Abstract | PURPOSE: PATIENTS AND METHODS: RESULTS: A total of 460 patients (223 CEF and 237 CMF) were randomized. Overall response rate was superior for CEF than CMF in all randomized patients (57% v 46%, respectively; P =.01) and in the assessable subset (66% v 52%, respectively; P =.005). With a median follow-up of more than 20 months, time to progression ( TTP) was significantly longer with CEF than CMF (median 8.9 v 6.3 months, respectively; P =.0064), as was time to treatment failure (TTF) (median 6.2 v 5.0 months, respectively; P =.01). Significant survival differences were not observed between CEF and CMF (median 20.1 v 18.2 months, respectively; P =.23). Granulocytopenia and infections were similar in both arms. Grade 3/4 nausea/ vomiting and alopecia were more frequent with CEF, whereas diarrhea was more frequent with CMF. Cardiac toxicity, primarily asymptomatic, required withdrawal from study of 15 patients on CEF (7%) and one patient on CMF. CONCLUSION: This CEF regimen safely provides significantly better tumor control than CMF, manifest as a higher response rate, and longer TTP and TTF, but not survival, when used as first-line chemotherapy for metastatic breast cancer.
|
Authors | S P Ackland, A Anton, G P Breitbach, E Colajori, J M Tursi, C Delfino, A Efremidis, A Ezzat, A Fittipaldo, K Kolaric, M Lopez, D Viaro, HEPI 013 study group |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 19
Issue 4
Pg. 943-53
(Feb 15 2001)
ISSN: 0732-183X [Print] United States |
PMID | 11181656
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
Chemical References |
- Cytarabine
- Epirubicin
- Cyclophosphamide
- Cisplatin
- Fluorouracil
- Methotrexate
|
Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage, adverse effects)
- Breast Neoplasms
(drug therapy, mortality)
- Cisplatin
(administration & dosage, adverse effects)
- Cyclophosphamide
(administration & dosage, adverse effects)
- Cytarabine
(administration & dosage, adverse effects)
- Disease-Free Survival
- Drug Administration Schedule
- Epirubicin
(administration & dosage, adverse effects)
- Female
- Fluorouracil
(administration & dosage, adverse effects)
- Humans
- Injections, Intravenous
- Methotrexate
(administration & dosage, adverse effects)
- Middle Aged
- Neoplasm Metastasis
- Survival Analysis
|
|
Join CureHunter, for free Research Interface BASIC access!
Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease.
Find out why thousands of doctors, pharma researchers and patient activists
around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!
|