Neoadjuvant chemotherapy improved surgical outcomes in patients with resectable pancreatic head cancer but did not improve overall survival, NorPACT-1 finds.
In patients with resectable pancreatic cancer, complete resection and effective systemic therapy achieve the best outcomes. Upfront surgery followed by adjuvant chemotherapy, preferably mFOLFIRINOX, is the current standard of care. However, neoadjuvant treatment may offer early control of systemic disease, improved delivery of chemotherapy, or improved surgical outcomes, or both (R0 and N0 resection rates). The aim of the phase 2 unblinded NorPACT-1 trial (NCT02919787) was to test the efficacy of neoadjuvant FOLFIRINOX treatment for resectable pancreatic head cancer. Knut Labori, MD, PhD, presented the results at the 2023 ASCO Annual Meeting, held June 2-6 in Chicago.
The study randomly assigned 140 participants with resectable pancreatic head cancer to upfront surgery followed by 12 cycles of mFOLFIRINOX or to four cycles of mFOLFIRINOX followed by surgery and eight additional cycles of mFOLFIRINOX. The primary endpoint was the overall survival rate 18 months after randomization (in the intention-to-treat [ITT] population). In the neoadjuvant arm, 77% of participants underwent resection compared with 89% in the upfront surgery arm; 66% of participants in the neoadjuvant arm started adjuvant chemotherapy compared with 75% in the upfront surgery arm.
Neoadjuvant treatment did not improve overall survival in the ITT population. At 18 months, 60% of participants were alive in the neoadjuvant arm versus 73% in the upfront surgery arm. The median overall survival was 25.1 versus 38.5 months, respectively. The median overall survival per protocol was 23.0 versus 34.4 months, respectively.
On the other hand, neoadjuvant mFOLFIRINOX did improve histological outcomes. R0 (per protocol) was 59% in the neoadjuvant arm versus 33% in the upfront surgery arm (P=0.011); N0 was 37% versus 10% (P=0.002). “However, this improvement was not translated into a better survival.” Neoadjuvant mFOLFIRINOX further resulted in more grade 3–4 adverse events compared with adjuvant mFOLFIRINOX: 55.6% versus 40%.
Dr. Labori concluded that “these results do not support neoadjuvant mFOLFIRINOX as a standard-of-care in resectable pancreatic cancer. However, additional follow-up may better elucidate the long-term effects of the improvement in R0 and N0 rates in the neoadjuvant arm.”
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