医脉通编译，转载请务必注明出处
2015年ASCO年会将于5月29日—6月2日在美国芝加哥召开。5月31日上午的消化系统（非结直肠）肿瘤口头报告专场上，将会发表术前调整FOLFIRINOX（mFOLFIRINOX）序贯化放疗（CRT）对可能切除胰腺癌患者的效果，即Alliance试验A021101的初步结果。医脉通提前与大家分享这项研究摘要：
静脉滴注5-FU，奥沙利铂，亚叶酸，和伊立替康（FOLFIRINOX）对转移性胰腺癌有效，而新辅助FOLFIRINOX和CRT对可能切除胰腺癌的耐受性和疗效是未知的。
研究方法：
入组患者满足ECOG评分0/1，以及胰腺癌满足以下影像学标准：1）肿瘤血管累及（TVI）肠系膜上/门静脉（SMV）≥180°，2）肿瘤血管累及肠系膜上动脉（SMA）＜180°，3）肿瘤血管累及任何程度的肝动脉。这些患者接受mFOLFIRINOX（第1天奥沙利铂85mg/m2，伊立替康180mg/m2，亚叶酸400mg/m2，序贯5-FU2400mg/m2×48小时，维持4个周期）和CRT（50.4Gy，分28次）+卡培他滨（825mg/m2，bid）在胰腺切除术前，以及术后吉西他滨（1000mg/m2 d1，8，15，维持2个周期）。
研究结果：
23例患者中有22例开始治疗（中位年龄64岁，64%的ECOG评分为0）。所有患者完成mFOLFIRINOX，21例（95%）患者完成CRT。在手术治疗过程中最佳的RECIST缓解是2例CR，4例PR，15例SD，以及1例PD。7例患者由于进展（6例）或者拒绝手术（1例）没有接受计划性切除术。在没有进行胰腺切除术的15名（68%）患者中，14例（93%）手术是R0；手术的80%和27%分别需要静脉或肝动脉切除；7例（47%）样本出现＜5%的手术后残留肿瘤细胞。在所有患者中，68%[95% CI（45.1-86.4）]接受R0/R1切除，2（9%）例达到病理上CR。
相关的III级和IV级不良事件在化疗期间发生在46%（10/22）和5%（1/22）的患者中，CRT期间发生在38%（8/21）和0%的患者中，以及胰腺切除术后发生在15%（2/13）和31%（5/13）的患者均观察到；手术90天内1例患者死亡。18例患者在不成熟的中位随访期10个月是存活。
结论：
在这项多中心胰腺癌患者研究中，肿瘤与SMV，SMA或肝动脉有大量放射累及，mFOLFIRINOX和CRT与可管理的毒性相关，但不能排除后续的切除。虽然RECIST缓解是罕见的，这种术前方案的疗效以高的R0切除率和病理缓解为基础是推荐的。临床试验信息：NCT01821612
会议专题》》》2015年ASCO年会专题报道
阅读摘要原文
Preoperative modified FOLFIRINOX (mFOLFIRINOX) followed by chemoradiation (CRT) for borderline resectable (BLR) pancreatic cancer (PDAC): Initial results from Alliance Trial A021101.（Abstract 4008）
Authors：Matthew H. G. Katz, Qian Shi，et al.
Session Type：Oral Abstract Session
Background：Infusional 5-FU, oxaliplatin, leucovorin and irinotecan (FOLFIRINOX) is effective for metastatic PDAC. The tolerability and efficacy of neoadjuvant FOLFIRINOX and CRT for BLR PDAC is unknown.
Methods：Patients (pts) with ECOG PS 0/1 and PDAC meeting any of the following centrally-reviewed radiographic criteria: 1) tumor-vessel interface (TVI) with superior mesenteric/portal vein (SMV) ≥ 180°, 2) TVI with superior mesenteric artery (SMA) < 180°, 3) TVI with hepatic artery of any degree, received mFOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, leucovorin 400 mg/m2 on day 1 followed by 5-FU 2400 mg/m2 x 48 hours for 4 cycles) and CRT (50.4 Gy in 28 fractions) with capecitabine (825mg/m2 BID) prior to pancreatectomy and postoperative gemcitabine (1000 mg/m2 d1, 8,15 x 2 cycles).
Results：22 of 23 enrolled pts started therapy (median age 64 years, 64% ECOG PS 0). All pts completed mFOLFIRINOX and 21 (95%) completed CRT. The best RECIST responses during pre-op treatment were 2 CR, 4 PR, 15 SD and 1 PD. 7 patients did not undergo planned resection due either to progression (6) or refusal (1). Among the 15 (68%) patients who did undergo pancreatectomy, 14 (93%) operations were R0; 80% and 27% of operations required vein or hepatic artery resection, respectively; 7 (47%) specimens had < 5% residual tumor cells following therapy. Among all pts, 68% [95% CI (45.1 – 86.4)] underwent R0/R1 resections and 2 (9%) achieved pathologic CR. Related grade III and IV adverse events were observed in 46% (10 of 22) and 5% (1 of 22) of pts during chemotherapy, 38% (8 of 21) and 0% during CRT, and 15% (2 of 13) and 31% (5 of 13) following pancreatectomy; 1 pt died within 90 days of surgery. 18 pts are alive with an immature median follow-up of 10 months.
Conclusions：In this multi-institutional study of pts with PDAC tumors that had a substantial radiographic interface with the SMV, SMA or hepatic artery, mFOLFIRINOX and CRT was associated with manageable toxicity that did not preclude subsequent resection. Although a RECIST response was uncommon, the efficacy of this preoperative regimen is suggested by high rates of R0 resection and pathologic response. Clinical trial information: NCT01821612
