Department of Ultrasound, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University, 651 Dongfengdong Road, Guangzhou, 510060, China.
Department of Ultrasound, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, No. 52 of Fucheng Road, Haidian District, Beijing, 100142, China.
Eur Radiol. 2024 Mar;34(3):1481-1492. doi: 10.1007/s00330-023-10210-4. Epub 2023 Oct 5.
Sonochemotherapy, which uses microbubble (MB)-assisted ultrasound (US) to deliver chemotherapeutic agents, has the potential to enhance tumour chemotherapy. The combination of US and MB has been demonstrated to prolong the survival of patients with pancreatic cancer. This phase 2 clinical trial aimed to determine the clinical efficacy and safety of sonochemotherapy for inoperable pancreatic ductal adenocarcinoma by using US and MB.
Eighty-two patients with stage III or IV pancreatic cancer were recruited from July 2018 to March 2021 and followed up until September 2022. US treatment was performed with a modified diagnostic US scanner for 30 min after chemotherapeutic infusion. The primary endpoint was overall survival (OS), and the secondary endpoints were Eastern Cooperative Oncology Group (ECOG) status < 2, progression-free survival (PFS), disease control rate (DCR), and adverse events.
Seventy-eight patients were randomly allocated (40 to chemotherapy and 38 to sonochemotherapy). The median OS was longer with sonochemotherapy than with chemotherapy (9.10 vs. 6.10 months; p = 0.037). The median PFS with sonochemotherapy was 5.50 months, compared with 3.50 months (p = 0.080) for chemotherapy. The time of ECOG status < 2 was longer with sonochemotherapy (7.20 months) than with chemotherapy (5.00 months; p = 0.029). The DCR was 73.68% for sonochemotherapy compared with 42.50% for the control (p = 0.005). The incidence of overall adverse events was balanced between the two groups.
The use of sonochemotherapy can extend the survival and well-being time of stage III or IV pancreatic cancer patients without any increase in serious adverse events.
ChineseClinicalTrials.gov ChiCTR2100044721 CLINICAL RELEVANCE STATEMENT: This multicentre, randomised, controlled trial has proven that sonochemotherapy, namely, the combination of diagnostic ultrasound, microbubbles, and chemotherapy, could extend the overall survival of patients with end-stage pancreatic ductal adenocarcinoma from 6.10 to 9.10 months without increasing any serious adverse events.
• This is the first multicentre, randomised, controlled trial of sonochemotherapy for clinical pancreatic cancer treatment using ultrasound and a commercial ultrasound contrast agent. • Sonochemotherapy extended the median overall survival from 6.10 (chemotherapy alone) to 9.10 months. • The disease control rate increased from 42.50% with chemotherapy to 73.68% with sonochemotherapy.
声化疗利用微泡（MB）辅助超声（US）来递送化疗药物，具有增强肿瘤化疗的潜力。已经证明，US 和 MB 的联合使用可以延长胰腺癌患者的生存时间。这项 2 期临床试验旨在通过 US 和 MB 确定无法手术的胰腺导管腺癌的声化疗的临床疗效和安全性。
2018 年 7 月至 2021 年 3 月期间招募了 82 名 III 期或 IV 期胰腺癌患者，并随访至 2022 年 9 月。在化疗输注后使用改良的诊断性 US 扫描仪进行 30 分钟的 US 治疗。主要终点是总生存期（OS），次要终点是东部合作肿瘤学组（ECOG）状态<2、无进展生存期（PFS）、疾病控制率（DCR）和不良事件。
78 名患者被随机分配（化疗组 40 名，声化疗组 38 名）。声化疗的中位 OS 长于化疗组（9.10 个月比 6.10 个月；p = 0.037）。声化疗的中位 PFS 为 5.50 个月，而化疗组为 3.50 个月（p = 0.080）。声化疗组 ECOG 状态<2 的时间长于化疗组（7.20 个月比 5.00 个月；p = 0.029）。声化疗组的 DCR 为 73.68%，对照组为 42.50%（p = 0.005）。两组总体不良事件发生率平衡。
声化疗可延长 III 或 IV 期胰腺癌患者的生存和缓解时间，而不会增加严重不良事件。
ChineseClinicalTrials.gov ChiCTR2100044721 临床相关性声明：这项多中心、随机、对照试验已经证明，声化疗，即诊断性超声、微泡和化疗的联合使用，可以将终末期胰腺导管腺癌患者的总生存期从 6.10 个月延长至 9.10 个月，而不会增加任何严重的不良事件。
• 这是首次使用超声和商业超声造影剂治疗临床胰腺癌的多中心、随机、对照的声化疗试验。
• 声化疗将中位总生存期从 6.10 个月（单独化疗）延长至 9.10 个月。
• 疾病控制率从化疗的 42.50%增加到声化疗的 73.68%。
