| 杨允奔,褚嘉栋,应杰儿.胰腺导管腺癌寡转移患者转移灶定向治疗联合系统治疗生存获益：EXTEND研究结果解读[J].肿瘤学杂志,2024,30(11):967-973. |
| 胰腺导管腺癌寡转移患者转移灶定向治疗联合系统治疗生存获益：EXTEND研究结果解读 |
| Survival Benefit of Metastasis-Directed Therapy Combined with Systemic Treatment for Patients with Oligometastatic Pancreatic Ductal Adenocarcinoma： Interpretation of EXTEND Study |
| 投稿时间：2024-10-19 |
| DOI：10.11735/j.issn.1671-170X.2024.11.B012 |
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| 中文关键词: 胰腺导管腺癌 寡转移 转移灶定向治疗 立体定向放射治疗 疗效 |
| 英文关键词:pancreatic ductal adenocarcinoma oligometastasis metastasis-directed therapy stereotactic radiotherapy efficacy |
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| 摘要点击次数: 52 |
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| 中文摘要: |
| 摘 要： EXTEND研究是一项多中心、基于篮式设计的临床研究，报告了其中针对胰腺导管腺癌（pancreatic ductal adenocarcinoma，PDAC）寡转移患者的随机对照研究结果，即评估转移灶定向治疗（metastasis-directed therapy，MDT）联合化疗对比单纯化疗是否能改善PDAC寡转移患者的生存状况。该研究共纳入41例患者，按1∶1随机分配到MDT联合组（n=20）和对照组（n=21）。主要入组标准：①年龄≥18岁；②既往接受过≤4次转移性疾病系统治疗；③转移性病灶≤5个，且适合MDT；④ECOG评分0~2分。主要终点为无进展生存期（临床进展/影像学进展/死亡），次要终点包括总生存时间、至下一线系统治疗时间、安全性和生活质量等。探索性终点为系统免疫反应相关指标。在中位随访17.3个月后，40例患者可评估疗效（MDT联合组19例，对照组21例）。与对照组比较，MDT联合组中位无进展生存期显著性延长［10.3个月（95%CI： 4.6~14.0个月） vs 2.5个月（95%CI： 1.7~5.1个月），HR=0.43，95%CI： 0.20~0.94，P=0.030 ］，中位总生存时间无明显获益［ 12个月（95%CI： 8~23个月） vs 10个月（95%CI：7个月~未达到），HR=0.58，95%CI： 0.25~1.34，P=0.200］；未观察到与MDT相关的≥3级不良事件。该研究主要终点无进展生存期分析达到统计学意义，提示PDAC寡转移患者进行MDT可能带来临床获益。然而，鉴于样本量有限，仍需大规模随机对照试验进一步验证MDT在这一人群中的长期疗效和安全性。 |
| 英文摘要: |
| Abstract： The EXTEND study is a multicenter， basket-designed clinical trial. This article reports the study results targeting oligometastatic pancreatic ductal adenocarcinoma(PDAC)， evaluating whether metastasis-directed therapy(MDT) combined with chemotherapy can improve survival compared to chemotherapy alone in patients with PDAC. Forty one eligible patients were enrolled and randomly assigned (1∶1) to the MDT plus chemotherapy group (n=20) or the control group (n=21). Key inclusion criteria were： ① age ≥18 years； ② prior receipt of no more than four lines of systemic therapy for metastatic disease； ③≤5 metastatic lesions amenable to MDT； ④ Eastern Cooperative Oncology Group (ECOG) performance status score of 0~2. The primary endpoint was progression-free survival (PFS)， defined as clinical progression， radiographic progression or death. Secondary endpoints included overall survival (OS)， time to next-line systemic therapy， toxicity and quality of life. Exploratory endpoints involved systemic immune response indicators. After a median follow-up of 17.3 months， 40 patients were evaluable (MDT plus chemotherapy group n=19， control group n=21). Compared with the control group， the MDT plus chemotherapy group significantly prolonged median PFS ［10.3 months (95%CI： 4.6~14.0) vs 2.5 months (95%CI： 1.7~5.1)， HR=0.43， 95%CI： 0.20~0.94， P=0.030］ ， but had no significant benefit for median OS ［12 months (95%CI： 8~23) vs 10 months (95%CI： 7~not available)， HR=0.58， 95%CI： 0.25~1.34， P=0.200］. No MDT-related ≥ grade 3 adverse events were observed. The analysis of the primary endpoint PFS achieved statistical significance， suggesting that MDT may provide clinical benefits for patients with oligometastatic PDAC. However， given the limited sample size， large-scale phase Ⅲ randomized controlled trials are necessary to verify the long-term efficacy and safety of MDT in this population. |
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