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Liposomal Irinotecan: A Review in Metastatic Pancreatic Adenocarcinoma

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Abstract

Intravenous liposomal irinotecan injection (Onivyde®) is approved for use in combination with 5-fluorouracil and leucovorin (5-FU/LV) in patients with metastatic pancreatic adenocarcinoma that has progressed following gemcitabine-based therapy. Liposomal irinotecan is a liposome-encapsulated formulation of the topoisomerase-1 inhibitor irinotecan, developed to overcome the pharmacological and clinical limitations of non-liposomal irinotecan. In the pivotal multinational, phase III NAPOLI-1 trial in patients with metastatic pancreatic adenocarcinoma that had progressed following gemcitabine-based therapy, liposomal irinotecan in combination with 5-FU/LV significantly prolonged median overall survival (OS; primary endpoint) and median progression-free survival (PFS) at the time of the primary analysis (after 313 events) and final analysis (after 382 events) compared with 5-FU/LV control therapy. The objective response rate was also significantly higher in the liposomal irinotecan plus 5-FU/LV group than in the control group. Liposomal irinotecan-based combination therapy had a manageable safety profile; the most common treatment-emergent adverse events (TEAEs) of grade ≥3 severity were haematological or gastrointestinal in nature. The incidence of neutropenic sepsis was low. In a setting where there is a paucity of second-line treatment options, liposomal irinotecan in combination with 5-FU/LV is an important emerging treatment option for metastatic adenocarcinoma of the pancreas that has progressed following gemcitabine-based therapy.

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Acknowledgements

During the peer review process, the manufacturer of liposomal irinotecan was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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    Yvette N. Lamb & Lesley J. Scott

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  1. Yvette N. Lamb
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Correspondence to Yvette N. Lamb.

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The preparation of this review was not supported by any external funding.

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Yvette Lamb and Lesley Scott are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.

Additional information

The manuscript was reviewed by: D. Grapsa, Oncology Unit, 3rd Department of Medicine, Sotiria Athens General Hospital, Athens University School of Medicine, Athens, Greece; M. Harris, Department of Medical Oncology, Monash Health, East Bentleigh, Victoria, Australia; C.-T. Hsueh, Division of Medical Oncology and Haematology, Department of Internal Medicine, Loma Linda University, Loma Linda, CA, USA; E. M. O’Reilly, David M. Rubenstein Centre for Pancreas Cancer Research, Department of Medicine, Memorial Sloan-Kettering Cancer Centre, New York, NY, USA; T. Seufferlein, Department of Internal Medicine I, University of Ulm, Ulm, Germany.

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Lamb, Y.N., Scott, L.J. Liposomal Irinotecan: A Review in Metastatic Pancreatic Adenocarcinoma. Drugs 77, 785–792 (2017). https://doi.org/10.1007/s40265-017-0741-1

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