The safety, efficacy, and treatment outcomes of a combination of low-dose decitabine treatment in patients with recurrent ovarian cancer
The safety, efficacy, and treatment outcomes of a combination of low-dose decitabine treatment in patients with recurrent ovarian cancer
复制标题
小剂量地西他滨联合治疗复发性卵巢癌患者的安全性、有效性和治疗结果
DOI：
10.1080/2162402x.2017.1323619
复制
发表时间：
2017
期刊：
影响因子：
7.2
通讯作者：
Han Weidong
中科院分区：
文献类型：
--
作者：
Zhang Yan;Mei Qian;Liu Yang;Li Xiang;Brock Malcolm V.;Chen Meixia;Dong Liang;Shi Lu;Wang Yao;Guo Mingzhou;Nie Jing;Han Weidong
目的：DNA去甲基化剂在血液肿瘤和实体瘤中显示出临床有效性。本试验测试的安全性，疗效和治疗结果的地西他滨为基础的化疗或结合免疫治疗复发性卵巢癌patients.Patients和方法：55例复发性卵巢癌患者参加了52评估的临床反应和生存。患者接受5-d地西他滨治疗，然后减少紫杉醇/卡铂给药剂量（DTC队列），或上述方案联合苦参碱诱导的杀伤细胞治疗（DTC+CIK队列）。主要终点是临床反应率和无进展生存期（PFS）。结果：按RECIST标准，疾病可测量患者的疾病控制率（DCR）和客观缓解率（ORR）分别为73.91%和23.91%，合计76.92%和30.77%，包括疾病不可测量患者，铂类耐药/难治患者的DCR和ORR均高于铂类耐药/难治患者。临床获益可能与DAC治疗周期数和CIK免疫治疗的纳入相关。在DTC+CIK队列中，DCR和ORR分别达到100%和58.30%。值得注意的是，DTC+CIK治疗铂类耐药/难治性患者的ORR为87.50%。一致地，与铂敏感患者相比，铂耐药/难治患者的PFS更长。DTC+CIK治疗铂类耐药/难治患者的PFS和OS分别为8和19个月。最常见的毒副反应为恶心、厌食、乏力、中性粒细胞减少和贫血，其中多为1- 2级。结论：低剂量DAC/紫杉醇/卡铂方案对铂类耐药/难治性卵巢癌患者有较好的疗效，联合过继免疫治疗对铂类耐药/难治性卵巢癌患者有较好的临床疗效。
Purpose: DNA demethylating agents have shown clinical effectiveness in hematological and solid tumors. This trial tested the safety, efficacy, and treatment outcomes of decitabine-based chemotherapy or combined with immunotherapy in recurrent ovarian cancer patients.Patients and methods: Fifty-five patients with recurrent ovarian cancer were enrolled and 52 were assessable for clinical response and survival. Patients either received 5-d decitabine treatment, followed by reduced-dose of paclitaxel/carboplatin administration (DTC cohort), or the aforementioned regimen combined with cytokine-induced killer cells therapy (DTC+CIK cohort). The primary end point was clinical response rate and progression-free survival (PFS). Secondary evaluation included safety assessment and overall survival (OS).Results: Disease control rate (DCR) and objective response rate (ORR) were 73.91% and 23.91% in disease measurable patients by RECIST criteria, totally 76.92% and 30.77%, including disease non-measurable patients, which were higher in platinum-resistant/refractory patients. Clinical benefits could be associated with the number of DAC treatment cycles and the inclusion of CIK immunotherapy. In DTC+CIK cohort, DCR and ORR reached 100% and 58.30%, respectively. Notably, DTC+CIK treatment in platinum-resistant/refractory patients had an ORR of 87.50%. Consistently, PFS was longer in platinum-resistant/refractory patients comparing with that of platinum-sensitive patients. PFS and OS were 8 and 19 mo in platinum-resistant/refractory patients with DTC+CIK therapy. The most common toxicities were nausea, anorexia, fatigue, neutropenia, and anemia; many of which were grade 1–2.Conclusion: Low-dose DAC/paclitaxel/carboplatin regimen demonstrates disease benefit, especially in patients with platinum-resistant/refractory ovarian cancer, and might show remarkable clinical response when combined with adoptive immunotherapy in platinum-resistant/refractory ovarian cancer patients.