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Fifteen-year median follow-up results after neoadjuvant doxorubicin, followed by mastectomy, followed by adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) followed by radiation for stage III breast cancer: a phase II trial (CALGB 8944).

Publication ,  Journal Article
Kimmick, GG; Cirrincione, C; Duggan, DB; Bhalla, K; Robert, N; Berry, D; Norton, L; Lemke, S; Henderson, IC; Hudis, C; Winer, E ...
Published in: Breast Cancer Res Treat
February 2009

PURPOSE: To describe long-term results of a multimodality strategy for stage III breast cancer utilizing neoadjuvant doxorubicin followed by mastectomy, CMF, and radiotherapy. PATIENTS AND METHODS: Women with biopsy-proven, clinical stage III breast cancer and adequate organ function were eligible. Neoadjuvant doxorubicin (30 mg/m(2) days 1-3, every 28 days for 4 cycles) was followed by mastectomy, in stable or responding patients. Sixteen weeks of postoperative CMF followed (continuous oral cyclophosphamide (2 mg/kg/day); methotrexate (0.7 mg/kg IV) and fluorouracil (12 mg/kg IV) weekly, weeks 1-8, and than biweekly, weeks 9-16). Radiation therapy followed adjuvant chemotherapy. RESULTS: Clinical response rate was 71% (79/111, 95% CI = 62-79%), with 19% complete clinical response. Pathologic complete response was 5% (95% CI = 2-11%). Median follow-up is 15.6 years. Half of the patients progressed by 2.2 years; half died by 5.4 years (range 6 months-15 years). The hazard of dying was greatest in the first 5 years after diagnosis and declined thereafter. Time to progression and overall survival were predicted by number of pathologically involved lymph nodes (TTP: HR [10 vs. 1 node] 2.40, 95% CI = 1.63-3.53, P < 0.0001; OS: HR 2.50, 95% CI = 1.74-3.58, P < 0.0001). CONCLUSIONS: After multimodality treatment for locally advanced breast cancer, long-term survival was correlated with the number of pathologically positive lymph nodes, but not to clinical response. The hazard of death was highest during the first 5 years after diagnosis and declined thereafter, indicating a possible intermediate endpoint for future trials of neoadjuvant treatment.

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Published In

Breast Cancer Res Treat

DOI

EISSN

1573-7217

Publication Date

February 2009

Volume

113

Issue

3

Start / End Page

479 / 490

Location

Netherlands

Related Subject Headings

  • Survival Analysis
  • Radiotherapy, Adjuvant
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Neoadjuvant Therapy
  • Middle Aged
  • Methotrexate
  • Mastectomy
  • Humans
  • Follow-Up Studies
 

Citation

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Kimmick, G. G., Cirrincione, C., Duggan, D. B., Bhalla, K., Robert, N., Berry, D., … Cancer and Leukemia Group B, . (2009). Fifteen-year median follow-up results after neoadjuvant doxorubicin, followed by mastectomy, followed by adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) followed by radiation for stage III breast cancer: a phase II trial (CALGB 8944). Breast Cancer Res Treat, 113(3), 479–490. https://doi.org/10.1007/s10549-008-9943-2
Kimmick, G. G., C. Cirrincione, D. B. Duggan, K. Bhalla, N. Robert, D. Berry, L. Norton, et al. “Fifteen-year median follow-up results after neoadjuvant doxorubicin, followed by mastectomy, followed by adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) followed by radiation for stage III breast cancer: a phase II trial (CALGB 8944).Breast Cancer Res Treat 113, no. 3 (February 2009): 479–90. https://doi.org/10.1007/s10549-008-9943-2.
Kimmick GG, Cirrincione C, Duggan DB, Bhalla K, Robert N, Berry D, Norton L, Lemke S, Henderson IC, Hudis C, Winer E, Cancer and Leukemia Group B. Fifteen-year median follow-up results after neoadjuvant doxorubicin, followed by mastectomy, followed by adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) followed by radiation for stage III breast cancer: a phase II trial (CALGB 8944). Breast Cancer Res Treat. 2009 Feb;113(3):479–490.
Journal cover image

Published In

Breast Cancer Res Treat

DOI

EISSN

1573-7217

Publication Date

February 2009

Volume

113

Issue

3

Start / End Page

479 / 490

Location

Netherlands

Related Subject Headings

  • Survival Analysis
  • Radiotherapy, Adjuvant
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Neoadjuvant Therapy
  • Middle Aged
  • Methotrexate
  • Mastectomy
  • Humans
  • Follow-Up Studies