Gynecologic Oncology, Gynäkologisch-Onkologische Praxis am Pelikanplatz, Hannover, Germany.
Department of Obstetrics and Gynecology, University Medical Center Mainz, Mainz, Germany.
Oncologist. 2023 Dec 11;28(12):e1152-e1159. doi: 10.1093/oncolo/oyad191.
Eribulin, a halichondrin-class microtubule dynamics inhibitor, is a preferred treatment option for patients with advanced breast cancer who have been pretreated with an anthracycline and a taxane. Peripheral neuropathy (PN) is a common side effect of chemotherapies for breast cancer and other tumors. The Incidence and Resolution of Eribulin-Induced Peripheral Neuropathy (IRENE) noninterventional postauthorization safety study assessed the incidence and severity of PN in patients with breast cancer treated with eribulin.
IRENE is an ongoing observational, single-arm, prospective, multicenter, cohort study. Adult patients (≥18 years of age) with locally advanced or metastatic breast cancer and disease progression after 1-2 prior chemotherapeutic regimen(s) for advanced disease were treated with eribulin. Patients with eribulin-induced PN (new-onset PN or worsening of preexisting PN) were monitored until death or resolution of PN. Primary endpoints included the incidence, severity, and time to resolution of eribulin-induced PN. Secondary endpoints included time to disease progression and safety.
In this interim analysis (data cutoff date: July 1, 2019), 67 (32.4%) patients experienced any grade eribulin-induced PN, and 12 (5.8%) patients experienced grade ≥3 eribulin-induced PN. Median time to resolution of eribulin-induced PN was not reached. Median time to disease progression was 4.6 months (95% CI, 4.0-6.5). Treatment-emergent adverse events (TEAEs) occurred in 195 (93.8%) patients and serious TEAEs occurred in 107 (51.4%) patients.
The rates of any grade and grade ≥3 eribulin-induced PN observed in this real-world study were consistent with those observed in phase III randomized clinical trials. No new safety findings were observed.
埃博霉素是一种海鞘素类微管动力学抑制剂，是既往接受过蒽环类和紫杉烷类化疗的晚期乳腺癌患者的首选治疗方案。周围神经病变（PN）是乳腺癌和其他肿瘤化疗的常见副作用。埃博霉素引起的周围神经病变（IRENE）非干预性上市后安全性研究评估了接受埃博霉素治疗的乳腺癌患者中 PN 的发生率和严重程度。
IRENE 是一项正在进行的观察性、单臂、前瞻性、多中心、队列研究。患有局部晚期或转移性乳腺癌的成年患者（≥18 岁），且在晚期疾病的 1-2 种先前化疗方案后疾病进展，接受埃博霉素治疗。出现埃博霉素诱导的 PN（新发 PN 或原有 PN 恶化）的患者接受监测，直至死亡或 PN 缓解。主要终点包括埃博霉素诱导的 PN 的发生率、严重程度和缓解时间。次要终点包括疾病进展时间和安全性。
在这项中期分析（数据截止日期：2019 年 7 月 1 日）中，67 名（32.4%）患者出现任何级别埃博霉素诱导的 PN，12 名（5.8%）患者出现≥3 级埃博霉素诱导的 PN。埃博霉素诱导的 PN 缓解的中位时间未达到。中位疾病进展时间为 4.6 个月（95%CI，4.0-6.5）。195 名（93.8%）患者出现治疗相关不良事件（TEAEs），107 名（51.4%）患者出现严重 TEAEs。
在这项真实世界研究中观察到的任何级别和≥3 级埃博霉素诱导的 PN 的发生率与 III 期随机临床试验中观察到的发生率一致。未观察到新的安全性发现。
