Lliposomal irinotecan (nal-IRI) 2nd line & neoadjuvant
Abstract 344: Multicenter retrospective analysis for efficacy and safety of liposomal irinotecan (nal-IRI) plus 5-FU/leucovorin (5-FU/LV) after progression on gemcitabine-based therapy in Korean patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC): A study by Korean cancer study group (KCSG).
First Author: Changhoon Yoo, MD
Conclusions: Nal-IRI plus 5-FU/LV was well tolerated and effective for mPDAC patients who progressed on gemcitabine-based therapy. Despite heavily pretreated patients were included, efficacy and safety outcomes in our cohort were consistent with the results of previous NAPOLI-1 trial.
Abstract 383: Efficacy of liposomal-irinotecan (nal-IRI) plus 5-fluorouracil / folinic acid (5-FU/LV) versus oxaliplatin plus fluoropyrimidines in previous gemcitabine treated pancreatic adenocarcinoma (PAC) patients (pts).
First Author: Markus Kieler, MD
Conclusions: The efficacy of nal-IRI plus 5-FU/LV in our study is encouraging and outperforms oxaliplatin-based chemotherapy in the 2nd line treatment setting for PAC pts pretreated with gemcitabine. Prospective randomized trials are urged to validate our observation.
Abstract TPS476: A phase II, open-label pilot study evaluating the safety and activity of nal-IRI in combination with 5-FU and oxaliplatin in preoperative treatment of pancreatic adenocarcinoma (NEO-Nal-IRI study).
First Author: Hiral Parekh, MD, MPH
Trial in Progress:
This phase II, open-label, single-arm study targets patients with borderline resectable PCa without metastatic disease. Other key eligibility criteria include age ≥ 18 years, measurable disease by RECIST v1.1, adequate cardiac, renal, hepatic function, and Eastern Cooperative Oncology Group performance status of 0 to 1. Patients receive FOLFNal-IRINOX regimen as per table every two weeks for four months followed by disease reassessment. Patients who remain surgical candidates will undergo surgical resection within four to eight weeks following the last dose of therapy. The primary endpoint is to assess safety and feasibility of regimen in the perioperative setting. Secondary endpoints include R0 resection rate, clinical, biochemical and radiological response rate and patient-reported quality of life as measured by the NCI validated FACT-G scale. Enrollment continues to a maximum of 28 evaluable patients to demonstrate a reduction in historical 30-day postoperative complication rate. FOLFNal-IRINOX regimen. Clinical trial information: NCT03483038