Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2004-10-27
pubmed:abstractText
The addition of capecitabine to docetaxel on a 3-week schedule resulted in superior response rate, increased time to progression (TTP), and improved overall survival in patients with anthracycline-pretreated metastatic breast cancer (MBC). Because the toxicity profile of weekly docetaxel differs from the standard 21-day docetaxel schedule, we performed a phase I/II trial to test the efficacy and safety of weekly docetaxel in combination with capecitabine given for 14 days every 21 days. The phase I study identified the doses of docetaxel (30 mg/m2 weekly) and capecitabine (900 mg/m2 twice daily on days 1-14 every 21 days) used in phase II. Twenty female patients with measurable or assessable MBC were enrolled. Eighteen patients had previously received anthracyclines; 2 had contraindications to anthracyclines. Patients remained on study for a maximum of eight 3-week cycles or until tumor progression or unacceptable toxicity occurred; response assessments were scheduled after cycle 2, 5, and 8. Seventeen patients were assessed after cycle 2; 3 subjects (18%) had a partial response (PR), 9 had stable disease (53%; SD), and 5 patients (29%) had progressive disease (PD). Ten patients were assessable after cycle 5. Two patients (20%) had a PR, 5 patients (50%) had SD, and 3 patients (30%) had PD. The most common grade 3 toxicities were nail loss (45%), asthenia (30%), and hand-foot syndrome (30%), and toxicities led to study discontinuation in 10 patients. The median time to treatment failure was 10 weeks and median TTP was 26 weeks. The median duration of response was 9 weeks and the median duration of SD was 16 weeks. The median overall survival was 82 weeks. This schedule of weekly docetaxel in combination with day 1-14 capecitabine has activity; however, toxicity discourages the use of this schedule in lieu of the standard docetaxel/capecitabine regimen.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Oct
pubmed:issn
1526-8209
pubmed:author
pubmed:issnType
Print
pubmed:volume
5
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
287-92
pubmed:dateRevised
2007-11-15
pubmed:meshHeading
pubmed-meshheading:15507175-Adult, pubmed-meshheading:15507175-Aged, pubmed-meshheading:15507175-Anthracyclines, pubmed-meshheading:15507175-Antimetabolites, Antineoplastic, pubmed-meshheading:15507175-Antineoplastic Agents, Phytogenic, pubmed-meshheading:15507175-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:15507175-Asthenia, pubmed-meshheading:15507175-Breast Neoplasms, pubmed-meshheading:15507175-Deoxycytidine, pubmed-meshheading:15507175-Diarrhea, pubmed-meshheading:15507175-Dose-Response Relationship, Drug, pubmed-meshheading:15507175-Drug Administration Schedule, pubmed-meshheading:15507175-Female, pubmed-meshheading:15507175-Fluorouracil, pubmed-meshheading:15507175-Foot, pubmed-meshheading:15507175-Hand, pubmed-meshheading:15507175-Humans, pubmed-meshheading:15507175-Middle Aged, pubmed-meshheading:15507175-Nail Diseases, pubmed-meshheading:15507175-Neoplasm Metastasis, pubmed-meshheading:15507175-Survival Analysis, pubmed-meshheading:15507175-Taxoids, pubmed-meshheading:15507175-Time Factors, pubmed-meshheading:15507175-Treatment Outcome
pubmed:year
2004
pubmed:articleTitle
Final results of a phase II clinical trial of weekly docetaxel in combination with capecitabine in anthracycline-pretreated metastatic breast cancer.
pubmed:affiliation
Cross Cancer Institute, Universite de Montreal Canada. johnmack@cancerboard.ab.ca
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase II