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: Expanded analysis of a global phase 3 trial

Li Tzong Chen; Jens T. Siveke; Andrea Wang-Gillam; Chung Pin Li; György Bodoky; Andrew P. Dean; Yan Shen Shan; Gayle S. Jameson; Teresa Macarulla; Kyung Hun Lee; David Cunningham; Jean Frédéric Blanc; Chang Fang Chiu; Gilberto Schwartsmann; Fadi S. Braiteh; Khalid Mamlouk; Bruce Belanger; Floris A. de Jong; Richard A. Hubner

doi:10.1016/j.ejca.2018.09.010

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: Expanded analysis of a global phase 3 trial

Li Tzong Chen
, Jens T. Siveke
, Andrea Wang-Gillam
, Chung Pin Li
, György Bodoky
, Andrew P. Dean
, Yan Shen Shan
, Gayle S. Jameson
, Teresa Macarulla
, Kyung Hun Lee
, David Cunningham
, Jean Frédéric Blanc
, Chang Fang Chiu
, Gilberto Schwartsmann
, Fadi S. Braiteh
, Khalid Mamlouk
, Bruce Belanger
, Floris A. de Jong
, Richard A. Hubner

Research output: Contribution to journal › Article › peer-review

27 Scopus citations

Abstract

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.

Original language	English
Pages (from-to)	71-78
Number of pages	8
Journal	European Journal of Cancer
Volume	105
DOIs	https://doi.org/10.1016/j.ejca.2018.09.010
State	Published - Dec 2018

Keywords

Clinical trial, phase III
Drug combinations, Antineoplastic
Gemcitabine
Neoplasm metastasis
Pancreatic neoplasms
Sensitivity and specificity
Survival analysis

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Chen, L. T., Siveke, J. T., Wang-Gillam, A., Li, C. P., Bodoky, G., Dean, A. P., Shan, Y. S., Jameson, G. S., Macarulla, T., Lee, K. H., Cunningham, D., Blanc, J. F., Chiu, C. F., Schwartsmann, G., Braiteh, F. S., Mamlouk, K., Belanger, B., de Jong, F. A., & Hubner, R. A. (2018). 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: Expanded analysis of a global phase 3 trial. European Journal of Cancer, 105, 71-78. https://doi.org/10.1016/j.ejca.2018.09.010

@article{602ae7529f7443d4b42d69dc44018501,

title = "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: Expanded analysis of a global phase 3 trial",

abstract = "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.",

keywords = "Clinical trial, phase III, Drug combinations, Antineoplastic, Gemcitabine, Neoplasm metastasis, Pancreatic neoplasms, Sensitivity and specificity, Survival analysis",

author = "Chen, \{Li Tzong\} and Siveke, \{Jens T.\} and Andrea Wang-Gillam and Li, \{Chung Pin\} and Gy{\"o}rgy Bodoky and Dean, \{Andrew P.\} and Shan, \{Yan Shen\} and Jameson, \{Gayle S.\} and Teresa Macarulla and Lee, \{Kyung Hun\} and David Cunningham and Blanc, \{Jean Fr{\'e}d{\'e}ric\} and Chiu, \{Chang Fang\} and Gilberto Schwartsmann and Braiteh, \{Fadi S.\} and Khalid Mamlouk and Bruce Belanger and \{de Jong\}, \{Floris A.\} and Hubner, \{Richard A.\}",

note = "Publisher Copyright: {\textcopyright} 2018 The Authors",

year = "2018",

month = dec,

doi = "10.1016/j.ejca.2018.09.010",

language = "English",

volume = "105",

pages = "71--78",

journal = "European Journal of Cancer",

issn = "0959-8049",

}

Chen, LT, Siveke, JT, Wang-Gillam, A, Li, CP, Bodoky, G, Dean, AP, Shan, YS, Jameson, GS, Macarulla, T, Lee, KH, Cunningham, D, Blanc, JF, Chiu, CF, Schwartsmann, G, Braiteh, FS, Mamlouk, K, Belanger, B, de Jong, FA & Hubner, RA 2018, '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: Expanded analysis of a global phase 3 trial', European Journal of Cancer, vol. 105, pp. 71-78. https://doi.org/10.1016/j.ejca.2018.09.010

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: Expanded analysis of a global phase 3 trial. / Chen, Li Tzong; Siveke, Jens T.; Wang-Gillam, Andrea et al.
In: European Journal of Cancer, Vol. 105, 12.2018, p. 71-78.

Research output: Contribution to journal › Article › peer-review

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.

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 - https://www.scopus.com/pages/publications/85056206341

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 -

Chen LT, Siveke JT, Wang-Gillam A, Li CP, Bodoky G, Dean AP et al. 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: Expanded analysis of a global phase 3 trial. European Journal of Cancer. 2018 Dec;105:71-78. doi: 10.1016/j.ejca.2018.09.010

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: Expanded analysis of a global phase 3 trial

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