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Journal of Clinical Oncology, Vol 22, No 16 (August 15), 2004: pp. 3431-3432 © 2004 American Society of Clinical Oncology. DOI: 10.1200/JCO.2004.99.098
In Reply:Hematology Department, CH Lyon-Sud, Pierre-Benite, France Zaidi et al raised several points in their letter, the first one being the definition of the group of patients when looking at any preventive measure, in our case prevention of complications occurring in tumor lysis syndrome. Tumor lysis syndrome is a potentially fatal disease occurring spontaneously in patients with very aggressive hematologic cancers, such as Burkitt's lymphoma or acute lymphoblastic leukemia, but also observed after the initiation of chemotherapy in less aggressive cancers, such as diffuse large B-cell lymphoma. Currently, there is not any prospective or retrospective study allowing a good definition of patients at risk of tumor lysis syndrome. Because this syndrome is potentially life threatening, the definition should encompass nearly all patients at risk, and thus might be too large by including patients with a high risk of tumor lysis syndrome but also patients with a medium risk. We thus decided to look in our study at patients with highly proliferative lymphoma and addressed patients with parameters that have been associated with occurrence of this syndrome in the literature: large tumor mass, high lactate dehydrogenase level, above normal value of uric acid or creatinine, and low urine output.1,2 Our patient selection was not based on the lymphoma subtype, as Zaidi et al wrote in their letter, and we agree that most patients with diffuse large B-cell lymphoma or peripheral T-cell lymphoma have a low risk of developing tumor lysis syndrome and might be treated with simple preventive measures such as hydration. However, for patients with high risk of tumor lysis syndrome as defined in our study, good prevention is mandatory because if such a syndrome occurs, it will decrease the chance of cure with chemotherapy. A randomized study of the benefit of rasburicase treatment compared with allopurinol treatment would have been better, but we already have (in the Groupe d'Etude des Lymphomes de l'Adulte [GELA]) the experience of tumor lysis syndrome prevention with crude urate oxidase for 25 years, and going back to allopurinol prevention was not a possibility. As presented in the article,3 such a study was organized in the United States, the BENEFIT trial. This study was a comparison of rasburicase with allopurinol in adults with leukemia and lymphoma. The study was stopped in July 2003 after 6 months because of low accrual. This clearly demonstrated that when confronted with a potential life-threatening complication, US physicians, like GELA physicians, prefer to overtreat a small fraction of patients, rather than exposing all patients to the risk of this complication. Finally, our study was designed with 3 to 7 days of rasburicase treatment because it was the number of days allopurinol is given in standard practice. However, as shown in this study and in others,4,5 rasburicase has a rapid efficacy, allowing the normalization of uric acid level in less than 4 hours, and such a long duration of treatment is not necessary in most of the patients. In two compassionate-use studies, rasburicase was given for only 3 days in more than half of the patients.5,6 Thus, we recommend the use of rasburicase for the prevention of tumor lysis syndrome in patients at risk because of highly proliferative tumor or a large tumor, and for those with impaired renal function. Rasburicase must be used as a treatment for spontaneous tumor lysis syndrome. Author's Disclosures of Potential Conflicts of Interest The following author or his immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Consultant/Advisory Role: Bertrand Coiffier, Sanofi-Synthelabo. Honoraria: Bertrand Coiffier, Sanofi-Synthelabo. Other Remuneration: Bertrand Coiffier, Sanofi-Synthelabo. For a detailed description of these categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration form and the Disclosures of Potential Conflicts of Interest section of Information for Contributors found in the front of every issue. REFERENCES 1. Arrambide K, Toto RD: Tumor lysis syndrome. Semin Nephrol 13:273–280, 1993[Medline] 2. Altman A: Acute tumor lysis syndrome. Semin Oncol 28:3–8, 2001
3. Coiffier B, Mounier N, Bologna S, et al: Efficacy and safety of rasburicase (recombinant urate oxidase) for the prevention and treatment of hyperuricemia during induction chemotherapy of aggressive non-Hodgkin's lymphoma: Results of the GRAAL1 study. J Clin Oncol 21:4402–4406, 2003
4. Goldman SC, Holcenberg JS, Finklestein JZ, et al: A randomized comparison between rasburicase and allopurinol in children with lymphoma or leukemia at high risk for tumor lysis. Blood 97:2998–3003, 2001 5. Pui CH, Jeha S, Irwin D, et al: Recombinant urate oxidase (rasburicase) in the prevention and treatment of malignancy-associated hyperuricemia in pediatric and adult patients: Results of a compassionate-use trial. Leukemia 15:1505–1509, 2001[CrossRef][Medline] 6. Bosly A, Sonet A, Pinkerton CR, et al: Rasburicase (recombinant urate oxidase) for the management of hyperuricemia in patients with cancer: Report of an international compassionate use study. Cancer 98:1048–1054, 2003[CrossRef][Medline]
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Copyright © 2004 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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