Abstract / Summary
BackgroundMetastatic pancreatic ductal adenocarcinoma (mPDAC) is associated with poor prognosis and has limited therapeutic options.Nanoliposomal irinotecan (Nal-IRI), evaluated in the NAPOLI-1 and NAPOLI-3 clinical trials, has demonstrated survival benefit in later-line and first-line settings, respectively.However, realworld data, particularly from low-and middle-income countries (LMICs) such as India, remain limited.We aimed to evaluate the real-world tolerability and early effectiveness of nal-IRI-based regimens in Indian patients with mPDAC. MethodsThis multicentre, retrospective observational study included 24 patients with histologically confirmed mPDAC treated with nal-IRI-based regimens (either nal-IRI + 5-FU/LV or nal-IRI + 5-FU/LV + oxaliplatin) between June 2024 and September 2025.The primary objective was to assess tolerability using CTCAE v5.0graded adverse events (AEs).Secondary objectives included early effectiveness outcomes, assessed by overall survival (OS) using the Kaplan-Meier method.Restricted mean survival time (RMST) was calculated at threeand six-month landmarks due to limited follow-up. ResultsThe mean age was 63.7 years (SD 6.89), and 75% of patients were male.Nal-IRI was administered in the firstline setting in six patients and in second or later lines in 18 patients.The median follow-up was four months.A total of 55 AEs were reported, most commonly diarrhea (20%), fatigue (12.7%), and mucositis and neutropenia (10.9% each).Among graded events, 26.4% were grade 1, 39.6% were grade 2, and 34.0% were grade 3. Dose modifications were required in 36.5% of events, and treatment discontinuation due to AEs occurred in 11.5% of events.Kaplan-Meier-estimated OS probabilities at three and six months were 95% and 88%, respectively, with an RMST of 2.89 months up to three months and 5.57 months up to six months. ConclusionsIn this multicentre real-world Indian cohort, nal-IRI-based regimens demonstrated manageable tolerability.These findings support the feasibility of nal-IRI in routine clinical practice and provide important real-world evidence (RWE) from an underrepresented population.However, survival outcomes were exploratory because of the short follow-up and high degree of censoring.Larger prospective studies with longer followup are warranted.