Journal article
A Phase I Study of Neoadjuvant Chemotherapy With Nab-Paclitaxel, Doxorubicin, and Cyclophosphamide in Patients With Stage II to III Breast Cancer
Clinical breast cancer, Vol.17(7), pp.503-509
11/2017
DOI: 10.1016/j.clbc.2017.04.010
PMID: 28579139
Abstract
We investigated a novel combinatorial approach using old drugs doxorubicin, cyclophosphamide and nab-paclitaxel in the neoadjuvant setting. Patients were enrolled in Alabama and Utah in a standard 3+3 phase I design. The clinical response rate was 100%; the pathologic complete response (pCR) was over 56%. All 10 patients with triple negative disease (TNBC) achieved pCR (100%). Toxicities were as expected for chemotherapy. This approach warrants further studies in TNBC.
The aims of this study were to assess the safety and tolerability of nanoparticle albumin bound paclitaxel (nab-paclitaxel), doxorubicin, and cyclophosphamide as combination therapy for breast cancer patients in the neoadjuvant setting and to assess the overall clinical response and pathologic complete response (pCR).
Twenty-six women with newly diagnosed stage II to III histologically or cytologically proven adenocarcinoma of the breast with negative HER2 status were enrolled. Patients were treated with nab-paclitaxel 100 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2 on day 1 and nab-paclitaxel 100 mg/m2 on day 8 in a 21-day cycle for 6 cycles total.
Most adverse events attributed to treatment were decreased white blood cell count, neutropenia, anemia, thrombocytopenia, and lymphopenia with a median duration of 8 days. Fifteen of 23 (65.2%; 95% confidence interval [CI], 45.7%-84.6%) had a complete clinical response and 8 of 23 (34.7%; 95% CI, 15.2%-54.1%) had a partial clinical response for an overall clinical response rate of 100%. Thirteen of 23 patients (56.5%; 95% CI, 36.2%-76.7%) had a pCR. All 10 triple-negative breast cancer (TNBC) patients (100%) achieved a pCR.
The regimen of nab-paclitaxel, doxorubicin, and cyclophosphamide chemotherapy was well tolerated and resulted in high clinical as well as pathologic responses, particularly in TNBC.
Details
- Title: Subtitle
- A Phase I Study of Neoadjuvant Chemotherapy With Nab-Paclitaxel, Doxorubicin, and Cyclophosphamide in Patients With Stage II to III Breast Cancer
- Creators
- Theresa L. Werner - Huntsman Cancer InstituteAbhijit Ray - Huntsman Cancer InstituteJohn G. Lamb - University of UtahMatthew VanBrocklin - University of UtahKristin Hueftle - University of UtahAdam L. Cohen - University of UtahAnna C. Beck - Huntsman Cancer InstituteSaundra S. Buys - Huntsman Cancer InstituteDonna L. Dyess - USA Mitchell Cancer InstituteThomas W. Butler - USA Mitchell Cancer InstituteTheresa L. Dumlao - The University of Texas MD Anderson Cancer CenterLeigh Neumayer - Huntsman Cancer InstituteHung T. Khong - USA Mitchell Cancer Institute
- Resource Type
- Journal article
- Publication Details
- Clinical breast cancer, Vol.17(7), pp.503-509
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.clbc.2017.04.010
- PMID
- 28579139
- ISSN
- 1526-8209
- eISSN
- 1938-0666
- Language
- English
- Date published
- 11/2017
- Academic Unit
- Surgery
- Record Identifier
- 9984366261302771
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