Effect of previous conventional irinotecan treatment in patients with pancreatic cancer being treated with liposomal irinotecan plus 5‐fluorouracil and leucovorin

Chiu, Tai‐Jan; Chiu, Sz-Chi; Hsueh, Shun‐Wen; Chiang, Nai‐Jung; Li, Chung–Pin; Bai, Li‐Yuan; Cheng, Fu-Ming; Chuang, Shih‐Chang; Shan, Yan–Shen; Chan, De-Chuan; Chen, Li-Tzong; Yen, Chia‐Jui; Peng, Cheng-Ming; Su, Yung-Yeh; Chen, Yen‐Yang; Chen, Jen‐Shi; Chou, Wen‐Chi

doi:10.1002/jhbp.1128

Cited by 5 publications

(7 citation statements)

References 20 publications

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“…Therefore, conventional IRI may not preclude the benefits of nal-IRI, particularly in the third-line and later treatment lines. This view is supported by previous comparative studies, which found no significant difference in the median OS between patients who were and were not previously treated with conventional IRI ( 21 , 24 , 28 ). A subgroup analysis of the NAPOLI-1 trial also found that prior exposure to conventional IRI was not an independent predictor of nal-IRI outcomes ( 29 ).…”

Section: Discussionsupporting

confidence: 76%

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Clinical outcomes of liposomal irinotecan in advanced pancreatic adenocarcinoma patients previously treated with conventional irinotecan-based chemotherapy: a real-world study

Gupta,

De Jesus-Acosta,

Zheng

et al. 2023

Front. Oncol.

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BackgroundThe efficacy of combination chemotherapy beyond the first-line setting remains modest in patients with advanced pancreatic adenocarcinoma (PAC). Evidence from recent clinical studies has shown that liposomal irinotecan (nal-IRI) plus 5-fluorouracil (5-FU) and leucovorin (LV) resulted in survival benefits in patients with advanced pancreatic adenocarcinoma (APAC) after progression on gemcitabine-based treatment. However, the survival benefits of nal-IRI in the third and later lines, in which limited options are available, have yet to be extensively studied. Also, some studies have shown conflicting results regarding the impact of prior treatment with conventional IRI on patient outcomes following treatment with nal-IRI. Therefore, this real-world study aimed to evaluate the efficacy and safety of nal-IRI plus 5FU-LV in advanced PAC patients who progressed on conventional IRI-containing regimens.MethodsA retrospective chart review was conducted between November 2016 to December 2022 on 30 patients diagnosed with advanced PAC who completed at least one cycle of nal-IRI plus 5-FU- LV and were previously treated with conventional IRI. Data regarding survival outcomes were retrieved.ResultsThirty patients met the inclusion criteria. Overall, 76.7% of the patients received at least two lines of therapy prior to nal-IRI. The median overall duration of nal-IRI treatment was 2.0 months (IQR: 1.3 – 3.9 months). One patient (3.3%) had a partial response, and seven patients (23.3%) had stable disease as their best response. The median progression-free survival (PFS) was 1.9 months (95% CI 1.6 - 2.0) and the 6-month PFS rate was 20.0%. The median overall survival (OS) was 5.0 months (95% CI 3.4 – 7.0), and the 6-month OS rate was 36.7%. An interval between conventional IRI and nal-IRI ≥5.5 months was significantly associated with prolonged OS of 10.2 months (95% CI 3.3 – 12.1) versus 4.3 months (95% CI 2.1 – 5.9; p =0.003). Ten patients (33.3%) experienced grade 3 adverse events, most commonly nausea, fatigue, diarrhea, and non-neutropenic fever.ConclusionNal-IRI plus 5FU/LV had modest survival benefits and an acceptable safety profile in patients with prior conventional IRI. A longer interval between conventional IRI and nal-IRI was associated with increased survival outcomes.

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Section: Discussionsupporting

confidence: 76%

“…In another retrospective study performed at Memorial Sloan Kettering Cancer Center by Glassman et al., the median PFS and OS of patients previously treated with IRI were 2.2 and 3.9 months, respectively ( 20 ). Other reports showed a median PFS of 1.6-2 months and a median OS of 4.1 months ( 21 , 24 ).…”

Section: Discussionmentioning

confidence: 89%

Clinical outcomes of liposomal irinotecan in advanced pancreatic adenocarcinoma patients previously treated with conventional irinotecan-based chemotherapy: a real-world study

Gupta,

De Jesus-Acosta,

Zheng

et al. 2023

Front. Oncol.

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“… 17 , 18 , 19 A recent real‐world study comparing 86 matched pairs of patients treated with liposomal irinotecan‐based regimens observed no significant differences in survival times and tumor response rates based on prior exposure to irinotecan. 20 …”

Section: Introductionmentioning

confidence: 99%

“…[17][18][19] A recent real-world study comparing 86 matched pairs of patients treated with liposomal irinotecan-based regimens observed no significant differences in survival times and tumor response rates based on prior exposure to irinotecan. 20 NCCN guidelines currently recommend liposomal irinotecan as Category I unless patients have previously received irinotecan. 6 As NCCN guidelines can impact payer formulary decisions and prior authorization processes affecting patient access.…”

Section: Introductionmentioning

confidence: 99%

“…Results from nonrandomized real‐world studies, with total study sample sizes (with and without prior irinotecan) of 56, 86, and 257 patients treated with liposomal irinotecan, have generated results suggesting prior irinotecan exposure is associated with worse outcomes among patients with mPDAC later treated with liposomal irinotecan 17–19 . A recent real‐world study comparing 86 matched pairs of patients treated with liposomal irinotecan‐based regimens observed no significant differences in survival times and tumor response rates based on prior exposure to irinotecan 20 …”

Section: Introductionmentioning

confidence: 99%

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Prior irinotecan exposure does not preclude benefit to liposomal irinotecan in patients with metastatic pancreatic ductal adenocarcinoma

Cockrum

Surinach³

et al. 2023

Cancer Medicine

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Background Subgroup analyses of the NAPOLI‐1 study identified that among patients who were irinotecan naïve prior to entering the clinical trial, a survival benefit was observed between the study arm and control arm. This treatment benefit was not observed among those previously exposed to irinotecan. This study sought to understand the impact of prior exposure to irinotecan on clinical outcomes among patients treated with liposomal irinotecan in the real‐world setting. Methods This retrospective observational study utilized a nationwide electronic health record (EHR)‐derived deidentified database. Data for adult patients with mPDAC treated with liposomal irinotecan‐based regimens between January 2016 and October 2020 were analyzed. Patient characteristics, overall survival (OS), and progression‐free survival (PFS) were assessed. Cox proportional hazard methods were used to calculate hazard ratios (HRs). HRs were adjusted for demographics and relevant clinical covariates. Results Six hundred and seventy‐five patients with mPDAC treated with a liposomal irinotecan‐based regimen were included. The unadjusted OS HR was 1.3 (95% CI: 1.1–1.6, p < 0.001) and unadjusted PFS was HR 1.4 (95% CI: 1.2–1.7, p < 0.001). After adjustment for baseline characteristics, the adjusted OS HR was 1.0 (95% CI: 0.8–1.3, p = 0.8836) and the adjusted PFS HR was 1.1 (95% CI: 0.8–1.4, p = 0.5626). Conclusions Prior irinotecan was not found to be a significant predictor of patient outcomes in those later treated with liposomal irinotecan. Thus, the results may inform the rationale for utilizing liposomal irinotecan combination therapy following prior irinotecan exposure in mPDAC, in particular where the prior irinotecan exposure was more distant in time.

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Clinical outcomes of liposomal irinotecan in patients with advanced pancreatic cancer previously treated with conventional irinotecan: A meta‐analysis of real‐world evidence

Gupta,

De Jesus‐Acosta,

et al. 2024

Cancer

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BackgroundPivotal clinical trials supported survival benefits of liposomal irinotecan (nal‐IRI) plus fluorouracil/leucovorin in patients with pancreatic ductal adenocarcinoma (PDAC) who previously received gemcitabine‐based therapy. There are concerns about the benefits of nal‐IRI in patients who received FOLFIRINOX (combined fluorouracil, leucovorin, IRI, and oxaliplatin) because of potential cross‐resistance to IRI. The objective of this meta‐analysis was to characterize the impact of the previous receipt of IRI on the outcomes of nal‐IRI regimens in patients with advanced PDAC.MethodsReal‐world studies evaluating the outcomes of nal‐IRI in patients who had prior IRI exposure published up to April 2023 were searched using electronic databases. The meta‐analysis was conducted using a random effects model to estimate pooled hazard ratios (HRs) and 95% confidence intervals (CIs).ResultsEight studies (n = 1368 patients) were included. The pooled median progression‐free survival (PFS) was 2.02 months (95% CI, 1.43–2.57 months), and the median overall survival (OS) was 4.26 months (95% CI, 3.03–5.39 months). Patients with prior IRI exposure had PFS (HR, 1.17; 95% CI, 0.94–1.47; p = .17) and OS (HR, 1.16; 95% CI, 0.95–1.42; p = .16) comparable to patients without prior IRI exposure. Likewise, patients who had progressive disease on conventional IRI had PFS (HR, 1.50; 95% CI, 0.73–3.08; p = .24) and OS (HR, 1.70; 95% CI, 0.68–4.27; p = .26) with nal‐IRI comparable to patients who had no progressive disease.ConclusionsPrior IRI exposure does not affect the survival outcomes of nal‐IRI regimens in patients who have advanced PDAC. The selection of later lines of chemotherapy regimens should be based on the differential safety profile, patient status, the cost of treatment, and health‐related quality of life.

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Effect of previous conventional irinotecan treatment in patients with pancreatic cancer being treated with liposomal irinotecan plus 5‐fluorouracil and leucovorin

Cited by 5 publications

References 20 publications

Clinical outcomes of liposomal irinotecan in advanced pancreatic adenocarcinoma patients previously treated with conventional irinotecan-based chemotherapy: a real-world study

Clinical outcomes of liposomal irinotecan in advanced pancreatic adenocarcinoma patients previously treated with conventional irinotecan-based chemotherapy: a real-world study

Prior irinotecan exposure does not preclude benefit to liposomal irinotecan in patients with metastatic pancreatic ductal adenocarcinoma

Clinical outcomes of liposomal irinotecan in patients with advanced pancreatic cancer previously treated with conventional irinotecan: A meta‐analysis of real‐world evidence

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