NEONAX

NEONAX randomised 127 patients 1 to 1 to perioperative (arm A) or adjuvant-only (arm B) gemcitabine 1,000 mg/m2 with nab-paclitaxel 125 mg/m2 on days 1, 8 and 15 of 28-day cycles. The pre-defined 18-month disease-free survival rate of 55 percent was reached in neither arm (A 33.3 percent, 95 percent confidence interval 18.5 to 48.1; B 41.4 percent, 20.7 to 62.0, in the modified intention-to-treat population of resected patients who started their allocated chemotherapy). Ninety percent of arm A completed neoadjuvant treatment while only 42 percent of arm B started adjuvant chemotherapy; R0 resection was 88 against 67 percent. In the full intention-to-treat population median overall survival was 25.5 months (19.7 to 29.7) in the perioperative arm against 16.7 months (11.6 to 22.2) with upfront surgery, and median disease-free survival 11.5 against 5.9 months. The authors called neoadjuvant treatment a novel option whose regimen remains to be defined; the corpus cites the trial beside NORPACT-1 and SWOG S1505 as the phase 2 evidence that frames Alliance A021806 and PREOPANC-3.