Phase II trial of preoperative modified FOLFIRINOX (mFOLFIRINOX) followed by postoperative gemcitabine (GEM) in patients (pts) with borderline resectable pancreatic ductal adenocarcinomas (BR-PDAC).

Authors

null

Changhoon Yoo

Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South)

Changhoon Yoo , Kyu-Pyo Kim , Ki Byung Song , Sang Soo Lee , Do Hyun Park , Tae Jun Song , Seung Soo Lee , Jin-hong Park , Dae Wook Hwang , Jae Hoon Lee , Sang Hyun Shin , Eunseon Shin , Baek-Yeol Ryoo , Song Cheol Kim

Organizations

Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South), University of Ulsan College of Medicine/Asan Medical Center, Seoul, Korea, Republic of (South), Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South), Department of Radiology, Asan Medical Center, Seoul, Korea, Republic of (South), Department of Radiation Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South), University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea, Republic of (South), Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Republic of (South), Department of Oncology, Asan Medical Center, Seoul, Korea, Republic of (South)

Research Funding

Pharmaceutical/Biotech Company

Background: mFOLFIRINOX and GEM are standard chemotherapy for metastatic and resected PDAC, respectively. This phase 2 trial assessed the efficacy and safety of perioperative chemotherapy consisted of preoperative mFOLFIRINOX and postoperative GEM in pts with BR-PDAC. Methods: Pts with histologically proven and radiologically confirmed BR-PDAC as defined by NCCN criteria were eligible. Pts received 8 cycles of preoperative mFOLFIRINOX (oxaliplatin 85 mg/m2, irinotecan 180 mg/m2, 5-FU 2,400 mg/m2 over 46 hours, and leucovorin 400 mg/m2), every 2 weeks. For pts who underwent surgery, postoperative GEM (1,000 mg/m2 D1, 8, 15, every 4 weeks) was given for 6 cycles. Primary endpoint was 1-year progression-free survival (PFS) rate and secondary endpoints were PFS, overall survival (OS) and curative surgery rate. A total of 44 pts were required to show the improvement in 1-year PFS rates from 30% to 50% with a two-sided alpha of 0.05, beta of 0.8 and drop-out rates of 10%. Results: Between May/2016 and Mar/2018, 44 patients were enrolled. Median age was 60 years (range, 35-76) and 26 pts (59%) were male. Pancreas head was most common site (n = 26, 59%). With mFOLFIRINOX, response rate was 34% and surgery was done in 27 patients (61%); 22 and 5 patients achieved R0 and R1 resection, respectively, and postoperative GEM was given in 24 patients (89%). With median follow-up of 16.6 months (95% CI, 10.9-22.2), 1-year PFS rate was 51.7% (95% CI, 35.2-68.2), and median PFS and OS was 13.0 months (95% CI, 7.7-18.4), and 14.3 months (95% CI, not available), respectively. PFS and OS were significantly differed according to the surgery (p < 0.001 for both) and response to mFOLFIRINOX (p < 0.001 and p = 0.03, respectively). Relative dose intensities of irinotecan, oxaliplatin and 5-FU were > 77% during mFOLFIRINOX. Grade 3-4 neutropenia (55%), anemia (14%), nausea (11%), and diarrhea (7%) were most common severe toxicities and 3 pts (7%) discontinued mFOLFIRINOX due to the toxicities. Conclusions: Perioperative chemotherapy using mFOLFIRINOX and GEM were feasible and effective for pts with BR-PDAC. Future randomized trial is warranted. Clinical trial information: NCT02749136

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Abstract Details

Meeting

2019 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Track

Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

NCT02749136

Citation

J Clin Oncol 37, 2019 (suppl 4; abstr 342)

DOI

10.1200/JCO.2019.37.4_suppl.342

Abstract #

342

Poster Bd #

H20

Abstract Disclosures