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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Liposomal Nanoformulation of Piperlongumine for Improved Aqueous Solubility and Enhanced Anti-tumour Activity In-vitro
Zhang, H. (2018) · International Journal of Pharmaceutics & Pharmacology · doi:10.31531/2581-3080.1000133 · Cited by 5
Sequential Treatment of Metastatic Adenocarcinoma of the Pancreatic Duct with Liver Metastasis Following the NAPOLI-1 Study Protocol with nal-Irinotecan plus 5-FU in the Second Line
Akhoundova, D., Reiner, C. S., Papageorgiou, P., & Siebenhüner, A. R. (2020) · Case Reports in Oncology · doi:10.1159/000504471 · Cited by 5
Developing liposomal nanomedicines for treatment of patients with neuroblastoma
Gilabert‐Oriol, R., Chernov, L., Deyell, R. J., & Bally, M. B. (2018) · Elsevier eBooks · doi:10.1016/b978-0-12-813687-4.00009-8 · Cited by 5
Consensus statement on the use of systemic therapies in pancreatic ductal adenocarcinoma in Asia
Oh, D., Shen, B., Satoi, S., Zhou, J., Kim, K., Choo, S. P., Woo, S. M., Chan, S. L., Shen, L., & Ikeda, M. (2025) · ESMO Gastrointestinal Oncology · doi:10.1016/j.esmogo.2025.100158 · Cited by 4
Review of design strategies for active targeted drug delivery systems for pancreatic cancer
Rahmatulla, A., Xiao-ling, B., Wang, P., Wang, X., Li, S., Zhang, X., Qiao, X., & Chen, Y. (2025) · European Journal of Pharmaceutics and Biopharmaceutics · doi:10.1016/j.ejpb.2025.114915 · Cited by 4
Self-citation
Targeting strategies, clinical translation and translational barriers of liposomes in cancer therapy
Su, J., Na, J., Yang, Q., Huang, H., Xiao, L., Wu, P., & Zhong, L. (2025) · Biochemical and Biophysical Research Communications · doi:10.1016/j.bbrc.2025.153155 · Cited by 7
Neuro-tumor-immune crosstalk in pancreatic cancer: Mechanisms and therapeutic insights.
Jin, J.-G., He, B., Wang, X., Zhang, Y., You, H., Mo, S., Guo, D., & Shi, S. (2026) · Biochimica et biophysica acta. Reviews on cancer · doi:10.1016/j.bbcan.2026.189575 · Cited by 4
A real-world analysis of second-line treatment option, gemcitabine plus anlotinib and anti-PD1, in advanced pancreatic cancer
Fan, M., Ma, Y., Deng, G., Si, H., Jia, R., Wang, Z., & Dai, G. (2024) · Pancreatology · doi:10.1016/j.pan.2024.03.017 · Cited by 4
Liposomal irinotecan, oxaliplatin, and S-1 as first-line therapy for patients with locally advanced or metastatic pancreatic adenocarcinoma (NASOX): A multicenter phase I/IIa study
Jeong, H., Kim, B. J., Lee, C., Park, I., Zang, D. Y., Choi, H. J., Lee, S. S., Park, D. H., Song, T. J., Oh, D., et al. (2024) · European Journal of Cancer · doi:10.1016/j.ejca.2024.114194 · Cited by 4
Self-citation
Clinical outcomes of liposomal irinotecan in patients with advanced pancreatic cancer previously treated with conventional irinotecan: A meta‐analysis of real‐world evidence
Gupta, A., Jesus‐Acosta, A. D., Le, D. T., Pishvaian, M. J., Zaidi, N., Zheng, L., & Laheru, D. A. (2024) · Cancer · doi:10.1002/cncr.35479 · Cited by 4
“20,33 Conversely, limited evidence exists regarding the predictors in patients who have prior IRI exposure.”
Influential
Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study
Ji, D., Shen, W., Li, T., Wang, H., Bai, J., Cao, J., & Hu, X. (2024) · Investigational New Drugs · doi:10.1007/s10637-024-01442-2 · Cited by 4
Nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable or recurrent pancreatic cancer: a multicenter observational study (NAPOLEON-2)
Shirakawa, T., Shimokawa, M., Otsuka, T., SHINOHARA, Y., Toyodome, K., Kusano, W., Nakazawa, J., Kodama, T., Kawahira, M., Shimokawa, H., et al. (2025) · ESMO Gastrointestinal Oncology · doi:10.1016/j.esmogo.2025.100150 · Cited by 4
A phase I study of liposomal Irinotecan (ONIVYDE®) in combination with TAS-102 (LONSURF®) in refractory solid tumors
Chiang, N., Bai, L., Ho, I., Hsu, C., Liang, Y., Chiu, C., Lin, C., Chang, K.-Y., Chen, S.-H., Tsai, H., et al. (2025) · Investigational New Drugs · doi:10.1007/s10637-025-01547-2 · Cited by 4
“In the standard regimen for metastatic PDAC, liposomal irinotecan is given at 70 mg/m 2 with 5-FU/LV (2400/400 mg/m 2 ) every 2 weeks [14].”
Self-citation
Prognostic impact of gene alterations via homologous recombination DNA repair gene alteration status in pancreatic ductal adenocarcinoma
Kawanaka, Y., Inagaki, C., Okura, M., Mitani, S., Takahama, T., Yonesaka, K., Chiba, Y., Nakagawa, K., Kawakami, H., & Hayashi, H. (2025) · Frontiers in Medicine · doi:10.3389/fmed.2025.1570731 · Cited by 4
TRYBECA-1: A Randomized Phase III Study of Eryaspase Combined With Chemotherapy Versus Chemotherapy as Second-Line Treatment in Patients With Advanced Pancreatic Adenocarcinoma
Hammel, P. R., Metges, J., Macarulla, T. M., García‐Carbonero, R., Bouché, O., Portales, F., Pazo-Cid, R., Mineur, L., Gracián, A. C., Trouilloud, I., et al. (2025) · Journal of Clinical Oncology · doi:10.1200/jco-25-00872 · Cited by 4
Self-citation
Prolonged Response to Liposomal Irinotecan in a Patient with Stage IV Pancreatic/Bile Duct Cancer Previously Treated with FOLFIRINOX and Gemcitabine Plus Nab-Paclitaxel
Surinach, A., Phung, T. L., Abdul-Rahim, O., & Khushman, M. M. (2020) · Current Oncology · doi:10.3747/co.27.5893 · Cited by 4
Advances in Systemic Therapy in Pancreatic Cancer
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The Trends and Outcomes of Initial Palliative Chemotherapy in Patients with Pancreatic Cancer in Korea Based on National Health Insurance Service Data
Jang, D. K., Kim, Y. A., Lee, J.-W., Kim, H., Lee, Y. S., Chun, J. W., Lee, J.-C., Woo, S. M., & Hwang, J. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13113229 · Cited by 4
Enhanced safety and efficacy profile of CD40 antibody upon encapsulation in pHe-triggered membrane-adhesive nanoliposomes
Althobaiti, S., Parajuli, P., Luong, D., Sau, S., Polin, L., Kim, S., Ge, Y., Iyer, A. K., & Gavande, N. S. (2024) · Nanomedicine · doi:10.1080/17435889.2024.2446008 · Cited by 4
Pharmacokinetic and Pharmacodynamic Insights of Bioactive Molecules Encapsulated in Liposomal Formulation
Balakrishnan, P., & Gopi, S. (2025) · Current Pharmacology Reports · doi:10.1007/s40495-025-00406-1 · Cited by 4
“Based on its ability to extend progression-free and overall survival in patients with metastatic pancreatic cancer who had previously received gemcitabine-based therapy, the FDA granted Onivyde™ approval in 2015 for use in conjunction with fluorouracil and folinic acid [76].”
Recomendaciones para el diagnóstico, la estadificación y el tratamiento de las lesiones premalignas y el adenocarcinoma de páncreas
Martín-Richard, M., Ginés, À., Ayuso, J. R., Sabater-Orti, L., Fabregat, J., Méndez, R., Fernández‐Esparrach, G., Molero, X., Vaquero, E. C., Cuatrecasas, M., et al. (2016) · Medicina Clínica · doi:10.1016/j.medcli.2016.07.033 · Cited by 4
Eastern Canadian Gastrointestinal Cancer Consensus Conference 2018
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Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (OESIRI)-PRODIGE 62: A multicentre, randomised, non-comparative phase II study
Randrian, V., Adenis, A., Desrame, J., Barbier, E., Fiore, F. D., Lièvre, A., Dahan, L., Laurent‐Puig, P., Mineur, L., Breysacher, G., et al. (2019) · Digestive and Liver Disease · doi:10.1016/j.dld.2019.11.014 · Cited by 4
Modulating the immune response with liposomal delivery
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Long-Term Survival With Nanoliposomal Irinotecan in Pancreatic Cancer
Assi, H., Shikdar, S., Alhyari, L., & Aljumaily, R. M. (2020) · Pancreas · doi:10.1097/mpa.0000000000001649 · Cited by 4
“1 months, respectively.(3) Real-world experience with nal-IRI+5FU/LV chemotherapy using data from the Flatiron Health database has recently been reported, with similar survival patterns.”
Method
Use and outcomes of chemotherapy for metastatic pancreatic cancer in Australia
Body, A. L., Wong, R., Shapiro, J. D., Jalali, A., McLachlan, S., Ananda, S. S., Lipton, L. R., Cooray, P. D., Gibbs, P., Lee, B., et al. (2020) · Internal Medicine Journal · doi:10.1111/imj.15094 · Cited by 4
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The Appropriate First-Line Chemotherapy Regimen for Incurable Pancreatic Cancer in Clinical Practice: A Consideration of Patients' Overall Survival and Quality of Life
Murakawa, Y., Ootsuka, K., & Abue, M. (2021) · Journal of Pancreatic Cancer · doi:10.1089/pancan.2021.0005 · Cited by 4
“It has also been reported that liposomal irinotecan +5FU/LV regimen could be used to prolong OS and maintain QOL as a second-line chemotherapy in patients with GEM refractory.(24,25) The importance of developing further strategies for individualized secondline treatment regimens based on the first-line chemotherapy ha…”
Background
The clinical outcomes of second-line chemotherapy in patients with advanced pancreatic cancer: a retrospective study
Jung, H. Y., & Lee, E. (2021) · Journal of Yeungnam Medical Science · doi:10.12701/yujm.2021.01347 · Cited by 4
“The only second-line chemotherapy regimen that showed a survival benefit in a phase 3 trial is the combination of nanoliposomal irinotecan and 5-FU/ leucovorin (the NAPOLRI trial) [7].”
Background
A Review of Potential Role of Capsule Endoscopy in the Work-Up for Chemotherapy-Induced Diarrhea
Ando, T., Sakumura, M., Mihara, H., Fujinami, H., & Yasuda, I. (2022) · Healthcare · doi:10.3390/healthcare10020218 · Cited by 4
ESMO Congress 2021: highlights from the EORTC gastrointestinal tract cancer group’s perspective
Koessler, T., Alsina, M., Arnold, D., Ben‐Aharon, I., Collienne, M., Lutz, M. P., Neuzillet, C., Obermannova, R. L., Peeters, M., Sclafani, F., et al. (2022) · ESMO Open · doi:10.1016/j.esmoop.2022.100392 · Cited by 4
“Of note, nal-iri with 5-FU/leucovorin was approved for metastatic pancreatic cancer based on positive survival of the NAPOLI-1 phase III trial.(23) The randomized, phase II NIFTY trial, presented at ASCO 2021, reported first results of this combination chemotherapy in second-line Asian cholangiocarcinoma carcinoma (CC…”
Method
Real-world safety and supportive care use of second-line 5-fluorouracil-based regimens among patients with metastatic pancreatic ductal adenocarcinoma
Kim, G., Cockrum, P. C., Surinach, A., Wang, S., & Wainberg, Z. A. (2022) · Current Medical Research and Opinion · doi:10.1080/03007995.2022.2059976 · Cited by 4
Determination of Extravasation Effects of Nal-Iri and Trabectedin and Evaluation of Treatment Options for Trabectedin Extravasation in a Preclinical Animal Model
Keritam, O., Juhász, V., Schöfer, C., Thallinger, C., Aretin, M., Schabbauer, G., Breuss, J. M., Unseld, M., & Uhrín, P. (2022) · Frontiers in Pharmacology · doi:10.3389/fphar.2022.875695 · Cited by 4
“, 2005), not to be expected, and since no adverse effects of extravasation of its nanoliposomal form administrated to metastatic pancreatic cancer patients were reported (Wang-Gillam et al., 2016).”
Background
The impact of spleen volume on the survival of metastatic pancreatic adenocarcinoma patients receiving nanoliposomal irinotecan.
Yang, S., Chiang, N., Chiu, S.-C., Chou, W., Bai, L., Li, C., Su, Y., Chiu, T., Chuang, S., Peng, C., et al. (2022) · PubMed Central · Cited by 4
Self-citation
Systemic Chemotherapy With or Without Hepatic Arterial Infusion Chemotherapy for Liver Metastases From Pancreatic Cancer: A Propensity Score Matching Analysis
Ouyang, H., Ma, W., Si, T., Liu, D., Chen, P., Gerdtsson, A. S., Song, J., Ni, Y., Luo, J., & Yan, Z. (2022) · Clinical Colorectal Cancer · doi:10.1016/j.clcc.2022.10.007 · Cited by 4
Self-citation
Efficacy and tolerance of LV5FU2-carboplatin chemotherapy in patients with advanced pancreatic ductal adenocarcinoma after failure of standard regimens
Chaigneau, T., Munoz, L. A., Oger, C., Gourdeau, C., Hentic, O., Laurent, L., Müller, N., Burgio, M. D., Gagaille, M.-P., Lévy, P., et al. (2023) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359231163776 · Cited by 4
A Retrospective Study Investigating the Safety and Efficacy of Nanoliposomal Irinotecan in Elderly Patients with Unresectable Pancreatic Cancer
Ikoma, T., Matsumoto, T., Boku, S., Yasuda, T., Masuda, M., Ito, T., Nakamaru, K., Yamaki, S., Nakayama, S., Hashimoto, D., et al. (2023) · Journal of Clinical Medicine · doi:10.3390/jcm12103477 · Cited by 4
Combination of mutations in genes controlling DNA repair and high mutational load plays a prognostic role in pancreatic ductal adenocarcinoma (PDAC): a retrospective real-life study in Sardinian population
Sini, M. C., Doro, M. G., Frogheri, L., Zinellu, A., Paliogiannis, P., Porcu, A., Scognamillo, F., Delogu, D., Santeufemia, D. A., Persico, I., et al. (2024) · Journal of Translational Medicine · doi:10.1186/s12967-024-04923-3 · Cited by 4
“Despite the introduction in clinical practice of new chemotherapeutic schedules [10, 11] and drugs [13], only little progresses have been made in recent years.”
Background
Sequential therapy of refractory metastatic pancreatic cancer with 5-FU/LV/irinotecan (FOLFIRI) vs. 5-FU/LV/oxaliplatin (OFF). The PANTHEON trial (AIO PAK 0116)
Modest, D. P., Heinemann, V., Schütt, P., Angermeier, S., Haberkorn, M., Waidmann, O., Graeven, U., Wille, K., Kunzmann, V., Henze, L., et al. (2024) · Journal of Cancer Research and Clinical Oncology · doi:10.1007/s00432-024-05827-x · Cited by 4
“…frequency of oxaliplatin/irinotecan-related adverse events is in line with other gastrointestinal cancers receiving oxaliplatin-or irinotecan-based regimens in pretreated patient cohorts (Oettle et al. 2014; Wang-Gillam et al. 2016; Lamarca et al. 2021; Bennouna et al. 2013; Lorenzen et al. 2022).”
BackgroundResult
Impact of Changes in the American Joint Committee on Cancer Staging Manual, Eighth Edition, for Pancreatic Ductal Adenocarcinoma
Kassardjian, A., Stanzione, N., Donahue, T. R., Wainberg, Z. A., Damato, L. M., & Wang, H. L. (2019) · Pancreas · doi:10.1097/mpa.0000000000001349 · Cited by 4
Correlation of skin rash and overall survival in patients with pancreatic cancer treated with gemcitabine and erlotinib – results from a non-interventional multi-center study
Westphalen, C. B., Kukiolka, T., Garlipp, B., Hahn, L., Fuchs, M., Malfertheiner, P., Reiser, M., Kütting, F., Heinemann, V., Beringer, A., et al. (2020) · BMC Cancer · doi:10.1186/s12885-020-6636-7 · Cited by 4
Self-citation
HPB cancers in older patients | inclusion of older/senior patients in clinical trials
Backen, A. C., Lamarca, Á., Hubner, R. A., McNamara, M. G., & Valle, J. W. (2020) · European Journal of Surgical Oncology · doi:10.1016/j.ejso.2020.11.002 · Cited by 4
Self-citation
Drug metabolism and pancreatic cancer
Flores, J. P. (2016) · Annals of Gastroenterology · doi:10.20524/aog.2016.0074 · Cited by 4
“Most recently, the combination of nanoliposomal irinotecan plus 5-FU and folinic acid has shown a survival benefit in the second-line setting after gemcitabine-based therapy [9].”
Background
Updated therapeutic outcome for patients with periampullary and pancreatic cancer related to recent translational research
Buanes, T. A. (2016) · World Journal of Gastroenterology · doi:10.3748/wjg.v22.i48.10502 · Cited by 4
Current challenges in optimizing systemic therapy for patients with pancreatic cancer: expert perspectives from the Australasian Gastrointestinal Trials Group (AGITG) with invited international faculty
Segelov, E., Lordick, F., Goldstein, D., Chantrill, L. A., Croagh, D. G., Lawrence, B. J., Arnold, D., Chau, I., Obermannova, R. L., & Price, T. J. (2017) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2017.1369882 · Cited by 4
“This regimen reported an improvement in median OS in the NAPOLI1 trial [30] after gemcitabine-based first-line therapy.”
Background
Low-dose nab-paclitaxel-based combination chemotherapy in heavily pretreated pancreatic cancer patients
Yang, S., Guo, J., Hsu, C., Kuo, S., Tien, Y., Cheng, A., & Yeh, K. (2019) · Journal of the Formosan Medical Association · doi:10.1016/j.jfma.2019.01.015 · Cited by 4
Healthcare Rationing Cutoffs and Sorites Indeterminacy
Rosoff, P. M. (2019) · The Journal of Medicine and Philosophy A Forum for Bioethics and Philosophy of Medicine · doi:10.1093/jmp/jhz012 · Cited by 4
Phase 1/2 study of liposomal irinotecan plus S-1 for metastatic pancreatic cancer refractory to gemcitabine-based treatment
Imaoka, H., Ikeda, M., Ozaka, M., Oshima, K., Okano, N., Shimizu, S., Tsumura, H., Komatsu, Y., Yamashita, T., Kataoka, S., et al. (2025) · European Journal of Cancer · doi:10.1016/j.ejca.2025.115424 · Cited by 3
Predictive and prognostic factors of efficacy of third-line chemotherapy in patients with unresectable pancreatic cancer: a cohort-based study
Evrard, C., Pelras, A., Rivet, S., Bachet, J., Dubreuil, O., Pointet, A., Taı̈eb, J., Lahlou, W., Portal, A., Lepère, C., et al. (2025) · The Oncologist · doi:10.1093/oncolo/oyaf125 · Cited by 3
Phase 1 trial of HR070803 (an Irinotecan liposome) in combination with 5-fluorouracil, leucovorin, and oxaliplatin for untreated advanced or metastatic pancreatic ductal adenocarcinoma
Xu, Q., Zhao, X. H., Wang, X., Zhu, R., Cheng, Y., Xia, T., Wu, H., Tian, H., Sun, Y., Zhang, M., et al. (2025) · BMC Medicine · doi:10.1186/s12916-025-04234-4 · Cited by 3
“The adverse event profiles both in the total patients and the RP2D group (60/85) observed in the current trial were generally in line with that previously reported for liposome irinotecan [16, 17, 24].”
Self-citation
A FRET-based toolkit for quantifying lipid incorporation into nanoparticles
Rosales, P. D., Viravalli, A., Schneider, A., & Boehnke, N. (2025) · Nanoscale · doi:10.1039/d5nr03734d · Cited by 3
Liposomal irinotecan plus fluorouracil/leucovorin in older patients with advanced pancreatic cancer: a single-center retrospective study
Nagashima, S., Kobayashi, S., Tsunoda, S., Yamachika, Y., Tozuka, Y., Fukushima, T., Morimoto, M., Ueno, M., Furuse, J., & Maeda, S. (2023) · International Journal of Clinical Oncology · doi:10.1007/s10147-023-02432-9 · Cited by 3
“Patients received Nal-IRI, 70 mg/m 2 for 90 min; LV, 400 mg/ m 2 for 30 min; and 5-FU, 2400 mg/m 2 for 46 h every 2 weeks, as possible [6, 9].”
Clinical Significance of Increased Skeletal Muscle Mass During Nab-Paclitaxel Plus Gemcitabine Treatment in Patients With Advanced Pancreatic Cancer
Iede, K., Yamada, T., Ishida, T., Tsuda, Y., Nakashima, S., Tanida, T., Matsuyama, J., Nakata, K., & Tominaga, S. (2023) · Pancreas · doi:10.1097/mpa.0000000000002269 · Cited by 3
Impact of an Inter-Professional Clinic on Pancreatic Cancer Outcomes: A Retrospective Cohort Study
Moffat, G. T., Coyne, Z. L., Albaba, H., Aung, K. L., Dodd, A., Espin‐Garcia, O., Moura, S. L., Gallinger, S., Kim, J., Fraser, A., et al. (2024) · Current Oncology · doi:10.3390/curroncol31050194 · Cited by 3
Self-citation
Irinotecan dosing and pharmacogenomics: a comprehensive exploration based on UGT1A1 variants and emerging insights
Faisal, M. S., Hussain, I., Ikram, M. A., Shah, S. B., Rehman, A., & Iqbal, W. (2024) · Journal of Chemotherapy · doi:10.1080/1120009x.2024.2349444 · Cited by 5
“Moreover, in 2015, the FDA approved liposomal irinotecan as a second-line therapy for metastatic pancreatic ductal adenocarcinoma (PDAC) in conjunction with 5-FU and folinic acid following the ineffectiveness of the initial gemcitabine-based treat-ment [7].”
Influential
Survival predictors in patients with pancreatic cancer on liposomal irinotecan plus fluorouracil/leucovorin: a multicenter observational study
Keum, J., Lee, H. S., Park, C. S., Kim, J., Jang, W., Shin, K. I., Kang, H., Lee, S. H., Jo, J. H., Jang, S. I., et al. (2024) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241279688 · Cited by 3
Self-citation
Second-line treatment of PD-1 and CTLA-4 blockade combined with liposomal irinotecan plus leucovorin and fluorouracil for advanced cholangiocarcinoma: study protocol of a single-arm, prospective phase II trial
Yang, H., Li, L., Li, X., Ma, Y., Yu, Y., & Cao, D. (2024) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241292264 · Cited by 3
“Two clinical trials (NAPOLI-1 and NAPOLI-3) 5,6 have confirmed the effectiveness of liposomal irinotecan as a first-line and second-line treat-ment for pancreatic cancer and have been recommended in guidelines.”
Medical oncology and pancreatic cancer: what the radiologist needs to know
Fogelman, D. R., & Varadhachary, G. A. (2017) · Abdominal Radiology · doi:10.1007/s00261-017-1432-9 · Cited by 3

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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