Clinical utility of circulating tumour cell-based monitoring of late-line chemotherapy for metastatic breast cancer: the randomised CirCe01 trial.
Clinical utility of circulating tumour cell-based monitoring of late-line chemotherapy for metastatic breast cancer: the randomised CirCe01 trial.
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转移性乳腺癌晚期化疗循环肿瘤细胞监测的临床效用：随机CirCe01试验
DOI：
10.1038/s41416-020-01227-3
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发表时间：
2021-03
影响因子：
8.8
通讯作者：
Bidard FC
中科院分区：
文献类型：
--
作者：
Cabel L;Berger F;Cottu P;Loirat D;Rampanou A;Brain E;Cyrille S;Bourgeois H;Kiavue N;Deluche E;Ladoire S;Campone M;Pierga JY;Bidard FC
CirCe01试验旨在评估基于循环肿瘤细胞（CTC）监测的转移性乳腺癌（MBC）患者在三线化疗（LC）后的临床应用。CirCe01是一项前瞻性、多中心、随机试验（NCT01349842），纳入了两次系统性LC后的MBC患者。≥5 CTC/7.5 mL （CellSearch®）的患者被随机分为CTC驱动组和标准组。在CTC组中，在每个LC的第一个周期评估CTC计数的变化；CTC水平预测早期肿瘤进展的患者必须切换到随后的LC。N = 101/204例患者大于或等于5 CTC/7.5 mL。在CTC组（N = 51）中，分别有43例（83%）和18例（44%）患者完成了第三线和第四线的CTC监测，其中分别有18例（42%）和11例（61%）患者没有CTC应答。这些患者中有13例（72%）和5例（46%）早期切换到下一个LC。两组的总生存率无差异（风险比= 0.95,95%可信区间= [0.6;1.4],p = 0.8）。在亚组分析中，没有CTC反应的患者切换化疗比没有化疗的患者生存时间更长。由于有限的累积和依从性，该试验未能证明CTC监测的临床效用。NCT, NCT01349842, https://clinicaltrials.gov/ct2/show/NCT01349842, 2011年5月9日注册。
CirCe01 trial aimed to assess the clinical utility of circulating tumour cell (CTC)-based monitoring in metastatic breast cancer (MBC) patients beyond the third line of chemotherapy (LC). CirCe01 was a prospective, multicentre, randomised trial (NCT01349842) that included patients with MBC after two systemic LC. Patients with ≥5 CTC/7.5 mL (CellSearch®) were randomised between the CTC-driven and the standard arm. In the CTC arm, changes in CTC count were assessed at the first cycle of each LC; patients in whom CTC levels predicted early tumour progression had to switch to a subsequent LC. Greater than or equal to 5 CTC/7.5 mL were observed in N = 101/204 patients. In the CTC arm (N = 51), 43 (83%) and 18 (44%) patients completed CTC monitoring in the third and fourth lines, respectively, and 18 (42%) and 11 (61%) of these patients, respectively, had no CTC response. Thirteen (72%) and 5 (46%) of these patients underwent early switch to the next LC. Overall survival was not different between the two arms (hazard ratio = 0.95, 95% confidence interval = [0.6;1.4], p = 0.8). In subgroup analyses, patients with no CTC response who switched chemotherapy experienced longer survival than patients who did not. Due to the limited accrual and compliance, this trial failed to demonstrate the clinical utility of CTC monitoring. NCT, NCT01349842, https://clinicaltrials.gov/ct2/show/NCT01349842, registered 9 May 2011.
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影响因子：
158.5
作者：
Cristofanilli, M;Budd, GT;Hayes, DF
通讯作者：
Hayes, DF
影响因子：
11.5
作者：
Hayes, Daniel F.;Cristofanilli, Massimo;Terstappen, Leon W. W. M.
通讯作者：
Terstappen, Leon W. W. M.
影响因子：
9.2
作者：
Bidard, Francois-Clement;Fehm, Tanja;Ignatiadis, Michail;Smerage, Jeffrey B.;Alix-Panabieres, Catherine;Janni, Wolfgang;Messina, Carlo;Paoletti, Costanza;Mueller, Volkmar;Hayes, Daniel F.;Piccart, Martine;Pierga, Jean-Yves
通讯作者：
Pierga, Jean-Yves
影响因子：
254.7
作者：
Parkin, DM;Bray, F;Pisani, P
通讯作者：
Pisani, P
影响因子：
254.7
作者：
Torre, Lindsey A.;Bray, Freddie;Jemal, Ahmedin
通讯作者：
Jemal, Ahmedin