改良FOLFIRINOX新辅助化疗治疗可能切除胰腺癌的临床疗效

Clinical efficacy of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer

    摘要
  • 摘要: 目的:探讨改良FOLFIRINOX新辅助化疗治疗可能切除胰腺癌的临床疗效。
    方法:采用回顾性横断面研究方法。收集2013年4月至2015年10月天津医科大学肿瘤医院收治的28例可能切除胰腺癌患者的临床病理资料。改良FOLFIRINOX方案(伊立替康135 mg/m2，奥沙利铂64 mg/m2，亚叶酸钙400 mg/m2，5氟尿嘧啶2 400 mg/m2，每2周重复)作为新辅助化疗方案。新辅助化疗结束3周后评估手术可行性并制订手术方案。观察指标：(1)新辅助化疗效果。(2)新辅助化疗不良事件。(3)手术及术后情况。(4)随访情况。采用门诊、电话及微信群方式进行随访，了解患者生存情况，随访日期截至2017年 1月。偏态分布的计量资料以M(范围)表示。采用KaplanMeier法绘制生存曲线。采用Logrank检验进行生存分析。
    结果:(1)新辅助化疗效果：28例患者新辅助化疗中位周期为6个周期(3～12个周期)。 28例患者治疗反应：部分缓解14例，疾病稳定10例，疾病进展4例。(2)新辅助化疗不良事件：28例患者中，22例发生不良事件，其中1～2级15例，3～4级7例。新辅助化疗期间无因不良反应死亡患者，相关不良反应经对症处理后均能维持原剂量化疗。(3)手术及术后情况：28例患者中，18例施行胰腺癌根治术，其中胰十二指肠切除术11例、胰体尾部切除联合脾脏切除术7例；手术包括切除并重建门静脉及肠系膜上静脉6例，腹腔干切除1例；R0切除10例，R1切除8例。18例患者中，8例发生术后并发症，其中胰瘘 2例、胆瘘1例、胃排空功能障碍3例，吻合口出血1例、淋巴漏1例。所有并发症经保守治疗后好转，无行二次手术或术后30 d内死亡患者。术后病理学TNM分期：Ⅰ～Ⅱ期2例，Ⅲ期14例，Ⅳ期2例；术后全部患者接受化疗。10例未施行手术患者继续原方案化疗。(4)随访情况：28例患者均获得随访，中位随访时间为13个月(5～21个月)。随访期间15例患者死亡，其中5例为手术患者，10例为未施行手术患者。 18例施行手术患者的中位无进展生存时间和中位总体生存时间分别为14个月和19个月，10例未施行手术患者分别为7个月和11个月，两者生存情况比较，差异均有统计学意义(x2=7.335，9.950，P<0.05)。
    结论:改良FOLFIRINOX新辅助化疗治疗可能切除胰腺癌安全可行，患者能耐受较轻的不良反应；新辅助化疗后评估可行手术患者预后相对较好。

     

    Abstract: Objective:To investigate the clinical efficacy of modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer.
    Methods:The retrospective crosssectional study was conducted. The clinicopathological data of 28 patients diagnosed as borderline resectable pancreatic cancer who were admitted to the Tianjin Medical University Cancer Institute and Hospital between April 2013 and October 2015 were collected. Twentyeight patients were treated with modified FOLFIRINOX( irinotecan 135 mg/m2, oxaliplatin 64 mg/m2, leucovorin 400 mg/m2, 5-FU 2 400 mg/m2, repeat the regimen every 2 weeks) as neoadjuvant chemotherapy. After the completion of neoadjuvant chemotherapy, patients were evaluated operation feasibility and developed surgical planning in 3 weeks. Observation indicators: (1) Efficacy of neoadjuvant chemotherapy; (2) adverse events of neoadjuvant chemotherapy; (3) surgical and postoperative situations; (4) followup situations. Followup using outpatient examination, telephone interview and wechat was performed to detect survival of patients up to January 2017. Measurement data with skewed distribution were described as median (range). The survival curve was drawn by KaplanMeier method and the survival analysis was done by Logrank test.
    Results:(1) Efficacy of neoadjuvant chemotherapy: 28 patients received chemotherapy with a median cycle of 6 cycles (range, 3- 12 cycles). Chemotherapy reaction of 28 patients: 14 had partial remission, 10 had stable disease and 4 had progressive disease. (2) Adverse events of neoadjuvant chemotherapy: there were 22 adverse events of 28 patients during chemotherapy,including 15 with grade1-2 and 7 with grade 3-4. (3) Surgical and postoperative situations: of 28 patients, 18 received radical resection for pancreatic cancer including 11 receiving pancreaticoduodenectomy, 7 receiving distal pancreatectomy with splenectomy. Surgeries included 6 with portal vein and superior mesenteric vein resection and reconstruction, 1 with coeliac trunk resection. Ten patients received R0 resection and 8 received R1 resection. Of 18 patients, 8 with postoperative complications were improved by conservative treatment, including 2 with pancreatic fistula, 1 with biliary fistula, 3 with delayed gastric empty, 1 with anastomotic hemorrhage, 1 with lympha fistula. No patient received reoperation or died within 30 days postoperatively. Pathological TNM staging: 2 patients were detected in stage Ⅰ-Ⅱ, 14 in stage Ⅲ and 2 in stage Ⅳ. All the 18 patients received chemotherapy after operation. Ten patients without operation continued chemotherapy. (4) Following up: 28 patients were followed up for 5-21 months with a median time of 13 months. Of the 15 died patients, 5 received operation and 10 received no operation. The median progressionfree survival time and median overall survival time were 14 months and 19 months in the 18 operative patients, 7 months and 11 months in the 10 nonoperative patients, respectively, with statistically significant differences (x2=7.335, 9.950, P<0.05).
    Conclusions:Modified FOLFIRINOX as neoadjuvant chemotherapy for borderline resectable pancreatic cancer is safe and effective, and patients can tolerate mild adverse reactions. Operable patients undergo surgeries after chemotherapy have relatively good outcome.

     

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