The efficacy and safety of endostar combined with taxane-based regimens for HER-2-negative metastatic breast cancer patients.
The efficacy and safety of endostar combined with taxane-based regimens for HER-2-negative metastatic breast cancer patients.
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DOI：
10.18632/oncotarget.8967
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发表时间：
2016-05-24
期刊：
影响因子：
--
通讯作者：
Lin L
中科院分区：
文献类型：
--
作者：
Huang W;Liu J;Wu F;Chen K;Li N;Hong Y;Huang C;Zhen H;Lin L
本研究的目的是前瞻性评估内皮抑素的重组产品恩度联合基于紫杉烷的治疗方案对 HER-2 阴性转移性乳腺癌 (MBC) 患者的疗效和安全性。年龄在 18-70 岁之间、经组织学证实 MBC 且记录为 HER-2 阴性的女性也被纳入其中。恩度的给药剂量为 7.5 mg/m2，d1-14，q21d，持续治疗直至疾病进展、出现不可接受的毒性、撤回同意或完成 24 个月的恩度治疗（以先到者为准）。继续基于紫杉烷的化疗，直至出现疾病进展、不可接受的毒性、撤回同意或最多 8 个周期。主要终点是总体缓解率（ORR）。招募了 57 名患者。整个人群、一线、二线和三线或以上治疗的 ORR 分别为 68.4%、79.3%、54.5% 和 16.7%。中位 PFS 为 10.8 (8.0–12.1) 个月，但中位 OS 仍未达到。对于接受一线、二线和三线及以上治疗的患者，中位 PFS 分别为 11.9、7.5 和 7.4 个月（P=0.048）。激素受体阳性和阴性患者之间的中位 PFS 没有显着差异。最常见的药物相关 3-4 级血液学毒性是中性粒细胞减少症 (80.7%) 和白细胞减少症 (77.2%)。六名（10.5%）患者出现发热性中性粒细胞减少症。最常见的药物相关 3-4 级非血液毒性是肝功能障碍 (10.5%) 和周围神经毒性 (8.8%)。没有报告与治疗相关的死亡。我们的结论是，恩度联合基于紫杉烷的治疗方案对于治疗 HER-2 阴性 MBC 可能是有效且安全的。然而，有必要对其长期功效和毒性进行进一步研究。
The purpose of the present study was to prospectively evaluate the efficacy and safety of endostar, a recombinant product of endostatin, combined with taxane-based regimens for HER-2 negative metastatic breast cancer (MBC) patients. Women with ages between 18–70 years with histologically confirmed MBC documented as HER-2-negative were included. Endostar was administered at 7.5 mg/m2, d1–14, q21d and was continued until progressive disease, unacceptable toxicity, consent withdrawal, or completion of 24 months of endostar, whichever came first. Taxane-based chemotherapy was continued until progressive disease, unacceptable toxicity, consent withdrawal, or up to 8 cycles. The primary endpoint was overall response rate (ORR). Fifty-seven patients were recruited. The ORRs for the whole population, first-, second-, and third-line therapy or beyond were 68.4%, 79.3%, 54.5%, and 16.7%, respectively. The median PFS was 10.8 (8.0–12.1) months, yet the median OS was still not attained. For the patients receiving first-, second-, and third-line therapy or beyond, median PFS was 11.9, 7.5, and 7.4 months, respectively (P=0.048). No significant difference in median PFS between hormonal receptor-positive and -negative patients was observed. The most common drug-related grade 3–4 hematologic toxicities were neutropenia (80.7%) and leukopenia (77.2%). Six (10.5%) patients experienced febrile neutropenia. The most frequent drug-related grade 3–4 non-hematologic toxicities were liver dysfunction (10.5%) and peripheral neurotoxicity (8.8%). No treatment-related deaths were reported. We conclude that Endostar combined with taxane-based regimens may be effective and safe for the treatment of HER-2-negative MBC. However, further investigations on its long-term efficacy and toxicity are warranted.
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新辅助重组人血管内皮抑素、多西紫杉醇和表柔比星治疗乳腺癌：前瞻性、随机、II 期研究的疗效和安全性
影响因子：
3.8
作者：
Chen J;Yao Q;Li D;Zhang J;Wang T;Yu M;Zhou X;Huan Y;Wang J;Wang L
通讯作者：
Wang L
影响因子：
64.8
作者：
KIM, KJ;LI, B;FERRARA, N
通讯作者：
FERRARA, N
影响因子：
5.1
作者：
Subramanian, I. V.;Devineni, S.;Ramakrishnan, S.
通讯作者：
Ramakrishnan, S.
DOI：
10.1073/pnas.0730882100
发表时间：
2003-04-15
影响因子：
11.1
作者：
Sudhakar, A;Sugimoto, H;Kalluri, R
通讯作者：
Kalluri, R
影响因子：
20.3
作者：
Dixelius, J;Larsson, H;Claesson-Welsh, L
通讯作者：
Claesson-Welsh, L