CORRESPONDENCE

EDITOR'S NOTE: Re: Randomized Trial of High-Dose Chemotherapy and Blood Cell Autografts for High-Risk Primary Breast Carcinoma

Like other journals, we give particularly high priority to definitive clinical studies, whether positive or negative. Small studies often have wide confidence intervals associated with treatment effects and are more subject to random error than are large studies. Therefore, small studies can fail to detect small treatment benefits. On the other hand, they are also more subject to falsely positive results. However, when the procedure itself (i.e., bone marrow transplantation) carries a high risk of morbidity and finite risk of mortality, the potential magnitude of benefits should be accordingly large. In such cases, even small studies can supply important information in guiding clinical practice.

Additionally, no study exists in a vacuum. In the last year, there have been several studies on high-dose chemotherapy, bone marrow transplantation, and high-risk primary breast cancer—one positive (1) [that has been discredited (2)] and four negative (36). The results of the negative studies can be used in aggregate to help determine if a benefit of sufficient magnitude exists to fully counterbalance the substantial toxicity incurred by high-dose chemotherapy and bone marrow or stem-cell "rescue." The jury is still out on the ultimate role of high-dose chemotherapy in operable breast cancer. However, the results of randomized trials such as those conducted by Hortobagyi et al. do suggest that the substantial number of published uncontrolled studies gave an overly optimistic impression of the therapy's strategic worth.

REFERENCES

1 Bezwoda WR. Randomised, controlled trial of high dose chemotherapy (HD-CNVp) versus standard dose (CAF) chemotherapy for high risk, surgically treated, primary breast cancer [abstract]. Proc ASCO 1999;18:2.

2 Weiss RB, Rifkin RM, Stewart FM, Theriault RL, Williams LA, Herman AA, et al. High-dose chemotherapy for high-risk primary breast cancer: an on-site review of the Bezwoda study. Lancet 2000;355:999–1003.[Medline]

3 Peters WP, Rosner G, Vredenburgh J, Shpall E, Crump M, Richardson P, et al. A prospective, randomized comparison to two doses of combination alkylating agents as consolidation after CAF in high-risk primary breast cancer involving ten or more axillary lymph nodes: preliminary results of CALGB 9082/SWOG 9114/NCIC MA-13 [abstract]. Proc ASCO 1999;18:1.

4 Rodenhuis S, Richel DJ, van der Wall E, Schornagel JH, Baars JW, Koning CC, et al. Randomised trial of high-dose chemotherapy and haemopoietic progenitor-cell support in operable breast cancer with extensive axillary lymph-node involvement. Lancet 1998;352:515–21.[Medline]

5 Hortobagyi GN, Buzdar AU, Theriault RL, Valero V, Frye E, Booser DJ, et al. Randomized trial of high-dose chemotherapy and blood cell autografts for high-risk primary breast carcinoma. J Natl Cancer Inst 2000;92:225–33.[Abstract/Free Full Text]

6 The Scandinavian Breast Cancer Study Group 9401. Results from a randomized adjuvant breast cancer study with high dose chemotherapy with CTCb supported by autologous bone marrow stem cells versus dose escalated and tailored FEC therapy [abstract]. Proc ASCO 1999;18:2a.



             
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