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Volume 342:1069-1076 April 13, 2000 Number 15 Next

	Full Text PDF Editorial by Lippman, M. E. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background We conducted a randomized trial in which we compared high-dose chemotherapy plus hematopoietic stem-cell rescue with a prolonged course of monthly conventional-dose chemotherapy in women with metastatic breast cancer.

Methods Women 18 to 60 years of age who had metastatic breast cancer received four to six cycles of standard combination chemotherapy. Patients who had a complete or partial response to induction chemotherapy were then randomly assigned to receive either a single course of high doses of carboplatin, thiotepa, and cyclophosphamide plus transplantation of autologous hematopoietic stem cells or up to 24 cycles of cyclophosphamide, methotrexate, and fluorouracil in conventional doses. The primary end point was survival.

Results The median follow-up was 37 months. Of 553 patients who enrolled in the study, 58 had a complete response to induction chemotherapy and 252 had a partial response. Of these, 110 patients were assigned to receive high-dose chemotherapy plus hematopoietic stem cells and 89 were assigned to receive conventional-dose chemotherapy. In an intention-to-treat analysis, we found no significant difference in survival overall at three years between the two treatment groups (32 percent in the transplantation group and 38 percent in the conventional-chemotherapy group). There was no significant difference between the two treatments in the median time to progression of the disease (9.6 months for high-dose chemotherapy plus hematopoietic stem cells and 9.0 months for conventional-dose chemotherapy).

Conclusions As compared with maintenance chemotherapy in conventional doses, high-dose chemotherapy plus autologous stem-cell transplantation soon after the induction of a complete or partial remission with conventional-dose chemotherapy does not improve survival in women with metastatic breast cancer.

Source Information

From the University of Pennsylvania Cancer Center, Philadelphia (E.A.S., C.S., J.H.G.); Dana–Farber Cancer Institute, Boston (A.O.); Fox Chase Cancer Center, Philadelphia (L.J.G.); Hahnemann University, Philadelphia (P.A.C., I.B.); Temple University, Philadelphia (K.F.M.); Mayo Clinic, Rochester, Minn. (J.N.I.); John Wayne Cancer Institute, Santa Monica, Calif. (S.M.); University Hospitals of Cleveland, Cleveland (H.M.L.); and Tufts–New England Medical Center, Boston (J.K.E.). Other authors were Selina M. Luger, M.D., University of Pennsylvania Cancer Center, Philadelphia; Thomas R. Klumpp, M.D., Temple University, Philadelphia; Mark R. Litzow, M.D., Mayo Clinic, Rochester, Minn.; and David L. Topolsky, M.D., Hahnemann University Hospital, Philadelphia.

Address reprint requests to Dr. Stadtmauer at the Bone Marrow and Stem Cell Transplant Program, University of Pennsylvania Cancer Center, 16 Penn Tower, 3400 Spruce St., Philadelphia, PA 19104, or at stadtmau{at}mail.med.upenn.edu.

Full Text of this Article

Related Letters:

High-Dose Chemotherapy plus Hematopoietic Stem-Cell Rescue for Metastatic Breast Cancer
Tempfer C., Seifert M., Brodowicz T., Auerbach L., Zielinski C., Iacopino P., Palazzo S., Patrone F., Stadtmauer E. A., Goldstein L. J., Glick J. H.
Extract | Full Text  
N Engl J Med 2000; 343:439-441, Aug 10, 2000. Correspondence

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