Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.
Clinical Study Group of Osaka University, Hepato-Biliary-Pancreatic Group, Osaka, Japan.
Ann Surg Oncol. 2019 Dec;26(13):4498-4505. doi: 10.1245/s10434-019-07735-8. Epub 2019 Aug 22.
Neoadjuvant therapy reportedly shows only marginal clinical benefit in pancreatic ductal adenocarcinoma (PDAC), especially in resectable cases. However, with more effective regimens, neoadjuvant therapy may become a standard of care for resectable cases. A prospective, open-label, multicenter phases 1 and 2 trial of neoadjuvant therapy was conducted using full-dose gemcitabine and S-1 concurrently with 50.4 Gy of radiation therapy (GSRT) for resectable PDAC. This report describes the phase 2 results.
The phase 2 part of this study enrolled 57 patients with cytologically or histologically proven PDAC deemed resectable based on imaging before neoadjuvant therapy. These patients received GSRT. After reevaluation by computed tomography scan, surgical exploration was performed, followed by adjuvant therapy. According to the prescribed protocol of the clinical trial, statistical analyses included 57 phase 2 patients and 6 phase 1 patients who received the same dosage as in phase 2.
This trial enrolled 63 patients (42 men and 21 women) with a median age of 70 years. Leukopenia or neutropenia of grade 3 or higher occurred for 79% of the patients, but no other severe adverse events were observed. Among the 63 patients, 54 underwent surgical resection. Intention-to-treat analysis of the 63 patients showed an excellent median survival time lasting as long as 55.3 months. The patients who completed neoadjuvant therapy, surgery, and adjuvant therapy had a 5-year survival rate of 56.6%.
This regimen showed outstanding clinical efficacy with acceptable tolerability for patients with resectable PDAC.
新辅助治疗据称仅在胰腺导管腺癌（PDAC）中显示出轻微的临床获益，尤其是在可切除病例中。然而，随着更有效的方案的出现，新辅助治疗可能成为可切除病例的标准治疗方法。一项使用全剂量吉西他滨和 S-1 联合 50.4Gy 放射治疗（GSRT）治疗可切除 PDAC 的新辅助治疗的前瞻性、开放标签、多中心 1 期和 2 期试验进行了描述。本报告介绍了 2 期结果。
本研究的 2 期部分纳入了 57 名经细胞学或组织学证实的 PDAC 患者，这些患者根据新辅助治疗前的影像学检查被认为是可切除的。这些患者接受 GSRT。在计算机断层扫描重新评估后，进行手术探查，然后进行辅助治疗。根据临床试验的规定方案，统计分析包括 57 名接受 2 期相同剂量的 2 期患者和 6 名接受 1 期相同剂量的患者。
该试验纳入了 63 名患者（42 名男性和 21 名女性），中位年龄为 70 岁。79%的患者出现 3 级或以上的白细胞减少或中性粒细胞减少，但未观察到其他严重不良事件。在 63 名患者中，54 名接受了手术切除。63 名患者的意向治疗分析显示，中位生存时间长达 55.3 个月，效果极佳。完成新辅助治疗、手术和辅助治疗的患者 5 年生存率为 56.6%。
对于可切除的 PDAC 患者，该方案具有出色的临床疗效和可接受的耐受性。
