Intensive dose-dense compared with high-dose adjuvant chemotherapy for high-risk operable breast cancer: Southwest Oncology Group/Intergroup study 9623

Halle C F Moore, Stephanie J. Green, Julie R. Gralow, Scott I. Bearman, Danika Lew, William E. Barlow, Clifford Hudis, Antonio C. Wolff, James N. Ingle, Helen K. Chew, Anthony D. Elias, Robert B. Livingston, Silvana Martino

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Abstract

Purpose: Southwest Oncology Group (SWOG)/Intergroup study 9623 was undertaken to compare treatment with an anthracycline-based adjuvant chemotherapy regimen followed by high-dose chemotherapy (HDC) with autologous hematopoietic progenitor cell support (AHPCS) with a modern dose-dense dose-escalated (nonstandard) regimen including both an anthracycline and a taxane. Patients and Methods: Participants in this phase III randomized study had operable breast cancer involving four or more axillary lymph nodes and had completed mastectomy or breast-conserving surgery. Patients were randomly assigned to receive four cycles of doxorubicin and cyclophosphamide followed by HDC with AHPCS or to receive sequential dose-dense and dose-escalated chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide. The primary end point of this study was disease-free survival (DFS). Results: Among 536 eligible patients, there was no significant difference between the two arms for DFS or overall survival (OS). Estimated five-year DFS was 80% (95% CI, 76% to 85%) for dose-dense therapy and 75% (95% CI, 69% to 80%) for transplantation. Estimated 5-year OS was 88% (95% CI, 84% to 92%) for dose-dense therapy and 84% (95% CI, 79% to 88%) for transplantation. Conclusion: There is no evidence that transplantation was superior to dose-dense dose-escalated therapy. Transplantation was associated with an increase in toxicity and a possibly inferior outcome, although the hazard ratios were not significantly different from 1.

Original languageEnglish (US)
Pages (from-to)1677-1682
Number of pages6
JournalJournal of Clinical Oncology
Volume25
Issue number13
DOIs
StatePublished - May 1 2007

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Adjuvant Chemotherapy
Transplantation
Breast Neoplasms
Disease-Free Survival
Anthracyclines
Hematopoietic Stem Cells
Drug Therapy
Doxorubicin
Cyclophosphamide
Survival
Segmental Mastectomy
Mastectomy
Therapeutics
Paclitaxel
Lymph Nodes

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Intensive dose-dense compared with high-dose adjuvant chemotherapy for high-risk operable breast cancer : Southwest Oncology Group/Intergroup study 9623. / Moore, Halle C F; Green, Stephanie J.; Gralow, Julie R.; Bearman, Scott I.; Lew, Danika; Barlow, William E.; Hudis, Clifford; Wolff, Antonio C.; Ingle, James N.; Chew, Helen K.; Elias, Anthony D.; Livingston, Robert B.; Martino, Silvana.

In: Journal of Clinical Oncology, Vol. 25, No. 13, 01.05.2007, p. 1677-1682.

Research output: Contribution to journalArticle

Moore, HCF, Green, SJ, Gralow, JR, Bearman, SI, Lew, D, Barlow, WE, Hudis, C, Wolff, AC, Ingle, JN, Chew, HK, Elias, AD, Livingston, RB & Martino, S 2007, 'Intensive dose-dense compared with high-dose adjuvant chemotherapy for high-risk operable breast cancer: Southwest Oncology Group/Intergroup study 9623', Journal of Clinical Oncology, vol. 25, no. 13, pp. 1677-1682. https://doi.org/10.1200/JCO.2006.08.9383
Moore, Halle C F ; Green, Stephanie J. ; Gralow, Julie R. ; Bearman, Scott I. ; Lew, Danika ; Barlow, William E. ; Hudis, Clifford ; Wolff, Antonio C. ; Ingle, James N. ; Chew, Helen K. ; Elias, Anthony D. ; Livingston, Robert B. ; Martino, Silvana. / Intensive dose-dense compared with high-dose adjuvant chemotherapy for high-risk operable breast cancer : Southwest Oncology Group/Intergroup study 9623. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 13. pp. 1677-1682.
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abstract = "Purpose: Southwest Oncology Group (SWOG)/Intergroup study 9623 was undertaken to compare treatment with an anthracycline-based adjuvant chemotherapy regimen followed by high-dose chemotherapy (HDC) with autologous hematopoietic progenitor cell support (AHPCS) with a modern dose-dense dose-escalated (nonstandard) regimen including both an anthracycline and a taxane. Patients and Methods: Participants in this phase III randomized study had operable breast cancer involving four or more axillary lymph nodes and had completed mastectomy or breast-conserving surgery. Patients were randomly assigned to receive four cycles of doxorubicin and cyclophosphamide followed by HDC with AHPCS or to receive sequential dose-dense and dose-escalated chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide. The primary end point of this study was disease-free survival (DFS). Results: Among 536 eligible patients, there was no significant difference between the two arms for DFS or overall survival (OS). Estimated five-year DFS was 80{\%} (95{\%} CI, 76{\%} to 85{\%}) for dose-dense therapy and 75{\%} (95{\%} CI, 69{\%} to 80{\%}) for transplantation. Estimated 5-year OS was 88{\%} (95{\%} CI, 84{\%} to 92{\%}) for dose-dense therapy and 84{\%} (95{\%} CI, 79{\%} to 88{\%}) for transplantation. Conclusion: There is no evidence that transplantation was superior to dose-dense dose-escalated therapy. Transplantation was associated with an increase in toxicity and a possibly inferior outcome, although the hazard ratios were not significantly different from 1.",
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T1 - Intensive dose-dense compared with high-dose adjuvant chemotherapy for high-risk operable breast cancer

T2 - Southwest Oncology Group/Intergroup study 9623

AU - Moore, Halle C F

AU - Green, Stephanie J.

AU - Gralow, Julie R.

AU - Bearman, Scott I.

AU - Lew, Danika

AU - Barlow, William E.

AU - Hudis, Clifford

AU - Wolff, Antonio C.

AU - Ingle, James N.

AU - Chew, Helen K.

AU - Elias, Anthony D.

AU - Livingston, Robert B.

AU - Martino, Silvana

PY - 2007/5/1

Y1 - 2007/5/1

N2 - Purpose: Southwest Oncology Group (SWOG)/Intergroup study 9623 was undertaken to compare treatment with an anthracycline-based adjuvant chemotherapy regimen followed by high-dose chemotherapy (HDC) with autologous hematopoietic progenitor cell support (AHPCS) with a modern dose-dense dose-escalated (nonstandard) regimen including both an anthracycline and a taxane. Patients and Methods: Participants in this phase III randomized study had operable breast cancer involving four or more axillary lymph nodes and had completed mastectomy or breast-conserving surgery. Patients were randomly assigned to receive four cycles of doxorubicin and cyclophosphamide followed by HDC with AHPCS or to receive sequential dose-dense and dose-escalated chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide. The primary end point of this study was disease-free survival (DFS). Results: Among 536 eligible patients, there was no significant difference between the two arms for DFS or overall survival (OS). Estimated five-year DFS was 80% (95% CI, 76% to 85%) for dose-dense therapy and 75% (95% CI, 69% to 80%) for transplantation. Estimated 5-year OS was 88% (95% CI, 84% to 92%) for dose-dense therapy and 84% (95% CI, 79% to 88%) for transplantation. Conclusion: There is no evidence that transplantation was superior to dose-dense dose-escalated therapy. Transplantation was associated with an increase in toxicity and a possibly inferior outcome, although the hazard ratios were not significantly different from 1.

AB - Purpose: Southwest Oncology Group (SWOG)/Intergroup study 9623 was undertaken to compare treatment with an anthracycline-based adjuvant chemotherapy regimen followed by high-dose chemotherapy (HDC) with autologous hematopoietic progenitor cell support (AHPCS) with a modern dose-dense dose-escalated (nonstandard) regimen including both an anthracycline and a taxane. Patients and Methods: Participants in this phase III randomized study had operable breast cancer involving four or more axillary lymph nodes and had completed mastectomy or breast-conserving surgery. Patients were randomly assigned to receive four cycles of doxorubicin and cyclophosphamide followed by HDC with AHPCS or to receive sequential dose-dense and dose-escalated chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide. The primary end point of this study was disease-free survival (DFS). Results: Among 536 eligible patients, there was no significant difference between the two arms for DFS or overall survival (OS). Estimated five-year DFS was 80% (95% CI, 76% to 85%) for dose-dense therapy and 75% (95% CI, 69% to 80%) for transplantation. Estimated 5-year OS was 88% (95% CI, 84% to 92%) for dose-dense therapy and 84% (95% CI, 79% to 88%) for transplantation. Conclusion: There is no evidence that transplantation was superior to dose-dense dose-escalated therapy. Transplantation was associated with an increase in toxicity and a possibly inferior outcome, although the hazard ratios were not significantly different from 1.

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