Quality-controlled trials can and ought to be conducted in multi-institutional settings on patients with borderline resectable pancreatic cancer, according to a study published in the Journal of the Medical Association (JAMA) Surgery.1
To date, no prospective, quality-controlled, multicenter studies of multimodal therapies for patients with borderline resectable pancreatic cancer have been conducted, and it was unclear whether such studies are feasible.
Researchers enrolled 22 patients to receive multimodal therapy who met radiographic criteria to this prospective, multicenter, single-arm trial. These patients received FOLFIRINOX treatment, which consists of 85 mg/m2 of oxaliplatin, 180 mg/m2 of irinotecan hydrochloride, 400 mg/m2 of leucovorin calcium, and 2400 mg/m2 of 5-fluorouracil for 4 cycles. This is followed by 5.5 weeks of external-beam radiation (50.4 Gy delivered in 28 daily fractions) with capecitabine (825 mg/m2 orally twice daily) prior to surgical resection.
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Sixty-four percent of patients experienced grade 3 or worse adverse events; 68% underwent surgical resection, 80% of which (12 of 15) needed vascular resection. The specimens of 2% had pathologic complete responses. Patient accrual was also greater than anticipated.
It was concluded that this study demonstrated multi-institutional study feasibility for patients with borderline resectable prostate cancer. Data from this trial are being used to develop future cooperative studies.
- Katz MH, Shi Q, Ahmad SA, Herman JM, Marsh RW, Collisson E, et al. Preoperative modified FOLFIRINOX treatment followed by capecitabine-Based chemoradiation for borderline resectable pancreatic cancer [published online ahead of print June 08, 2016]. JAMA Surg. doi: 10.1001/jamasurg.2016.1137.