Background: Here we report QoL results from the randomized, phase 3 NAPOLI-1 study of nal—IRI + 5—FU/LV vs 5-FU/LV alone in pts with mPDAC previously treated with gemcitabine-based therapy. Methods: QoL was assessed using the EORTC-QLQ-C30, which includes Functional, Symptom, and Global Health and QoL scales. Pts completed the questionnaire at treatment start, every 6 weeks (wks) and 30 days post-follow-up. Pts who were assessed at baseline and at ≥1 subsequent visit were included. Scores were reported in a 0–100 range after linear transformations were applied to raw scores. For each subscale, pt response was classified as improved (≥10% increase in scale of breadth at a post-baseline time point and remained above baseline for ≥6 wks), worsened (did not meet improvement criteria and died,...
Date:
2016-09
Relation:
Annals of Oncology. 2016 Sep;27(Suppl. 4):Meeting Abstract B04.
