Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan
Advanced Cancer Translational Research Institute, Showa University, Tokyo, Japan.
BMJ Open. 2023 Apr 3;13(4):e070304. doi: 10.1136/bmjopen-2022-070304.
The antibody-drug conjugate trastuzumab deruxtecan (T-DXd) has led to a change in the clinical management of breast cancer. Nausea and vomiting are the most common adverse events of T-DXd, which cannot be completely alleviated by standard prophylactic regimens. Olanzapine is particularly effective in preventing delayed nausea caused by chemotherapy. In this study, we will evaluate the efficacy of olanzapine in managing persistent nausea and vomiting during T-DXd treatment.
The ERICA study is a multicentre, placebo-controlled, double-blind, randomised phase II study with the aim to evaluate the antiemetic effects of the prophylactic olanzapine (5 mg orally, on days 1-6) or placebo combined with a 1,5-hydroxytryptamine-3 (5-HT)-receptor antagonist and dexamethasone in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer undergoing T-DXd treatment. For a period of 22 days from the day of T-DXd treatment, patients will document their experience in an electronic symptom diary daily during observational periods. The primary endpoint is the complete response rate, defined as no vomiting and no rescue medications during the 'delayed phase' of 24-120 hours post-T-DXd administration. In addition, we define 120-504 hour as the 'persistent phase' and 0-504 hours as the 'overall phase' for secondary endpoint analysis. We have estimated that a total sample size of at least 156 patients is needed to allow a power of 80% at a one-sided significance level of 20% in this study. The target sample size is set to 166 to account for possible case exclusions.
The study protocol is approved by the West Japan Oncology Group protocol review committee and the SHOWA University Clinical Research Review Board. The study results will be presented at international conferences and published in a peer-reviewed journal.
jRCTs031210410.
抗体药物偶联物曲妥珠单抗 deruxtecan（T-DXd）改变了乳腺癌的临床治疗策略。恶心和呕吐是 T-DXd 最常见的不良反应，标准预防方案无法完全缓解。奥氮平在预防化疗引起的迟发性恶心方面特别有效。在这项研究中，我们将评估奥氮平在管理 T-DXd 治疗期间持续性恶心和呕吐方面的疗效。
ERICA 研究是一项多中心、安慰剂对照、双盲、随机的 II 期研究，旨在评估预防性奥氮平（5mg 口服，第 1-6 天）或安慰剂联合 5-羟色胺 3（5-HT3）受体拮抗剂和地塞米松在接受 T-DXd 治疗的人表皮生长因子受体 2 阳性转移性乳腺癌患者中的止吐效果。在 T-DXd 治疗后的 22 天内，患者将在观察期内每天通过电子症状日记记录自己的体验。主要终点是完全缓解率，定义为在 T-DXd 给药后 24-120 小时的“迟发性”期间无呕吐且无需解救药物。此外，我们将 120-504 小时定义为“持续性”阶段，0-504 小时定义为次要终点分析的“总”阶段。我们估计，在这项研究中，需要至少 156 例患者的总样本量，才能在单侧显著性水平为 20%的情况下达到 80%的功效。目标样本量设定为 166，以考虑可能的病例排除。
研究方案已获得西日本肿瘤组方案审查委员会和昭和大学临床研究审查委员会的批准。研究结果将在国际会议上公布，并发表在同行评议的期刊上。
jRCTs031210410。
