| Weekly paclitaxel, 5-fluorouracil and folinic acid with granulocyte colony-stimulating factor support in metastatic breast cancer patients: a phase II study. | |
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MedLine Citation:
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PMID: 16520664 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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We conducted a phase II study to determine the activity and tolerability of weekly paclitaxel, 5-fluorouracil (5-FU) and folinic acid plus granulocyte colony-stimulating factor (G-CSF) support in anthracycline-pre-treated or -resistant metastatic breast cancer patients. The phase II study was designed following the Simon optimal-two stage method. Patients received paclitaxel 80 mg/m, folinic acid 10 mg/m and bolus infusion of 5-FU 300 mg/m every week plus G-CSF on day 3 for 24 consecutive weeks in the absence of disease progression. From May 1998 to May 2000, 51 patients entered the study. Patients received a median relative dose intensity of 97.5% (range 81-100%). No severe toxicities were observed. Seven patients (14%) experienced neutropenia grade 2. Seven patients (14%) experienced grade 2 anemia. Two patients (4%) experienced severe asthenia. Three out of 50 evaluable patients [6%, 95% confidence interval (CI) 2-12.6%] showed a complete response, whereas 23 (46%, 95% CI 32.2-59.8%) had a partial response, with an overall response rate of 52% (95% CI 38.2-65.8%). In addition, eight patients (15.7%) had stable disease. In the 13 patients untreated for metastatic disease, the overall response rate was 92.3% (CI 77.8-100), with one complete response and 11 partial responses (84.6% CI 65-100%). In the whole group, the median time to progression and overall survival were 8 (range 1-18) and 14 months (95% CI 11-17), respectively. Thus, in metastatic breast cancer patients pre-treated with anthracyclines, the weekly administration of paclitaxel, 5-FU and folinic acid with G-CSF support seems to be extremely tolerable and active. |
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Authors:
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Cecilia Nistico; Emilio Bria; Biagio Agostara; Sandro Barni; Elvira Colella; Luciano Frontini; Anna Maria D'Ottavio; Federica Cuppone; Roberto Valenza; Isabella Sperduti; Fiorentino Izzo; Edmondo Terzoli |
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Publication Detail:
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Type: Clinical Trial, Phase II; Journal Article |
Journal Detail:
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Title: Anti-cancer drugs Volume: 17 ISSN: 0959-4973 ISO Abbreviation: Anticancer Drugs Publication Date: 2006 Mar |
Date Detail:
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Created Date: 2006-03-07 Completed Date: 2006-12-04 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9100823 Medline TA: Anticancer Drugs Country: England |
Other Details:
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Languages: eng Pagination: 345-51 Citation Subset: IM |
Affiliation:
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Department of Medical Oncology, Regina Elena National Cancer Institute, Roma, Italy. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Anthracyclines / pharmacology Antineoplastic Combined Chemotherapy Protocols / adverse effects, therapeutic use* Breast Neoplasms / drug therapy*, pathology Drug Administration Schedule Drug Resistance, Neoplasm Female Fluorouracil / administration & dosage, adverse effects Granulocyte-Macrophage Colony-Stimulating Factor / administration & dosage Humans Leucovorin / administration & dosage, adverse effects Middle Aged Neoplasm Metastasis Paclitaxel / administration & dosage, adverse effects |
| Chemical | |
Reg. No./Substance:
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0/Anthracyclines; 33069-62-4/Paclitaxel; 51-21-8/Fluorouracil; 58-05-9/Leucovorin; 83869-56-1/Granulocyte-Macrophage Colony-Stimulating Factor |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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