Lessons learned: Modification of FOLFIRINOX significantly improves safety and tolerability in Chinese patients with locally advanced pancreatic cancer.Patients with locally advanced pancreatic cancer benefit from neoadjuvant therapy and experience a much better survival than patients with upfront surgery.
Background: The objective of this study was to evaluate the efficacy of modified-FOLFIRINOX (mFOLFIRINOX) regimens in Chinese patients with locally advanced pancreatic cancer (LAPC) and to compare outcomes between patients with LAPC treated with mFOLFIRINOX-based neoadjuvant therapy (LAPC-N) and patients with LAPC who underwent upfront surgery (LAPC-S).
Methods: Forty-one patients with LAPC-N were enrolled prospectively. Imaging features, chemotherapy response, adverse events, perioperative complications, histology, and survival were analyzed. Seventy-four patients with resectable pancreatic cancer (RPC) (from April 2012 to November 2017) and 19 patients with LAPC-S (from April 2012 to March 2014) were set as observational cohorts, and data were collected retrospectively. LAPC-N patients with adequate response underwent surgical treatment, whereas continuous chemotherapy was given to LAPC-N patients who were not deemed resectable after treatment, and the response was re-evaluated every 2 months.
Results: Forty-one patients with LAPC received mFOLFIRINOX with a response rate of 37.1%. The most common severe adverse events were neutropenia and anemia. mFOLFIRINOX-based neoadjuvant therapy contributed to a remarkable decrease in CA19-9 level and tumor diameter. Fourteen LAPC-N patients underwent surgery (LAPC-N-S) after downstaging. Compared with LAPC-N-S cases, LAPC-S patients had longer operative time, more blood loss, and a higher risk of grade 5 complications. The median overall survival (OS) and progression-free survival (PFS) of LAPC-N-S patients were 27.7 months and 19.3 months, respectively, which were similar to those of patients with RPC (30.0 months and 23.0 months) and much longer than those of patients with LAPC-S (8.9 months and 7.6 months), respectively.
Conclusion: Neoadjuvant chemotherapy such as the mFOLFIRINOX regimen can be recommended for Chinese patients with LAPC after dose modification. Patients with LAPC-N who underwent surgery obtained significantly improved survival compared with patients in the observational LAPC-S cohort, who did not undergo neoadjuvant therapy.
经验教训
• FOLFIRINOX 的改良显著提高了中国局部晚期胰腺癌患者的安全性和耐受性。
• 局部晚期胰腺癌患者从新辅助治疗中获益，并且比前期手术患者的生存率更高。
摘要
背景。本研究的目的是评估改良 FOLFIRINOX (mFOLFIRINOX) 方案对中国局部晚期胰腺癌 (LAPC) 患者的疗效，并将采用基于 mFOLFIRINOX 的新辅助治疗 (LAPC‐N) 进行治疗的 LAPC 患者的预后与接受了前期手术 (LAPC‐S) 的 LAPC 患者的预后进行比较。
方法。41例LAPC‐N 患者前瞻性入组。对影像特征、化疗反应、不良事件、围手术期并发症、组织学和生存率进行了分析。将 74例可切除的胰腺癌 (RPC) 患者(2012 年 4 月至 2017 年 11 月)和 19例LAPC‐S 患者(2012 年 4 月至 2014 年 3 月)作为观察队列，并回顾性收集数据。具有适当缓解的 LAPC‐N 患者接受了手术治疗，而对于在治疗后认为不可进行切除手术的 LAPC‐N 患者进行连续化疗，并且每 2 个月重新评估一次缓解。
结果。接受了 mFOLFIRINOX 的 41 例 LAPC 患者的缓解率为 37.1%。最常见的严重不良事件是中性粒细胞减少和贫血。基于 mFOLFIRINOX 的新辅助治疗有助于 CA19‐9 水平和肿瘤直径的显著降低。14例LAPC‐N 患者在指标下降后接受了手术 (LAPC‐N‐S)。与 LAPC‐N‐S 病例相比，LAPC‐S 患者的手术时间更长，失血更多，5 级并发症风险更高。LAPC‐N‐S 患者的中位总生存期 (OS) 和无进展生存期 (PFS) 分别为 27.7 个月和 19.3 个月，与 RPC 患者(30.0 个月和 23.0 个月)相似，且远远长于 LAPC‐S 患者(8.9 个月和 7.6 个月)。
结论。推荐中国 LAPC 患者采用调整剂量后的新辅助化疗，如 mFOLFIRINOX 方案。与未接受新辅助治疗的观察性 LAPC‐S 队列患者相比，接受手术的 LAPC‐N 患者的生存率显著提高。
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