Phase III randomized trial of sunitinib versus capecitabine in patients with previously treated HER2-negative advanced breast cancer View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2010-05

AUTHORS

Carlos H. Barrios, Mei-Ching Liu, Soo Chin Lee, Laurence Vanlemmens, Jean-Marc Ferrero, Toshio Tabei, Xavier Pivot, Hiroji Iwata, Kenjiro Aogi, Roberto Lugo-Quintana, Nadia Harbeck, Marla J. Brickman, Ke Zhang, Kenneth A. Kern, Miguel Martin

ABSTRACT

This multicenter, randomized, open-label phase III trial (planned enrollment: 700 patients) was conducted to test the hypothesis that single-agent sunitinib improves progression-free survival (PFS) compared with capecitabine as treatment for advanced breast cancer (ABC). Patients with HER2-negative ABC that recurred after anthracycline and taxane therapy were randomized (1:1) to sunitinib 37.5 mg/day or capecitabine 1,250 mg/m(2) (1,000 mg/m(2) in patients >65 years) BID on days 1-14 q3w. The independent data-monitoring committee (DMC) determined during the first interim analysis (238 patients randomized to sunitinib, 244 to capecitabine) that the trial be terminated due to futility in reaching the primary endpoint. No statistical evidence supported the hypothesis that sunitinib improved PFS compared with capecitabine (one-sided P = 0.999). The data indicated that PFS was shorter with sunitinib than capecitabine (median 2.8 vs. 4.2 months, respectively; HR, 1.47; 95% CI, 1.16-1.87; two-sided P = 0.002). Median overall survival (15.3 vs. 24.6 months; HR, 1.17; two-sided P = 0.350) and objective response rates (11 vs. 16%; odds ratio, 0.65; P = 0.109) were numerically inferior with sunitinib versus capecitabine. While no new or unexpected safety findings were reported, sunitinib treatment was associated with higher frequencies and greater severities of many common adverse events (AEs) compared with capecitabine, resulting in more temporary discontinuations due to AEs with sunitinib (66 vs. 51%). The relative dose intensity was lower with sunitinib than capecitabine (73 vs. 95%). Based on these efficacy and safety results, sunitinib should not be used as monotherapy for patients with ABC. More... »

PAGES

121-131

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10549-010-0788-0

DOI

http://dx.doi.org/10.1007/s10549-010-0788-0

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1027199206

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/20339913


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curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s10549-010-0788-0'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s10549-010-0788-0'


 

This table displays all metadata directly associated to this object as RDF triples.

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