Preoperative mFOLFIRINOX versus PAXG for stage I-III resectable and borderline resectable pancreatic ductal adenocarcinoma (PACT-21 CASSANDRA): results of the first randomisation analysis of a randomised, open-label, 2 × 2 factorial phase 3 trial.
Michele Reni, Marina Macchini, Giulia Orsi et al.
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In 30 seconds
The CASSANDRA randomised, open-label, phase 3 trial compared preoperative PAXG with mFOLFIRINOX in adults with resectable or borderline resectable pancreatic ductal adenocarcinoma at 17 Italian academic hospitals. In the first randomisation analysis, 260 patients were assigned to treatment. Median event-free survival was longer with PAXG than with mFOLFIRINOX (16·0 months [95% CI 12·4-19·8] vs 10·2 months [8·6-13·5]; hazard ratio 0·63 [0·47-0·84]; p=0·0018). Grade 3 or worse adverse events occurred in 66% and 61%, respectively; overall survival follow-up is ongoing.
Key findings
- Median event-free survival was 16·0 months with PAXG versus 10·2 months with mFOLFIRINOX (hazard ratio 0·63 [95% CI 0·47-0·84]; p=0·0018).
- At least one grade 3 or worse adverse event occurred in 87 (66%) of 132 PAXG recipients and 78 (61%) of 128 mFOLFIRINOX recipients; one fatal event was reported.
Why it matters
The trial provides a randomised comparison of two preoperative chemotherapy regimens in resectable and borderline resectable pancreatic cancer, with longer event-free survival observed for PAXG. The similar reported proportions experiencing severe adverse events are relevant when weighing the efficacy result, while ongoing overall-survival follow-up means the longer-term outcome comparison is not yet available.
What to keep in mind
This report presents the first randomisation analysis; overall-survival follow-up is ongoing. The open-label design may also affect outcomes susceptible to assessment or management decisions.