Long-term trastuzumab (Herceptin®) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer.
Long-term trastuzumab (Herceptin®) treatment in a continuation study of patients with HER2-positive breast cancer or HER2-positive gastric cancer.
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DOI：
10.1186/s12885-018-4183-2
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发表时间：
2018-03-15
期刊：
影响因子：
3.8
通讯作者：
Bang YJ
中科院分区：
文献类型：
--
作者：
Müller V;Clemens M;Jassem J;Al-Sakaff N;Auclair P;Nüesch E;Holloway D;Shing M;Bang YJ
曲妥珠单抗(Herceptin®[H])是HER2阳性局部晚期/转移性乳腺癌和胃/胃食道交界处(GEJ)癌的标准治疗药物。然而，关于患者长期接受H治疗的数据很少。滚动方案(ROP)研究是为了报告接受长期H治疗(乳腺癌和胃癌/胃癌分别为≥5年和≥3年)的HER2阳性局部进展期/转移性乳腺癌和胃癌/GEJ癌患者的安全性数据。ROP研究是一项关于H的单臂、多中心、国际延续试验，研究对象是那些先前已完成罗氏赞助的全球H疗法试验、病情稳定并在引入试验结束时接受H治疗的患者。在引入试验期间患有慢性心力衰竭的患者可以包括在风险-收益分析之后。主要目标是在引入研究结束时为HER2过度表达的局部晚期/转移性乳腺癌或胃癌/GEJ癌患者提供H疗法，并跟踪这些患者的长期结果和长期总体安全性。在参加ROP研究的69名患者中，有25名接受了长期的H治疗(19例乳腺癌和6例胃癌/GEJ癌)。乳腺癌患者H治疗的中位持续时间为8年7个月，胃癌/GEJ癌患者的H治疗中位持续时间为5年2个月。随着时间的推移，患者的心脏状态保持稳定，没有严重的心脏不良事件或左心室射血分数(LVEF)显著变化。中位数总体最差的左心室射血分数为57.0%，没有患者的左心室射血分数达到<； 45%(范围47-63%)。没有发生与研究治疗相关的严重不良事件。这些结果表明，H具有可接受的安全性，并且在接受长期H治疗的患者中耐受性良好(乳腺癌和胃癌/胃癌分别为≥5年和≥3年)。进一步研究和报道长期的H疗法将是有价值的。这项研究于2016年3月24日在ClinicalTrials.gov注册，编号为NCT02721641。本文的在线版本(10.1186/s12885-0184183-2)包含补充材料，可供授权用户使用。
Trastuzumab (Herceptin® [H]) is the standard of care for HER2-positive locally advanced/metastatic breast cancer and gastric/gastroesophageal junction (GEJ) cancer. However, there is a paucity of data available on long-term H treatment of patients. The Rollover Protocol (ROP) Study was conducted to report safety data for patients with HER2-positive locally advanced/metastatic breast and gastric/GEJ cancer who have received long-term H therapy (≥ 5 years and ≥ 3 years for breast and gastric/GEJ cancer, respectively). The ROP Study was a single-arm, multicenter, international continuation trial of H in patients who had previously completed a global Roche-sponsored trial with H therapy, had stable disease, and were receiving H at the end of the lead-in trial. Patients with chronic heart failure during the lead-in trial could be included following a risk–benefit analysis. The primary objectives were to provide H therapy to patients with HER2-overexpressing locally advanced/metastatic breast or gastric/GEJ cancer at the end of the lead-in study, and to follow the long-term outcomes and long-term overall safety in these patients. Twenty-five of 69 patients enrolled in the ROP Study received long-term H therapy (19 breast cancer and 6 gastric/GEJ cancer). The median duration of H treatment for patients with breast cancer was 8 years 7 months, and 5 years 2 months for patients with gastric/GEJ cancer. The cardiac status of the patients remained stable over time, with no serious cardiac adverse events or marked changes in left ventricular ejection fraction (LVEF). The median overall worst LVEF measurement was 57.0%, and no patients experienced an LVEF of < 45% (range 47–63%). There were no serious adverse events related to study treatment. These results suggest that H has an acceptable safety profile and was well tolerated in patients who received long-term H therapy (≥ 5 years and ≥ 3 years for breast and gastric/GEJ cancer, respectively). Further investigation and reporting of long-term H therapy would be valuable. This study was retrospectively registered on March 24, 2016 with Clinicaltrials.gov, number NCT02721641. The online version of this article (10.1186/s12885-018-4183-2) contains supplementary material, which is available to authorized users.
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