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BR96-Doxorubicin: Been There, Done That!

Institute for Drug Development Cancer Therapy & Research Center San Antonio, TX

To the Editor:The report by Saleh et al, entitled "Phase I Trial of the Anti–Lewis Y Drug Immunoconjugate BR96-Doxorubicin in Patients with Lewis Y–Expressing Epithelial Tumors," published in the June 2000 issue of the Journal of Clinical Oncology, was read with great interest. I was surprised, however, by the conclusions of the authors that a phase II study in breast cancer is warranted and that such a study has been conducted and awaits publication.

As the authors should be aware, a "Randomized Phase II Study of BR96-Doxorubicin Conjugate in Patients with Metastatic Breast Cancer" was performed and published in the Journal of Clinical Oncology, in February 1999.² Unfortunately, the BR96-doxorubicin conjugate did not demonstrate antitumor activity at a level that would be considered worthy of further clinical development. I am somewhat surprised that the authors and the reviewers did not more thoroughly review the published literature, since this may leave the reader to mistakenly believe that this agent is still in clinical development.

REFERENCES

1. Saleh MN, Sugarman S, Murray J, et al: Phase I trial of the anti–Lewis Y drug immunoconjugate BR96-doxorubicin in patients with Lewis Y–expressing epithelial tumors. J Clin Oncol 18: 2282-2292, 2000[Abstract/Free Full Text]

2. Tolcher AW, Sugarman S, Gelmon KA, et al: Randomized phase II study of BR96-doxorubicin conjugate in patients with metastatic breast cancer. J Clin Oncol 17: 478-484, 1999[Abstract/Free Full Text]

Response

The University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, AL

In Reply:Dr Tolcher is correct in pointing out that the randomized phase II study of BR96-doxorubicin conjugate did not demonstrate antitumor activity of the single agent in breast cancer.¹ We did neglect to reference the publication cited by Tolcher in our publication. This was an error on our part. In vitro data demonstrate significant synergy between BR96-doxorubicin and taxanes. A phase I study of the combination of BR96-doxorubicin and docetaxel was completed recently, and a phase II study in metastatic breast cancer is ongoing. This study awaits completion.

REFERENCES

1. Tolcher AW, Sugarman S, Gelmon KA, et al: Randomized phase II study of BR96-doxorubicin conjugate in patients with metastatic breast cancer. J Clin Oncol 17: 478-484, 1999

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