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

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.

• Authors: 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, Southwest Oncology Group/Intergroup Study 9623
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 25 Issue 13 Pg. 1677-82 (May 01 2007) ISSN: 1527-7755 [Electronic] United States
• PMID: 17404368 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Topics

• Adult
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, surgery)
• Chemotherapy, Adjuvant
• Combined Modality Therapy
• Dose-Response Relationship, Drug
• Female
• Humans
• Middle Aged
• Recurrence
• Stem Cell Transplantation
• Survival Analysis