Sharma Aparna, Vanidassane Ilavarasi, Aggarwal Aditi, Mridha Asit Ranjan, Pandey Rambha, Dhamija Ekta, Barwad Adarsh, Rastogi Sameer
Department of Medical Oncology, Dr. B.R Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, India.
Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi, India.
Indian J Cancer. 2019 Jul-Sep;56(3):207-210. doi: 10.4103/ijc.IJC_105_18.
There is no study till date determining the spectrum of adverse events of pazopanib in Indian patients with advanced sarcoma.
We conducted a retrospective study by analyzing the case records of metastatic sarcoma patients treated with pazopanib from January 2016 to July 2017 in sarcoma medical oncology clinic. Toxicity was assessed according to CTCAE v.4.03 criteria. SPSS version 23 was used for statistical evaluation.
A total of 33 patients received pazopanib. The median age was 41 years (range, 19-75 years), with a male predominance (54.5%). Twenty-six patients (78.8%) had ECOG performance status 1 at the time of pazopanib initiation. The most common type of sarcoma was synovial sarcoma, and the mean duration of pazopanib intake in patients was 4.12 months. The median follow-up was 13 months. Median progression-free survival was 5 months, and median overall survival was 18 months. Overall response rate was 6.0%. Out of the 33 patients, 42.4% (n = 14) received it after first line of therapy. Six patients (18.2%) required dose reductions due to toxicity. Thirteen (39.4%) patients experienced CTCAE grade 3 or 4 toxicities. Most common grade 3 and 4 toxicities experienced among patients were hand-foot skin reaction (18.2%) and proteinuria (9.1%). No significant difference was seen when analyzed for variables such as age, sex, ECOG performance status, comorbidities, and number of previous lines received in patients experiencing grade 3 and 4 toxicities.
The spectrum of adverse events in Indian patients at doses lower than the recommended dose is distinctly different from the western population. However, this unique toxicity profile needs to be validated in prospective studies.
迄今为止，尚无研究确定帕唑帕尼在印度晚期肉瘤患者中的不良事件谱。
我们通过分析2016年1月至2017年7月在肉瘤医学肿瘤诊所接受帕唑帕尼治疗的转移性肉瘤患者的病例记录进行了一项回顾性研究。根据CTCAE v.4.03标准评估毒性。使用SPSS 23版进行统计评估。
共有33例患者接受了帕唑帕尼治疗。中位年龄为41岁（范围19 - 75岁），男性占优势（54.5%）。26例患者（78.8%）在开始使用帕唑帕尼时ECOG体能状态为1。最常见的肉瘤类型是滑膜肉瘤，患者帕唑帕尼的平均服用时间为4.12个月。中位随访时间为13个月。中位无进展生存期为5个月，中位总生存期为18个月。总缓解率为6.0%。在33例患者中，42.4%（n = 14）在一线治疗后接受了该药物。6例患者（18.2%）因毒性需要降低剂量。13例患者（39.4%）出现CTCAE 3级或4级毒性。患者中最常见的3级和4级毒性是手足皮肤反应（18.2%）和蛋白尿（9.1%）。在分析3级和4级毒性患者的年龄、性别、ECOG体能状态、合并症以及之前接受的治疗线数等变量时，未发现显著差异。
印度患者在低于推荐剂量下的不良事件谱与西方人群明显不同。然而，这种独特的毒性特征需要在前瞻性研究中得到验证。
