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Journal of Clinical Oncology, Vol 26, No 14 (May 10), 2008: pp. 2417
© 2008 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2008.16.4491

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CORRESPONDENCE

In Reply

Michele De Laurentiis, Sabino De Placido

Dipartimento di Endocrinologia ed Oncologia Molecolare e Clinica, Università di Napoli "Federico II", Napoli, Italy

We read Dr Graham's letter with interest and are pleased to have the opportunity to clarify a very important issue which warrants further attention.

We endorse Dr Graham's view that generalization of meta-analysis results to populations not included in the original trials can be misleading. This is a rule that applies to single clinical trials as well as meta-analyses. We would like to point out that in our article we did not extrapolate the results of our meta-analysis to all breast cancer patients. Rather, we note that our conclusions apply to patients with high-risk early breast cancer (eg, the conclusions of the abstract and the Discussion).1

In the high-risk populations included in our meta-analysis (> 85% of patients were node positive), we found no interaction between the effect of taxane and estrogen-receptor status, age/menopausal status, and HER2 status. Consequently, all aforegoing subgroups of this high-risk population should benefit from the addition of taxane to adjuvant anthracycline-based therapy.

We agree that appropriate estimates of the absolute benefit is a crucial factor when deciding the optimal therapy for the individual patient. Obviously, the benefit is indirectly correlated with the baseline risk assuming a constant hazard ratio. Rather than general indications, we would like to take this opportunity of providing an approximate estimate of the absolute benefit for different risk categories as calculated based on the results of our meta-analysis (Table 1).


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Table 1. Absolute Improvement of DFS and OS Expected From Adding a Taxane to an Anthracycline-Based Therapy According to Baseline Risk of Patients

 
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. 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 or Leadership Position: None Consultant or Advisory Role: None Stock Ownership: None Honoraria: Michele De Laurentiis, Sanofi-aventis; Sabino De Placido, Sanofi-aventis Research Funding: Sabino De Placido, Sanofi-aventis Expert Testimony: None Other Remuneration: None

REFERENCE

1. De Laurentiis M, Cancello G, D'Agostino D, et al: Taxane-based combinations as adjuvant chemotherapy of early breast cancer: A meta-analysis of randomized trials. J Clin Oncol 26:44-53, 2008[Abstract/Free Full Text]


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Related Correspondence

  • Selection of a Taxane As Well As Anthracycline for Early Breast Cancer
    Peter H. Graham
    JCO 2008 26: 2416-2417 [Full Text]



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