scholarly journals 1513P Real-world treatment discontinuation patterns among patients (pts) with metastatic pancreatic ductal adenocarcinoma (mPDAC) treated with liposomal irinotecan-based regimens in the United States

2021 ◽  
Vol 32 ◽  
pp. S1107-S1108
Author(s):  
G. Kim ◽  
A. Surinach ◽  
S. Wang ◽  
N. Lamarre ◽  
P. Cockrum
Keyword(s):  
United States ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Real World ◽  
The United States ◽  
Treatment Discontinuation ◽  
Ductal Adenocarcinoma ◽  
Liposomal Irinotecan

scholarly journals Clinical Outcomes Among Patients With Metastatic Pancreatic Ductal Adenocarcinoma Treated With Liposomal Irinotecan

2021 ◽  
Vol 11 ◽  
Author(s):  
Kenneth H. Yu ◽  
Andrew E. Hendifar ◽  
Olatunji B. Alese ◽  
Amber Draper ◽  
Maen Abdelrahim ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Clinical Outcomes ◽  
Real World ◽  
Performance Status ◽  
Retrospective Chart Review ◽  
The United States ◽  
Ductal Adenocarcinoma ◽  
Real World Data ◽  
Metastatic Setting ◽  
Liposomal Irinotecan

BackgroundThe NAPOLI-1 trial demonstrated that liposomal irinotecan in combination with fluorouracil (5-FU) and leucovorin (LV) prolonged survival with a manageable safety profile in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy. Real-world data on clinical outcomes associated with liposomal irinotecan in NAPOLI-1-based regimens is needed to further substantiate this.MethodsThis real-world, retrospective chart review study included patients with mPDAC who received NAPOLI-1-based regimens from six academic centers in the United States. Liposomal irinotecan initiation defined the index date. Overall survival (OS) and progression-free survival (PFS) were assessed with Kaplan-Meier methodology.ResultsThere were 374 patients evaluated; median age was 68 years, and 51% were female. Among 326 patients with baseline ECOG information, approximately 74% had ECOG score <2. Liposomal irinotecan was administered as a doublet with 5-FU in a NAPOLI-1-based regimen in the first line (1L; 16%), 2L (42%), and 3L+ (42%) of the metastatic setting. For patients treated in 1L, 2L, and 3L+, median [95% confidence interval (CI)] OS was 8.0 [5.1, 11.2], 7.3 [5.3, 8.8], and 4.6 [4.0, 5.7] months, and median [95% CI] PFS was 4.2 [2.2, 6.6], 3.0 [2.6, 3.7], and 2.0 [1.7, 2.2] months, respectively.ConclusionsPatients in a real-world setting treated with NAPOLI-1-based liposomal irinotecan doublet regimens at academic centers were older with poorer performance status compared to trial patients yet had similar outcomes and efficacy. Furthermore, liposomal irinotecan was frequently used in the 3L+ setting where no treatment has been approved and provided clinical benefit.

Temporal trends of pancreatic ductal adenocarcinoma in young adults in the United States: A Population-Based Study

2020 ◽  
Vol 44 (2) ◽  
pp. 204-210
Author(s):  
Mohamed M. Gad ◽  
Anas M. Saad ◽  
Muneer J. Al-Husseini ◽  
Youssef M. Abdel-Gawad ◽  
Obai M. Alsalhani ◽  
...  
Keyword(s):  
United States ◽  
Young Adults ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Temporal Trends ◽  
The United States ◽  
Population Based ◽  
Ductal Adenocarcinoma ◽  
Population Based Study

scholarly journals Trends in the Incidence of Pancreatic Adenocarcinoma in All 50 United States Examined Through an Age-Period-Cohort Analysis

2020 ◽  
Vol 4 (4) ◽  
Author(s):  
Wilson L da Costa ◽  
Abiodun O Oluyomi ◽  
Aaron P Thrift
Keyword(s):  
United States ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Cohort Analysis ◽  
The United States ◽  
Incidence Rates ◽  
Ductal Adenocarcinoma ◽  
Birth Cohorts ◽  
Men And Women ◽  
Cancer Statistics ◽  
Incidence Trends

Abstract Background Pancreatic ductal adenocarcinoma is a major contributor to cancer-related mortality in the United States. We aimed to investigate trends in incidence rates from all 50 states from 2001 to 2016, overall and by race, sex, and state and using age-period-cohort analyses. Methods Age-adjusted incidence rates and trends in adults aged 35 years and older were calculated using data from the US Cancer Statistics registry. We used joinpoint regression to compute annual percent changes (APC) and average annual percent changes. We also analyzed incidence trends by age groups and birth cohorts through age-period-cohort modeling. Results Age-standardized incidence rates increased by 1.23% (95% confidence interval [CI] = 0.92% to 1.54%) annually between 2001 and 2008 but were stable between 2008 and 2016 (APC = 0.11%, 95% CI = -0.13% to 0.35%). APCs and inflection points were no different for men and women. Rates increased statistically significantly among non-Hispanic whites (NHW) and non-Hispanic blacks between 2001 and 2007 and between 2001 and 2008, respectively, but, in later years, rates increased slowly among NHWs (APC = 0.36%, 95% CI = 0.12% to 0.60%), and were stable among non-Hispanic blacks (APC = -0.40%, 95% CI = -0.89% to 0.10%). The number of states with age-standardized incidence rates no less than 20.4 per 100 000 increased from 16 in 2001–2003 to 40 by 2015–2016. We found a strong birth cohort effect in both men and women and increasing rates among successive birth cohorts of NHWs. Conclusions The incidence of pancreatic ductal adenocarcinoma has consistently increased in the United States, albeit at slower rates recently. We observed notable increases among NHWs and in some states in the central and southern part of the country.

A multicenter chart review study of patients with metastatic pancreatic ductal adenocarcinoma receiving liposomal irinotecan after gemcitabine-based therapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16733-e16733
Author(s):  
Kenneth H. Yu ◽  
Andrew Eugene Hendifar ◽  
Olatunji B. Alese ◽  
Amber Draper ◽  
Maen Abdelrahim ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Real World ◽  
Chart Review ◽  
Medical Center ◽  
Ductal Adenocarcinoma ◽  
Cancer Center ◽  
Real World Data ◽  
World Data ◽  
Review Study ◽  
Liposomal Irinotecan

e16733 Background: Real-world data allows healthcare decision-makers to assess and manage therapeutic and economic options for patients, including those who would and would not have met eligibility criteria for randomized control trials (RCT) and are instead managed under usual care. This retrospective multi-academic center chart review study describes real-world characteristics and outcomes of US patients receiving liposomal irinotecan for the management of metastatic pancreatic ductal adenocarcinoma (mPDAC). Methods: Patients with mPDAC treated with liposomal irinotecan were eligible. Initiation of liposomal irinotecan defined index date; covariates assessed included clinical characteristics and treatment patterns; real-world overall survival (rwOS) was assessed via Kaplan-Meier methodology. The target enrollment is 300 patients. The study centers included were Memorial Sloan Kettering Cancer Center, Cedars-Sinai Medical Center, Emory Winship Cancer Institute, Houston Methodist Cancer Center, Henry Ford Cancer Institute, and University of Pittsburgh Medical Center. Results: Data on 26 patients were available for initial analyses. Mean age was 68 years; 58% were female and 65% Caucasian. 54% of patients had stage IV disease at first diagnosis, and 17%, 65%, and 17% had index ECOG score of 0, 1, and 2, respectively. Common genetic mutations include KRAS (40%) and TP53 (40%). Prior to liposomal irinotecan, treatments received for metastatic disease include gemcitabine+nab-paclitaxel (77%) and fluorouracil (5-FU)/leucovorin (LV)+irinotecan+oxaliplatin (19%). Patients had received 0 (12%), 1 (23%), and ≥2 (65%) lines of therapy in the metastatic setting prior to liposomal irinotecan. Mean duration of liposomal irinotecan use was 3.0 months; liposomal irinotecan was mostly received with 5-FU (23%) or 5-FU/LV (69%). Median rwOS was 4.9 months (95% CI: 3.0, 6.3). Conclusions: Real-world data of the first 26 patients in this study show patients treated with liposomal irinotecan are older, sicker, and have had more lines of therapy than previously reported in RCT data.

scholarly journals Real-World Dosing Patterns and Outcomes of Patients With Metastatic Pancreatic Cancer Treated With a Liposomal Irinotecan Regimen in the United States

Pancreas ◽  
2020 ◽  
Vol 49 (2) ◽  
pp. 193-200 ◽  
Author(s):  
Afsaneh Barzi ◽  
Rebecca Miksad ◽  
Andy Surinach ◽  
Frank A. Corvino ◽  
Siqi Wang ◽  
...  
Keyword(s):  
United States ◽  
Pancreatic Cancer ◽  
Real World ◽  
The United States ◽  
Metastatic Pancreatic Cancer ◽  
Liposomal Irinotecan ◽  
Dosing Patterns

scholarly journals Comparing real-world evidence among patients with metastatic pancreatic ductal adenocarcinoma treated with liposomal irinotecan

2020 ◽  
Vol 12 ◽  
pp. 175883592094405
Author(s):  
Jim Koeller ◽  
Andy Surinach ◽  
Steven R. Arikian ◽  
Marko Zivkovic ◽  
Patrick Janeczko ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Real World ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Poor Performance Status ◽  
Real World Evidence ◽  
Liposomal Irinotecan

There are questions surrounding the real-world effectiveness of chemotherapeutic treatments for pancreatic ductal adenocarcinoma. This literature review compared the clinical characteristics and outcomes of available real-world evidence (RWE) for liposomal irinotecan in combination with 5-fluorouracil (5-FU) and leucovorin (LV), a treatment regimen indicated for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) who previously progressed on gemcitabine-based therapy. A targeted literature search was conducted in the PubMed Central® and Embase® databases to identify available RWE regarding patients with mPDAC receiving liposomal irinotecan published within the last 5 years (January 2014–September 2019). Data were extracted for prior lines of therapy, performance status, overall survival (OS), progression-free survival (PFS), duration of exposure, and adverse events. Six studies met inclusion criteria. A comparison of baseline patient characteristics and results with the included evidence reveals a clinically fragile, real-world patient population in terms of age (range: 61–68), prior lines of therapy with 34–61% of patients receiving ⩾2 lines of lines of prior therapy and performance status [49.8–100% of patients with Eastern Cooperative Oncology Group (ECOG) 0–1]. Studies observed wide OS (range: 5.3–9.4 months) and similar PFS (range: 2.3–4.1 months), with two studies measuring duration of exposure (7.3 weeks, 3.1 months). Patients analyzed by RWE studies tended to be older with significant disease progression, poor performance status, and more heavily pretreated compared with the phase III registrational trial (NAPOLI-1). Despite this, patients treated with liposomal irinotecan + 5-FU/LV therapy had similar outcomes as those in NAPOLI-1.

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