Fukuoka, S., Shitara, K., Noguchi, M., Kawazoe, A., Kuboki, Y., Bando, H., . . . Yoshino, T. (2016). Prophylactic use of oral dexamethasone to alleviate fatigue during regorafenib treatment for patients with metastatic colorectal cancer. Clinical Colorectal Cancer. Advance online publication. 

To investigate the effect of dexamethasone (DEX) on fatigue and other toxicities in patients treated with regorafenib

Data were obtained from medical records for analysis. DEX was given to some patients prophylactically at the physician’s discretion at 2 mg/day throughout regorafenib treatment. Data from those given DEX versus those not given DEX were analyzed. Patients received 120–160 mg regorafenib on weeks 1–3 of each four-week cycle.

• N = 105, 31 received prophylactic DEX
• MEDIAN AGE = 63–63
• AGE RANGE = 38–80 years
• MALES: 52.4%, FEMALES: 47.6%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: 
• OTHER KEY SAMPLE CHARACTERISTICS: The median follow-up period was 15.7 months, and the mean treatment duration was three months.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Japan

PHASE OF CARE: Active antitumor treatment

Retrospective cohort

Common Terminology Criteria for Adverse Events (CTCAE)

The most frequent adverse event leading to dose modification in both groups was hand-foot syndrome (55.6%). No patients in the DEX group had dose modification because of fatigue compared to 8% in the non-DEX group. Median time to dose modification was longer in the DEX group (p = 0.009). The incidence of fatigue was lower in the DEX group (25.8% versus 50%, p = 0.022). The incidence of at least grade 3 hand-foot syndrome was lower in the DEX group (3% versus 25.7%, p = 0.002). The incidence of oral candidiasis was greater in the DEX group (16.2% versus 0%, p < 0.001).

Systemic corticosteroids were associated with a lower incidence of more severe hand-foot syndrome but also associated with a higher incidence of oral candidiasis in this group of patients.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)

Prophylactic oral DEX was associated with reduced fatigue and incidence of hand-foot syndrome in patients receiving regorafenib. Systemic DEX may reduce some treatment side effects but was also associated with the development of oral candidiasis. Effectiveness of prophylactic DEX and associated adverse effects warrant further investigation. Nurses need to be aware of the potential infectious complications of patients receiving systemic corticosteroids, and the effects of long-term use needs to be investigated.