Preoperative modified FOLFIRINOX (mFOLFIRINOX) followed by chemoradiation (CRT) for borderline resectable (BLR) pancreatic cancer (PDAC): Initial results from Alliance Trial A021101.

Gastrointestinal (Noncolorectal) Cancer
Session Type and Session Title: 
Oral Abstract Session, Gastrointestinal (Noncolorectal) Cancer
Abstract Number: 


J Clin Oncol 33, 2015 (suppl; abstr 4008)
Matthew H. G. Katz, Qian Shi, Syed A. Ahmad, Joseph M. Herman, Robert de Wilton Marsh, Eric Andrew Collisson, Lawrence H. Schwartz, Robert C. G. Martin, William Charles Conway, Mark Truty, Hedy Lee Kindler, Andrew M. Lowy, Philip Agop Philip, Tanios S. Bekaii-Saab, Dana Backlund Cardin, Noelle K. LoConte, Alan P. Venook; The University of Texas MD Anderson Cancer Center, Houston, TX; Mayo Clinic, Rochester, MN; University of Cincinnati Med Ctr, Cincinnati, OH; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Kellogg Cancer Center, NorthShore University Health System, Evanston, IL; UC San Francisco, San Francisco, CA; Columbia University Medical Center/New York Presbyterian Hospital, New York, NY; Norton Healthcare Pavil, Louisville, KY; Ochsner Medical Center, New Orleans, LA; Mayo Clinic, Rochester, NY; The University of Chicago, Chicago, IL; UC San Diego Moores Cancer Center, La Jolla, CA; Department of Oncology, Karmanos Cancer Center, Detroit, MI; The Ohio State University Comprehensive Cancer Center, Columbus, OH; Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN; University of Wisconsin Madison, Madison, WI; University of California, San Francisco, San Francisco, CA

Abstract Disclosures


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