Real-world efficacy and safety of liposomal irinotecan plus fluorouracil/leucovorin in patients with metastatic pancreatic adenocarcinoma: a study by the Korean Cancer Study Group

Changhoon Yoo, Hyeon-Su Im, Kyu-Pyo Kim, Do-Youn Oh, Kyung-Hun Lee, Hong Jae Chon, Joo Hoon Kim, Myoungjoo Kang, Ilhwan Kim, Guk Jin Lee, Sung Yong Oh, Younak Choi, Hye Jin Choi, Seung Tae Kim, Joon Oh Park, Baek-Yeol Ryoo, Changhoon Yoo, Hyeon-Su Im, Kyu-Pyo Kim, Do-Youn Oh, Kyung-Hun Lee, Hong Jae Chon, Joo Hoon Kim, Myoungjoo Kang, Ilhwan Kim, Guk Jin Lee, Sung Yong Oh, Younak Choi, Hye Jin Choi, Seung Tae Kim, Joon Oh Park, Baek-Yeol Ryoo

Abstract

Background: Liposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) was effective and well-tolerated in patients with metastatic pancreatic adenocarcinoma (mPAC) that progressed on gemcitabine-based therapy in the global NAPOLI-1 trial. Real-world data may further clarify the outcomes and safety profile of nal-IRI + 5-FU/LV in clinical practice.

Methods: This retrospective analysis included patients with mPAC who received nal-IRI + 5-FU/LV following gemcitabine-based therapy under a Managed Access Program in Korea.

Results: From January 2017 to April 2018, 86 patients across 10 institutions received nal-IRI + 5-FU/LV (median age, 61 years; 60% male; ECOG performance status, 0-1). A total of 35 (41%) and 51 (59%) patients had received less than two and two or more lines of chemotherapy before inclusion, respectively. At a median follow up of 6.4 months, median overall survival (OS) was 9.4 months (95% confidence interval [CI] 7.4-11.4) and median progression-free survival (PFS) was 3.5 months (95% CI 1.3-5.7). Six-month OS and PFS rates were 65.1% and 37.5%, respectively. Objective response and disease control rates were 10% and 55%, respectively. Most common grade 3-4 toxicities were neutropenia (37.2%), nausea (10.5%), vomiting (9.3%), anorexia (8.1%) and diarrhoea (4.7%).

Conclusion: Real-life data for Korean patients indicate that, consistent with NAPOLI-1, nal-IRI + 5-FU/LV is effective and well-tolerated in patients with mPAC that progressed on gemcitabine-based therapy.

Keywords: chemotherapy; liposomal irinotecan; pancreatic adenocarcinoma; real-world evidence.

Conflict of interest statement

Conflict of interest statement: CY has received research funding from Shire and Servier, and has acted as an advisor for Shire. DYO and JOP have acted as advisors for Shire. All other authors declare that they have no conflicts of interest.

Figures

Figure 1.
Figure 1.
Survival outcomes with nal-IRI + 5-FU/LV.
Figure 2.
Figure 2.
Survival outcomes with nal-IRI + 5-FU/LV according to number of previous lines of palliative chemotherapy and type of first-line therapy: (A) overall survival according to number of previous lines of palliative chemotherapy; (B) progression-free survival according to number of previous lines of palliative chemotherapy; (C) overall survival according to type of first-line palliative chemotherapy; and (D) progression-free survival according to type of first-line palliative chemotherapy. AG, gemcitabine plus nab-paclitaxel; CTx, chemotherapy; FFX, FOLFIRINOX; GEM, gemcitabine monotherapy.

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