Department of Obstetrics and Gynecology, Konkuk University School of Medicine, Chungju, Korea.
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
J Gynecol Oncol. 2018 Jan;29(1):e3. doi: 10.3802/jgo.2018.29.e3.
In the treatment of metastatic soft tissue sarcoma (STS), pazopanib is considered a standard treatment after failure of chemotherapy. We retrospectively investigated outcomes of pazopanib in patients with metastatic uterine STS.
A retrospective study was performed on 35 consecutive patients with uterine STS treated with oral pazopanib 800 mg daily as salvage therapy for metastatic disease between September 2013 and December 2015. Endpoints included response rate, survival, and safety.
Among 35 patients, 27 (77%) had a histologic diagnosis of leiomyosarcoma (LMS) and the median age was 57 years (range, 36-70). Median number of metastatic sites was one (range, 1-5) with lung as the most frequently involved site. Pazopanib was generally well-tolerated: the major hematologic toxicity was grade 1/2 anemia (14%). Among the non-hematologic toxicities, grade 1/2 stomatitis was most commonly observed (22%), followed by fatigue and hypertension. Objective response and stable disease were observed in 10 (29%) and 11 (31%) patients, respectively. However, most cases of clinical response were observed in patients with LMS: 33% for LMS, 20% for undifferentiated pleomorphic sarcoma, and 0% for endometrial stromal sarcoma. Median progression-free and overall survivals were 5.8 months (95% confidence interval [CI]=3.6-8.1) and 20.0 months (95% CI=11.6-28.4), respectively.
In this "real-world" retrospective study, salvage therapy with pazopanib demonstrated clinically relevant efficacy and tolerability in unselected patients with uterine STS. Although it is encouraging that outcomes for Korean patients with uterine STS were similar to those reported in the phase III trial, the clinical benefit was limited to LMS.
在转移性软组织肉瘤(STS)的治疗中,帕唑帕尼被认为是化疗失败后的标准治疗方法。我们回顾性研究了帕唑帕尼在转移性子宫 STS 患者中的应用效果。
对 2013 年 9 月至 2015 年 12 月期间,35 例接受口服帕唑帕尼 800mg/d 挽救性治疗转移性疾病的子宫 STS 患者进行了回顾性研究。研究终点包括缓解率、生存率和安全性。
35 例患者中,27 例(77%)的组织学诊断为平滑肌肉瘤(LMS),中位年龄为 57 岁(范围,36-70 岁)。转移灶的中位数为 1 个(范围,1-5 个),最常受累的部位是肺部。帕唑帕尼总体耐受性良好:主要血液学毒性为 1/2 级贫血(14%)。非血液学毒性中,最常见的是 1/2 级口腔炎(22%),其次是疲劳和高血压。10 例(29%)和 11 例(31%)患者分别观察到客观缓解和疾病稳定。然而,大多数临床缓解病例发生在 LMS 患者中:LMS 为 33%,未分化多形性肉瘤为 20%,子宫内膜间质肉瘤为 0%。中位无进展生存期和总生存期分别为 5.8 个月(95%置信区间[CI]:3.6-8.1)和 20.0 个月(95%CI:11.6-28.4)。
在这项“真实世界”的回顾性研究中,帕唑帕尼的挽救性治疗在未选择的子宫 STS 患者中显示出了有临床意义的疗效和耐受性。尽管韩国患者的结果与 III 期试验相似令人鼓舞,但临床获益仅限于 LMS。