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nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial

BACKGROUND: Metastatic triple-negative breast cancer (mTNBC) has a poor prognosis and aggressive clinical course. tnAcity evaluated the efficacy and safety of first-line nab-paclitaxel plus carboplatin (nab-P/C), nab-paclitaxel plus gemcitabine (nab-P/G), and gemcitabine plus carboplatin (G/C) in pa...

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Autores principales: Yardley, D A, Coleman, R, Conte, P, Cortes, J, Brufsky, A, Shtivelband, M, Young, R, Bengala, C, Ali, H, Eakel, J, Schneeweiss, A, de la Cruz-Merino, L, Wilks, S, O’Shaughnessy, J, Glück, S, Li, H, Miller, J, Barton, D, Harbeck, N
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6096741/
https://www.ncbi.nlm.nih.gov/pubmed/29878040
http://dx.doi.org/10.1093/annonc/mdy201
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author Yardley, D A
Coleman, R
Conte, P
Cortes, J
Brufsky, A
Shtivelband, M
Young, R
Bengala, C
Ali, H
Eakel, J
Schneeweiss, A
de la Cruz-Merino, L
Wilks, S
O’Shaughnessy, J
Glück, S
Li, H
Miller, J
Barton, D
Harbeck, N
author_facet Yardley, D A
Coleman, R
Conte, P
Cortes, J
Brufsky, A
Shtivelband, M
Young, R
Bengala, C
Ali, H
Eakel, J
Schneeweiss, A
de la Cruz-Merino, L
Wilks, S
O’Shaughnessy, J
Glück, S
Li, H
Miller, J
Barton, D
Harbeck, N
author_sort Yardley, D A
collection PubMed
description BACKGROUND: Metastatic triple-negative breast cancer (mTNBC) has a poor prognosis and aggressive clinical course. tnAcity evaluated the efficacy and safety of first-line nab-paclitaxel plus carboplatin (nab-P/C), nab-paclitaxel plus gemcitabine (nab-P/G), and gemcitabine plus carboplatin (G/C) in patients with mTNBC. PATIENTS AND METHODS: Patients with pathologically confirmed mTNBC and no prior chemotherapy for metastatic BC received (1 : 1 : 1) nab-P 125 mg/m(2) plus C AUC 2, nab-P 125 mg/m(2) plus G 1000 mg/m(2), or G 1000 mg/m(2) plus C AUC 2, all on days 1, 8 q3w. Phase II primary end point: investigator-assessed progression-free survival (PFS); secondary end points included overall response rate (ORR), overall survival (OS), percentage of patients initiating cycle 6 with doublet therapy, and safety. RESULTS: In total, 191 patients were enrolled (nab-P/C, n = 64; nab-P/G, n = 61; G/C, n = 66). PFS was significantly longer with nab-P/C versus nab-P/G [median, 8.3 versus 5.5 months; hazard ratio (HR), 0.59 [95% CI, 0.38–0.92]; P = 0.02] or G/C (median, 8.3 versus 6.0 months; HR, 0.58 [95% CI, 0.37–0.90]; P = 0.02). OS was numerically longer with nab-P/C versus nab-P/G (median, 16.8 versus 12.1 months; HR, 0.73 [95% CI, 0.47–1.13]; P = 0.16) or G/C (median, 16.8 versus 12.6 months; HR, 0.80 [95% CI, 0.52–1.22]; P = 0.29). ORR was 73%, 39%, and 44%, respectively. In the nab-P/C, nab-P/G, and G/C groups, 64%, 56%, and 50% of patients initiated cycle 6 with a doublet. Grade ≥3 adverse events were mainly hematologic. CONCLUSIONS: First-line nab-P/C was active in mTNBC and resulted in a significantly longer PFS and improved risk/benefit profile versus nab-P/G or G/C.
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spelling pubmed-60967412018-08-22 nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial Yardley, D A Coleman, R Conte, P Cortes, J Brufsky, A Shtivelband, M Young, R Bengala, C Ali, H Eakel, J Schneeweiss, A de la Cruz-Merino, L Wilks, S O’Shaughnessy, J Glück, S Li, H Miller, J Barton, D Harbeck, N Ann Oncol Original Articles BACKGROUND: Metastatic triple-negative breast cancer (mTNBC) has a poor prognosis and aggressive clinical course. tnAcity evaluated the efficacy and safety of first-line nab-paclitaxel plus carboplatin (nab-P/C), nab-paclitaxel plus gemcitabine (nab-P/G), and gemcitabine plus carboplatin (G/C) in patients with mTNBC. PATIENTS AND METHODS: Patients with pathologically confirmed mTNBC and no prior chemotherapy for metastatic BC received (1 : 1 : 1) nab-P 125 mg/m(2) plus C AUC 2, nab-P 125 mg/m(2) plus G 1000 mg/m(2), or G 1000 mg/m(2) plus C AUC 2, all on days 1, 8 q3w. Phase II primary end point: investigator-assessed progression-free survival (PFS); secondary end points included overall response rate (ORR), overall survival (OS), percentage of patients initiating cycle 6 with doublet therapy, and safety. RESULTS: In total, 191 patients were enrolled (nab-P/C, n = 64; nab-P/G, n = 61; G/C, n = 66). PFS was significantly longer with nab-P/C versus nab-P/G [median, 8.3 versus 5.5 months; hazard ratio (HR), 0.59 [95% CI, 0.38–0.92]; P = 0.02] or G/C (median, 8.3 versus 6.0 months; HR, 0.58 [95% CI, 0.37–0.90]; P = 0.02). OS was numerically longer with nab-P/C versus nab-P/G (median, 16.8 versus 12.1 months; HR, 0.73 [95% CI, 0.47–1.13]; P = 0.16) or G/C (median, 16.8 versus 12.6 months; HR, 0.80 [95% CI, 0.52–1.22]; P = 0.29). ORR was 73%, 39%, and 44%, respectively. In the nab-P/C, nab-P/G, and G/C groups, 64%, 56%, and 50% of patients initiated cycle 6 with a doublet. Grade ≥3 adverse events were mainly hematologic. CONCLUSIONS: First-line nab-P/C was active in mTNBC and resulted in a significantly longer PFS and improved risk/benefit profile versus nab-P/G or G/C. Oxford University Press 2018-08 2018-06-06 /pmc/articles/PMC6096741/ /pubmed/29878040 http://dx.doi.org/10.1093/annonc/mdy201 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of the European Society for Medical Oncology. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Articles
Yardley, D A
Coleman, R
Conte, P
Cortes, J
Brufsky, A
Shtivelband, M
Young, R
Bengala, C
Ali, H
Eakel, J
Schneeweiss, A
de la Cruz-Merino, L
Wilks, S
O’Shaughnessy, J
Glück, S
Li, H
Miller, J
Barton, D
Harbeck, N
nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial
title nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial
title_full nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial
title_fullStr nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial
title_full_unstemmed nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial
title_short nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial
title_sort nab-paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnacity trial
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6096741/
https://www.ncbi.nlm.nih.gov/pubmed/29878040
http://dx.doi.org/10.1093/annonc/mdy201
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