In a retrospective cohort study reported in JAMA Oncology, Stoop et al found that use of adjuvant modified leucovorin, fluorouracil, irinotecan, and oxaliplatin (mFOLFIRINOX) and other multiagent chemotherapy regimens improved overall survival vs no adjuvant chemotherapy in patients with localized pancreatic adenocarcinoma undergoing resection after preoperative mFOLFIRINOX.
Study Details
The study included data from patients enrolled from 40 centers in Europe, 4 in the United States, and 4 in Japan who had received 2 to 11 cycles of preoperative mFOLFIRINOX followed by resection between 2010 and 2018. Patients who died within 3 months after surgery (landmark) were excluded from analysis. The primary outcome measure was overall survival calculated from the 3-month landmark.
Key Findings
Among 742 patients in the cohort, 551 received adjuvant chemotherapy. Among patients receiving adjuvant chemotherapy, 201 received mFOLFIRINOX, 94 received other multiagent regimens, and 261 received singe-agent regimens.
Receipt of any adjuvant chemotherapy was independently associated with prolonged overall survival vs no adjuvant chemotherapy (median = 32 vs 26 months, hazard ratio [HR] = 0.66, 95% confidence interval [CI] = 0.49–0.87, P = .02). Rates at 1, 3, and 5 years were 80.8% vs 64.0%, 47.0% vs 43.8%, and 30.2% vs 29.0%, respectively.
Interaction tests showed a potential lesser impact of adjuvant chemotherapy on overall survival among patients with 8 to 11 cycles of preoperative mFOLFIRINOX (HR = 1.01, 95% CI = 0.57–1.80), those with radiological response (HR = 1.01, 95% CI = 0.61–1.67), and those with ypN0 disease (HR = 0.87, 95% CI = 0.57–1.31).
Compared with patients who did not receive adjuvant chemotherapy, those who received adjuvant mFOLFIRINOX (HR = 0.57, 95% CI = 0.40–0.80) and those who received other adjuvant multiagent regimens (HR = 0.61, 95% CI = 0.41–0.92) had significantly better overall survival, whereas the improvement with single-agent chemotherapy did not achieve significance (HR = 0.75, 95% CI = 0.55–1.03).
The investigators concluded: “In this cohort study, adjuvant (m)FOLFIRINOX and other multiagent chemotherapy regimens were associated with improved [overall survival] following resection of localized pancreatic adenocarcinoma after preoperative (m)FOLFIRINOX, whereas single-agent adjuvant chemotherapy was not. The impact of adjuvant chemotherapy on [overall survival] may be lower in subgroups such as patients with eight or more preoperative cycles of (m)FOLFIRINOX, those having radiological response, and those with ypN0 [disease].”
Thomas F. Stoop, MD, and Marc G. Besselink, MD, PhD, of Amsterdam UMC, University of Amsterdam, are the corresponding authors of the JAMA Oncology article.
Disclosure: For full disclosures of the study authors, visit jamanetwork.com.
