162 - Is Patient-Reported Baseline Fatigue Associated with Overall Survival among Patients with Resected Head of the Pancreas Adenocarcinoma on NRG Oncology/RTOG 0848?
Presenter(s)
L. A. Kachnic1, K. Winter2, R. A. Abrams3, W. F. Regine Jr4, K. A. Goodman5, A. M. Lowy6, S. A. Seaward7, A. J. Wu8, A. Ramalingam9, H. Hatoum10, T. A. DiPetrillo11, R. Geva12, M. G. Haddock13, J. J. Wu14, J. Moughan15, B. Movsas16, and T. S. Hong17; 1Department of Radiation Oncology, Columbia University Irving Medical Center, New York, NY, 2NRG Oncology Statistics and Data Management Center, Philadelphia, PA, 3Department of Radiation Oncology, Rush University Medical Center, Chicago, IL, 4Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD, 5Icahn School of Medicine at Mount Sinai, New York, NY, 6University of California at San Diego, San Diego, CA, 7Kaiser Permanente Oncology Clinical Trials, Vallejo, CA, 8Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, 9Akron General Medical Center, Akron, OH, United States, 10University of Oklahoma Health Sciences Center, Oklahoma City, OK, 11Department of Radiation Oncology, Rhode Island Hospital, Lifespan Cancer Institute, Warren Alpert Medical School of Brown University, Providence, RI, 12Institute of Oncology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel, 13Department of Radiation Oncology, Mayo Clinic, Rochester, MN, 14UNC Cancer Care at Nash, Rocky Mount, NC, 15NRG Oncology Statistics and Data Management Center/ACR, Philadelphia, PA, 16Department of Radiation Oncology, Henry Ford Health, Detroit, MI, 17Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA
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.