A Prospective Randomized Feasibility and Phase II Adjuvant Breast Cancer Study of the Netherlands Working Party for Autotransplantation in Solid Tumors.
High-dose chemotherapy with the alkylating agent combination CTC appears to add
significantly to the efficacy of conventional dose chemotherapy in patients with high-risk
breast cancer, provided that the HER-2/neu gene is not amplified in the tumor. As a
high-dose chemotherapy regimen, CTC is associated with significant toxicity [31,32].
Although high-dose alkylating therapy seems to be effective, there is virtually nothing
known about the dose-response curve for this combination (for a detailed discussion see the
classical paper by E. Frei III . If one assumes that the efficacy increase levels off
with increasing dose, the efficacy of tCTC might be almost as great as that of CTC, but with
considerably less toxicity. In addition, two closely spaced courses of tCTC might further
increase the efficacy of the regimen. There are some suggestions that a double transplant
may be more effective than a single one, in multiple myeloma and in Ewing sarcoma. A similar
suggestion has also been made for breast cancer (study of Nitz et al ref 4, table 1).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum degree of non-hematological toxicity.
Elisabeth G.E. de Vries, MD, PhD
University Medical Centre Groningen
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)