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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