局部晚期胰腺腺癌患者对高强度聚焦超声治疗的反应：中国一项单中心、前瞻性病例系列研究
Response of patients with locally advanced pancreatic adenocarcinoma to high-intensity focused ultrasound treatment: a single-center, prospective, case series in China.
作者信息
Ji Yongshuo, Zhang Yu, Zhu Junqiu, Zhu Linglin, Zhu Yanfei, Hu Kaimeng, Zhao Hong
机构信息
HIFU Center of Oncology Department, Huadong Hospital Affiliated to Fudan University, Shanghai 200000, China,
Marketing Department, Shanghai A&S Science Technology Development Co., Ltd, Shanghai 200000, China.
出版信息
Cancer Manag Res. 2018 Oct 9;10:4439-4446. doi: 10.2147/CMAR.S173740. eCollection 2018.
PURPOSE
Patients with unresectable locally advanced pancreatic cancer (LAPC) are still in dire need of effective therapies. We performed this cohort study in order to assess the efficacy and safety of high-intensity focused ultrasound (HIFU) ablation in treating patients with unresectable LAPC.
PATIENTS AND METHODS
Eighty-seven cases with unresectable LAPC from January 2014 to December 2016 were finally recruited according to the inclusion criteria. The primary end point of our study was OS of all the cases, and the secondary end points included 6-month and 12-month survival rate, tumor response rate, carbohydrate antigen (CA) 19-9 response rate, VAS, quality of life, and safety.
RESULTS
All the 87 patients received HIFU ablation successfully, and were included in the efficacy and safety analysis. With a median follow-up of 16 months, median OS was estimated to be 12.2 months, with 95 % CI of 11.1-12.7 months. The 6-month and 12-month survival rates were 94.25% (95% CI =86.74-97.57) and 50.85% (95% CI =38.17-62.21), respectively. Multivariate analysis revealed that patients with VAS <4, Karnofsky performance status ≥80, and tumor size <3 cm have a significant improvement in their OS (adjusted HR [aHR] =0.26 [95% CI =0.12-0.57], =0.001; aHR =0.34 [95% CI =0.17-0.68], =0.02; and aHR =0.39 [95% CI =0.20-0.78], =0.007; respectively). Tumor responses were observed in 32 (36.8%) of 87 patients and CA 19-9 response rate was 56.2%. Global health status, physical function, emotional function, and cognitive function of patients were significantly improved after HIFU treatment, and symptoms of fatigue and pain were significantly reduced. A total of 28.7% (25/87) of patients reported adverse events (AEs), mainly including fatigue (14/87), abdominal pain (7/87), fever (7/87), nausea (5/87), and rash (4/87). No severe AEs and HIFU-related deaths were reported.
CONCLUSION
HIFU ablation might be a potentially effective and safe therapeutic option for the patients with unresectable LAPC.
目的
无法切除的局部晚期胰腺癌（LAPC）患者仍迫切需要有效的治疗方法。我们进行这项队列研究以评估高强度聚焦超声（HIFU）消融治疗无法切除的LAPC患者的疗效和安全性。
患者与方法
根据纳入标准，最终纳入了2014年1月至2016年12月期间87例无法切除的LAPC患者。本研究的主要终点是所有病例的总生存期（OS），次要终点包括6个月和12个月生存率、肿瘤缓解率、糖类抗原（CA）19-9缓解率、视觉模拟评分（VAS）、生活质量和安全性。
结果
87例患者均成功接受了HIFU消融，并纳入疗效和安全性分析。中位随访16个月，中位OS估计为12.2个月，95%置信区间为11.1 - 12.7个月。6个月和12个月生存率分别为94.25%（95%CI = 86.74 - 97.57）和50.85%（95%CI = 38.17 - 62.21）。多因素分析显示，VAS<4分、卡氏功能状态评分（Karnofsky performance status）≥80分以及肿瘤大小<3 cm的患者OS有显著改善（校正风险比[aHR]=0.26[95%CI = 0.12 - 0.57]，P = 0.001；aHR = 0.34[95%CI = 0.17 - 0.68]，P = 0.02；aHR = 0.39[95%CI = 0.20 - 0.78]，P = 0.007）。87例患者中有32例（36.8%）观察到肿瘤缓解，CA 19-9缓解率为56.2%。HIFU治疗后患者的总体健康状况、身体功能区、情感功能区及认知功能区均有显著改善，疲劳和疼痛症状明显减轻。共有28.7%（25/87）的患者报告了不良事件（AE），主要包括疲劳（14/87）、腹痛（7/87）、发热（7/87）、恶心（5/87）和皮疹（4/87）。未报告严重AE及与HIFU相关的死亡病例。
结论
HIFU消融可能是无法切除的LAPC患者一种潜在有效且安全的治疗选择。
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