TY - JOUR
T1 - Survival with nal-IRI (liposomal irinotecan) plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin in per-protocol and non-per-protocol populations of NAPOLI-1
T2 - Expanded analysis of a global phase 3 trial
AU - Chen, Li Tzong
AU - Siveke, Jens T.
AU - Wang-Gillam, Andrea
AU - Li, Chung Pin
AU - Bodoky, György
AU - Dean, Andrew P.
AU - Shan, Yan Shen
AU - Jameson, Gayle S.
AU - Macarulla, Teresa
AU - Lee, Kyung Hun
AU - Cunningham, David
AU - Blanc, Jean Frédéric
AU - Chiu, Chang Fang
AU - Schwartsmann, Gilberto
AU - Braiteh, Fadi S.
AU - Mamlouk, Khalid
AU - Belanger, Bruce
AU - de Jong, Floris A.
AU - Hubner, Richard A.
N1 - Publisher Copyright:
© 2018 The Authors
PY - 2018/12
Y1 - 2018/12
N2 - Background: In the phase 3 randomised NAPOLI-1 clinical study, a 45% increase in median overall survival (OS) was shown with liposomal irinotecan, 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) versus 5-FU/LV in patients with metastatic pancreatic cancer progressing after gemcitabine-based therapy. Here, we report data from a pre-specified, expanded analysis of outcomes in the per-protocol (PP) population. Materials and methods: The PP population comprised patients receiving ≥80% of planned treatment during the first 6 weeks, with no major protocol violations. A post-hoc analysis of the non-PP population was also performed. Results: For PP patients, median OS was 8.9 (95% confidence interval: 6.4–10.5) months with nal-IRI+5-FU/LV (n = 66) vs 5.1 (4.0–7.2) months with 5-FU/LV (n = 71; unstratified hazard ratio [HR] 0.57, p = 0.011). For non-PP patients, it was 4.4 (3.3–5.3) months with nal-IRI+5-FU/LV (n = 51) vs 2.8 (1.7–3.2) months with 5-FU/LV (n = 48; unstratified HR 0.64, p = 0.0648). Conclusion: A statistically significant survival advantage was observed with nal-IRI+5-FU/LV vs 5-FU/LV in the PP patient population.
AB - Background: In the phase 3 randomised NAPOLI-1 clinical study, a 45% increase in median overall survival (OS) was shown with liposomal irinotecan, 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) versus 5-FU/LV in patients with metastatic pancreatic cancer progressing after gemcitabine-based therapy. Here, we report data from a pre-specified, expanded analysis of outcomes in the per-protocol (PP) population. Materials and methods: The PP population comprised patients receiving ≥80% of planned treatment during the first 6 weeks, with no major protocol violations. A post-hoc analysis of the non-PP population was also performed. Results: For PP patients, median OS was 8.9 (95% confidence interval: 6.4–10.5) months with nal-IRI+5-FU/LV (n = 66) vs 5.1 (4.0–7.2) months with 5-FU/LV (n = 71; unstratified hazard ratio [HR] 0.57, p = 0.011). For non-PP patients, it was 4.4 (3.3–5.3) months with nal-IRI+5-FU/LV (n = 51) vs 2.8 (1.7–3.2) months with 5-FU/LV (n = 48; unstratified HR 0.64, p = 0.0648). Conclusion: A statistically significant survival advantage was observed with nal-IRI+5-FU/LV vs 5-FU/LV in the PP patient population.
KW - Clinical trial, phase III
KW - Drug combinations, Antineoplastic
KW - Gemcitabine
KW - Neoplasm metastasis
KW - Pancreatic neoplasms
KW - Sensitivity and specificity
KW - Survival analysis
UR - http://www.scopus.com/inward/record.url?scp=85056206341&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2018.09.010
DO - 10.1016/j.ejca.2018.09.010
M3 - Article
C2 - 30414528
AN - SCOPUS:85056206341
SN - 0959-8049
VL - 105
SP - 71
EP - 78
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -