Is Patient-Reported Baseline Fatigue Associated with Overall Survival among Patients with Resected Head of the Pancreas Adenocarcinoma on NRG Oncology/RTOG 0848?

Document Type

Conference Proceeding

Publication Date

9-1-2025

Publication Title

Int J Radiat Oncol Biol Phys

Abstract

Purpose/Objective(s): The primary health-related quality of life (HRQOL) objective of NRG/RTOG 0848 was to determine if patient-reported baseline fatigue, as measured by the 13-item Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT–F) version 4, correlates with overall survival (OS) in patients (pts) with resected head of the pancreas adenocarcinoma (PA). Materials/Methods: NRG/RTOG 0848 was a 2-step randomized phase II & III study assessing the efficacy of adjuvant erlotinib (Step 1) and adjuvant concurrent fluoropyrimidine and 50.4 Gy radiation (CRT) following gemcitabine-based chemotherapy (Step 2). Eligibility included localized primary head invasive PA having gross total resection. Step 1 (Ph IIR) results showed no OS benefit with erlotinib. Step 2 (Ph IIIR) showed no OS differences with CRT; however, CRT improved overall disease-free survival (DFS) and both OS and DFS in node negative pts. For the HRQOL endpoint, 400 evaluable patients provided at least 90% power to detect a HR of 0.70 between low (> 30) and high (≤ 30) fatigue using a log-rank test with a 1-sided alpha=0.05. Distributions of pt/tumor characteristics were compared using Chi-square or Fisher's exact test at alpha=0.05. Multivariable Cox regression models tested associations between baseline FACIT-F scores and OS after adjusting for Step 1 and Step 2 treatment, stratification factors (CA19-9 [ ≤ 90 vs. >90-180], nodal status [N0 vs. N+] and surgical margins [R0 vs. R1]), and other relevant factors. Results: NRG/RTOG 0848 opened accrual 11/2009 and closed 10/2018. Of 546 randomized patients, 522 were eligible with 436 (83.5%) consenting to HRQOL, 423 (97.0%) with baseline. Pts included in HRQOL were more likely to be white (84.4% vs. 70.9%, p=0.0028). Median (min-max) baseline FACIT-F score was 41 (6-52) with 71 (16.8%) pts having high baseline fatigue and 352 (83.2%) low baseline fatigue scores. Pts with high fatigue were more likely to be female (59.2% vs. 39.5%, p=0.0022) and have Zubrod=1 (73.2% vs. 53.7%, p=0.0024). Median (min-max) follow-up was 2.3 years (0.04-13.2). With 327 deaths (59 high and 268 low fatigue), baseline fatigue was not correlated with OS (1-sided p=0.21; HR=0.89 90%CI [0.71,1.13]). Due to only 17% pts with high baseline fatigue, an additional sensitivity analysis was done (based on Eek 2021 cut point of 43), resulting in 258 (61%) pts with high fatigue, with similar results (1-sided p=0.14; HR=0.88 90%CI [0.73,1.06]). For each cut point, after adjusting for treatment and stratification factors, baseline FACIT-F fatigue score remained not statistically significantly associated with OS. Conclusion: Patients who had low baseline fatigue on NRG/RTOG 0848, as measured by the FACIT-F tool, did not have significantly better OS than those with high baseline fatigue.

Volume

123

Issue

1S

First Page

S65

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