Department of Surgery, Erasmus MC Cancer Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands.
Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
J Natl Cancer Inst. 2022 May 9;114(5):695-703. doi: 10.1093/jnci/djac018.
Large pragmatic studies of patients who received 5-fluorouracil with leucovorin, irinotecan, and oxaliplatin ([m]FOLFIRINOX) as initial treatment for localized pancreatic ductal adenocarcinoma (PDAC) are lacking. This study aimed to provide realistic estimates of oncologic outcomes in these patients.
This international retrospective cohort study included all consecutive patients presenting with localized PDAC who received at least 1 cycle of (m)FOLFIRINOX as initial treatment in 5 referral centers from the United States and the Netherlands (2012-2019). Primary outcome was median overall survival (OS), calculated from the date of tissue diagnosis, assessed using Kaplan-Meier estimates. Log-rank test was used to compare OS between groups. A Cox proportional hazards regression model was used to assess prognostic baseline factors for OS. All statistical tests were 2-sided.
Overall, 1835 patients were included, of whom 958 (52.2%) had locally advanced (LA), 531 (28.9%) had borderline resectable (BR), and 346 (18.9%) had potentially resectable (PR) PDAC. The median number of (m)FOLFIRINOX cycles was 6 (interquartile range = 4-8). Subsequent treatment included second chemotherapy (12.9%), radiotherapy (49.0%), and resection (37.9%). The resection rate was 17.6% for LA, 53.1% for BR, and 70.5% for PR PDAC (P < .001). The margin-negative resection rate (>1 mm) was 55.2% for LA, 62.6% for BR, and 79.2% for PR PDAC (P < .001). The median OS was 18.7 months (95% confidence interval [CI] = 17.7 to 19.9 months) for LA, 23.2 months (95% CI = 21.0 to 25.7 months) for BR, and 31.2 months (95% CI = 26.2 to 36.6 months) for PR PDAC (P < .001). The median OS for 695 patients who underwent a resection was 38.3 months (95% CI = 36.1 to 42.0 months). Independent prognostic factors at baseline for worse OS were more advanced stage, worse performance status, baseline carbohydrate antigen (CA) 19-9 > 500 U/mL, and body mass index ≤18.5 kg/m2.
This large international cohort study provides realistic estimates of resection rates and survival in patients with LA, BR, and PR PDAC who started (m)FOLFIRINOX treatment in PDAC referral centers.
缺乏接受氟尿嘧啶+亚叶酸钙、伊立替康和奥沙利铂（[m]FOLFIRINOX）作为局部胰腺导管腺癌（PDAC）初始治疗的患者的大型实用研究。本研究旨在提供这些患者的肿瘤学结果的真实估计。
本国际回顾性队列研究纳入了在美国和荷兰的 5 个转诊中心接受至少 1 个周期（m）FOLFIRINOX 作为初始治疗的所有局部 PDAC 连续患者（2012-2019 年）。主要结局是从组织诊断日期计算的中位总生存期（OS），使用 Kaplan-Meier 估计进行评估。对数秩检验用于比较组间的 OS。使用 Cox 比例风险回归模型评估 OS 的预后基线因素。所有统计检验均为双侧。
共有 1835 例患者入选，其中 958 例（52.2%）为局部晚期（LA），531 例（28.9%）为交界可切除（BR），346 例（18.9%）为潜在可切除（PR）PDAC。（m）FOLFIRINOX 周期的中位数为 6（四分位间距=4-8）。后续治疗包括二线化疗（12.9%）、放疗（49.0%）和切除术（37.9%）。LA 的切除术率为 17.6%，BR 为 53.1%，PR PDAC 为 70.5%（P<0.001）。LA 的阴性切缘切除术率（>1 mm）为 55.2%，BR 为 62.6%，PR PDAC 为 79.2%（P<0.001）。LA 的中位 OS 为 18.7 个月（95%置信区间[CI] = 17.7 至 19.9 个月），BR 为 23.2 个月（95% CI = 21.0 至 25.7 个月），PR PDAC 为 31.2 个月（95% CI = 26.2 至 36.6 个月）（P<0.001）。接受切除术的 695 例患者的中位 OS 为 38.3 个月（95% CI = 36.1 至 42.0 个月）。基线时 OS 较差的独立预后因素包括更晚期的分期、更差的体能状态、基线碳水化合物抗原（CA）19-9>500 U/mL 和体重指数≤18.5 kg/m2。
本大型国际队列研究提供了在 PDAC 转诊中心接受（m）FOLFIRINOX 治疗的 LA、BR 和 PR PDAC 患者的切除术率和生存的真实估计。
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