LETTER
High-Dose Chemotherapy for Breast Cancer
Daniel A. Rushing, MD
1 June 1997 | Volume 126 Issue 11 | Page 917
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.
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Author and Article Information
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Marshfield Clinic, Marshfield, WI 54449
1. Gradishar WJ, Tallman MS, Abrams JS. High-dose chemotherapy for breast cancer. Ann Intern Med. 1996; 125:599-604.
2. Philip T, Guglielmi C, Hagenbeek A, Somers R, Van der Lelie H, Bron D, et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med. 1995; 333:1540-5.
3. Eilber F, Giuliano A, Eckardt J, Patterson K, Moseley S, Goodnight J. Adjuvant chemotherapy for osteosarcoma: a randomized prospective trial. J Clin Oncol. 1987; 5:21-6.
4. Holland JF. Adjuvant chemotherapy of osteosarcoma: no runs, no hits, two men left on base [Editorial]. J Clin Oncol. 1987; 5:4-6.
5. Einhorn LH, Donohue J. Cis-diamminedichloroplatinum, vinblastine and bleomycin combination chemotherapy in disseminated testicular cancer. Ann Intern Med. 1977; 87:293-8.
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