Correction for Citron et al., J Clin Oncol 21 (8) 1431-1439.

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In Reply:

Klinik für Gynakologie und Gerburtshilfe, Kiel, Germany

Thank you for giving us the opportunity to respond to the letters relating to the Zoladex Early Breast Cancer Research Association (ZEBRA) trial comparing goserelin (Zoladex; AstraZeneca, Macclesfield, United Kingdom) with cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy in premenopausal patients with early breast cancer.

First, in response to the comments by Drs Samur and Bozcuk, the conclusion of the ZEBRA trial is that goserelin offers an effective alternative to CMF chemotherapy — these are the findings of the trial. From the evidence available to date, it is not absolutely clear that anthracycline-containing regimens demonstrate superiority over CMF in estrogen-receptor– (ER-) positive premenopausal patients; trials to assess the relative merits of different regimens in this patient population are needed.

With respect to the comments by Dr Malayeri, we agree with the author that during recent years, it has become recognized that overexpression of neu/erbB-2 is associated with poor prognosis and a possible decrease in response to both chemotherapy and endocrine therapy. Had this information been available when the ZEBRA trial began in 1990, measurement of neu/erbB-2 expression would undoubtedly have been considered.

The ZEBRA trial was a large randomized study, and the treatment groups (goserelin 3.6 mg v CMF) were similar with respect to patient characteristics, primary tumor characteristics, and local therapy or radiotherapy. We therefore believe it unlikely that there would have been any relevant imbalance in neu/erbB-2 status between treatment groups in this study. Furthermore, for patients with ER-positive tumors (ie, 63% of patients disease-free at 5 years in both treatment groups), the results of the ZEBRA trial indicate that both goserelin and CMF are effective treatments in this patient population, with these results being consistent with previous findings for adjuvant therapies in premenopausal patients.^1,2

In summary, although we agree that future studies should consider including analyses of predictive markers such as neu/erbB-2, we firmly believe that the results of the ZEBRA trial are robust and that goserelin is a valuable treatment option for premenopausal patients with ER-positive, node-positive disease.

REFERENCES

1. Early Breast Cancer Trialists’ Collaborative Group: Polychemotherapy for early breast cancer: An overview of the randomised trials. Lancet 352:930–942, 1998[CrossRef][Medline]

2. Early Breast Cancer Trialists’ Collaborative Group: Ovarian ablation in early breast cancer: Overview of the randomised trials. Lancet 348:1189–1196, 1996[CrossRef][Medline]

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