Available for patients with metastatic pancreatic cancer who have previously been treated with gemcitabine-based chemotherapy.
A novel encapsulated form of irinotecan in a long-circulating nanoliposome (Onivyde) for use in combination with fluorouracil and leucovorin.
Effectiveness of the product was demonstrated in a three-arm, randomized, open-label study (known as the NAPOLI-1 trial), which was conducted in 417 patients with metastatic pancreatic adenocarcinoma whose cancer had progressed after treatment with gemcitabine alone or in combination with other agents.
The regimen used in the trial was a combination of liposomal irinotecan (80 mg/m² IV over 90 min) administered prior to fluorouracil (2400 mg/m² over 46 hr) and leucovorin (400 mg/m² over 30 min) every 2 weeks.
Patients treated with this combination of liposomal irinotecan plus fluorouracil/leucovorin lived for an average of 6.1 months, compared with 4.2 months for those treated with only fluorouracil/leucovorin in the control group, and 4.2 months for patients in another group who were treated with liposomal irinotecan alone.
There was also an improvement in progression-free survival, to a median of 3.1 months with liposomal irinotecan plus fluorouracil/leucovorin compared with 1.5 months for those receiving fluorouracil/leucovorin.
Updated results from this trial indicated the median overall survival with the combination of liposomal irinotecan, fluorouracil, and leucovorin was 8.9 months vs 5.9 months with fluorouracil and leucovorin alone.
The most common side effects of treatment with liposomal irinotecan include: diarrhea, fatigue, vomiting, nausea, decreased appetite, stomatitis, and pyrexia.
There are reports of lymphopenia and neutropenia, and death due to sepsis following neutropenia.