Lessons learned: The triple combination chemotherapy of SOXIRI (S-1/oxaliplatin/irinotecan) in patients with unresectable pancreatic ductal adenocarcinoma was an effective treatment that appeared to be better tolerated than the widely used FOLFIRINOX regimen.SOXIRI regimen may provide an alternative approach for advanced pancreatic cancer.
Background: In our previous phase I study, we determined the recommended dose of a biweekly S-1, oxaliplatin, and irinotecan (SOXIRI) regimen in patients with unresectable pancreatic ductal adenocarcinoma (PDAC). This phase II study was conducted to assess the safety and clinical efficacy in patients with unresectable PDAC.
Methods: Patients with previously untreated metastatic and locally advanced PDAC were enrolled. The primary endpoint was response rate (RR). Secondary endpoints were adverse events (AEs), progression-free survival (PFS), and overall survival (OS). Patients received 80 mg/m2 of S-1 twice a day for 2 weeks in alternate-day administration, 150 mg/m2 of irinotecan on day 1, and 85 mg/m2 of oxaliplatin on day 1 of a 2-week cycle.
Results: Thirty-five enrolled patients received a median of six (range: 2-15) treatment cycles. The RR was 22.8% (95% confidence interval [CI]: 10.4-40.1); median OS, 17.7 months (95% CI: 9.8-22.0); and median PFS, 7.4 months (95% CI: 4.2-8.4). Furthermore, the median OS in patients with distant metastasis was 10.1 months, whereas that in patients with locally advanced PDAC was 22.6 months. Major grade 3 or 4 toxicity included neutropenia (54%), anemia (17%), febrile neutropenia (11%), anorexia (9%), diarrhea (9%), and nausea (9%). There were no treatment-related deaths.
Conclusion: SOXIRI is considered a promising and well-tolerated regimen in patients with unresectable PDAC.
经验获取
•SOXIRI(S‐1/奥沙利铂/伊立替康)三联化疗治疗无法切除的胰腺导管腺癌患者，似乎比目前广泛使用的 FOLFIRINOX 方案要更耐受，是一种有效的治疗方案。
•SOXIRI 方案可能为晚期胰腺癌提供另一种治疗方法。
摘要
背景。在我们之前的 I 期研究中，我们确定了两周一次的 S‐1，奥沙利铂和伊立替康 (SOXIRI) 方案的推荐剂量用于治疗患有无法切除的胰腺导管腺癌 (PDAC) 的患者。进行这项 II 期研究旨在评估无法切除的 PDAC 患者的安全性和临床疗效。
方法。招募未经治的转移性和局部晚期 PDAC 的患者。主要终点为缓解率 (RR)。次要终点为不良事件 (AE)，无进展生存期 (PFS) 和总生存期 (OS)。患者接受 2 周S‐1 80 mg/m2，隔日给药，每天两次， 在第 1 天接受伊立替康 150 mg/m2 和奥沙利铂 85mg/m2，2 周为一周期。
结果。35 名入组患者接受中位数为 6(范围:2‐15 )的治疗周期。RR 为 22.8% [95% 置信区间 (CI):10.4‐40.1]；中位OS，17.7 个月(95% CI:9.8‐22.0)；中位PFS，7.4 个月(95% CI:4.2‐8.4)。此外，发生远处转移的患者的中位 OS 为 10.1 个月，而局部晚期 PDAC 患者的中位 OS 为 22.6 个月。主要的 3 级或 4 级毒性包括中性粒细胞减少症(54%)、贫血症(17%)、发热性中性粒细胞减少症(11%)、厌食(9%)、腹泻(9%)和恶心(9%)。无治疗相关的死亡。
结论。对于无法切除的 PDAC 患者，SOXIRI 被认为是一种颇具前景且耐受良好的治疗方案。
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