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.
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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.
Reference
- 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.
