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In Reply

St Jude Children’s Research Hospital, Memphis, TN

Jeffrey D. Hord

Children’s Hospital Medical Center of Akron, Akron, OH

Dr Waxman is correct that mean hemoglobin remained greater than 8 g/dL at each study visit as reported in our article.¹ However, our Figure 2 presented the mean hemoglobin for all patients, regardless of whether they received a blood transfusion. The mean pretransfusion hemoglobin values were 7.46 (standard deviation [SD], 1.04) and 7.71 (SD, 1.02) g/dL in the epoetin alfa (EPO) and placebo arms, respectively. These values were not significantly different between treatment groups (P = .16), which demonstrates that the observed differences in transfusion use were the result of higher mean hemoglobin (Hb) levels in the EPO group, not because of variations in transfusion practices between the groups. Although mean pretransfusion hemoglobin values were greater than the study cutoff of 7 g/dL for blood transfusion, it was below the target value of 8 g/dL that Dr Waxman has suggested. In addition, the cutoff value was only suggested, not compulsory. Transfusions were given according to institutional and personal practice. Some patients received transfusions to maintain their hemoglobin levels at higher values than suggested in the study protocol because they underwent surgery or radiation therapy. Thus, use of a higher suggested Hb cutoff for blood transfusion probably would not have altered the study findings appreciably.

Inferential testing of the frequency of clinically relevant thrombotic vascular events in the EPO and placebo groups was not performed because such testing may lead to false-positive or false-negative results when it is not specified in the study design and is not considered during the sample size determination. In our study, the test for the comparison would be negative, but this might be a false-negative result, because the sample size was not specified to detect an effect the size of the one that was observed. In our report, only one thrombotic event in each group (EPO and placebo) was felt to be even "possibly" related to the study drug used. Thrombotic vascular events may occur with or without EPO therapy in children with cancer and clinicians should continue to monitor individual patients closely for evidence of these or other adverse events, and they should refer to the product label² for guidance on how to use epoetin alfa in a manner that is likely to minimize this risk. Specifically, the dose of EPO should be reduced by 25% if Hb levels exceed 12 g/dL or increase by more than 1 g/dL in any 2-week period, and EPO should be withheld if Hb levels exceed 13 g/dL.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following authors or their immediate family members 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. For a detailed description of the disclosure categories, or for more information about ASCO’s conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment: N/A Leadership: N/A Consultant: N/A Stock: N/A Honoraria: N/A Research Funds: Bassem I. Razzouk, Orthobiotec; Jeffrey D. Hord, Orthobiotec Testimony: N/A Other: N/A

REFERENCES

1. Razzouk BI, Hord JD, Hockenberry M, et al: Double-blind, placebo-controlled study of quality of life, hematologic end points, and safety of weekly epoetin alfa in children with cancer receiving myelosuppressive chemotherapy. J Clin Oncol 24:3583-3589, 2006[Abstract/Free Full Text]

2. PROCRIT (Epoetin alfa) Prescribing Information [package insert]. Raritan, NJ, Ortho Biotech Products LP, 2006

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Related Correspondence

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This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Razzouk, B. I. Articles by Hord, J. D. Search for Related Content PubMed Articles by Razzouk, B. I. Articles by Hord, J. D. Related Articles Related Correspondence Social Bookmarking                            What's this?