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Abstract: TH-OR065

Pegloticase for Tumor Lysis Syndrome

Session Information

Category: Onconephrology

  • 1700 Onconephrology

Authors

  • Mandayam, Sreedhar A., The University of Texas MD Anderson Cancer Center Division of Internal Medicine, Houston, Texas, United States
  • Fatakdawala, Mariya Mustafa, Baylor College of Medicine, Houston, Texas, United States
  • Rodriguez, Ashley Janey, The University of Texas MD Anderson Cancer Center Division of Internal Medicine, Houston, Texas, United States
  • Page, Valda D., The University of Texas MD Anderson Cancer Center Division of Internal Medicine, Houston, Texas, United States
  • Soebbing, Doris R, The University of Texas MD Anderson Cancer Center Division of Internal Medicine, Houston, Texas, United States
  • Workeneh, Biruh, The University of Texas MD Anderson Cancer Center Division of Internal Medicine, Houston, Texas, United States
Background

Tumor lysis syndrome (TLS) is a major onco-metabolic entity requiring emergent recognition and management. In our analysis of 398 cases of TLS at UTMD Anderson Cancer Center in 2018, we found that almost 60% (240 cases) needed repeated doses of rasburicase, often up to 3 doses several days apart to bring the serum uric acid down to 6.0 and help with recovery of acute kidney injury (AKI).
Pegloticase is a PEGylated version of uricase which has a longer half-life than rasburicase and brings the uric acid levels down to zero (undetectable) in 24 hours after IV infusion. Given that 60% of patients need more than one dose of Rasburicase, Pegloticase with its longer half-life and improved efficacy could be a better option for treating patients with hyperuricemia in the setting of Tumor Lysis Syndrome.

Methods

Patients admitted to MD Anderson Cancer Center with ongoing tumor lysis syndrome as determined by type of cancer considered high risk for TLS by MDACC criteria and elevated uric acid were identified as potential subjects. After obtaining confirmation from treating oncologist about high risk for TLS, patients signed informed consent, G6PD screening was performed and patient were given a single dose of Pegloticase IV (with rescue therapy on day 2 if needed). All patients were followed with daily labs including uric acid for duration of hospital stay up to 4 weeks after infusion. AEs were determined by study coordinator from EMR and labs and interview with subjects.

Results

32 patients were screened over a period of 24 months, 12 met all inclusion and exclusion criteria and signed consent. 10 subjects were dosed a single dose of Pegloticase and followed for 4 weeks. Mean SUA at initiation was 8.68 (6.9-13.9). All 10 patients achieved uric acid levels < 0.4 mg/dl, 70% in 6 hours after Pegloticase treatment ended. Mean SUA at 7 and 14 days were 0.49 mg/dl and 1.1 mg/dl. Mean change in SUA by day 7 was -8.2mg/dL. Mean uric acid at 30 days was 3.3 in 7/10 patients with data available and mean time for SUA to be >7 after Pegloticase was 124.6 day. Interestingly mean serum creatinine reduced by 3.5 mg/dl by day 7 in the Pegloticase treated patients.

Conclusion

Pegloticase is extremely effective and safe in cancer patients with severe tumor lysis syndrome. Uric acid levels were less than 1 for 14 days after a single dose and stayed below 3.5 for 30 days.

Funding

  • Commercial Support – Horizon/Amgen

Digital Object Identifier (DOI)