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Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Ixabepilone or Paclitaxel in Early Stage Breast Cancer and Evaluation of βIII-Tubulin Expression as a Predictive Marker.
- Source :
- Oncologist; Jul2013, Vol. 18 Issue 7, p787-794, 8p
- Publication Year :
- 2013
-
Abstract
- Background. This randomized phase II trial was designed to compare the rate of pathologic complete response (pCR) induced by neoadjuvant cyclophosphamide plus doxorubicin (AC) followed by ixabepilone or paclitaxel in women with early stage breast cancer (BC). Expression of βIII-tubulin as a predictive marker was also evaluated. Patients and Methods. Women with untreated, histologically confirmed primary invasive breast adenocarcinoma received four cycles of AC followed by 1:1 randomization to either ixabepilone 40 mg/m<superscript>2</superscript> (3-hour infusion) every 3 weeks for four cycles (n = 148) or weekly paclitaxel 80 mg/m<superscript>2</superscript> (1-hour infusion) for 12 weeks (n = 147). All patients underwent a core needle biopsy of the primary cancer for molecular marker analysis prior to chemotherapy. βIII-Tubulin expression was assessed using immunohistochemistry. Results. There was no significant difference in the rate of pCR in the ixabepilone treatment arm (24.3%; 90% confidence interval [CI],18.6-30.8)and the paclitaxel treatment arm (25.2%;90%CI, 19.4-31.7). βIII-Tubulin-positive patients obtained higher pCR Rates compared with βIII-tubulin-negative patients in both treatment arms; however, βIII-tubulin expression was not significantly associated with a differential response to ixabepilone or paclitaxel. The safety profiles of both regimens were generally similar, although neutropenia occurred more frequently in the ixabepilone arm (grade 3/4: 41.3% vs. 8.4%). The most common nonhematologic toxicity was peripheral neuropathy. Conclusions. Neoadjuvant treatment of early stage BC with AC followed by ixabepilone every 3 weeks or weekly paclitaxel was well tolerated with no significant difference in efficacy. Higher response rates were observed among βIII-tubulin-positive patients. [ABSTRACT FROM AUTHOR]
- Subjects :
- DOXORUBICIN
PACLITAXEL
MACROLIDE antibiotics
CYCLOPHOSPHAMIDE
ANALYSIS of variance
BIOMARKERS
BREAST tumors
CONFIDENCE intervals
DRUG side effects
FISHER exact test
MEDICAL cooperation
NERVE tissue proteins
HEALTH outcome assessment
RESEARCH
RESEARCH funding
T-test (Statistics)
LOGISTIC regression analysis
RANDOMIZED controlled trials
TREATMENT effectiveness
EARLY medical intervention
STATISTICAL models
DESCRIPTIVE statistics
KARNOFSKY Performance Status
THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 10837159
- Volume :
- 18
- Issue :
- 7
- Database :
- Complementary Index
- Journal :
- Oncologist
- Publication Type :
- Academic Journal
- Accession number :
- 90143653
- Full Text :
- https://doi.org/10.1634/theoncologist.2013-0075