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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A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer
Yoo, C., Hwang, J. Y., Kim, J. H., Kim, T. W., Lee, J. S., Park, D. H., Lee, S. K., Seo, D. W., Lee, S. S., Kim, M., et al. (2009) · British Journal of Cancer · doi:10.1038/sj.bjc.6605374 · Cited by 169
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Ko, A. H., Tempero, M. A., Shan, Y.-S., Su, W., Lin, Y.-L., Dito, E., Ong, A., Wang, Y.-W., Yeh, C. G., & Chen, L.-T. (2013) · British Journal of Cancer · doi:10.1038/bjc.2013.408 · Cited by 160
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Background
Predictive value of albumin combined with neutrophil-to-lymphocyte ratio for efficacy and safety profiles in patients with pancreatic ductal adenocarcinoma receiving liposomal irinotecan plus 5-fluorouracil and leucovorin.
Chen, Y., Hsueh, S., Yang, S., Chiu, S.-C., Chiang, N., Chiu, T., Li, C., Bai, L., Chiu, C., Chuang, S., et al. (2022) · PubMed Central · Cited by 10
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Fine-tuning the sequential drug release of nano-formulated mutual prodrugs dictates the combination effects
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“…with Gem Advanced PDAC, ECOG ≤2 221 PFS: 6.6 mo OS: 9.8 mo nal-IRI* Topoisomerase I inhibitor encapsulate within a lipid layer vesicle Phase III (NAPOLI-1: Wang-Gillam et al, 2016)22 Combined with 5-FU/LV vs 5-FU/LV alone Second line mPDAC 417 PFS: 3.1 vs 1.5 mo (P = 0.0001) OS: 6.1 vs 4.2…”
BackgroundMethodInfluentialSelf-citation
Cracking KRASG12C across all solid tumors: the new kid on the block for tissue-agnostic precision medicine
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“While the data are early, the results are promising given the limited availability of effective treatment options particularly for patients with pancreatic and hepatobiliary cancers where PFS with standard therapies in the second line is dismal.(21,22) In KRYSTAL-1, there were patients who were able to achieve disease…”
Result
Third-line treatment options in metastatic pancreatic cancer patients: a real-world study
Lu, H., Zhu, P.-F., Deng, Y.-Y., Chen, Z.-L., & Yang, L. (2023) · Frontiers in Oncology · doi:10.3389/fonc.2023.1251258 · Cited by 9
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“bine-based therapy received nanoliposomal irinotecan as single agent or in combination with fluorouracil and folinic acid (5-FU/LV) versus 5-FU/LV alone [22].”
Method
Scientific rationale for integrative and personalised strategies for pancreatic ductal adenocarcinoma management
Korhan, P., Verkerk, R. M., & Critchley, W. R. (2017) · Integrative Molecular Medicine · doi:10.15761/imm.1000310 · Cited by 8
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“Results from the recent NAPOLI-1 phase III trial showed significant improvements in both progression-free survival (PFS) and OS in patients with metastatic PC after previous GEM-based therapy and irinotecan liposomal injection combined with 5-FU/LV, indicating a new treatment option for this population [11].”
Background
Management and supportive treatment of frail patients with metastatic pancreatic cancer
Macarulla, T. M., Carrato, A., Díaz, R., Garcia-Velasco, A., Laquente, B., Sastre, J., Álvarez, R., Muñoz, A., & Hidalgo, M. M. (2018) · Journal of Geriatric Oncology · doi:10.1016/j.jgo.2018.06.005 · Cited by 9
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“FOLFnal‐IRI was applied according to the NAPOLI‐1 trial protocol: Liposomal irinotecan at 70 mg/m2 and folinic acid at 400 mg/m2, followed by 5‐fluorouracil infusion at 2,400 mg/m2 over the course of 46 h every 2 weeks (23).”
Dosing Pattern and Early Cumulative Dose of Liposomal Irinotecan in Metastatic Pancreatic Cancer: A Real-World Multicenter Study
Su, Y., Chiang, N., Li, C., Yen, C., Yang, S., Chou, W., Chen, J., Chiu, T., Chen, Y., Chuang, S., et al. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.800842 · Cited by 9
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“1 months (NOPALI-1 regimen).(38) In this study, a PFS of 3.”
Background
Biomarker analysis for patients with pancreatic cancer treated with nanoliposomal irinotecan plus 5-fluorouracil/leucovorin
Kawakami, T., Todaka, A., Oshima, K., Fushiki, K., Hamauchi, S., Tsushima, T., Yokota, T., Onozawa, Y., Yasui, H., & Yamazaki, K. (2023) · BMC Cancer · doi:10.1186/s12885-023-10542-w · Cited by 9
“We observed more incidences of grade 3 or higher neutropenia, nausea, and anorexia than in previous reports [3, 4].”
MethodResult
Tackling pancreatic cancer with metronomic chemotherapy
Romiti, A., Falcone, R., Roberto, M., & Marchetti, P. (2017) · Cancer Letters · doi:10.1016/j.canlet.2017.02.017 · Cited by 9
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A retrospective comparative study of S-IROX and modified FOLFIRINOX for patients with advanced pancreatic cancer refractory to gemcitabine plus nab-paclitaxel
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Correlation of UGT1A1 Gene Polymorphisms or Prior Irinotecan Treatment and Treatment Outcomes of Nanoliposomal-Irinotecan plus 5-Fluorouracil/Leucovorin for Pancreatic Ductal Adenocarcinoma: A Multicenter, Retrospective Cohort Study (HGCSG2101)
Harada, K., Yamamura, T., Muto, O., Nakamura, M., Sogabe, S., Sawada, K., Nakano, S., Yagisawa, M., Muranaka, T., Dazai, M., et al. (2023) · Journal of Clinical Medicine · doi:10.3390/jcm12041596 · Cited by 8
Integration of liposomal irinotecan in the first-line treatment of metastatic pancreatic cancer: try to do not think about the white bear
Melisi, D., Casalino, S., Pietrobono, S., Quinzii, A., Zecchetto, C., & Merz, V. (2024) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241234487 · Cited by 8
“…to the standard gemcitabine plus nab-paclitaxel, 7 and as a second-line treatment in combination with 5FU/LV compared to the standard 5FU/LV. 8 Notably, NALIRIFOX has been also included in the most recent National Comprehensive Cancer Network guidelines as one of the recommended regimens…”
BackgroundMethodInfluential
Second-Line Treatment of Pancreatic Adenocarcinoma: Shedding Light on New Opportunities and Key Talking Points from Clinical Trials
Imperial, R. J. L., Mosalem, O. M., Majeed, U., Tran, N. H., Borad, M. J., & Babiker, H. M. (2024) · Clinical and Experimental Gastroenterology · doi:10.2147/ceg.s390655 · Cited by 7
Nanoliposomal irinotecan (Nal-IRI)-based chemotherapy after irinotecan -based chemotherapy in patients with pancreas cancer
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Modified FOLFIRINOX versus sequential chemotherapy (FOLFIRI/FOLFOX) as a second‐line treatment regimen for unresectable pancreatic cancer: A real‐world analysis
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A Multicenter Phase 1 Trial Evaluating Nanoliposomal Irinotecan for Heated Intraperitoneal Chemotherapy Combined with Cytoreductive Surgery for Patients with Peritoneal Surface Disease
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“As a novel formulation of standard irinotecan, Nal-IRI was approved for intravenous administration by the FDA in 2015.(12) This nanoliposomal formulation shows extended PK parameters and thus increases prodrug and active metabolite delivery to tumor cells, thereby enabling higher anti-tumor efficacy with lower doses c…”
BackgroundMethodInfluentialSelf-citation
Lipid Nanoparticles-Based Therapy in Liver Metastasis Management: From Tumor Cell-Directed Strategy to Liver Microenvironment-Directed Strategy
Wang, Y., Yin, Z., Gao, L., Ma, B., Shi, J., & Chen, H. (2023) · International Journal of Nanomedicine · doi:10.2147/ijn.s402821 · Cited by 8
“A Phase III open-label randomized trial NAPOLI-1 evaluated the survival benefits of liposomal irinotecan monotherapy or combing fluorouracil and folinic acid in gemcitabine-refractory metastatic pancreatic cancer.(37) Median overall survival in patients using liposomal irinotecan plus fluorouracil and folinic acid was…”
Background
Clinical outcomes of liposomal irinotecan in advanced pancreatic adenocarcinoma patients previously treated with conventional irinotecan-based chemotherapy: a real-world study
Gupta, A., Jesus‐Acosta, A. D., Zheng, L., Lee, V., Kamel, I. R., Le, D. T., Pishvaian, M. J., & Laheru, D. A. (2023) · Frontiers in Oncology · doi:10.3389/fonc.2023.1250136 · Cited by 8
Morbidity and mortality in patients with stage IV pancreatic adenocarcinoma and acute cholangitis: Outcomes and risk prognostication
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Orphan drug approvals of 2015: Europe and the United States
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“The results of both phase II and III studies with this formulation have been published and shown that it improves survival in patients who are refractory to gemcitabine.[45,46] Trabectedin is a natural product isolated from the sea squirt that binds to DNA and regulates cell transcription.”
Background
Retrospective analysis of efficacy and safety of Gemcitabine-based chemotherapy in patients with metastatic pancreatic adenocarcinoma experiencing disease progression on FOLFIRINOX
de Jesus, V. H. F., Camandaroba, M. P. G., Donadio, M. D. S., Cabral, A., Muniz, T. P., Leite, L. D. M., & Sant’Ana, L. F. (2018) · Journal of Gastrointestinal Oncology · doi:10.21037/jgo.2018.06.08 · Cited by 8
Long-term outcome of patients with advanced pancreatic cancer treated with sequential chemotherapies before the era of modern combination therapy protocols
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Evolving Treatment Paradigms for Pancreatic Cancer
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Possibilities of palliative chemotherapy in patients with locally advanced and metastatic pancreatic cancer
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Metastatic pancreatic cancer with complete response to FOLFIRINOX treatment
Shelemey, P. T., Amaro, C. P., Ng, D., Falck, V., & Tam, V. C. (2021) · BMJ Case Reports · doi:10.1136/bcr-2020-238395 · Cited by 8
Gemcitabine Plus Nab-Paclitaxel as Second-Line Chemotherapy following FOLFIRINOX in Patients with Unresectable Pancreatic Cancer: A Single-Institution, Retrospective Analysis
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Self-citation
Pancreatic adenocarcinoma and pancreatic high-grade neuroendocrine carcinoma: two sides of the moon
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“In the light of the data from the NAPOLI-1 study, a combination treatment with 5-FU, Leucorvin and Irinotecan may be chosen, if a disease progression occurs after Gemcitabine chemotherapy [64].”
Method
Treatment outcomes of nanoliposomal irinotecan as second-line chemotherapy after gemcitabine and nab-paclitaxel in metastatic and recurrent pancreatic cancer
Mie, T., Sasaki, T., Okamoto, T., Takeda, T., Mori, C., Furukawa, T., Kasuga, A., Matsuyama, M., Ozaka, M., & Sasahira, N. (2022) · Japanese Journal of Clinical Oncology · doi:10.1093/jjco/hyac145 · Cited by 8
Current and emerging anti-angiogenic therapies in gastrointestinal and hepatobiliary cancers
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Self-citation
Second-line therapy in pancreatic ductal adenocarcinoma (PDAC) patients with germline BRCA1-2 pathogenic variants (gBRCA1-2pv)
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“free chemotherapy (48% versus 24%, respectively) and higher to that reported in the literature on second-line therapy in PDAC, both in RCTs (11–16% in [9, 11, 20]) and in non-randomised trials (0–23 %) [7].”
BackgroundResultInfluential
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The European Society for Medical Oncology 'Magnitude of Clinical Benefit Scale' field-tested in infrequent tumour entities: an extended analysis of its feasibility at the Medical University of Vienna
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Nab-paclitaxel plus gemcitabine as first line therapy in metastatic pancreatic cancer patients relapsed after gemcitabine adjuvant treatment
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Guidelines for holistic integrative management of pancreatic cancer
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Enhancing Pancreatic Cancer Therapy With Targeted CD133-Exosome Delivery of PD-L1 siRNA
Yoon, Y. C., Lee, D., Park, J. H., Kim, O., Choi, H. J., & Kim, S. (2024) · Pancreas · doi:10.1097/mpa.0000000000002419 · Cited by 7
“7,9 RNA interference (RNAi) has demonstrated its capability to downregulate oncogenes, tumor suppressor genes, and their regulatory counterparts.”
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Therapeutic co-assemblies for synergistic NSCLC treatment through dual topoisomerase I and tubulin inhibitors
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Real-world clinical outcome of unresectable locally advanced & de-novo metastatic pancreatic ductal adenocarcinoma: a multicentre retrospective study
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Implication of Skeletal Muscle Loss in the Prognosis of Patients with Pancreatic Ductal Adenocarcinoma Receiving Chemotherapy
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BackgroundInfluential
Efficacy of liposomal irinotecan + 5-FU/LV vs. S-1 in gemcitabine-refractory metastatic pancreatic cancer: a real-world study using inverse probability of treatment weighting
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“Reports have been presented in meeting abstracts [28, 29, 35].”

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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