1674P - VILP registry of patients with metastatic pancreatic cancer treated with pegylated liposomal irinotecan plus 5-fluoroucil and leucovorin in the Czech Republic

Background

Following the NAPOLI-1 trial, pegylated liposomal irinotecan (nal-IRI), in combination with 5-fluorouracil (5-FU) and leucovorin (LV) (nal-IRI + 5-FU/LV), is a standard treatment for advanced pancreatic ductal adenocarcinoma (PDAC) patients progressing after gemcitabine-based chemotherapy. The VILP registry captured real-world data on metastatic PDAC patients in Czech Republic receiving nal-IRI + 5-FU/LV.

Methods

Data were collected on all metastatic PDAC patients that received nal-IRI + 5-FU/LV, had an Eastern Cooperative Oncology Group performance status 0 or 1, and had progressed on gemcitabine-based chemotherapy, first line or (neo)adjuvant. Treatment was until progression or unmanageable toxicity. For the final evaluation of data, endpoints correspond to those published in the NAPOLI-1 trial; primary endpoint was overall survival (OS), calculated as the time from the treatment initiation to the date of death. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR) and treatment toxicity.

Results

As of April 6, 2023, 142 PDAC patients were enrolled, of which 129 were evaluable. Patients had a median age of 66 years, 95 (73.6%) received nal-IRI + 5-FU/LV as second line therapy and 101 (78.3%) had ECOG PS 1. A total of 93 (72.1%) patients discontinued treatment and median treatment duration was 2.3 months (range: 0.0-18.8) with the principal reason for discontinuation being disease progression (n=45, 48.4%). Median and 6-months OS were 10.1 months (95% CI 6.0–not reached) and 57.1% (95% CI 47.4–68.7), respectively. Median and 6-months PFS were 3.5 months (95% CI 3.1–5.7) and 35.5% (95% CI 27.1–46.6), respectively. ORR was 10.1% (12 cases of partial response and 1 complete response). A total of 19 adverse events (AEs) occurred in 17 (13.2%) patients, with the most frequent AEs being diarrhoea (n=9; grade 3 n=3) and fatigue (n=3; grade 3 n=1).

Conclusions

The VILP register confirms the effectiveness of nal-IRI + 5-FU/LV as a well-tolerated treatment option for patients with PDAC in real-world practice.

Clinical trial identification

Editorial acknowledgement

Editorial assistance was provided by Emily Eagles of Empowering Strategic Performance Ltd and supported by Servier Medical Affairs.

Legal entity responsible for the study

Servier.

Funding

Servier.

Disclosure

S. Batko: Financial Interests, Personal, Other, Honoraria: Amgen, Bristol Myers Squibb, Eli-Lilly, Ipsen, Merck, Pierre Fabre, Servier. T. Buchler: Financial Interests, Personal, Invited Speaker: Roche, Bristol Myers Squibb, Astellas, Janssen, Ipsen, Merck; Financial Interests, Personal, Advisory Board: Bayer, Bristol Myers Squibb, Ipsen, Merck, Servier, Eli Lilly, Pfizer, Accord; Financial Interests, Institutional, Local PI: Bristol Myers Squibb, Merck, Bayer, Exelixis, Eisai, Eli Lilly, Roche, MSD; Financial Interests, Personal and Institutional, Coordinating PI: AstraZeneca; Non-Financial Interests, Advisory Role: Leram Pharmaceuticals. B. Melichar: Financial Interests, Personal, Advisory Board: Roche, BMS, MSD, Novartis, Merck, E. Lilly, Pfizer, AstraZeneca. All other authors have declared no conflicts of interest.