(HealthDay News) — Adding radiotherapy to neoadjuvant modified FOLFIRINOX (mFOLFIRINOX) does not improve survival in patients with borderline resectable pancreatic ductal adenocarcinoma (PDAC), according to a study published in JAMA Oncology.
Matthew H.G. Katz, MD, from the University of Texas MD Anderson Cancer Center in Houston, and colleagues conducted a randomized, phase 2 trial involving 126 patients with borderline resectable PDAC.
Participants were randomly assigned to receive mFOLFIRINOX (oxaliplatin, irinotecan, leucovorin, and fluorouracil) alone or in combination with radiotherapy. Patients received 8 cycles of mFOLFIRINOX alone (55.6%) or 7 cycles of mFOLFIRINOX followed by stereotactic body radiotherapy or hypofractionated image-guided radiotherapy (44.4%).
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Among the first 30 evaluable patients enrolled in each arm, 17 in the mFOLFIRINOX-alone arm and 10 in the radiotherapy arm had undergone R0 resection. This resulted in closure of the radiotherapy arm and full enrollment in the mFOLFIRINOX-alone arm.
The 18-month overall survival (OS) rate was 66.7% in the mFOLFIRINOX-alone arm and 47.3% in the radiotherapy arm. The median OS was 29.8 months and 17.1 months, respectively.
“This randomized clinical trial found that treatment with neoadjuvant mFOLFIRINOX alone was associated with favorable OS in patients with borderline resectable PDAC compared with mFOLFIRINOX treatment plus hypofractionated radiotherapy; thus, mFOLFIRINOX represents a reference regimen in this setting,” the authors wrote.
Several authors disclosed financial ties to the biopharmaceutical industry.
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