Borderline resectable pancreatic cancer: phase 2 results

Presented by

Prof. Matthew H. Katz, University of Texas MD Anderson Cancer Center, USA

Conference

ASCO GI 2021

Trial

Phase 2, Alliance A021501

Neoadjuvant therapy is known to improve radical resection, but overall survival (OS) benefit has not yet been proven. mFOLFIRINOX is a preoperative regimen that may change this notion.

Prof. Matthew H. Katz (University of Texas MD Anderson Cancer Center, USA) presented the results from the Alliance A021501 study (NCT02839343) [1]. This phase 2 study included 126 patients who were randomly assigned to receive either an mFOLFIRINOX regimen (8 cycles of neoadjuvant mFOLFIRINOX; arm A) or a combination regiment of mFOLFIRINOX plus radiotherapy (7 cycles of neoadjuvant mFOLFIRINOX followed by 5 days of hypofractionated radiotherapy with either stereotactic body radiotherapy or hypofractionated image-guided radiotherapy; arm B). Post-pancreatectomy, all patients received 4 cycles of adjuvant mFOLFOX6 (oxaliplatin 85 mg/m², leucovorin 400 mg/m², and 5-fluorouracil 2,400 mg/m²). The primary endpoint was a prespecified 13% improvement of 18-month OS in comparison to a historical control of 50%, however, treatment arms could only be compared if both met the 63% OS rate. As a consequence, arm B was considered futile and closed subject accrual following the interim analysis of the first 30 patients.

At 18 months, evaluable study participants in arm A (n=62) had an OS rate of 66.4%, which was significantly higher than the 47.3% rate in arm B (n=62). The median OS in arm A was 29.8 months, with a median event-free survival of 15 months; in arm B, OS was 17.1 months and event-free survival was 10.2 months. Nearly half (49%) of the participants in arm A proceeded to pancreatectomy following neoadjuvant therapy, as opposed to 35% in arm B. For those who had undergone resection and adjuvant therapy, the 18-month OS for arm A was 93.1%, while for arm B it was 78.9%.

Prof. Katz concluded: "Preoperative mFOLFIRINOX was associated with favourable OS relative to historical criteria in patients with borderline resectable PDAC, and mFOLFIRINOX with radiation therapy met the predefined futility boundary for R0 resection at interim analysis. Therefore, mFOLFIRINOX represents a reference preoperative regimen for patient with borderline resectable PDAC."

Katz MH, et al. Alliance A021501: Preoperative mFOLFIRINOX or mFOLFIRINOX plus hypofractionated radiation therapy (RT) for borderline resectable (BR) adenocarcinoma of the pancreas. ASCO Gastrointestinal Cancers Symposium 2021, 15-17 January. Abstract 377.

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