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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
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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“Patients progressing on first-line regimens can be offered the possibility of switching to the other regimen, or a second-line regimen that includes a liposomal formulation of irinotecan in combination with 5-FU10, provided they have not received either of these agents previously.”
From Pancreatic cancer: Advances and challenges (2023) · cites this paper as [10]
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Brendel, K., Bekaii‐Saab, T., Boland, P. M., Dayyani, F., Dean, A. P., Macarulla, T. M., Maxwell, F., Mody, K., Pedret‐Dunn, A., Wainberg, Z. A., et al. (2021) · CPT Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12725 · Cited by 15
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“042) in the nal-IRI + 5-FU/LV group (Wang-Gillam et al., 2016).”
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“This was based on the data from the NAPOLI-1 trial published in 2016 (mOS was 6.1 months with liposomal irinotecan plus 5-FU and folinic acid and 4.2 months with 5-FU and folinic acid, p = 0.012) [18].”
MethodInfluentialSelf-citationFukahori, M., Okabe, Y., Shimokawa, M., Otsuka, T., Koga, F., Ueda, Y., Nakazawa, J., Komori, A., Otsu, S., Arima, S., et al. (2023) · Scientific Reports · doi:10.1038/s41598-023-46924-0 · Cited by 16
“The NAPOLI-1 study, a pivotal phase III RCT, found that nal-IRI plus 5-FU/FA significantly improved survival compared with 5-FU/FA (median: 6.1 versus 4.2 months, p = 0.0012) and PFS (median, 3.1 versus 1.5 months, p = 0.00001) in patients previously treated with a gemcitabine-based regimen 11 .”
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Combined strategies for tumor immunotherapy with nanoparticles
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Advancements in nanotechnology for the diagnosis and treatment of multiple myeloma
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Self-citationClassic versus innovative strategies for immuno-therapy in pancreatic cancer
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Bernardi, M., Signore, G., Moscardini, A., Pugliese, L. A., Pesce, L., Beltram, F., & Cardarelli, F. (2023) · ACS Applied Bio Materials · doi:10.1021/acsabm.3c00478 · Cited by 15
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Self-citationTowards an Optimal Treatment Algorithm for Metastatic Pancreatic Ductal Adenocarcinoma (PDA)
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“Recently, based on the results of the NAPOLI-1 trial, the Food and Drug Administration (FDA) approved combination of nano-liposomal-IRI (Nal-IRI) with 5-FU and folinic acid in previously treated patients with gemcitabine-based chemotherapy.(6) Moreover, studies testing FOLFIRINOX after Gem-NabP failure are ongoing.”
BackgroundPancreatic ductal adenocarcinoma in the era of precision medicine
Zheng-Lin, B., & O'Reilly, E. M. (2021) · Seminars in Oncology · doi:10.1053/j.seminoncol.2021.01.005 · Cited by 16
“1) in durvalumab alone arm, both notably inferior to historical outcomes with chemotherapy [52, 53].”
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“Abraxane (paclitaxel/ albumin complex) and Onivyde (irinotecan liposome), were recently approved by FDA, these early-stage nano formulations (that rely on EPR for tumor targeting) only lead to »2 months overall survival in PDAC patients.(4,5) PDAC develops a range of disease-specific barriers, including high pericyte…”
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“In Europe, after a gemcitabine-based first-line therapy, the NAPOLI regimen (nal-irinotecan 80mg/m(2); leucovorin 400mg/m(2); 5-fluorouracil 2400mg/m(2) 46 h; qd15) is approved for second-line treatment [12].”
BackgroundLipid-based Nanoplatforms in Cancer Therapy: Recent Advances and Applications
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Siddiqui, R. S., & Sardar, M. R. (2021) · Cureus · doi:10.7759/cureus.14494 · Cited by 15
“Similarly, in relapsed metastatic pancreatic cancer, a nanoliposomal irinotecan and 5FU-based regimen in gemcitabine refractory patients had a response rate of 16% [34].”
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“Other 0 9 (6) American Journal of Clinical Oncology Volume 42, Number 2, February 2019 Second-line Therapies for APC”
Background
Metadata
- 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
- 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
- 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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