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 - Funding Information:
The NAPOLI-1 study ( ClinicalTrials.gov Identifier: NCT01494506) was sponsored by Merrimack Pharmaceuticals, Inc. , Cambridge, MA 02139, USA. This post-hoc analysis was sponsored by Shire; rights for nal-IRI now reside with Ipsen in the USA (April 2017); PharmaEngine, Inc. holds the rights in Taiwan; Servier holds the rights in the rest of the world through a licensing agreement with Ipsen. Bruce Belanger (Merrimack Pharmaceuticals, Inc. at the time of study, now Ipsen) was responsible for statistical analyses of this post-hoc study.
Funding Information:
Medical writing support was provided by Florian Szardenings of Physicians World Europe GmbH, 68259 Mannheim, Germany, and funded by Shire, 6300 Zug, Switzerland. Publication costs were funded by Servier, 92284 Suresnes, France.
Funding Information:
Medical writing support was provided by Florian Szardenings of Physicians World Europe GmbH , 68259 Mannheim, Germany, and funded by Shire , 6300 Zug, Switzerland. Publication costs were funded by Servier , 92284 Suresnes, France.
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 -