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

Theresa L. Werner, Abhijit Ray, John G. Lamb, Matthew VanBrocklin, Kristin Hueftle, Adam L. Cohen, Anna C. Beck, Saundra S. Buys, Donna L. Dyess, Thomas W. Butler, Theresa L. Dumlao, Leigh A Neumayer, Hung T. Khong

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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/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. 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.

Original languageEnglish (US)
JournalClinical Breast Cancer
DOIs
StateAccepted/In press - Oct 28 2016

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Doxorubicin
Cyclophosphamide
Nanoparticles
Breast Neoplasms
Drug Therapy
Triple Negative Breast Neoplasms
Confidence Intervals
Lymphopenia
Neutropenia
Leukocyte Count
Thrombocytopenia
Anemia
Adenocarcinoma
Breast
130-nm albumin-bound paclitaxel
Safety
Albumin-Bound Paclitaxel
Therapeutics

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A Phase I Study of Neoadjuvant Chemotherapy With Nab-Paclitaxel, Doxorubicin, and Cyclophosphamide in Patients With Stage II to III Breast Cancer. / 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 A; Khong, Hung T.

In: Clinical Breast Cancer, 28.10.2016.

Research output: Contribution to journalArticle

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 A ; Khong, Hung T. / A Phase I Study of Neoadjuvant Chemotherapy With Nab-Paclitaxel, Doxorubicin, and Cyclophosphamide in Patients With Stage II to III Breast Cancer. In: Clinical Breast Cancer. 2016.
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abstract = "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/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. 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.",
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T1 - A Phase I Study of Neoadjuvant Chemotherapy With Nab-Paclitaxel, Doxorubicin, and Cyclophosphamide in Patients With Stage II to III Breast Cancer

AU - Werner, Theresa L.

AU - Ray, Abhijit

AU - Lamb, John G.

AU - VanBrocklin, Matthew

AU - Hueftle, Kristin

AU - Cohen, Adam L.

AU - Beck, Anna C.

AU - Buys, Saundra S.

AU - Dyess, Donna L.

AU - Butler, Thomas W.

AU - Dumlao, Theresa L.

AU - Neumayer, Leigh A

AU - Khong, Hung T.

PY - 2016/10/28

Y1 - 2016/10/28

N2 - 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/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. 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.

AB - 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/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. 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.

KW - Estrogen receptor

KW - Pathologic complete response (pCR)

KW - SPARC

KW - Triple-negative breast cancer

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