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.
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.
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DOI：
10.1093/annonc/mdy201
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发表时间：
2018-08-01
期刊：
影响因子：
--
通讯作者：
tnAcity investigators
中科院分区：
文献类型：
--
作者：
Yardley DA;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;tnAcity investigators
转移性三阴性乳腺癌（mTNBC）具有不良预后和侵袭性临床病程。tnAcity评估了一线nab-paclitaxel + carboplatin（nab-P/C）、nab-paclitaxel + gemcitabine（nab-P/G）和gemcitabine + carboplatin（G/C）在mTNBC患者中的疗效和安全性。患有病理学证实的mTNBC且先前未接受转移性BC化疗的患者接受（1：1：1）nab-P 125 mg/m2加C AUC 2、nab-P 125 mg/m2加G 1000 mg/m2或G 1000 mg/m2加C AUC 2，均在第1天，8 q3 w。II期主要终点：评估者评估的无进展生存期（PFS）;次要终点包括总缓解率（ORR）、总生存期（OS）、开始第6周期双联治疗的患者百分比和安全性。总共招募了191名患者（nab-P/C，n = 64; nab-P/G，n = 61; G/C，n = 66）。nab-P/C组PFS显著长于nab-P/G组[中位数，8.3 vs 5.5个月;风险比（HR），0.59 [95% CI，0.38-0.92]; P = 0.02]或G/C组（中位数，8.3 vs 6.0个月; HR，0.58 [95% CI，0.37-0.90]; P = 0.02）。nab-P/C组的OS在数值上长于nab-P/G组（中位数，16.8 vs 12.1个月; HR，0.73 [95% CI，0.47-1.13]; P = 0.16）或G/C组（中位数，16.8 vs 12.6个月; HR，0.80 [95% CI，0.52-1.22]; P = 0.29）。ORR分别为73%、39%和44%。在nab-P/C、nab-P/G和G/C组中，64%、56%和50%的患者以双联体开始第6周期。≥3级不良事件主要为血液学不良事件。一线nab-P/C在mTNBC中具有活性，与nab-P/G或G/C相比，PFS显著延长，风险/获益特征改善。
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 with pathologically confirmed mTNBC and no prior chemotherapy for metastatic BC received (1 : 1 : 1) nab-P 125 mg/m2 plus C AUC 2, nab-P 125 mg/m2 plus G 1000 mg/m2, or G 1000 mg/m2 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. 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. 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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影响因子：
5.5
作者：
Wahba HA;El-Hadaad HA
通讯作者：
El-Hadaad HA
影响因子：
2.5
作者：
Yardley DA;Brufsky A;Coleman RE;Conte PF;Cortes J;Glück S;Nabholtz JM;O'Shaughnessy J;Beck RM;Ko A;Renschler MF;Barton D;Harbeck N
通讯作者：
Harbeck N
DOI：
10.1093/annonc/mdw544
发表时间：
2017-01-01
期刊：
Annals of oncology : official journal of the European Society for Medical Oncology
影响因子：
--
作者：
Cardoso F;Costa A;Senkus E;Aapro M;André F;Barrios CH;Bergh J;Bhattacharyya G;Biganzoli L;Cardoso MJ;Carey L;Corneliussen-James D;Curigliano G;Dieras V;El Saghir N;Eniu A;Fallowfield L;Fenech D;Francis P;Gelmon K;Gennari A;Harbeck N;Hudis C;Kaufman B;Krop I;Mayer M;Meijer H;Mertz S;Ohno S;Pagani O;Papadopoulos E;Peccatori F;Penault-Llorca F;Piccart MJ;Pierga JY;Rugo H;Shockney L;Sledge G;Swain S;Thomssen C;Tutt A;Vorobiof D;Xu B;Norton L;Winer E
通讯作者：
Winer E
影响因子：
45.3
作者：
Liedtke, Cornelia;Mazouni, Chafika;Pusztai, Lajos
通讯作者：
Pusztai, Lajos
影响因子：
50.5
作者：
Miles, D. W.;Dieras, V.;O'Shaughnessy, J.
通讯作者：
O'Shaughnessy, J.