Department of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Department of Orthopedic Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
In Vivo. 2019 Sep-Oct;33(5):1609-1614. doi: 10.21873/invivo.11644.
BACKGROUND/AIM: Trabectedin is a synthetic antineoplastic agent approved for advanced soft tissue sarcoma (STS) in Japan. The aim of this study was to evaluate the efficacy and safety of the Japan-approved dose of trabectedin for advanced STS.
We retrospectively reviewed 38 patients with advanced STS who received salvage chemotherapy with trabectedin.
The overall response and disease control rates were 16% (5 patients) and 67% (20 patients), respectively. The median progression-free and overall survival were 7.3 and 17.8 months, respectively. There were no significant differences between patients with liposarcoma or leiomyosarcoma and those without, or between patients with TRS and those without. The most common grade 3-4 AEs were elevated transaminases and neutropenia.
Trabectedin 1.2 mg/m, as the approved dose in Japan, showed similar efficacy to the dose of 1.5 mg/m used in Western countries. Trabectedin could be an option for advanced STS in Japan, regardless of histological subtype.
背景/目的：盐酸多柔比星脂质体注射液是一种合成的抗肿瘤药物，在日本被批准用于治疗晚期软组织肉瘤（STS）。本研究旨在评估日本批准的多柔比星脂质体注射液剂量治疗晚期 STS 的疗效和安全性。
我们回顾性分析了 38 例接受多柔比星脂质体注射液挽救化疗的晚期 STS 患者。
总缓解率和疾病控制率分别为 16%（5 例）和 67%（20 例）。中位无进展生存期和总生存期分别为 7.3 个月和 17.8 个月。脂肪肉瘤或平滑肌肉瘤患者与非脂肪肉瘤或平滑肌肉瘤患者之间，以及存在 TRS 的患者与不存在 TRS 的患者之间，均无显著差异。最常见的 3-4 级不良反应为转氨酶升高和中性粒细胞减少。
日本批准的 1.2mg/m 剂量的多柔比星脂质体注射液与西方国家使用的 1.5mg/m 剂量的疗效相似。多柔比星脂质体注射液可能是日本晚期 STS 的一种选择，无论组织学亚型如何。
