TITAN: phase III study of doxorubicin/cyclophosphamide followed by ixabepilone or paclitaxel in early-stage triple-negative breast cancer View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-08

AUTHORS

Denise A. Yardley, Edward R. Arrowsmith, Brooke R. Daniel, Janice Eakle, Adam Brufsky, David R. Drosick, Fred Kudrik, Linda D. Bosserman, Mark R. Keaton, Sharon A. Goble, Jeffrey A. Bubis, Victor M. Priego, Kelly Pendergrass, Yvonne Manalo, Martin Bury, Donald S. Gravenor, Gladys I. Rodriguez, Roger C. Inhorn, Robyn R. Young, William N. Harwin, Caryn Silver, John D. Hainsworth, Howard A. Burris

ABSTRACT

PURPOSE: Ixabepilone is a microtubule stabilizer with activity in taxane-refractory metastatic breast cancer and low susceptibility to taxane-resistance mechanisms including multidrug-resistant phenotypes and high β-III tubulin expression. Since these resistance mechanisms are common in triple-negative breast cancer (TNBC), ixabepilone may have particular advantages in this patient population. This study evaluated the substitution of ixabepilone for paclitaxel following doxorubicin/cyclophosphamide (AC) in the adjuvant treatment of early-stage TNBC. METHODS: Patients with operable TNBC were eligible following definitive breast surgery. Patients were randomized (1:1) to receive four cycles of AC followed by either four cycles (12 weeks) of ixabepilone or 12 weekly doses of paclitaxel. RESULTS: 614 patients were randomized: 306 to AC/ixabepilone and 308 to AC/paclitaxel. At a median follow-up of 48 months, 59 patients had relapsed (AC/ixabepilone, 29; AC/paclitaxel, 30). The median time from diagnosis to relapse was 20.8 months. The 5-year disease-free survival (DFS) rates of the two groups were similar [HR 0.92; ixabepilone 87.1% (95% CI 82.6-90.5) vs. paclitaxel 84.7% (95% CI 79.7-88.6)]. The estimated 5-year overall survival (OS) rates were also similar [HR 1.1; ixabepilone 89.7% (95% CI 85.5-92.7) vs. paclitaxel 89.6% (95% CI 85.0-92.9)]. Peripheral neuropathy was the most common grade 3/4 event. Dose reductions and treatment discontinuations occurred more frequently during paclitaxel treatment. CONCLUSIONS: Treatment with AC/ixabepilone provided similar DFS and OS in patients with operable TNBC when compared to treatment with AC/paclitaxel. The two regimens had similar toxicity, although treatment discontinuation, dose modifications, and overall peripheral neuropathy were more frequent with AC/paclitaxel. TRIAL REGISTRATION: Clinical Trials.gov Identifier, NCT00789581. More... »

PAGES

649-658

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10549-017-4285-6

DOI

http://dx.doi.org/10.1007/s10549-017-4285-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1085419107

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28508185


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