Liposomal Irinotecan: A Review in Metastatic Pancreatic Adenocarcinoma
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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.
KeywordsIrinotecan Median Overall Survival Karnofsky Performance Status Metastatic Pancreatic Cancer Control Therapy
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.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
Yvette Lamb and Lesley Scott are salaried employees of Adis/Springer, are responsible for the article content and declare no relevant conflicts of interest.
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