甲磺酸阿帕替尼在晚期难治性骨与软组织肉瘤治疗中的临床应用观察

目的:观察甲磺酸阿帕替尼治疗晚期难治性骨与软组织肉瘤的有效性及安全性,同时分析影响患者无进展生存期(progression free survival,PFS)的可能相关因素。方法:选取云南省肿瘤医院2017年6月至2018年9月收治的21例晚期难治性骨与软组织肉瘤患者,予以甲磺酸阿帕替尼片,主要疗效指标为PFS,次要疗效指标为总生存时间(overall survival,OS)。根据实体瘤疗效评定标准RECIST 1.1评价临床疗效,包括总缓解率(overall response rate,ORR)、疾病控制率(disease control rate,DCR),同时根据美国国家癌症研究所(National Cancer Institute,NCI)4.0标准随访观察安全性。结果:21例患者均获得随访,截至最后1次随访时间2019年3月31日,无完全缓解(complete response,CR),部分缓解(partial response,PR)患者有2例(9.5%),疾病稳定(stable disease,SD)患者7例(33.3%),疾病进展(progressive disease,PD)患者12例(57.1%),ORR为9.5%,DCR为(42.8%),中位无进展生存期(median progression free survival,mPFS)为8个月,中位总生存时间(median overall survival,mOS)为14个月。患者的性别、年龄、ECOG评分、组织来源、是否手术、是否化疗对患者PFS的影响差异无统计学意义(P>0.05),只有服用阿帕替尼前是否有放疗史这一因素对患者PFS的影响差异均具有统计学意义(P<0.05),有放疗史患者的PFS低于无放疗史患者。Ⅲ级及以上不良反应依次为手足综合征(14.3%)、气胸(14.3%)和贫血(4.8%)。结论:甲磺酸阿帕替尼在治疗晚期难治性骨与软组织肉瘤中显现出一定的疗效,不良反应总体来说是可预见、可控制和可逆转的,对于治疗依从性良好、无其他治疗方法可选择的晚期难治性骨与软组织肉瘤的患者可以尝试。

Clinical application of apatinib in the treatment of advanced bone and soft tissue sarcoma

  Objectives  To observe the efficacy and safety of apatinib in the treatment of advanced bone and soft tissue sarcoma, and to analyze the possible related factors affecting the progression-free survival (PFS) of patients.  Methods  Twenty-one patients with advanced bone and soft tissue sarcoma admitted to the Department of Orthopaedics, Yunnan Cancer Hospital from June 2017 to September 2018, were treated with apatinib tablets.The main efficacy index was progression free survival (PFS), and the secondary efficacy index was overall survival (OS).Clinical efficacy was evaluated according to response evaluation criteria in solid tumors (RECIST)1.1, and overall response rate (ORR), disease control rate (DCR), and safety were olserved according to the National Cancer Institute (NCI) 4.0 standard.  Results  All of the 21 patients were followed up.At the last follow-up time point, March 31st, 2019, there were no CR, 2 patients (9.5%) with PR, 7 patients with SD (33.3%), and 12 patients with PD (57.1%).The ORR was 9.5%, the DCR was 42.8%, the median PFS was 8 months, and the median OS was 14 months.The patient's gender, age, ECOG score, tissue source, surgery, or chemotherapy had no statistically significant effect on PFS (P>0.05).Only the history of radiotherapy before taking apatinib was a factor for patients with PFS.The effect was statistically significant (P< 0.05), and patients with a history of radiotherapy had a lower PFS than patients without a history of radiotherapy.The adverse reactions of grade Ⅲ and above had hand-foot syndrome (14.3%), pneumothorax (14.3%) and anemia (4.8%).  Conclusions  Apatinib has a certain effect for advanced bone and soft tissue sarcoma.The adverse reactions are generally predictable, controllable and reversible.Apatinib can be a choice for patients with advanced bone and soft tissue sarcoma with good treatment adherence and no other treatment options.