Trial reportInternational journal of clinical oncology2016
Efficacy and safety of febuxostat for prevention of tumor lysis syndrome in patients with malignant tumors receiving chemotherapy: a phase III, randomized, multi-center trial comparing febuxostat and allopurinol.
Trial report in International journal of clinical oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.
- Chapter 3: Management of kidney injury caused by cancer drug therapy, from clinical practice guidelines for the management of kidney injury during anticancer drug therapy 2022.International journal of clinical oncology · 2023Guideline
- [Chinese expert consensus on the diagnosis and treatment of Burkitt lymphoma (2026)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026Article
- Formulation, characterization and evaluation of cytotoxic potential for febuxostat loaded chitosomes against cervical cancer cells (Hela cells).Scientific reports · 2026Article
- Comprehensive Review on Febuxostat for Hyperuricemia with Gout: Insights from Current Practice and Clinical Trials.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2026Review
- Febuxostat ternary inclusion complex using SBE7-βCD in presence of a water-soluble polymer: physicochemical characterization, in vitro dissolution, and in vivo evaluation.Drug delivery and translational research · 2024Article
- The double faced role of xanthine oxidoreductase in cancer.Acta pharmacologica Sinica · 2022Review
- Venetoclax-based chemotherapy in acute and chronic myeloid neoplasms: literature survey and practice points.Blood cancer journal · 2020Review
- Article
- The Encapsulation of Febuxostat into Emulsomes Strongly Enhances the Cytotoxic Potential of the Drug on HCT 116 Colon Cancer Cells.Pharmaceutics · 2020Article
- The Roles of ROS Generation in RANKL-Induced Osteoclastogenesis: Suppressive Effects of Febuxostat.Cancers · 2020Article
- Anti-tumor effect of PEG-coated PLGA nanoparticles of febuxostat on A549 non-small cell lung cancer cells.3 Biotech · 2020Article
- Inhibitors of Human ABCG2: From Technical Background to Recent Updates With Clinical Implications.Frontiers in pharmacology · 2019Review
- [Metabolic disorders as paraneoplastic syndromes].Der Internist · 2018Review
- Anti-tumour effects of polysaccharide extracted fromExperimental and therapeutic medicine · 2018Article
- Tumor Lysis Syndrome in Chronic Lymphocytic Leukemia with Novel Targeted Agents.The oncologist · 2017Review
- Reply to comments from Vincent et al.International journal of clinical oncology · 2017Article
- Febuxostat and tumor lysis syndrome: an indication that remains unclear.International journal of clinical oncology · 2017Article
- Tumor Lysis Syndrome in Patients with Hematological Malignancies.Journal of oncology · 2017Review
- Prevention and treatment of tumor lysis syndrome, and the efficacy and role of rasburicase.OncoTargets and therapy · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 12 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundControl of serum uric acid (sUA) levels is very important during chemotherapy in patients with malignant tumors, as the risks of tumor lysis syndrome (TLS) and renal events are increased with increasing levels of sUA. We investigated the efficacy and safety of febuxostat, a potent non-purine xanthine oxidase inhibitor, compared with allopurinol for prevention of hyperuricemia in patients with malignant tumors, including solid tumors, receiving chemotherapy in Japan.
methodsAn allopurinol-controlled multicenter, open-label, randomized, parallel-group comparative study was carried out. Patients with malignant tumors receiving chemotherapy, who had an intermediate risk of TLS or a high risk of TLS and were not scheduled to be treated with rasburicase, were enrolled and then randomized to febuxostat (60 mg/day) or allopurinol (300 or 200 mg/day). All patients started to take the study drug 24 h before chemotherapy. The primary objective was to confirm the non-inferiority of febuxostat to allopurinol based on the area under the curve (AUC) of sUA for a 6-day treatment period.
resultsForty-nine and 51 patients took febuxostat and allopurinol, respectively. sUA decreased over time after initiation of study treatment. The least squares mean difference of the AUC of sUA between the treatment groups was -33.61 mg h/dL, and the 95 % confidence interval was -70.67 to 3.45, demonstrating the non-inferiority of febuxostat to allopurinol. No differences were noted in safety outcomes between the treatment groups.
conclusionFebuxostat demonstrated an efficacy and safety similar to allopurinol in patients with malignant tumors receiving chemotherapy. TRIAL REGISTRY: http://www.clinicaltrials.jp ; Identifier: JapicCTI-132398.
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