Adjuvant Chemotherapy After Pancreatic Cancer Resection and Neoadjuvant FOLFIRINOX: Improvement in Overall Survival?

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In a retrospective cohort study reported in JAMA Oncology, van Roessel et al found that adjuvant chemotherapy after pancreatic cancer resection and neoadjuvant FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin) was associated with an improvement in overall survival. The benefit was limited to patients with node-positive disease.

Study Details

The study—initiated by the scientific committee of the European-African Hepato-Pancreato-Biliary Association—included data from 520 consecutive patients from 31 sites in 19 countries who underwent pancreatic surgery after at least two cycles of neoadjuvant FOLFIRINOX for nonmetastatic pancreatic cancer. Patients with in-hospital mortality or who died within 3 months after surgery were excluded from the study. Overall survival was defined as the time starting from surgery plus 3 months (time of eligibility for adjuvant therapy).

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Key Findings

The median number of neoadjuvant cycles of FOLFIRINOX was six.

Among the 520 patients, 343 (66.0%) received adjuvant chemotherapy, including FOLFIRINOX in 19.8%, gemcitabine-based chemotherapy in 58.6%, capecitabine in 4.1%, a combination or other agents in 13.1%, and unknown chemotherapy in 4.4%. A total of 177 patients received no adjuvant chemotherapy.

Median overall survival was 29 months in the adjuvant therapy group vs 29 months in the no adjuvant therapy group (hazard ratio [HR] = 0.99; 95% confidence interval [CI] = 0.77–1.28, P = .93). On multivariate analysis, the hazard ratio was 0.85 (95% CI = 0.35–2.10, P = .73).

On multivariate analysis, only the interaction term of nodal status with adjuvant chemotherapy was significant. Among the 50% vs 38% of patients with pathology-proven, node-positive disease, median overall survival was 26 months with adjuvant chemotherapy vs 13 months with no adjuvant chemotherapy (HR = 0.41, 95% CI = 0.22–0.75, P = .004). Among patients with node-negative disease, median overall survival was 38 months vs 54 months (HR = 0.85, 95% CI = 0.35–2.10, P = .73).

The investigators concluded, “These results suggest that adjuvant chemotherapy after neoadjuvant FOLFIRINOX and resection of pancreatic cancer was associated with improved survival only in patients with pathology-proven, node-positive disease. Future randomized studies should be conducted to confirm this finding.”

Marc G. Besselink, MD, MSc, PhD, of the Department of Surgery, Cancer Center Amsterdam, Amsterdam University Medical Center, is the corresponding author for the JAMA Oncology article.

Disclosure: For full disclosures of the study authors, visit