Skip to content
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Menu
Home
About Us
Resources
Profiles Metrics
Authors Directory
Institutions Directory
Top Authors
Top Institutions
Top Sponsors
AI Digest
Contact Us
Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Randomized phase II non-inferiority study (no16853) of two different doses of capecitabine in combination with docetaxel for locally advanced/metastatic breast cancer
Annals of Oncology, Volume 23, No. 3, Year 2012
Notification
URL copied to clipboard!
Description
Background: This phase II study investigated whether a lower-than-approved dose of capecitabine, plus docetaxel (XT), would improve tolerability versus standard-dose XT without compromising efficacy. Patients and methods: Women aged ≥18 years with locally advanced/metastatic breast cancer resistant to anthracycline-based chemotherapy in the (neo)adjuvant, first- or second-line metastatic setting were eligible. Patients were randomly assigned to receive standard-dose XT (capecitabine 1250 mg/m. 2 twice daily, days 1-14; docetaxel 75 mg/m. 2, day 1 every 3 weeks) or low-dose XT (capecitabine 825 mg/m. 2 twice daily, days 1-14; docetaxel as above). The primary objective was to demonstrate non-inferiority of low-dose to standard-dose XT in terms of progression-free survival (PFS). Results: 470 patients were randomly allocated in a 1 1 ratio to standard-dose or low-dose XT. Median PFS was 7.9 versus 5.8 months [hazard ratio 1.16, 95% confidence interval (CI) 0.95-1.43] in the standard-dose and low-dose arms, respectively. The upper limit of the 95% CI was above the predefined non-inferiority margin (1.35, P = 0.078). Secondary efficacy end points were consistent with PFS. The frequency and severity of adverse events was similar in both treatment arms. Conclusions: Non-inferiority of low-dose to standard-dose XT in terms of PFS was not demonstrated; this may be due to regional subgroup effects. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
Authors & Co-Authors
Buzdar, Aman U.
Unknown Affiliation
Xu, Binghe
Unknown Affiliation
Digumarti, Raghunadharao
Unknown Affiliation
Goedhals, Louis
Unknown Affiliation
Hu, X.
Unknown Affiliation
Semiglazov, Vladimir Fedorovich
Unknown Affiliation
Cheporov, S.
Unknown Affiliation
Gotovkin, E.
Unknown Affiliation
Hoersch, S.
Unknown Affiliation
Rittweger, K.
Unknown Affiliation
Miles, David W.
Unknown Affiliation
O'Shaughnessy, Joyce Ann
Unknown Affiliation
Tjulandin, Sergei A.
Unknown Affiliation
Statistics
Citations: 13
Authors: 13
Affiliations: 13
Identifiers
Doi:
10.1093/annonc/mdr256
ISSN:
09237534
e-ISSN:
15698041
Research Areas
Cancer
Environmental
Participants Gender
Female