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) Journal Article

   

Authors:	Kimmick, G. G.; Cirrincione, C.; Duggan, D. B.; Bhalla, K.; Robert, N.; Berry, D.; Norton, L.; Lemke, S.; Henderson, I. C.; Hudis, C.; Winer, E.
Article Title:	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)
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<sup>2</sup> 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 &lt; 0.0001; OS: HR 2.50, 95% CI = 1.74-3.58, P &lt; 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. © 2008 Springer Science+Business Media, LLC.
Keywords:	adult; treatment response; aged; middle aged; survival analysis; major clinical study; overall survival; clinical trial; fatigue; neutropenia; doxorubicin; fluorouracil; diarrhea; antineoplastic agents; cancer adjuvant therapy; cancer radiotherapy; combined modality therapy; neoadjuvant therapy; radiotherapy, adjuvant; chemotherapy; methotrexate; cancer staging; follow up; follow-up studies; neoplasm staging; anorexia; adenocarcinoma; infection; multiple cycle treatment; pain; phase 2 clinical trial; breast cancer; anemia; mastectomy; esophagitis; gastrointestinal symptom; heart disease; nausea; stomatitis; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; cyclophosphamide; breast neoplasms; hematuria; dyspnea; fever; lymphocytopenia; dysphagia; malaise; disease progression; skin disease; locally advanced; heart arrhythmia; long-term follow-up; neoadjuvant; stage iii; breast biopsy; granulocytopenia; heart muscle ischemia; hematologic disease; mood disorder
Journal Title:	Breast Cancer Research and Treatment
Volume:	113
Issue:	3
ISSN:	0167-6806
Publisher:	Springer
Date Published:	2009-02-01
Start Page:	479
End Page:	490
Language:	English
DOI:	10.1007/s10549-008-9943-2
PUBMED:	18306034
PROVIDER:	scopus
PMCID:	PMC4217205
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-58549118451&partnerID=40&md5=c5cf97fd53d902b8b5f292c2039a3264
Notes:	--- - "Cited By (since 1996): 3" - "Export Date: 30 November 2010" - "CODEN: BCTRD" - "Source: Scopus"

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