For patients with resectable pancreatic ductal adenocarcinoma (PDAC), the 12-month progression-free survival (PFS) may be increased with neoadjuvant modified 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan (mFOLFIRINOX), according to a study published online June 20 in JAMA Oncology.
Michael Cecchini, M.D., from the Yale University School of Medicine in New Haven, Connecticut, and colleagues examined whether neoadjuvant mFOLFIRINOX leads to early control of micrometastasis and improves survival among patients with resectable PDAC in an open-label phase 2 trial. Forty-six patients received six cycles of neoadjuvant mFOLFIRINOX before surgery and six cycles of adjuvant mFOLFIRINOX.
The researchers found that 37 patients completed all six preoperative mFOLFIRINOX cycles, and 33 underwent surgery. Twenty-seven patients underwent resection per protocol. During exploration, metastatic or unresectable disease was identified in six patients; 10 patients underwent off-protocol surgery. The 12-month PFS was 67 percent; the median PFS was 16.6 months, and median overall survival (OS) was 37.2 months. Sixteen of 22 patients (73 percent) had baseline circulating tumor (ct)DNA levels; 18 percent (three of 17) patients had detectable ctDNA after six cycles of mFOLFIRINOX. Worse PFS and OS were seen for those with detectable ctDNA levels four weeks postresection compared with those with undetectable levels.
“While our reported survival rates are promising, a randomized clinical trial is critical to determine whether perioperative mFOLFIRINOX enhances cure rates compared with adjuvant FOLFIRINOX,” the authors write.
Several authors disclosed ties to the pharmaceutical and biotechnology industries.
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