mFOLFIRINOX may have a limited role in pancreatic cancer in Phase II/III trial

1. In patients with metastatic pancreatic cancer, neither modified fluorouracil, leucovorin, irinotecan and oxaliplatin (mFOLFIRINOX) or S-1, irinotecan and oxaliplatin (S-IROX) demonstrated improved clinical benefits compared with nab-paclitaxel and gemcitabine. 

Evidence Rating Level: 1 (Excellent)

The vast majority of patients with pancreatic cancer have metastatic disease at diagnosis, with a poor prognosis. The standard of care for metastatic pancreatic cancer includes systemic chemotherapy regimens such as mFOLFIRINOX and nab-paclitaxel plus gemcitabine. As there have been no direct comparisons in the literature between these regimens, this randomized phase II/III trial sought to compare mFOLFIRINOX, S-IROX and nab-paclitaxel plus gemcitabine for the management of metastatic or recurrent pancreatic cancer. Between April 2019 and March 2023, 527 patients with metastatic pancreatic cancer from Japan were enrolled and randomly assigned to receive either nab-paclitaxel and gemcitabine (N = 176; median[IQR] age, 65[57-70] years), mFOLFIRINOX (N = 175; median[IQR] age, 67[59-71] years) or S-IROX (N = 176, median[IQR] age, 65[57-70]). The primary endpoint of the phase II portion of the trial was objective response rate (ORR) in the S-IROX group, while the primary endpoint of the phase III portion was overall survival (OS) in all patients. The median OS was highest in the nab-paclitaxel group at 17.0 months (95% CI, 14.5 to 18.9) compared with 14.0 months (95% CI, 11.4 to 16.3) in the mFOLFIRINOX group (HR, 1.29 [95% CI, 0.98 to 1.70]) 13.6 months (95% CI, 12.3 to 16.3) in the S-IROX group (HR, 1.29 [95% CI, 0.98 to 1.70]). During the phase III portion, the ORRs were 35.4% (95% CI, 28.4 to 43.0) in the nab-paclitaxel plus gemcitabine group, 32.4% (95% CI, 25.4 to 39.9) in the mFOLFIRINOX group, and 42.4% (95% CI, 34.8 to 50.2) in the S-IROX group. Overall, this study found that mFOLFIRINOX and S-IROX did not demonstrate improved survival benefits compared with nab-paclitaxel and gemcitabine. 

Click to read the study in JCO

Image: PD

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