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High-Dose Chemotherapy for Breast Cancer
The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:
•Include no more than 300 words of text, three authors, and five references
•Type with double-spacing
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Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.
Annals welcomes electronically submitted letters.
TO THE EDITOR:
In their article on high-dose chemotherapy for breast cancer, Gradishar and colleagues [1] state in their conclusions that they believe the barrier to the completion of the “pivotal phase III trials” is “preconceived preference to therapy.” First, I believe that for those physicians who are reluctant to place patients in such phase III trials, the issue is ethics and not personal preference. For some of us, the issue is whether we randomly assign a patient to a treatment that we believe has no hope of cure or to a treatment that does have a chance of cure (as is suggested by prolonged disease-free survival). The ethical issue was demonstrated in the study by Philip and colleagues [2], who reported on autologous bone marrow transplantation versus conventional chemotherapy in patients with relapsed non-Hodgkin lymphoma. That study of 216 patients from 51 institutions took 7 years to complete. The slow accrual was undoubtedly the result of numerous phase II trials that had already been reported as having positive findings. Similarly, when the randomized trial of adjuvant chemotherapy for osteosarcoma was reported [3], the accompanying editorial [4] questioned the ethics of conducting a phase III trial to confirm the benefit of survival, which had previously been demonstrated in phase II trials. Some physicians who do not believe that phase II trials are conclusive perhaps consider phase III trials to be necessary. Many physicians, however, do believe that depending on the magnitude of the differences demonstrated, phase II trials are in themselves conclusive. This is evidenced by the worldwide acceptance of PVB (cis-diamminedichloroplatinum, vinblastine, and bleomycin) for testicular cancer [5] after a phase II trial. Until there is universal acceptance of standards with which to judge efficacy of treatment, ethical issues will remain an obstacle to accrual of patients in clinical trials.
The Editors welcome submissions for possible publication in the Letters section. Authors of letters should:
•Include no more than 300 words of text, three authors, and five references
•Type with double-spacing
•Send three copies of the letter, an authors' form signed by all authors, and a cover letter describing any conflicts of interest related to the contents of the letter.
Letters commenting on an Annals article will be considered if they are received within 6 weeks of the time the article was published. Only some of the letters received can be published. Published letters are edited and may be shortened; tables and figures are included only selectively. Authors will be notified that the letter has been received. If the letter is selected for publication, the author will be notified about 3 weeks before the publication date. Unpublished letters cannot be returned.
Annals welcomes electronically submitted letters.
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