A Phase I Study of Neoadjuvant Chemotherapy With Nab-Paclitaxel, Doxorubicin, and Cyclophosphamide in Patients With Stage II to III Breast Cancer

作者：Werner Theresa L; Ray Abhijit; Lamb John G; VanBrocklin Matthew; Hueftle Kristin; Cohen Adam L; Beck Anna C; Buys Saundra S; Dyess Donna L; Butler Thomas W; Dumlao Theresa L; Neumayer Leigh; Khong Hung T^*

来源：Clinical Breast Cancer, 2017, 17(7): 503-509.

DOI：10.1016/j.clbc.2017.04.010

• Estrogen receptor
• Pathologic complete response (pCR)
• SPARC
• Triple-negative breast cancer

We investigated a novel combinatorial approach using old drugs doxorubicin, cyclophosphamide and nabpaclitaxel 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.
Background: 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). Patients and Methods: 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/m(2), doxorubicin 50 mg/m(2), and cyclophosphamide 500 mg/m(2) on day 1 and nab-paclitaxel 100 mg/m(2) on day 8 in a 21-day cycle for 6 cycles total. Results: 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. Conclusion: 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.

• 出版日期2017-11