Pegylated Liposomal Irinotecan + 5-FU/LV in the Treatment of mPDAC in Czech Clinical Practice – Results from the VILP Registry
At last year's annual congress of the European Society for Medical Oncology (ESMO) and this year's 15th PragueONCO, results from the Czech VILP registry were presented. This registry collected data on patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with pegylated liposomal irinotecan (nal-IRI) in combination with 5-fluorouracil (5-FU) and leucovorin (LV). The efficacy and safety of nal-IRI + 5-FU/LV in patients with mPDAC after failure or intolerance to gemcitabine-based chemotherapy, as found in the randomized controlled study NAPOLI-1, are thus confirmed in real clinical practice in the Czech Republic.
Purpose of the Registry
Pancreatic ductal adenocarcinoma (PDAC) is a disease with a very poor prognosis owing to the high proportion of cases with metastatic spread. In the second line of systemic treatment for patients with metastatic PDAC, who experienced progression after gemcitabine-based chemotherapy, following the publication of the results of the NAPOLI-1 study, the standard treatment became nal-IRI + 5-FU/LV. In the Czech Republic, a registry was implemented based on a mandate to collect data on very innovative medicinal products (VILP). This registry enables the evaluation of treatment outcomes for patients with mPDAC who received nal-IRI + 5-FU/LV in real clinical practice.
Methodology and Evaluated Population
Patients had to have a performance status (PS) according to ECOG 0/1 and confirmed progression of mPDAC on gemcitabine-based therapy. Treatment with nal-IRI + 5-FU/LV continued until progression or unbearable toxicity. The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), time to treatment failure (TTF), the proportion of patients with an objective response to treatment (ORR), and safety.
Results reflect the period since 2021 when nal-IRI was introduced in the Czech market until April 2023. As of April 6, 2023, 142 patients with mPDAC had been included in the VILP registry, of which 129 were evaluable. Reasons for exclusion included noncompliance with reimbursement criteria (n = 2), lack of treatment data (n = 4), unconfirmed progression on gemcitabine therapy (n = 9), and unreported ECOG PS (n = 6).
The median age of the evaluated patients was 66 years, with males constituting 58.1% of the population. The majority of patients (73.6%) received nal-IRI + 5-FU/LV in the second line of treatment, and 78.3% had ECOG PS 1. Over 81% of patients received the full dose of nal-IRI (70 mg/m2), while others had a reduced dose to 50 mg/m2. Dose adjustments occurred in 11 patients, mostly due to adverse effects. Treatment was discontinued in 93 (72.1%) patients, primarily due to disease progression (n = 45; 48.4%). The median duration of treatment was 2.3 months, with a wide range (0–18.8 months), indicating that some patients benefit from this treatment for over a year, which is remarkable for pancreatic cancer.
Results
Efficacy
- Median OS was 10.1 months, with 57.1% of patients achieving 6-month OS.
- Median PFS was 3.5 months, with 35.5% of patients achieving 6-month PFS.
- Median TTF was 2.9 months, with a 28.1% probability of not experiencing treatment failure within 6 months.
- ORR was 10.1%, comprising 12 patients with partial response (9.3%) and 1 with complete response (0.8%). Another 31 patients (24.0%) had disease stabilization. The median time to response was 3.1 months.
Fig. Overall survival of patients treated with nal-IRI + 5-FU/LV in the VILP registry.
Safety
A total of 19 adverse events occurred in 17 patients (13.2%), most commonly diarrhea (3 cases of grade 3; 4 cases of grade 2; 1 case of grade 1). Other adverse events included fatigue (n = 3), anemia (n = 2), herpes zoster infection (n = 1), sepsis (n = 1), hepatopathy (n = 1), and melena (n = 1). One patient experienced intestinal passage disorders and vomiting (grade 3).
Conclusion
The VILP registry expands the available data on the use of nal-IRI + 5-FU/LV in patients with metastatic pancreatic ductal adenocarcinoma after failure of gemcitabine-based therapy. It confirms the efficacy and good tolerance of this combination in Czech clinical practice.
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Source: Batko S., Vočka M., Mohelníková Duchoňová B. et al. 1674P VILP Registry of patients with metastatic pancreatic cancer treated with pegylated liposomal irinotecan plus 5-fluorouracil and leucovorin in the Czech Republic. ESMO Congress, Madrid, 2023 Oct 20−24.
QR code links to ONIVYDE pegylated liposomal SPC.
Last text review date: 08/2022.
The medicinal product is available by prescription only. The product is reimbursed by public health insurance − see List of reimbursed medicinal products: www.sukl.cz/sukl/seznam-leciv-a-pzlu-hrazenych-ze-zdrav-pojisteni
The product is available in pharmacies.
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