Randomized trial of high-dose chemotherapy with autologous peripheral-blood stem-cell support compared with standard-dose chemotherapy in women with metastatic breast cancer: NCIC MA.16

Michael Crump, Stefan Gluck, Dongsheng Tu, Doug Stewart, Mark Levine, Peter Kirkbride, Janet Dancey, Susan O'Reilly, Tsiporah Shore, Stephen Couban, Caroline Girouard, Susan Marlin, Lois Shepherd, Kathleen I. Pritchard

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Abstract

Purpose: We conducted a multicenter, randomized trial to compare progression-free survival (PFS), overall survival (OS), and quality of life in women with metastatic breast cancer (MBC) receiving high-dose chemotherapy plus autologous stem-cell transplantation (ASCT; HDCT) compared with standard-dose therapy. Patient and Methods: Between April 1997 and December 2000, 386 women with MBC and no prior chemotherapy for metastatic disease were registered. After initial response to anthracycline- or taxane-based induction chemotherapy, 224 patients were randomly assigned: 112 to high-dose cyclophosphamide, mitoxantrone, and carboplatin chemotherapy and ASCT (HDCT), and 112 to standard therapy (ST). Median age was 47 years (range, 25 to 67 years). Thirty two percent of women randomly assigned had estrogen and progesterone receptor-negative breast cancer, 42% had visceral metastases, and 58% had bone metastases. Complete remission rates before random assignment were 11% for those receiving HDCT and 12% for those receiving ST. Results: After a median follow-up of 48 months, 79 deaths were observed in the HDCT arm and 77 deaths were observed in the ST arm; seven patients (6%) in the HDCT arm died as a result of toxicity. The median OS was 24 months for the HDCT arm (95% CI, 21 to 35 months) and 28 months for ST (95% CI, 22 to 33 months; hazard ratio [HR], 0.9; 95% CI, 0.6 to 1.2; P = .43). PFS was 11 months for HDCT and 9 months for ST (HR, 0.6 in favor of HDCT; 95% CI, 0.5 to 0.9; P = .006). Conclusion: HDCT did not improve OS in women with MBC when used as consolidation after response to induction chemotherapy.

Original languageEnglish
Pages (from-to)37-43
Number of pages7
JournalJournal of Clinical Oncology
Volume26
Issue number1
DOIs
StatePublished - Jan 1 2008
Externally publishedYes

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Breast Neoplasms
Drug Therapy
Induction Chemotherapy
Disease-Free Survival
Survival
Therapeutics
Neoplasm Metastasis
Mitoxantrone
Anthracyclines
Carboplatin
Stem Cell Transplantation
Progesterone Receptors
Estrogen Receptors
Cyclophosphamide
Multicenter Studies
Peripheral Blood Stem Cells
Quality of Life
Bone and Bones

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Randomized trial of high-dose chemotherapy with autologous peripheral-blood stem-cell support compared with standard-dose chemotherapy in women with metastatic breast cancer : NCIC MA.16. / Crump, Michael; Gluck, Stefan; Tu, Dongsheng; Stewart, Doug; Levine, Mark; Kirkbride, Peter; Dancey, Janet; O'Reilly, Susan; Shore, Tsiporah; Couban, Stephen; Girouard, Caroline; Marlin, Susan; Shepherd, Lois; Pritchard, Kathleen I.

In: Journal of Clinical Oncology, Vol. 26, No. 1, 01.01.2008, p. 37-43.

Research output: Contribution to journalArticle

Crump, M, Gluck, S, Tu, D, Stewart, D, Levine, M, Kirkbride, P, Dancey, J, O'Reilly, S, Shore, T, Couban, S, Girouard, C, Marlin, S, Shepherd, L & Pritchard, KI 2008, 'Randomized trial of high-dose chemotherapy with autologous peripheral-blood stem-cell support compared with standard-dose chemotherapy in women with metastatic breast cancer: NCIC MA.16', Journal of Clinical Oncology, vol. 26, no. 1, pp. 37-43. https://doi.org/10.1200/JCO.2007.11.8851
Crump, Michael ; Gluck, Stefan ; Tu, Dongsheng ; Stewart, Doug ; Levine, Mark ; Kirkbride, Peter ; Dancey, Janet ; O'Reilly, Susan ; Shore, Tsiporah ; Couban, Stephen ; Girouard, Caroline ; Marlin, Susan ; Shepherd, Lois ; Pritchard, Kathleen I. / Randomized trial of high-dose chemotherapy with autologous peripheral-blood stem-cell support compared with standard-dose chemotherapy in women with metastatic breast cancer : NCIC MA.16. In: Journal of Clinical Oncology. 2008 ; Vol. 26, No. 1. pp. 37-43.
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abstract = "Purpose: We conducted a multicenter, randomized trial to compare progression-free survival (PFS), overall survival (OS), and quality of life in women with metastatic breast cancer (MBC) receiving high-dose chemotherapy plus autologous stem-cell transplantation (ASCT; HDCT) compared with standard-dose therapy. Patient and Methods: Between April 1997 and December 2000, 386 women with MBC and no prior chemotherapy for metastatic disease were registered. After initial response to anthracycline- or taxane-based induction chemotherapy, 224 patients were randomly assigned: 112 to high-dose cyclophosphamide, mitoxantrone, and carboplatin chemotherapy and ASCT (HDCT), and 112 to standard therapy (ST). Median age was 47 years (range, 25 to 67 years). Thirty two percent of women randomly assigned had estrogen and progesterone receptor-negative breast cancer, 42{\%} had visceral metastases, and 58{\%} had bone metastases. Complete remission rates before random assignment were 11{\%} for those receiving HDCT and 12{\%} for those receiving ST. Results: After a median follow-up of 48 months, 79 deaths were observed in the HDCT arm and 77 deaths were observed in the ST arm; seven patients (6{\%}) in the HDCT arm died as a result of toxicity. The median OS was 24 months for the HDCT arm (95{\%} CI, 21 to 35 months) and 28 months for ST (95{\%} CI, 22 to 33 months; hazard ratio [HR], 0.9; 95{\%} CI, 0.6 to 1.2; P = .43). PFS was 11 months for HDCT and 9 months for ST (HR, 0.6 in favor of HDCT; 95{\%} CI, 0.5 to 0.9; P = .006). Conclusion: HDCT did not improve OS in women with MBC when used as consolidation after response to induction chemotherapy.",
author = "Michael Crump and Stefan Gluck and Dongsheng Tu and Doug Stewart and Mark Levine and Peter Kirkbride and Janet Dancey and Susan O'Reilly and Tsiporah Shore and Stephen Couban and Caroline Girouard and Susan Marlin and Lois Shepherd and Pritchard, {Kathleen I.}",
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T1 - Randomized trial of high-dose chemotherapy with autologous peripheral-blood stem-cell support compared with standard-dose chemotherapy in women with metastatic breast cancer

T2 - NCIC MA.16

AU - Crump, Michael

AU - Gluck, Stefan

AU - Tu, Dongsheng

AU - Stewart, Doug

AU - Levine, Mark

AU - Kirkbride, Peter

AU - Dancey, Janet

AU - O'Reilly, Susan

AU - Shore, Tsiporah

AU - Couban, Stephen

AU - Girouard, Caroline

AU - Marlin, Susan

AU - Shepherd, Lois

AU - Pritchard, Kathleen I.

PY - 2008/1/1

Y1 - 2008/1/1

N2 - Purpose: We conducted a multicenter, randomized trial to compare progression-free survival (PFS), overall survival (OS), and quality of life in women with metastatic breast cancer (MBC) receiving high-dose chemotherapy plus autologous stem-cell transplantation (ASCT; HDCT) compared with standard-dose therapy. Patient and Methods: Between April 1997 and December 2000, 386 women with MBC and no prior chemotherapy for metastatic disease were registered. After initial response to anthracycline- or taxane-based induction chemotherapy, 224 patients were randomly assigned: 112 to high-dose cyclophosphamide, mitoxantrone, and carboplatin chemotherapy and ASCT (HDCT), and 112 to standard therapy (ST). Median age was 47 years (range, 25 to 67 years). Thirty two percent of women randomly assigned had estrogen and progesterone receptor-negative breast cancer, 42% had visceral metastases, and 58% had bone metastases. Complete remission rates before random assignment were 11% for those receiving HDCT and 12% for those receiving ST. Results: After a median follow-up of 48 months, 79 deaths were observed in the HDCT arm and 77 deaths were observed in the ST arm; seven patients (6%) in the HDCT arm died as a result of toxicity. The median OS was 24 months for the HDCT arm (95% CI, 21 to 35 months) and 28 months for ST (95% CI, 22 to 33 months; hazard ratio [HR], 0.9; 95% CI, 0.6 to 1.2; P = .43). PFS was 11 months for HDCT and 9 months for ST (HR, 0.6 in favor of HDCT; 95% CI, 0.5 to 0.9; P = .006). Conclusion: HDCT did not improve OS in women with MBC when used as consolidation after response to induction chemotherapy.

AB - Purpose: We conducted a multicenter, randomized trial to compare progression-free survival (PFS), overall survival (OS), and quality of life in women with metastatic breast cancer (MBC) receiving high-dose chemotherapy plus autologous stem-cell transplantation (ASCT; HDCT) compared with standard-dose therapy. Patient and Methods: Between April 1997 and December 2000, 386 women with MBC and no prior chemotherapy for metastatic disease were registered. After initial response to anthracycline- or taxane-based induction chemotherapy, 224 patients were randomly assigned: 112 to high-dose cyclophosphamide, mitoxantrone, and carboplatin chemotherapy and ASCT (HDCT), and 112 to standard therapy (ST). Median age was 47 years (range, 25 to 67 years). Thirty two percent of women randomly assigned had estrogen and progesterone receptor-negative breast cancer, 42% had visceral metastases, and 58% had bone metastases. Complete remission rates before random assignment were 11% for those receiving HDCT and 12% for those receiving ST. Results: After a median follow-up of 48 months, 79 deaths were observed in the HDCT arm and 77 deaths were observed in the ST arm; seven patients (6%) in the HDCT arm died as a result of toxicity. The median OS was 24 months for the HDCT arm (95% CI, 21 to 35 months) and 28 months for ST (95% CI, 22 to 33 months; hazard ratio [HR], 0.9; 95% CI, 0.6 to 1.2; P = .43). PFS was 11 months for HDCT and 9 months for ST (HR, 0.6 in favor of HDCT; 95% CI, 0.5 to 0.9; P = .006). Conclusion: HDCT did not improve OS in women with MBC when used as consolidation after response to induction chemotherapy.

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