Testosterone tied to less fatigue, better symptom control in metastatic renal cell carcinoma

Testosterone treatment among male patients with metastatic renal cell carcinoma (RCC) and hypogonadism is associated with less fatigue and better symptom control during targeted therapy, results of a recent study have shown.

The investigators randomized (1:1) 60 male patients with metastatic clear-cell RCC, normal prostate-specific antigen level, low testosterone level, and no evidence of hypothyroidism receiving first-line sunitinib or pazopanib with fatigue to either testosterone undecanoate 1,000 mg and targeted therapy (n=30) or targeted therapy alone (n=30).

The mean change in fatigue from baseline to 28 days according to the Functional Assessment of Chronic Illness Therapy—Fatigue scale was the primary endpoint, while the secondary ones included safety, Functional Assessment of Cancer Therapy—Kidney Symptom Index 19, testosterone serum concentrations, red blood cell count, and haemoglobin level.

Median follow-up was 18.2 months as of the data cutoff on 30 December 2019. The primary endpoint was achieved based on the significant differences at day 28, favouring testosterone over targeted therapy alone as regards the decreased level of fatigue (difference between groups, 22.5 points, 95 percent confidence interval, 18.4–26.6; p=0.012).

There were also significant changes in scores indicating the improved quality of life with testosterone relative to targeted therapy for Functional Assessment of Cancer Therapy—Kidney Symptom Index 19 disease-related symptoms (p=0.01).

Nonsignificant differences were observed in red blood cell count and haemoglobin level between the two groups (p>0.05 for all).

“Fatigue is one of the most common adverse events of systemic therapy in patients with metastatic RCC,” the investigators said.