Document Detail

Preliminary 3-year results of 12 versus 6 cycles of surgical adjuvant CMF in premenopausal breast cancer.
MedLine Citation:
PMID:  394864     Owner:  NLM     Status:  MEDLINE    
In hope of reducing the duration of adjuvant treatment in premenopausal patients with operable breast cancer and histologically positive axillary lymph nodes, a prospective controlled study was started in September 1975. A total of 160 patients were randomized to receive 12 cycles of adjuvant CMF, while 165 were allocated to receive 6 cycles. At 3 years from radical mastectomy, the relapse-free survival was 85.4% in the 12-cycle group compared to 82.6% for the 6-cycle subset (P = 0.29). In both treatment groups, the incidence of treatment failure was directly proportional to the number of involved axillary nodes and to the clinical tumor size. Drug-induced amenorrhea as well as estrogen receptor status failed to significantly affect the results obtained. Treatment failures were more often documented in distant sites, while only 4--5% relapse was observed in local-regional areas. Overall survival was also similar for both treatment arms (86.2% vs. 85.1%, P = 0.49). Toxicity was moderate and reversible and no drug-induced neoplasms were so far observed. Present results achieved with 6 cycles of adjuvant CMF appear encouraging. However, they are still too preliminary to recommend the routine use of 6 cycles instead of the classical 12 cycles.
G Tancini; E Bajetta; S Marchini; P Valagussa; G Bonadonna; U Veronesi
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Cancer clinical trials     Volume:  2     ISSN:  0190-1206     ISO Abbreviation:  Cancer Clin Trials     Publication Date:  1979  
Date Detail:
Created Date:  1980-05-14     Completed Date:  1980-05-14     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7905482     Medline TA:  Cancer Clin Trials     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  285-92     Citation Subset:  IM    
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MeSH Terms
Antineoplastic Agents / adverse effects
Bone Marrow / drug effects
Breast Neoplasms / therapy*
Clinical Trials as Topic
Cyclophosphamide / administration & dosage*
Drug Administration Schedule
Drug Therapy, Combination
Fluorouracil / administration & dosage*
Methotrexate / administration & dosage*
Middle Aged
Remission, Spontaneous
Time Factors
Reg. No./Substance:
0/Antineoplastic Agents; 50-18-0/Cyclophosphamide; 51-21-8/Fluorouracil; 59-05-2/Methotrexate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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