Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2009 Feb;113(3):479-90.
doi: 10.1007/s10549-008-9943-2. Epub 2008 Feb 28.

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)

Affiliations
Free PMC article
Clinical Trial

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)

G G Kimmick et al. Breast Cancer Res Treat. .
Free PMC article

Abstract

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.

Figures

Fig. 1
Fig. 1
Overall survival and time to progression for all patients
Fig. 2
Fig. 2
Overall survival by hormone receptor (HR) status and use of adjuvant tamoxifen
Fig. 3
Fig. 3
Hazard of dying for all patients
Fig. 4
Fig. 4
Hazard of dying by hormone receptor status and use of adjuvant tamoxifen

Similar articles

See all similar articles

Cited by 2 articles

Publication types

MeSH terms

Supplementary concepts

Feedback