© The Author 2006. Published by Oxford University Press.
CORRESPONDENCE |
Re: Randomized Trial of Letrozole Following Tamoxifen as Extended Adjuvant Therapy in Receptor-Positive Breast Cancer: Updated Findings from NCIC CTG MA.17
Correspondence to: Luc Vakaet, MD, PhD, UZ Gent, Radiotherapie, De Pintelaan 185, Gent 9000, Belgium (e-mail: luc.vakaet{at}ugent.be).
I read with great interest the updated findings of the NCIC CTG MA.17 trial (1) and want to compliment the authors for continuing to report on this paradigm-shifting trial. Although the conclusions about the main endpoints remain essentially unchanged compared with those in the original (2003) report of the trial (2) (Table 1), the two reports include different numbers of patients at risk and—correspondingly—different numbers of breast cancer events. The differences are unlikely to be explained by the difference in duration of follow-up, which is only 1.5 months. Instead, they are due to the thoroughness with which the patient follow-up was updated for the more recent report. However, if so, the difference raises the question of whether the completeness of follow-up should have been taken into consideration before the Data Safety and Monitoring Committee's decision to terminate this study prematurely.
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A second comment concerns the eligibility of some of the patients in the study. Originally the main protocol inclusion criteria (1,2) were "... (postmenopausal) patients with previous adjuvant tamoxifen therapy lasting 4.5-6 years." The more detailed description of the study population (1), however, states that "... the median time between initial diagnosis of breast cancer and random assignment in this study was 64.3 months (range 0.1 to 204 months)." If the 0.1 months is not a typographical error, then that patient was clearly ineligible according to the original criteria. The same holds for the patient with an interval of 204 months. The authors should report the distribution of this crucial parameter differently, including, for example, the 5th and 95th percentiles, which will be much more clinically interesting than data from ineligible patients.
REFERENCES
(1) Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, et al. Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst 2005;97:1262–71.
(2) Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, et al. A randomized trial of letrozole in postmenopausal women after 5 years of tamoxifen therapy for early-stage breast cancer. N Engl J Med 2003;349:1793–802.
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J Natl Cancer Inst 2006 98: 1162-1163.
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