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Napoli trial
•
Phase III.
•
Multicentric, international
(76 sites in 14 countries).
•
N
417 metastatic
patients. IK ≥ 70% (38% 70-80%)
•
Randomization between
Jan 2012 to Sept 2013 (1y and 9m)
.
•
34% ≥ 2L
of previous treatment,
12%
not had previous treatment for metastatic disease: more
than 2L trial.
•
Post gem monotherapy 45%.
•
Different 5-FU and folinic regimen
in experimental or control arm (higher intensity in control).
•
Post-progression tto
31% nanoliposomal irinotecan plus fluorouracil and folinic acid and 38%
allocated fluorouracil and folinic acid.
•
Safety issue:
No neuropathy
. Can be used after nab-paclitaxel.
•
Quality of life
of patients assigned nanoliposomal irinotecan plus fluorouracil and folinic acid was
not appreciably different
from those allocated the fluorouracil and folinic acid control.