221PD Efficacy and safety of nanoliposomal irinotecan (nal-IRI, MM-398, PEP02, BAX-2398) in patients with metastatic pancreatic cancer in Asia: A subgroup analysis of the phase 3 NAPOLI-1 Study

Chen, L.-T.; Li, C.-P.; Chiu, C-F; Shan, Ying; Park, J.O.; Chen, J.-S.; Kim, J.S.; Rau, Kung-Ming; Jong, F. de; Pipas, M.; Belanger, Bruce; Wang, E.; Lee, K.-H.; Bang, Yung‐Jue

doi:10.1093/annonc/mdw582.002

Cited by 4 publications

(6 citation statements)

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“…The 27.4% of grade 3-4 neutropenia in our patients was lower than that of 54.5% in the NAPOLI-1 Asian cohort, which can be partially attributed to the use of reduced starting dose of nal-IRI in 65.9% of our patients as well as lower mean dose intensity of nal-IRI in our patients, 57.7-68.6% versus 74.9% in the NAPOLI-1 Asian cohort 24 . None of our patients experienced grade 3-4 diarrhea further supports the observation that nal-IRI-based therapy-related grade 3-4 diarrhea less frequently occurs in Asian population as compared to non-Asian and its incidence is nal-IRI dose dependent regardless of ethnicity in earlier studies 26,27 . For instance, despite same dose intensity of nal-IRI in nal-IRI monotherapy (120 mg/m 2 , every 3 weeks) and nal-IRI + 5-FU/ LV (80 mg/m 2 , every 2 weeks), the incidence of grade 3-4 diarrhea was higher in nal-IRI monotherapy, 21.1% versus 12.8% in overall population and 16.0% versus 3.0% in Asian population of NAPOLI-1 study 24 .…”

Section: Treatment Responsesupporting

confidence: 88%

“…In addition, a post hoc analysis of NAPOLI-1 showed Asian patients with nal-IRI + 5-FU/LV had a 54.5% of grade 3-4 neutropenia as compared to the 17.8% in Caucasian patients 24,26 . Considering the higher incidence of hematological toxicities and thus more dose modification in the nal-IRI + 5-FU/LV treated Asian population of NAPOLI-1 study [24][25][26][27] , our physicians chose to give lower starting doses of nal-IRI at 60 mg/m 2 in some patients with poor physical performance and/or poor nutrition status. This is reflected by the fact that patients in the reduced dose group were more of ECOG PS > 2, 34.5% versus 13.3%, and had lower baseline median albumin level, 3.4 g/dl versus 4.1 g/dl, as compared to those in the standard dose group.…”

Section: Treatment Responsementioning

confidence: 99%

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The Impact of Liposomal Irinotecan on the Treatment of Advanced Pancreatic Adenocarcinoma: Real-World Experience in a Taiwanese Cohort

Chiang

Tsai

et al. 2020

Sci Rep

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Liposomal irinotecan plus 5-fluorouracil/leucovorin (nal-IRI + 5-FU/LV) has shown to provide survival benefits for patients with gemcitabine-refractory metastatic pancreatic ductal adenocarcinoma (PDAC) in NAPOLI-1 trial, in which Asian patients experienced more hematological toxicity and subsequent dose modification. A retrospective chart review to investigate the administration pattern, therapeutic efficacy and safety profile of nal-IRI + 5-FU/LV in 44 consecutive patients with gemcitabine-refractory advanced PDAC treated between December 2016 and December 2018 in National Cheng Kung University Hospital, Taiwan. Most of them had metastatic diseases (88.6%), one-line of prior treatment (72.7%), ECOG PS 0-1 (72.7%) and starting dose of nal-IRI at 60 mg/m2 (≈52 mg/m2 irinotecan free-base) in 65.9%. The overall response rate was 9.1%. The median OS was 6.6 months for the entire cohort, and 7.8 and 2.7 months for patients of ECOG PS 0-1 and>2, respectively. The median OS of ECOG PS 0-1 patients with nal-IRI starting doses at 80 mg/m2 (≈70 mg/m2 irinotecan free-base, n = 13) and 60 mg/m2 (n = 19) were 7.5 and 8.4 months, respectively. Thirty-four percent of patients experienced manageable grade 3-4 hematological toxicity. Our results confirm the clinical benefit of nal-IRI + 5-FU/LV for patients of gemcitabine-refractory advanced PDAC with good performance status in a real-world setting.

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Section: Treatment Responsesupporting

confidence: 88%

Section: Treatment Responsementioning

confidence: 99%

The Impact of Liposomal Irinotecan on the Treatment of Advanced Pancreatic Adenocarcinoma: Real-World Experience in a Taiwanese Cohort

Chiang

Tsai

et al. 2020

Sci Rep

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“…A notable exception was a higher rate of grade ≥ 3 neutropenia in Asian compared with Caucasian patients (55% vs. 18%; n = 33 and 73); neutropenic fever/neutropenic sepsis occurred in 6% and 1% of Asian and Caucasian patients, respectively [ 17 , 18 ]. This notwithstanding, the safety profile of nal-IRI + 5-FU/LV in the Asian cohort of NAPOLI-1 was manageable (abstract [ 44 ]). Indeed, Asian patients had a lower incidence of grade ≥ 3 diarrhoea compared with Caucasian patients (3% vs. 19%) [ 17 , 43 ].…”

Section: Tolerability Of Liposomal Irinotecanmentioning

confidence: 99%

Liposomal Irinotecan: A Review in Metastatic Pancreatic Adenocarcinoma

Frampton

2020

Drugs

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Liposomal irinotecan (nal-IRI; Onivyde ® ; also known as pegylated liposomal irinotecan) has been developed with the aim of maximising anti-tumour efficacy while minimising drug-related toxicities compared with the conventional (non-liposomal) formulation of this topoisomerase 1 inhibitor. In combination with 5-fluorouracil and leucovorin (5-FU/LV), nal-IRI is the first agent to be specifically approved for use in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have progressed following gemcitabine-based therapy. In the pivotal, phase III NAPOLI-1 trial, intravenous administration of nal-IRI + 5-FU/LV to gemcitabine-pretreated patients with mPDAC (as a second-line treatment in approximately two-thirds of cases) was associated with a significant ≈ 2-month median overall survival advantage compared with 5-FU/LV alone. Moreover, adding nal-IRI to 5-FU/LV extended survival with a manageable safety profile and without adversely affecting health-related quality of life, thereby producing significant and clinically meaningful gains in quality-adjusted survival relative to 5-FU/LV alone. Complementing the observed efficacy and safety of nal-IRI in NAPOLI-1 are an increasing number of real-world studies, which provide evidence of the effectiveness of this combination therapy in the treatment of mPDAC that has progressed following gemcitabine-based therapy in contemporary clinical practice in Europe, the USA and East Asia. Thus, nal-IRI, in combination with 5-FU/LV, is the first regimen specifically approved for use as a second- or subsequent-line therapy in gemcitabine-pretreated patients with mPDAC and, as such, represents a valuable treatment option in this setting.

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“…These findings were consistent with the results of the NAPOLI-1 study and previous retrospective analyses, 13,14 particularly with the Asian subgroup analysis. 15 In the NAPOLI-1 study, the median OS and PFS were 6.1 and 3.1 months, respectively, and the ORR was 16% in the nal-IRI + 5-FU/LV group. 13 In a recent retrospective analysis of nal-IRI + 5-FU/ LV, the median OS and PFS were 5.3 and 2.9 months, respectively, and the ORR was 5%.…”

Section: Discussionmentioning

confidence: 98%

“…The safety profile of nal-IRI + 5-FU/LV reported in this real-world study was consistent with the results of the NAPOLI-1 trial and its associated Asian subgroup analysis. 13,15 The most common grade 3–4 toxicities were neutropenia, nausea, vomiting, anaemia and diarrhoea. Febrile neutropenia occurred in seven patients.…”

Section: Discussionmentioning

confidence: 99%

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

Yoo

Kim

et al. 2019

Ther Adv Med Oncol

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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.

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221PD Efficacy and safety of nanoliposomal irinotecan (nal-IRI, MM-398, PEP02, BAX-2398) in patients with metastatic pancreatic cancer in Asia: A subgroup analysis of the phase 3 NAPOLI-1 Study

Cited by 4 publications

References 0 publications

The Impact of Liposomal Irinotecan on the Treatment of Advanced Pancreatic Adenocarcinoma: Real-World Experience in a Taiwanese Cohort

The Impact of Liposomal Irinotecan on the Treatment of Advanced Pancreatic Adenocarcinoma: Real-World Experience in a Taiwanese Cohort

Liposomal Irinotecan: A Review in Metastatic Pancreatic Adenocarcinoma

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

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