A was assessed in a recent phase 2 trial.
The optimal first-line chemotherapy for advanced pancreatic cancer, validated in phase 3 trials, is the triplet combination of infusional 5-FU, oxaliplatin, and either irinotecan or nanoliposome-encapsulated irinotecan (FOLFIRINOX or NALIRIFOX). Now, in an industry-supported, randomized, phase 2 trial involving patients with metastatic pancreatic cancer, investigators compared the combination of gemcitabine and nab-paclitaxel to a novel sequenced regimen of gemcitabine and nab-paclitaxel followed by mFOLFOX-6 on a 6-week cycle.
Of 157 patients, the median age was 66, 94% had metastatic disease, only 18% had undergone prior surgery, and 4% had received prior chemotherapy. The primary endpoint of 12-month overall survival (OS) was higher with the sequenced regimen compared with gemcitabine/nab-paclitaxel alone (55.3% vs. 35.4%, P =0.02); median OS was also higher (13.2 vs. 9.7 months; hazard ratio, 0.68). Median progression-free survival was higher with the sequenced regimen (7.0 vs 5.2 months; HR, 0.52) as was the response rate (39.7% vs. 20.3%). Adverse events and rates of grade 3/4 neurologic toxicity were similar between the two treatment arms.
This small phase 2 trial indicates potential superiority for the sequencing of mFOLFOX6 with gemcitabine/nab-paclitaxel compared with gemcitabine/nab-paclitaxel alone. However, this sequencing regimen offers no clear advantage over the two approved triplet regimens, FOLFIRINOX and NALIRIFOX, and any statement about superiority compared with standard triplet therapy would require proof in a phase 3 trial.
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