Nanoliposomal irinotecan (Nal-IRI)-based chemotherapy after irinotecan -based chemotherapy in patients with pancreas cancer

Smith, Caleb J.; Bekaii‐Saab, Tanios; Cook, Kathryn; Eiring, Rachel A.; Halfdanarson, Thorvardur R.; Hanna, Michael E.; Jin, Zhaohui; Jochum, Jacob A.; Wee, Wen; Mitchell, Jessica; Pitot, Henry C.; Jatoi, Aminah

doi:10.1016/j.pan.2020.10.042

Cited by 6 publications

(9 citation statements)

References 13 publications

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“…Second, in a previous study on the efficacy of nal-IRI/FF [ 11 ], patients who experienced no cancer progression with irinotecan treatment showed improved survival compared to those with prior cancer progression with irinotecan (mOS: 7.7 vs. 3.9 months). Smith et al [ 13 ] and Yu et al [ 14 ] showed a similar result in patients with APC who had been treated with irinotecan. Thus, we excluded patients who had received prior irinotecan-containing therapy to assess the effect of nal-IRI/FF without being confounded by the history of irinotecan administration.…”

Section: Discussionmentioning

confidence: 67%

Treatment Effect and Safety of Nanoliposomal Irinotecan with Fluorouracil and Folinic Acid after Gemcitabine-Based Therapy in Patients with Advanced Pancreatic Cancer: A Multicenter, Prospective Observational Study

Minemura

Fujimori

Ueda

et al. 2022

JCM

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Although the combination of nanoliposomal irinotecan plus fluorouracil/folinic acid (nal-IRI/FF) exhibited survival benefits in gemcitabine-refractory patients with advanced pancreatic cancer (APC) in the phase III NAPOLI-1 trial, there is limited data on the efficacy and safety of this regimen in real-world settings in Japan. This multicenter, prospective observational study enrolled patients with APC who received nal-IRI/FF after a gemcitabine-based regimen from July 2020 to June 2021. We collected and analyzed clinical data and conducted survival and multivariate analyses. Thirty-one (78%) of the 40 patients had metastases. Nal-IRI/FF was the second-line therapy in 36 patients (90%). The median duration was 3.2 months. The disease control rate was 57%. The median progression-free survival and overall survival (OS) were 4.5 months (95% confidence interval [CI]: 2.8–5.5) and 7.4 months (95% CI: 5.1–10.6), respectively. Common ≥grade 3 toxicities included neutropenia (28%) and fatigue (23%). Fatigue led to treatment discontinuation in 6 out of 10 patients. Multivariate analysis showed that a neutrophil-to-lymphocyte ratio > 4 was a significant risk factor for a short OS (hazard ratio (HR) = 3.08, 95% CI: 1.21–7.85, p = 0.02). In conclusion, nal-IRI/FF is an appropriate treatment option for APC following gemcitabine-containing regimens.

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Section: Discussionmentioning

confidence: 67%

Treatment Effect and Safety of Nanoliposomal Irinotecan with Fluorouracil and Folinic Acid after Gemcitabine-Based Therapy in Patients with Advanced Pancreatic Cancer: A Multicenter, Prospective Observational Study

Minemura

Fujimori

Ueda

et al. 2022

JCM

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“…Further retrospective analysis of OS rates under nal-IRI + 5-FU/LV after gemcitabine show a range from 4.4 to 9.4 months (15)(16)(17)(19)(20)(21)(22)(23)25). Interestingly, the median PFS reported in the same retrospective studies shows a relatively narrow range of 2.0 to 4.1 months.…”

Section: Discussionmentioning

confidence: 85%

“…Glassman et al and Smith et al took a closer look when they analyzed OS of patients who progressed under non-liposomal irinotecan compared to patients without progression under non-liposomal irinotecan. Both reported significantly shorter OS in patients with tumor progress (Glassman: 3.9 vs. 9.0 months, P=0.035; Smith: 4.3 vs. 6.1 months, P<0.001) (20,23). Conversely, Kasi et al demonstrated in their retrospective analysis no survival difference between these two groups, thus matching our findings (non-liposomal naïve vs. pre-exposed: 10.3 vs. 9.3 months) (19).…”

Section: Discussionmentioning

confidence: 99%

“…The pivotal NAPOLI-1 trial generated consensus about systemic second-line treatment using nal-IRI + 5-FU/LV by extending the survival rate of patients with gemcitabine-refractory advanced PC (14). However, data evaluating the efficacy and tolerability of nal-IRI + 5-FU/LV in a daily practice context in nonselected patients are very heterogenous, especially with the focus on application beyond second-line therapy (15)(16)(17)(19)(20)(21)(22)(23). Moreover, inconsistent data about the benefit of nal-IRI-based therapy after previous irinotecan exposure cause uncertainty about second-or third-line application after FOLFIRINOX, which is evolving to be the most important combined therapy for PC, both in the curative and the palliative setting (15,(19)(20)(21)23,24).…”

Section: Discussionmentioning

confidence: 99%

“…However, data evaluating the efficacy and tolerability of nal-IRI + 5-FU/LV in a daily practice context in nonselected patients are very heterogenous, especially with the focus on application beyond second-line therapy (15)(16)(17)(19)(20)(21)(22)(23). Moreover, inconsistent data about the benefit of nal-IRI-based therapy after previous irinotecan exposure cause uncertainty about second-or third-line application after FOLFIRINOX, which is evolving to be the most important combined therapy for PC, both in the curative and the palliative setting (15,(19)(20)(21)23,24). Thus, in this study, the impact on survival of nal-IRI + 5-FU/LV as thirdline therapy after previous exposition to FOLFIRINOX and gemcitabine-based therapy was analyzed in our cohort of patients.…”

Section: Discussionmentioning

confidence: 99%

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Second-line and third-line therapy with nanoliposomal irinotecan (nal-IRI) in pancreatic cancer: a single-center experience and review of literature

Möhring¹,

Graffe²,

Bartels³

et al. 2023

J Gastrointest Oncol

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Background: Prognosis of patients with pancreatic cancer is still extremely poor. First-line palliative therapies with FOLFIRINOX or gemcitabine/nab-paclitaxel have been established in the last decade. In the second-line, 5-FU/LV in combination with nanoliposomal irinotecan (nal-IRI) after gemcitabine has been shown to be effective. However, the use of nal-IRI as third-line therapy after FOLFIRINOX and gemcitabine-based chemotherapies is still controversial. In this study, we report about the use of 5-FU/LV + nal-IRI in a daily practice and analyze whether nal-IRI is an option as third-line therapy after FOLFIRINOX and gemcitabine/nab-paclitaxel.Methods: This is a single center retrospective analysis of patients with irresectable pancreatic cancer who were treated with 5-FU/LV and nal-IRI from 2017 to 2021 as second-or third-line palliative treatment.Overall survival (OS), progression-free survival (PFS) and toxicity were analyzed, and multivariate analysis was used to identify independent prognostic factors.Results: Twenty-nine patients receiving 5-FU/LV and nal-IRI were included in the analysis. The majority of patients (n=19) received 5-FU/nal-IRI as third-line therapy after pre-exposition to FOLFIRINOX and gemcitabine/nab-paclitaxel. Median OS and PFS were 9.33 months (95% CI: 3.37, 15.30) and 2.90 months (95% CI: 1.64, 4.16), respectively. Furthermore, patients receiving nal-IRI + 5-FU/LV as thirdline treatment also showed some benefits, with no OS difference compared to second-line patients (9.33 vs. 10.27 months; HR: 1.85; 95% CI: 0.64, 5.41; P=0.253). Adverse effects were similar to reported trials.Conclusions: In our study, the use of 5-FU/nal-IRI in unselected patients with advanced pancreatic cancer showed similar OS, PFS and tolerance as randomized prospective phase II/III trials. Interestingly, the use of 5-FU/nal-IRI seemed to be beneficial in third-line therapy, despite a pre-exposure to non-liposomal irinotecan.

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Pembrolizumab near the end of life in patients with metastatic pancreatic cancer: a multi-site consecutive series to examine survival and patient treatment burden

Storandt

Tran

Martin

et al. 2023

Cancer Immunol Immunother

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Nanoliposomal irinotecan (Nal-IRI)-based chemotherapy after irinotecan -based chemotherapy in patients with pancreas cancer

Cited by 6 publications

References 13 publications

Treatment Effect and Safety of Nanoliposomal Irinotecan with Fluorouracil and Folinic Acid after Gemcitabine-Based Therapy in Patients with Advanced Pancreatic Cancer: A Multicenter, Prospective Observational Study

Treatment Effect and Safety of Nanoliposomal Irinotecan with Fluorouracil and Folinic Acid after Gemcitabine-Based Therapy in Patients with Advanced Pancreatic Cancer: A Multicenter, Prospective Observational Study

Second-line and third-line therapy with nanoliposomal irinotecan (nal-IRI) in pancreatic cancer: a single-center experience and review of literature

Pembrolizumab near the end of life in patients with metastatic pancreatic cancer: a multi-site consecutive series to examine survival and patient treatment burden

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