Document Detail

Phase III study of standard combination versus rotating regimen of induction chemotherapy in patients with hormone insensitive metastatic breast cancer: an Eastern Cooperative Oncology Group Intergroup Study (E3185).
MedLine Citation:
PMID:  17414459     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: The objective of this multicenter phase III trial was to study the impact on time to treatment failure (TTF) and survival of cyclophosphamide, Adriamycin, and 5-fluorouracil (CAF) versus CAF/thiotepa, Adriamycin, vinblastine, and Halotestin (TsAVbH), a partially noncross-resistant regimen used in a rotating schedule in the treatment of hormone insensitive metastatic breast cancer in accordance with the Goldie and Coldman hypothesis. METHODS: Three hundred forty-three patients received 6 cycles of induction treatment with one of 2 regimens. Patients with estrogen receptor-negative tumors or those with estrogen receptor-positive or estrogen receptor-unknown tumors with demonstrated unresponsiveness to hormone treatment were eligible. Complete responders were randomized to either observation or maintenance therapy with cyclophosphamide, methotrexate, 5-fluorouracil, prednisone, tamoxifen, and Halotestin (CMF[P]TH). Patients with partial response or stable disease on completion of induction therapy were maintained on CMF plus Halotestin. RESULTS: There were no differences in the primary end point of TTF (median 7.3 and 7.4 months, respectively). There was a significant difference in TTF and survival by duration of disease-free interval: a median of 8.8 and 21.2 months for those with a disease-free interval of > or =2 years versus 6 to 8 and 13.3 months for those with a disease-free interval <2 years (P = 0.016 and <0.001), respectively. Toxicity of the 2 treatment regimens was similar. CONCLUSION: There were no differences observed in TTF, survival, and toxicities between the 2 treatment arms, both of which contained doxorubicin (Adriamycin) as the most active agent. The results of observation versus maintenance in complete responders were reported separately.
Kishan J Pandya; Ping Hu; C Kent Osborne; Geoffrey Falkson; Douglass C Tormey;
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural    
Journal Detail:
Title:  American journal of clinical oncology     Volume:  30     ISSN:  1537-453X     ISO Abbreviation:  Am. J. Clin. Oncol.     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-04-06     Completed Date:  2007-04-27     Revised Date:  2007-11-14    
Medline Journal Info:
Nlm Unique ID:  8207754     Medline TA:  Am J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  113-25     Citation Subset:  IM    
University of Rochester, James P. Wilmot Cancer Center, Rochester, New York 14642, USA.
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MeSH Terms
Antineoplastic Combined Chemotherapy Protocols / administration & dosage,  therapeutic use*
Breast Neoplasms / drug therapy*,  pathology
Cyclophosphamide / administration & dosage
Doxorubicin / administration & dosage
Drug Administration Schedule
Fluorouracil / administration & dosage
Neoplasm Metastasis / drug therapy
Patient Selection
Time Factors
Treatment Failure
Treatment Outcome
Grant Support
Reg. No./Substance:
0/CAF protocol; 23214-92-8/Doxorubicin; 50-18-0/Cyclophosphamide; 51-21-8/Fluorouracil

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