The efficacy and safety of febuxostat was noninferior to allopurinol for preventing tumor lysis syndrome (TLS) in patients with malignant tumors about to receive chemotherapy, according to a new study published in the journal, Oncology.
TLS, which can lead to hyperuricemia, is caused by the rapid destruction of tumor cells during chemotherapy. Allopurinol is a purine analogous xanthine oxidase (XO) inhibitor which reduces the production of serum uric acid. However, a greater number of doses is needed than febuxostat, and it is sometimes associated with adverse events such as hypersensitivity reactions (eg, rash, acute hepatitis, and eosinophilia).
In the Phase 3, randomized, parallel-group comparative study, researchers enrolled a total of 99 patients, with 49 randomized to the febuxostat group and 50 to the allopurinol group. Treatment with febuxostat reached its primary endpoint of area under the curve (AUC) of serum uric acid (sUA) from the day before chemotherapy start to Day 6 of chemotherapy. For the febuxostat group, sUA (mean ± standard deviation) was 5.65 ± 1.35mg h/dL at baseline, 3.08 ± 1.34mg h/dL at Day 3, and 2.55 ± 1.20mg h/dL at Day 6. For the allopurinol group, sUA was 5.52 ± 1.76mg h/dL at baseline, 3.12 ± 1.29mg h/dL at Day 3, and 2.60 ± 0.94mg h/dL at Day 6.
The authors noted that the efficacy was the result of prevention and not treatment, as the study drugs were administered 24 hours before the start of chemotherapy. They assert that treatment efficacy of febuxostat for TLS needs to be investigated in further studies.
In addition, no significant differences were displayed in both groups for the secondary endpoints. These included serum levels of UA, lactate dehydrogenase (LDH), serum creatinine, and serum electrolytes (K, Ca, and P), number of patients whose sUA exceeded the upper limit of normal on ≥2 consecutive days, and the number of patients who developed LTLS or CTLS according to the established criteria.
Adverse events occurred in 46 patients in the febuxostat group (93.9%; 252 events) and 48 patients in the allopurinol group (96.0%; 304 events).
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