Division of Surgical Oncology, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL.
Division of Surgical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.
Ann Surg. 2019 Sep;270(3):400-413. doi: 10.1097/SLA.0000000000003468.
To compare the survival outcomes associated with clinical and pathological response in pancreatic ductal adenocarcinoma (PDAC) patients receiving neoadjuvant chemotherapy (NAC) with FOLFIRINOX (FLX) or gemcitabine/nab-paclitaxel (GNP) followed by curative-intent pancreatectomy.
Newer multiagent NAC regimens have resulted in improved clinical and pathological responses in PDAC; however, the effects of these responses on survival outcomes remain unknown.
Clinicopathological and survival data of PDAC patients treated at 7 academic medical centers were analyzed. Primary outcomes were overall survival (OS), local recurrence-free survival (L-RFS), and metastasis-free survival (MFS) associated with biochemical (CA 19-9 decrease ≥50% vs <50%) and pathological response (complete, pCR; partial, pPR or limited, pLR) following NAC.
Of 274 included patients, 46.4% were borderline resectable, 25.5% locally advanced, and 83.2% had pancreatic head/neck tumors. Vein resection was performed in 34.7% and 30-day mortality was 2.2%. R0 and pCR rates were 82.5% and 6%, respectively. Median, 3-year, and 5-year OS were 32 months, 46.3%, and 30.3%, respectively. OS, L-RFS, and MFS were superior in patients with marked biochemical response (CA 19-9 decrease ≥50% vs <50%; OS: 42.3 vs 24.3 months, P < 0.001; L-RFS-27.3 vs 14.1 months, P = 0.042; MFS-29.3 vs 13 months, P = 0.047) and pathological response [pCR vs pPR vs pLR: OS- not reached (NR) vs 40.3 vs 26.1 months, P < 0.001; L-RFS-NR vs 24.5 vs 21.4 months, P = 0.044; MFS-NR vs 23.7 vs 20.2 months, P = 0.017]. There was no difference in L-RFS, MFS, or OS between patients who received FLX or GNP.
This large, multicenter study shows that improved biochemical, pathological, and clinical responses associated with NAC FLX or GNP result in improved OS, L-RFS, and MFS in PDAC. NAC with FLX or GNP has similar survival outcomes.
比较接受新辅助化疗（NAC）后行根治性胰腺切除术的胰腺导管腺癌（PDAC）患者临床和病理反应与生存结局的相关性，NAC 方案分别采用 FOLFIRINOX（FLX）或吉西他滨/白蛋白紫杉醇（GNP）。
新的多药 NAC 方案可提高 PDAC 的临床和病理反应，但这些反应对生存结局的影响尚不清楚。
分析 7 家学术医疗中心治疗的 PDAC 患者的临床病理和生存数据。主要结局是总生存（OS）、局部无复发生存（L-RFS）和无转移生存（MFS），与 NAC 后的生化反应（CA19-9 降低≥50%比<50%）和病理反应（完全缓解，pCR；部分缓解，pPR 或有限缓解，pLR）相关。
在 274 名纳入患者中，46.4%为边界可切除，25.5%为局部晚期，83.2%为胰头/颈部肿瘤。34.7%进行了静脉切除术，30 天死亡率为 2.2%。R0 和 pCR 率分别为 82.5%和 6%。中位、3 年和 5 年 OS 分别为 32 个月、46.3%和 30.3%。在具有显著生化反应（CA19-9 降低≥50%比<50%）和病理反应[ pCR 比 pPR 比 pLR：OS-未达到（NR）比 24.3 个月，P<0.001；L-RFS-27.3 比 14.1 个月，P=0.042；MFS-29.3 比 13 个月，P=0.047]的患者中，OS、L-RFS 和 MFS 更优。与接受 FLX 或 GNP 的患者相比，在接受 NAC FLX 或 GNP 后具有改善的生化、病理和临床反应的患者中，OS、L-RFS 和 MFS 无差异。
这项大型多中心研究表明，NAC FLX 或 GNP 相关的生化、病理和临床反应的改善导致 PDAC 的 OS、L-RFS 和 MFS 改善。接受 NAC FLX 或 GNP 的患者具有相似的生存结局。
