Fatigue in patients with cancer treated on immunotherapy-based early phase clinical trials.

Authors

Jibran Ahmed

Jibran Ahmed

The University of Texas MD Anderson Cancer Center, Houston, TX

Jibran Ahmed, Rony Dev, Evan Kwiatkowski, Bettzy Stephen, Ahsan Azhar, Akhila Reddy, Ali Haider, David Hui, Jeffrey Andrew How, Yali Yang, Justin Tyler Moyers, Sarina A. Piha-Paul, Jordi Rodon Ahnert, Siqing Fu, David S. Hong, Funda Meric-Bernstam, Eduardo Bruera, Aung Naing

Organizations

The University of Texas MD Anderson Cancer Center, Houston, TX

Research Funding

No funding received
None.

Background: Immunotherapy (IO)-related fatigue is a common yet underrecognized adverse event (AE). The objective of this study was to determine the frequency of IO-related fatigue and non-IO-related fatigue, contributing factors, and the association between fatigue and treatment outcome in patients with advanced tumors, who received different types of IO-based treatments. Methods: We performed a retrospective chart review of patients treated on IO-based early phase clinical trials between September 2016 and May 2021. We collected data on baseline patient characteristics, AEs, fatigue at baseline and on-treatment, response to treatment, progression free survival (PFS), and overall survival (OS). AEs attribution to treatment were determined by the investigator. We determined IO-related based on the timing of the highest-grade fatigue with respect to treatment start date. Cox proportional hazards were used to assess association between fatigue and survival endpoints. Results: A total of 511 patients with 45 different cancer types were included in this analysis. The most common tumor types were colon (n=50), pancreatic, ovarian, sarcoma (n=35 each), cervical (n=29), and melanoma (n=26). The median age was 62 years, and 98% of patients were ECOG 1. Of the 136 patients (26.6 %) who reported fatigue, 21 (4.1%) had baseline fatigue and 115 (22.5%) developed fatigue after treatment initiation. A total of 69 (13.5%) patients had IO-related and 67 (13.1%) had non-IO related fatigue. The majority of the patients (87.8%) were treated on immune checkpoint-inhibitor-based regimens. Among 69 patients with IO-related fatigue, 58% of the patients reported fatigue only after treatment initiation and 29% had worsening grades of fatigue. In univariate analysis, patients with IO-related fatigue had a higher frequency of baseline depression than those with non-IO-related (14.5% vs. 3%, p=0.0391). Among the 81 patients with fatigue who were evaluated for response by irRECIST, objective response rate was 11.1% (5/45) in patients with IO-related versus 8.3% (3/36) in those with non-IO related fatigue. The median PFS was 4.08 mo in patients with IO related versus 3.68 in non-IO-related fatigue (p=0.27). The median OS was 15 mo in patients with IO related vs 10.6 mo (p=0.8) in non-IO related fatigue. The median OS for all the patients on the study was 14.7 mo in patients with IO-related vs 9.4 mo in non-IO related fatigue (p=0.32). Conclusions: In half of the patients reporting fatigue on IO-based clinical trials, fatigue was related to treatment. Patients with IO-related fatigue had higher response rates, improved PFS and OS, although not significant. Ongoing analysis with patient-reported outcome may provide more insight into prevalence of fatigue in this patient population. Further understanding of underlying biology may help to develop treatment strategies.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2023 ASCO Quality Care Symposium

Session Type

Poster Session

Session Title

Poster Session B

Track

Health Care Access, Equity, and Disparities,Technology and Innovation in Quality of Care,Palliative and Supportive Care

Sub Track

Toxicity Prevention, Assessment, and Management

Citation

JCO Oncol Pract 19, 2023 (suppl 11; abstr 294)

DOI

10.1200/OP.2023.19.11_suppl.294

Abstract #

294

Poster Bd #

K5

Abstract Disclosures

Similar Abstracts

First Author: Sumit Gaur

First Author: Umang Swami