Cancer-related fatigue among patients with advanced cancer receiving immune-checkpoint inhibitors: a prospective study

The aim of this study was to determine the frequency and factors associated with severity of cancer related fatigue (CRF) as assessed by Functional Assessment of Cancer Illness Therapy–Fatigue (FACIT-F), prior to, and during 12 weeks of immune-checkpoint inhibitors (ICIs). We also explored the effects of ICIs on fatigue dimensions and interference with daily activities (Multidimensional Functional Symptom Inventory, MFSI-SF, Patient-Related Outcome Symptom Measurement Information System Short form Fatigue 7a, PROMIS F-SF), QOL (Functional Assessment of Cancer Therapy-General, FACT-G), and cancer symptoms (Edmonton Symptom Assessment Scale, ESAS).

In this prospective, longitudinal observational study, patients with a diagnosis of advanced cancer receiving ICIs were evaluated. Patient demographics, FACT-G, FACIT-F, MFSI-SF, PROMIS F-SF, and ESAS were collected prior to, and during 12 weeks of ICIs.

A total of 160 of the 212 enrolled patients were analyzed. The median age was 61 years, 60% were female, most common cancer was melanoma (73%), and most common ICI was nivolumab 46%. The frequency of clinically significant fatigue (defined as ≤ 34/52 on FACIT-F score) was 25.6% at baseline, 25.7% at week 8, and 19.5% at week 12. There was significant improvement in FACIT-F (P = 0.016), FACT-G physical well-being (P = 0.041), FACT-G emotional well-being (P = 0.011), ESAS anxiety (P = 0.045), and ESAS psychological distress (P = 0.03) scores from baseline to week 12 of ICIs. Multivariate analysis found significant association between clinically significant CRF and PROMIS F-SF (P < 0.001) and MFSI-SF global scores (P < 0.001).

CRF is frequent prior to the initiation of ICI treatment. Over 12 weeks of ICI treatment, CRF significantly improved. FACT-G physical well-being, FACT-G emotional well-being, ESAS anxiety, and ESAS psychological distress scores improved overtime. Further studies are needed to validate these findings.