Real World Efficacy, Safety of Nanoliposomal Irinotecan With Fluorouracil and Folinic Acid in Metastatic Pancreatic Cancer After Previous Gemcitabine-based Therapy

University Hospital, Bordeaux58 enrolled

Overview

The objectives of the study are to evaluate the efficacy (primary endpoint: overall survival), safety (secondary endpoint) and the medico-economic impact (secondary endpoint) of nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid in clinical practice

Nanoliposomal irinotecan combined with 5-fluorouracil and folinic acid was shown to be effective after gemcitabine-based treatment in patients with metastatic pancreatic adenocarcinoma in the phase III NAPOLI-1 randomized trial. Nanoliposomal irinotecan is authorized in combination with 5-fluorouracil (5-FU) and leucovorin (LV), as it has shown an improvement in overall survival (median +1.9 months, HR = 0.67) compared to 5-FU/LV alone, without degradation of quality-of-life scales. However, patients included in clinical trials regularly differ from patients in routine practice, and a real-life study is fundamental in this poor prognosis situation where quality of life preservation is paramount

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Adenocarcinoma Metastatic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years or older * histological or cytological confirmation of pancreatic ductal adenocarcinoma * measurable lesion(s) * progression after gemcitabine-based treatment administered in a neoadjuvant, adjuvant protocol (only if remote metastases developed within 6 months of the end of adjuvant treatment), locally advanced, or metastatic phase. They may have already received irinotecan and/or fluorouracil. * Performance Status (PS) 0 or 1 * Oral consent * Health insurance Exclusion Criteria: * symptomatic brain metastases (cerebral edema, corticosteroids, progressive disease) * thromboembolic events within six months of inclusion; * Class III or IV congestive heart failure, ventricular arrhythmia, uncontrolled hypertension. * Patient under legal protection * Hypersensitivity to irinotecan * Breast feeding

Locations (1)

CHU Bordeaux

Pessac, France

Outcomes

Primary Outcomes

Overall survival

Time frame: Up to 3 years

Secondary Outcomes

Response rate to treatment

Initial staging at the time of diagnosis is based on computed tomography (CT) or magnetic resonance imaging (MRI). Duration of treatment is calculated from the day of nal-IRI initiation to the day of disease progression, switch to other treatment regimens or when the patient is lost to follow-up. Tumor response is assessed by abdominal CT or MRI, according to the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) and CA19-9.

Time frame: Every 3 months up to 3 years

Progression-free survival

Time frame: Every 3 months up to 3 years

Cost evaluation

number of vials per patient

Time frame: Every 3 months up to 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.