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High dose chemotherapy and autologous stem cell transplantation as adjuvant therapy for primary breast cancer patients with four or more lymph nodes involved: long-term results of an international randomised trial

High dose chemotherapy and autologous stem cell transplantation as adjuvant therapy for primary breast cancer patients with four or more lymph nodes involved: long-term results of an international randomised trial
High dose chemotherapy and autologous stem cell transplantation as adjuvant therapy for primary breast cancer patients with four or more lymph nodes involved: long-term results of an international randomised trial
Background: the purpose of this study was to assess whether a short course of anthracycline containing chemotherapy followed by high dose therapy with autologous stem-cell support improves disease-free and overall survival as compared with conventional, anthracycline containing chemotherapy, in patients with primary breast cancer and four or more histologically involved lymph nodes.

Patients and methods: two hundred and eighty one patients entered into a randomised clinical trial were allocated to receive standard, conventional treatment (5-fluorouracil, epirubicin and cyclophosphamide–FEC for six cycles) or FEC for three cycles followed by high dose therapy consisting of cyclophosphamide, thiotepa and carboplatin and stem cell rescue (HDT). To be eligible, patients had to be free of overt metastatic disease and be ?60 years of age. Analyses were according to intention to treat.

Results: at a median follow up of 68 months, 118 patients have experienced a relapse or death from breast cancer (62 in the FEC followed by HDT arm and 56 in the conventional FEC arm) and a total of 100 patients have died (54 in the FEC followed by HDT arm and 46 in the conventional FEC arm). No significant difference was observed in relapse-free survival [hazard ratio 1.06, 95% CI 0.74–1.52, p?=?0.76] or overall survival [hazard ratio 1.18, 95% CI 0.80–1.75, p?=?0.40]. Five patients died from treatment related causes, three as a consequence of HDT and two in the conventional FEC arm.

Conclusions: at the present time, no benefit has been observed from replacing three cycles of conventional chemotherapy with the HDT regimen described here. Patients should continue to receive conventional chemotherapy as adjuvant therapy for breast cancer
1569-8041
726-734
Coombes, R.C.
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Howell, A.
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Emson, M.
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Peckitt, C.
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Gallagher, C.
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Bengala, C.
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Tres, A.
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Welch, R.
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Lawton, P.
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Rubens, R.
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Woods, E.
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Haviland, J.S.
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Vigushin, D.
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Kanfer, E.
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Bliss, J.M.
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Coombes, R.C.
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Howell, A.
d66cb75b-55f5-4b55-bdff-79a7536aec10
Emson, M.
71031c57-44dd-4e6b-a5c1-22a3095dbe76
Peckitt, C.
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Gallagher, C.
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Bengala, C.
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Tres, A.
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Welch, R.
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Lawton, P.
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Rubens, R.
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Woods, E.
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Haviland, J.S.
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Vigushin, D.
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Kanfer, E.
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Bliss, J.M.
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Coombes, R.C., Howell, A., Emson, M., Peckitt, C., Gallagher, C., Bengala, C., Tres, A., Welch, R., Lawton, P., Rubens, R., Woods, E., Haviland, J.S., Vigushin, D., Kanfer, E. and Bliss, J.M. (2005) High dose chemotherapy and autologous stem cell transplantation as adjuvant therapy for primary breast cancer patients with four or more lymph nodes involved: long-term results of an international randomised trial. Annals of Oncology, 16 (5), 726-734. (doi:10.1093/annonc/mdi166).

Record type: Article

Abstract

Background: the purpose of this study was to assess whether a short course of anthracycline containing chemotherapy followed by high dose therapy with autologous stem-cell support improves disease-free and overall survival as compared with conventional, anthracycline containing chemotherapy, in patients with primary breast cancer and four or more histologically involved lymph nodes.

Patients and methods: two hundred and eighty one patients entered into a randomised clinical trial were allocated to receive standard, conventional treatment (5-fluorouracil, epirubicin and cyclophosphamide–FEC for six cycles) or FEC for three cycles followed by high dose therapy consisting of cyclophosphamide, thiotepa and carboplatin and stem cell rescue (HDT). To be eligible, patients had to be free of overt metastatic disease and be ?60 years of age. Analyses were according to intention to treat.

Results: at a median follow up of 68 months, 118 patients have experienced a relapse or death from breast cancer (62 in the FEC followed by HDT arm and 56 in the conventional FEC arm) and a total of 100 patients have died (54 in the FEC followed by HDT arm and 46 in the conventional FEC arm). No significant difference was observed in relapse-free survival [hazard ratio 1.06, 95% CI 0.74–1.52, p?=?0.76] or overall survival [hazard ratio 1.18, 95% CI 0.80–1.75, p?=?0.40]. Five patients died from treatment related causes, three as a consequence of HDT and two in the conventional FEC arm.

Conclusions: at the present time, no benefit has been observed from replacing three cycles of conventional chemotherapy with the HDT regimen described here. Patients should continue to receive conventional chemotherapy as adjuvant therapy for breast cancer

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Published date: April 2005
Organisations: Faculty of Health Sciences

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Local EPrints ID: 365436
URI: https://eprints.soton.ac.uk/id/eprint/365436
ISSN: 1569-8041
PURE UUID: 19686899-d19e-49b6-b8f4-de74da911c74

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Date deposited: 09 Jun 2014 10:15
Last modified: 18 Jul 2017 02:21

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Contributors

Author: R.C. Coombes
Author: A. Howell
Author: M. Emson
Author: C. Peckitt
Author: C. Gallagher
Author: C. Bengala
Author: A. Tres
Author: R. Welch
Author: P. Lawton
Author: R. Rubens
Author: E. Woods
Author: J.S. Haviland
Author: D. Vigushin
Author: E. Kanfer
Author: J.M. Bliss

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