*Gastrointestinal Oncology Service †Department of Medicine ‡Hepatopancreaticobiliary Surgery Service §Gastroenterology and Nutrition Service Departments of ¶Epidemiology and Biostatistics ‖Pathology **Radiology ††Surgery; and ‡‡Gastric and Mixed Tumor Service, Memorial Sloan-Kettering Cancer Center, New York, NY.
Ann Surg. 2014 Jul;260(1):142-8. doi: 10.1097/SLA.0000000000000251.
The role for neoadjuvant systemic therapy in resectable pancreas adenocarcinoma remains undefined.
We evaluated the efficacy of gemcitabine and oxaliplatin administered as preoperative therapy in patients with resectable pancreas adenocarcinoma.
Eligible patients were screened using computed tomography-pancreas angiography, laparoscopy, endoscopic ultrasonography, and fine-needle aspiration cytology to identify 38 patients who received 4 cycles of neoadjuvant gemcitabine 1000 mg/m intravenously over 100 minutes and oxaliplatin 80 mg/m intravenously over 2 hours, every 2 weeks. Patients whose tumors remained resectable at restaging proceeded to operation and subsequently received 5 cycles of adjuvant gemcitabine (1000 mg/m intravenously over 30 minutes days 1, 8, and 15 every 4 weeks). The primary endpoint was 18-month overall survival and secondary endpoints included radiological, tumor marker and pathological response to neoadjuvant therapy, time to recurrence, patterns of failure, and feasibility of obtaining preoperative core biopsies.
Thirty-five of 38 patients (92%) completed neoadjuvant therapy. Twenty-seven patients underwent tumor resection (resectability rate 71%), of which 26 initiated adjuvant therapy for a total of 23 patients (60.5%) who completed all planned therapy. The 18-month survival was 63% (24 patients alive). The median overall survival for all 38 patients was 27.2 months (95% confidence interval: 17-NA) and the median disease-specific survival was 30.6 months (95% confidence interval: 19-NA).
This study met its endpoint and provided a signal suggesting that exploration of neoadjuvant systemic therapy is worthy of further investigation in resectable pancreas adenocarcinoma. Improved patient selection and more active systemic regimens are key. Clinical trials identification: NCT00536874.
新辅助系统治疗在可切除胰腺腺癌中的作用仍未确定。
我们评估了替吉奥联合奥沙利铂术前治疗可切除胰腺腺癌患者的疗效。
使用 CT 胰腺血管造影、腹腔镜检查、内镜超声检查和细针抽吸细胞学检查筛选符合条件的患者，共筛选出 38 例患者，接受 4 个周期的新辅助吉西他滨 1000mg/m2 静脉滴注 100 分钟，奥沙利铂 80mg/m2 静脉滴注 2 小时，每 2 周 1 次。在重新分期时肿瘤仍可切除的患者继续手术，随后接受 5 个周期的辅助吉西他滨（1000mg/m2 静脉滴注 30 分钟，第 1、8 和 15 天，每 4 周 1 次）。主要终点为 18 个月总生存率，次要终点包括新辅助治疗的影像学、肿瘤标志物和病理反应、复发时间、失败模式和获得术前核心活检的可行性。
38 例患者中 35 例（92%）完成新辅助治疗。27 例患者行肿瘤切除术（可切除率为 71%），其中 26 例患者开始接受辅助治疗，共有 23 例患者（60.5%）完成了所有计划的治疗。18 个月生存率为 63%（24 例存活）。38 例患者的中位总生存期为 27.2 个月（95%置信区间：17-N/A），中位疾病特异性生存期为 30.6 个月（95%置信区间：19-N/A）。
本研究达到了终点，并提供了一个信号，表明探索可切除胰腺腺癌的新辅助系统治疗是值得进一步研究的。关键是要改进患者选择和更积极的系统治疗方案。临床试验识别号：NCT00536874。
