Alliance A021501: preoperative modified FOLFIRINOX with or without hypofractionated radiotherapy for borderline resectable pancreatic cancer
In the first randomised US trial of neoadjuvant treatment for borderline resectable pancreatic cancer, eight cycles of modified FOLFIRINOX alone gave two-thirds of patients an 18-month survival, while replacing the last cycle with short-course radiotherapy did worse and that arm was stopped early.
Overview
Multicentre randomised phase 2 trial in 126 patients with borderline resectable pancreatic ductal adenocarcinoma, assigned to eight cycles of modified FOLFIRINOX or to seven cycles followed by stereotactic body radiotherapy or hypofractionated image-guided radiotherapy, then surgery and adjuvant FOLFOX. The radiotherapy arm was closed at a planned interim analysis for futility.
Eighteen-month overall survival was 66.7 percent with chemotherapy alone and 47.3 percent with chemotherapy and radiotherapy; median overall survival was 29.8 against 17.1 months. The chemotherapy-alone arm met its prespecified benchmark against historical controls.
- Eighteen-month overall survival 66.7 percent with modified FOLFIRINOX alone versus 47.3 percent with added radiotherapy.
- Median overall survival 29.8 versus 17.1 months; the radiotherapy arm was closed early for futility.
Neoadjuvant modified FOLFIRINOX without routine radiotherapy became the reference approach for borderline resectable disease in North America; radiotherapy is reserved for selected patients or trials.
- The two arms were not formally compared with each other; each was judged against a historical benchmark.
- Only about half of patients in each arm went on to resection, and the radiotherapy arm was small after early closure.
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