In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 37, No. 4_suppl ( 2019-02-01), p. 342-342
Abstract:
342 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/m 2 , irinotecan 180 mg/m 2 , 5-FU 2,400 mg/m 2 over 46 hours, and leucovorin 400 mg/m 2 ), every 2 weeks. For pts who underwent surgery, postoperative GEM (1,000 mg/m 2 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.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2019.37.4_suppl.342
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2019
detail.hit.zdb_id:
2005181-5
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