurrent chemoradiotherapy, decline, differences, dose, dose escalation, dose escalation strategies, dose-escalated radiotherapy, dose-escalation trial, dysphagia, dyspnoea, effect, effect of dose escalation, evaluating clinically meaningful changes, failure rate, fatigue, follow-up, fraction, fractionated doses, function, group, health-related quality, health-related quality of life, life, linear mixed-effects, local failure rate, localization, locally advanced non-small cell lung cancer, lung cancer, lung cancer patients, meaningful change, mixed-model, model, no significant difference, non-small cell lung cancer, non-small-cell lung cancer patients, outcomes, overall HRQoL, patient-reported HRQoL, patient-reported outcomes, patient-reported symptoms, patients, phase, physical function, primary tumor, quality of life, radiation, radiation treatment, radiotherapy, rate, results, scores, significant changes, significant difference, stage, stage II-III NSCLC, strategies, study, sum score, symptoms, timepoints, toxicity, treated with dose-escalated radiotherapy, treatment, treatment groups, trials, tumor, worsening

Funders

  • Dutch Cancer Society
  • European Commission

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