A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer.
A randomized phase 3 trial of Gemcitabine or Nab-paclitaxel combined with cisPlatin as first-line treatment in patients with metastatic triple-negative breast cancer.
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吉西他滨或白蛋白结合型紫杉醇联合顺铂作为转移性三阴性乳腺癌患者一线治疗的随机 3 期试验
DOI：
10.1038/s41467-022-31704-7
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发表时间：
2022-07-12
影响因子：
16.6
通讯作者：
中科院分区：
文献类型：
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作者：
铂类药物联合吉西他滨被推荐用于治疗转移性三阴性乳腺癌（mTNBC）。我们开展了一项随机3期、对照、开放标签试验，比较白蛋白结合型紫杉醇/顺铂（AP）与吉西他滨/顺铂（GP）在mTNBC患者中的疗效（ClinicalTrials.gov NCT02546934）。254例未经治疗的mTNBC患者随机接受AP（第1、8天白蛋白结合型紫杉醇125mg/m²，第1天顺铂75mg/m²）或GP（第1、8天吉西他滨1250mg/m²，第1天顺铂75mg/m²）静脉给药，每3周一次，直至疾病进展、出现无法耐受的毒性反应或患者撤回同意。主要终点是无进展生存期（PFS）；次要终点是客观缓解率（ORR）、安全性和总生存期（OS）。该试验已达到预先设定的终点。AP组的中位PFS为9.8个月，而GP组为7.4个月（分层风险比，0.67；95%置信区间，0.50 - 0.88；P = 0.004）。与GP相比，AP显著提高了ORR（81.1%对56.3%，P < 0.001）并延长了OS（分层风险比，0.62；95%置信区间，0.44 - 0.90；P = 0.010）。在3级或4级不良事件中，AP组神经病变的发生率显著较高，GP组血小板减少症的发生率显著较高。这些发现使得有必要进一步评估在白蛋白结合型紫杉醇/铂类基础方案中添加新型药物，因为该方案对mTNBC患者具有高效力。
卡铂和顺铂等铂类药物已被推荐与吉西他滨联合用于治疗转移性三阴性乳腺癌（TNBC）。在此作者报告了一项随机3期试验的结果，该试验比较了一线白蛋白结合型紫杉醇/顺铂与吉西他滨/顺铂在TNBC患者中的疗效。
Platinum is recommended in combination with gemcitabine in the treatment of metastatic triple-negative breast cancer (mTNBC). We conduct a randomized phase 3, controlled, open-label trial to compare nab-paclitaxel/cisplatin (AP) with gemcitabine/cisplatin (GP) in mTNBC patients (ClinicalTrials.gov NCT02546934). 254 patients with untreated mTNBC randomly receive AP (nab-paclitaxel 125 mg/m² on day 1, 8 and cisplatin 75 mg/m² on day 1) or GP (gemcitabine 1250 mg/m² on day 1, 8 and cisplatin 75 mg/m² on day 1) intravenously every 3 weeks until progression disease, intolerable toxicity or withdrawal of consent. The primary endpoint is progression-free survival (PFS); secondary endpoints are objective response rate (ORR), safety and overall survival (OS). The trial has met pre-specified endpoints. The median PFS is 9.8 months with AP as compared to 7.4 months with GP (stratified HR, 0.67; 95% CI, 0.50–0.88; P = 0.004). AP significantly increases ORR (81.1% vs. 56.3%, P < 0.001) and prolongs OS (stratified HR, 0.62; 95% CI, 0.44–0.90; P = 0.010) to GP. Of grade 3 or 4 adverse events, a significantly higher incidence of neuropathy in AP and thrombocytopenia in GP is noted. These findings warrant further assessment of adding novel agents to the nab-paclitaxel/platinum backbone due to its high potency for patients with mTNBC. Platinum agents, such as carboplatin and cisplatin, have been recommended in combination with gemcitabine for the treatment of metastatic triple negative breast cancer (TNBC). Here the authors report the results of a randomized phase 3 trial to compare the efficacy of first-line nab-paclitaxel/cisplatin to gemcitabine/cisplatin in patients with TNBC.
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DOI：
10.1093/annonc/mdy201
发表时间：
2018-08-01
期刊：
Annals of oncology : official journal of the European Society for Medical Oncology
影响因子：
--
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
通讯作者：
tnAcity investigators
影响因子：
45.3
作者：
Sikov, William M.;Berry, Donald A.;Winer, Eric P.
通讯作者：
Winer, Eric P.
影响因子：
51.1
作者：
Dieras, Veronique;Han, Hyo S.;Arun, Banu K.
通讯作者：
Arun, Banu K.
影响因子：
8
作者：
Sun S;Tang L;Zhang J;Lv F;Wang Z;Wang L;Zhang Q;Zheng C;Qiu L;Jia Z;Lu Y;Liu G;Shao Z;Wang B;Hu X
通讯作者：
Hu X
影响因子：
3.8
作者：
Wong-Brown, Michelle W.;Meldrum, Cliff J.;Scott, Rodney J.
通讯作者：
Scott, Rodney J.