Cited by 1,222Pancreatic and Hepatic Oncology ResearchCancer Treatment and PharmacologyPancreatitis Pathology and Treatment

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Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial

Wang-Gillam, Andrea, Li, Chung-Pin, Bodoky, György, Dean, Andrew, Shan, Yan-Shen, Jameson, Gayle, Macarulla, Teresa, Lee, Kyung-Hun, Cunningham, David, Blanc, Jean F, Hubner, Richard A, Chiu, Chang-Fang, Schwartsmann, Gilberto, Siveke, Jens T, Braiteh, Fadi, Moyo, Victor, Belanger, Bruce, Dhindsa, Navreet, Bayever, Eliel, Von Hoff, Daniel D, Chen, Li-Tzong, Adoo, Clarence, Anderson, Thomas, Asselah, Jamil, Azambuja, Alan, Bampton, Carolyn, Barrios, Carlos Henrique, Bekaii-Saab, Tanios, Bohuslav, Melichar, Chang, David, Chen, Jen-Shi, Chen, Yeu-Chin, Choi, Hye Jin, Chung, Ik Joo, Chung, Vincent, Csoszi, Tibor, Cubillo, Antonio, DeMarco, Linda, de Wit, Maike, Dragovich, Tomislav, Edenfield, William, Fein, Luis Enrique, Franke, Fábio, Fuchs, Martin, Gonzales-Cruz, Vega, Gozza, Alberto, Fernando, Rivera Herrero, Iaffaioli, Rosario, Jakesova, Jitka, Kahan, Zsuzsanna, Karimi, Misagh, Kim, Jun Suk, Korbenfeld, Ernesto, Lang, Istvan, Lee, Fa-Chyi, Lee, Kuan-Der, Lipton, Lara, Ma, Wen Wee, Mangel, Laszlo, Mena, Raul, Palmer, Daniel, Pant, Shubham, Park, Joon Oh, Piacentini, Paolo, Pelzer, Uwe, Plazas, Javier Gallego, Prasad, Cooray, Rau, Kun-Ming, Raoul, Jean-Luc, Richards, Donald, Ross, Paul, Schlittler, Luis, Smakal, Martin, Stahalova, Vladimira, Sternberg, Cora, Seufferlein, Thomas, Tebbutt, Niall, Vinholes, Jeferson Jose, Wadlow, Raymond, Wenczl, Milkos, Wong, Mark·2016·The Lancet

DOI 10.1016/s0140-6736(15)00986-1

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Abstract

Background Nanoliposomal irinotecan showed activity in a phase 2 study in patients with metastatic pancreatic ductal adenocarcinoma previously treated with gemcitabine-based therapies. We assessed the effect of nanoliposomal irinotecan alone or combined with fluorouracil and folinic acid in a phase 3 trial in this population.Methods We did a global, phase 3, randomised, open-label trial at 76 sites in 14 countries. Eligible patients with metastatic pancreatic ductal adenocarcinoma previously treated with gemcitabine-based therapy were randomly assigned (1:1) using an interactive web response system at a central location to receive either nanoliposomal irinotecan monotherapy (120 mg/m(2) every 3 weeks, equivalent to 100 mg/m(2) of irinotecan base) or fluorouracil and folinic acid. A third arm consisting of nanoliposomal irinotecan (80 mg/m(2), equivalent to 70 mg/m(2) of irinotecan base) with fluorouracil and folinic acid every 2 weeks was added later (1:1:1), in a protocol amendment. Randomisation was stratified by baseline albumin, Karnofsky performance status, and ethnic origin. Treatment was continued until disease progression or intolerable toxic effects. The primary endpoint was overall survival, assessed in the intention-to-treat population. The primary analysis was planned after 305 events. Safety was assessed in all patients who had received study drug. This trial is registered at ClinicalTrials.gov, number NCT01494506.Findings Between Jan 11, 2012, and Sept 11, 2013, 417 patients were randomly assigned either nanoliposomal irinotecan plus fluorouracil and folinic acid (n=117), nanoliposomal irinotecan monotherapy (n=151), or fluorouracil and folinic acid (n=149). After 313 events, median overall survival in patients assigned nanoliposomal irinotecan plus fluorouracil and folinic acid was 6.1 months (95% CI 4.8-8.9) vs 4.2 months (3.3-5.3) with fluorouracil and folinic acid (hazard ratio 0.67, 95% CI 0.49-0.92; p=0.012). Median overall survival did not differ between patients assigned nanoliposomal irinotecan monotherapy and those allocated fluorouracil and folinic acid (4.9 months [4.2-5.6] vs 4.2 months [3.6-4.9]; 0.99, 0.77-1.28; p=0.94). The grade 3 or 4 adverse events that occurred most frequently in the 117 patients assigned nanoliposomal irinotecan plus fluorouracil and folinic acid were neutropenia (32 [27%]), diarrhoea (15 [13%]), vomiting (13 [11%]), and fatigue (16 [14%]).Interpretation Nanoliposomal irinotecan in combination with fluorouracil and folinic acid extends survival with a manageable safety profile in patients with metastatic pancreatic ductal adenocarcinoma who previously received gemcitabine-based therapy. This agent represents a new treatment option for this population.Funding Merrimack Pharmaceuticals.

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Authors: Wang-Gillam, A., Li, C.-P., Bodoky, G., Dean, A., Shan, Y.-S., Jameson, G., Macarulla, T., Lee, K.-H., Cunningham, D., Blanc, J. F., Hubner, R. A., Chiu, C.-F., Schwartsmann, G., Siveke, J. T., Braiteh, F., Moyo, V., Belanger, B., Dhindsa, N., Bayever, E., Von Hoff, D. D., Chen, L.-T., Adoo, C., Anderson, T., Asselah, J., Azambuja, A., Bampton, C., Barrios, C. H., Bekaii-Saab, T., Bohuslav, M., Chang, D., Chen, J.-S., Chen, Y.-C., Choi, H. J., Chung, I. J., Chung, V., Csoszi, T., Cubillo, A., DeMarco, L., de Wit, M., Dragovich, T., Edenfield, W., Fein, L. E., Franke, F., Fuchs, M., Gonzales-Cruz, V., Gozza, A., Fernando, R. H., Iaffaioli, R., Jakesova, J., Kahan, Z., Karimi, M., Kim, J. S., Korbenfeld, E., Lang, I., Lee, F.-C., Lee, K.-D., Lipton, L., Ma, W. W., Mangel, L., Mena, R., Palmer, D., Pant, S., Park, J. O., Piacentini, P., Pelzer, U., Plazas, J. G., Prasad, C., Rau, K.-M., Raoul, J.-L., Richards, D., Ross, P., Schlittler, L., Smakal, M., Stahalova, V., Sternberg, C., Seufferlein, T., Tebbutt, N., Vinholes, J. J., Wadlow, R., Wenczl, M., & Wong, M.
Affiliations: Taipei Veterans General Hospital (TW)
St John of God Subiaco Hospital (AU)
National Cheng Kung University Hospital (TW)
Translational Genomics Research Institute (US)
Vall d'Hebron Institute of Oncology (ES)
Seoul National University Hospital (KR)
Royal Marsden Hospital (GB)
Hôpital Saint-André (FR)
The Christie NHS Foundation Trust (GB)
China Medical University Hospital (TW)
Hospital de Clínicas de Porto Alegre (BR)
TUM Klinikum (DE)
Comprehensive Cancer Centers of Nevada (US)
Merrimack Pharmaceuticals (United States) (US)
Kaohsiung Medical University (TW)
Corresponding author: Chen, Li-Tzong
ORCID: Li, Chung-Pin
Dean, Andrew
Shan, Yan-Shen
Jameson, Gayle
Macarulla, Teresa
Lee, Kyung-Hun
Cunningham, David
Hubner, Richard A
Schwartsmann, Gilberto
Siveke, Jens T
Braiteh, Fadi
Moyo, Victor
Belanger, Bruce
Chen, Li-Tzong
Asselah, Jamil
Barrios, Carlos Henrique
Chang, David
Chen, Jen-Shi
Chen, Yeu-Chin
Choi, Hye Jin
Chung, Vincent
Cubillo, Antonio
Dragovich, Tomislav
Fein, Luis Enrique
Fuchs, Martin
Korbenfeld, Ernesto
Lee, Fa-Chyi
Lee, Kuan-Der
Ma, Wen Wee
Palmer, Daniel
Pant, Shubham
Park, Joon Oh
Pelzer, Uwe
Rau, Kun-Ming
Raoul, Jean-Luc
Richards, Donald
Ross, Paul
Stahalova, Vladimira
Sternberg, Cora
Seufferlein, Thomas
Tebbutt, Niall
Wadlow, Raymond
Wong, Mark
Venue: The Lancet
Publisher: Elsevier BV
Published: 2016-02
Volume: 387
Issue: 10018
Pages: 545-557
ISSN: 0099-5355 (ISSN-L)
0140-6736
DOI: 10.1016/s0140-6736(15)00986-1
OpenAlex: W2187917981
Cited by: 1,222
References: 29
Citations by year: 2026: 92 · 2025: 123 · 2024: 122 · 2023: 116 · 2022: 119 · 2021: 156 · 2020: 117 · 2019: 116 · 2018: 99 · 2017: 101 · 2016: 53
FWCI: 37.85
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The Lancet (publishedVersion)
PubMed (publishedVersion)
mediaTUM (Technical University of Munich) (submittedVersion)
Topics: Health Sciences › Medicine › Oncology › Pancreatic and Hepatic Oncology Research
Health Sciences › Medicine › Oncology › Cancer Treatment and Pharmacology
Health Sciences › Medicine › Surgery › Pancreatitis Pathology and Treatment
Keywords: 5-fluorouracil, leucovorin, metastatic pancreatic ductal adenocarcinoma, gemcitabine-refractory disease, combination chemotherapy, overall survival, first-line therapy, NAPOLI-1 trial, albumin, Karnofsky performance status
MeSH terms: Irinotecan, Gemcitabine, Aged, Antineoplastic Combined Chemotherapy Protocols, Camptothecin, Leucovorin, Deoxycytidine, Diarrhea, Fatigue, Female, Fluorouracil, Humans, Liposomes, Male, Middle Aged, Neoplasm Metastasis, Neutropenia, Pancreatic Neoplasms, Vomiting, Treatment Outcome, Carcinoma, Pancreatic Ductal, Kaplan-Meier Estimate

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Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial

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