Healthcare utilization and costs associated with first-line treatment with obinutuzumab- and rituximab-based regimens for follicular lymphoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19536-e19536
Author(s):  
Jamie T. Ta ◽  
Tu My To ◽  
Cheryl Sud ◽  
Sheila Shapouri ◽  
Arpamas Seetasith
Keyword(s):  
Follicular Lymphoma ◽  
Healthcare Utilization ◽  
Real World ◽  
Healthcare Costs ◽  
Trial Participation ◽  
Administrative Claims ◽  
Cell Transplant ◽  
First Line ◽  
Real World Data ◽  
Eligibility Criteria

e19536 Background: Current real-world data on healthcare utilization (HCU) and costs of common first-line (1L) follicular lymphoma (FL) regimens, including obinutuzumab (G), remain limited. The aim of this study was to examine real-world HCU and costs for the most common National Comprehensive Cancer Network (NCCN)-recommended 1L FL treatments. Methods: This was a retrospective cohort study using administrative claims data from the IQVIA PharMetrics Plus and IBM MarketScan Commercial and Medicare Supplemental databases. We identified patients (pts) ≥18 years, who had ≥1 inpatient claim or ≥2 outpatient claims, with a diagnosis of FL from February 1, 2015 to March 31, 2020, and had received 1L FL treatment (per NCCN guidelines) between February 1, 2016 and September 30, 2019. The first claim for FL treatment was the index date. All pts had ≥12 months of pre- and ≥6 months of post-index continuous enrollment in medical and pharmacy benefits. Pts with other primary cancers, FL treatment, or stem cell transplant during the pre-index period, and clinical trial participation or end-stage renal disease during the study period were excluded. All-cause HCU and costs (2020 USD) per pt during the 6-month post-index period were reported for the five most common 1L FL regimens (only complete NCCN regimens were considered). Results: Overall, 1991 pts met the eligibility criteria, and 53% were male. The mean (standard deviation [SD]) age and Charlson Comorbidity Index at index were 58 (10.4) years, and 1.7 (1.0), respectively. The most common 1L regimens were rituximab-bendamustine (R-benda; n=818 [41.1%]), R-monotherapy (R-mono; n=592 [29.7%]), R-CHOP (n=461 [23.2%]), G-benda (n=86 [4.3%]), and R-CVP (n=34 [1.7%]). The proportion of pts who had ≥1 hospitalization or an emergency room visit was highest with R-CHOP (26.7% and 33.6%, respectively) and lowest with R-mono (11.3% and 18.1%, respectively). Mean (SD) all-cause total healthcare costs were highest with R-benda and G-benda, followed by R-CHOP, R-CVP, and R-mono (Table). Mean (SD) all-cause medical and FL treatment costs (drug and administration) were highest for R-benda ($174,407 [$110,520]; $135,520 [$96,492]) and lowest for R-mono ($87,368 [$83,910]; $54,271 [$40,433]). Conclusions: This real-world study provides an update on HCU and costs among pts initiating current NCCN-recommended 1L treatment for FL. Unadjusted 6-month total healthcare costs were highest with R-benda, followed by G-benda, while the lowest costs were seen with R-CVP and R-mono. Future studies with adjustment for pt characteristics are needed to compare HCU and costs between FL regimens.[Table: see text]

scholarly journals Incremental Healthcare Utilization and Cost Burden of Comorbid Insomnia in Alzheimer’s Disease Patients

2021 ◽  
pp. 1-12
Author(s):  
Zaina P. Qureshi ◽  
Ellen Thiel ◽  
James Nelson ◽  
Rezaul Khandker
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Healthcare Utilization ◽  
Real World ◽  
Healthcare Costs ◽  
Real World Data ◽  
Skilled Nursing ◽  
Comorbid Insomnia ◽  
Comorbidity Burden

Background: Insomnia is associated with worsened clinical outcomes among Alzheimer’s disease dementia (AD) patients, increased caregiver burden, and healthcare utilization. Objective: This study aimed to characterize the incremental healthcare burden of insomnia in AD using real-world data. Methods: A retrospective observational study was conducted on AD patients selected from the IBM® MarketScan Commercial and Medicare Supplemental Databases. AD patients with claims-based evidence of insomnia were direct matched to a non-insomnia cohort based on demographic factors. Healthcare utilization and associated costs were assessed for a 12-month follow-up period. Results: A total of 3,500 insomnia AD patients and 9,884 non-insomnia AD patients were analyzed. The insomnia cohort had a higher comorbidity burden at baseline (mean score on Charlson Comorbidity Index 2.5 versus 2.2, p <  0.001) and higher proportions of patients with baseline diagnoses for other conditions including depression: 40%, insomnia cohort versus 25%, non-insomnia (p <  0.001). AD patients with insomnia were more likely to have a claim for inpatient hospitalizations (39.8%versus 32.3%), emergency room services (56.4%versus 48.0%), and skilled-nursing services (42.6%versus 31.9%) (all p <  0.05). Mean total annual healthcare costs during the 12-month follow-up period were significantly higher among AD patients with insomnia as compared to those without. (Mean costs: $37,356 versus $27,990, p <  0.001). Conclusion: AD patients with comorbid insomnia are more likely to use higher-cost healthcare services such as inpatient hospitalization, and skilled nursing, and have higher total healthcare costs. This real-world analysis provides evidence that AD disease management should consider proper treatment of comorbid insomnia due to the incremental burden and cost implications.

Treatment patterns and characteristics of acute promyelocytic leukemia (APL) patients receiving arsenic trioxide (ATO) therapy in a real-world setting.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18522-e18522
Author(s):  
Boxiong Tang ◽  
Susan Gabriel ◽  
Jifang Zhou ◽  
Ashutosh K. Pathak ◽  
Debra Irwin ◽  
...  
Keyword(s):  
Real World ◽  
Index Date ◽  
Claims Data ◽  
Treatment Patterns ◽  
Chronic Obstructive ◽  
Administrative Claims ◽  
First Line ◽  
Real World Data ◽  
World Data

e18522 Background: Clinical trials have shown that low-risk APL patients had significantly better outcomes when receiving first-line all-trans retinoic acid (ATRA) + ATO compared with standard ATRA + chemotherapy. Few published studies have used real-world data to describe patients using ATO and their current treatment patterns. This study used United States (US) administrative claims data to describe treatment patterns and characteristics of patients receiving first-line ATO. Methods: This retrospective, observational cohort study used claims data from the MarketScan databases. As there is no ICD-9-CM diagnosis code for APL, ATO treatment was used as a surrogate for the diagnosis of APL since ATO is typically used only in APL patients. Patients were selected if they had ≥1 claims for ATO between January 1, 2000, and June 30, 2015. Date of first use was designated the index date. To identify first-line ATO initiation, patients with ATRA or other APL-indicated chemotherapy claims any time before the index date were excluded. Variable baseline and follow-up periods consisting of ≥3 months of pre-index and ≥30 days of post-index continuous enrollment in medical and pharmacy benefit were used. Results: In total, 331 patients were identified with a subset (n = 265) having ≥2 claims for ATO. The analysis focused on these 265 patients, 54% of whom were male. Mean age was 60.6 years; 45% were covered by Medicare. The most common comorbid conditions measured were diabetes (6%), chronic obstructive pulmonary disease (5%), and congestive heart failure (4%). The most commonly selected APL treatments administered during follow-up were ATRA (17%) and daunorubicin (9%) with the use of idarubicin, cytarabine, and mitoxantrone at less than 3%. Maintenance therapy with methotrexate or 6-mercaptopurine was observed in 7% and 6% of patients, respectively. Conclusions: This is one of the first studies to examine patient characteristics and treatment patterns for first-line ATO using real-world data. Further research is needed to evaluate outcomes for patients receiving ATO as first-line therapy and to re-evaluate treatment guidelines in light of these outcomes.

Differences in health care costs and utilization: BR vs RCHOP in patients with follicular lymphoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e19049-e19049
Author(s):  
Jifang Zhou ◽  
Ashutosh K. Pathak ◽  
Danielle M. Brander ◽  
Susan Gabriel
Keyword(s):  
Follicular Lymphoma ◽  
Healthcare Utilization ◽  
Healthcare Costs ◽  
Index Date ◽  
Linear Models ◽  
Newly Diagnosed ◽  
First Line ◽  
Non Hodgkin Lymphoma ◽  
Outpatient Visits ◽  
Pharmacy Claims

e19049 Background: Follicular lymphoma (FL) is the most common subtype of indolent non-Hodgkin lymphoma (iNHL) with an incidence of more than 1500 cases annually and comprising 35% of all iNHL cases in North America. Combination chemotherapy with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (RCHOP) or bendamustine plus rituximab (BR) are both category 1–approved first-line therapies. This analysis examined differences in healthcare costs and utilization between two cohorts of newly diagnosed FL patients undergoing BR or RCHOP therapy. Methods: Newly diagnosed FL patients from 1/1/2006 to 7/31/2016 treated with first-line RCHOP or BR were identified in the Truven Health MarketScan Research Databases. Inclusion criteria were age ≥18 years and continuous enrollment from 3 months before to 1 month after the index date (eg, first prescription for RCHOP/BR). Healthcare utilization and costs were calculated on a per month basis from the index date to 6 months post-index date. Costs included all payments made by insurance providers except for pharmacy claims. Healthcare utilization variables included number of outpatient visits, emergency room (ER) visits (yes/no), and hospitalizations (yes/no). Logistic regression and general linear models were used to test for differences. Results: Of the 6460 FL patients (male = 55%; mean age = 60.46 years, SD = 12.56) identified, 2360 were in the BR cohort and 4100 patients were in the RCHOP cohort. At baseline, the BR cohort was significantly older; had more comorbid conditions, lower costs, and fewer outpatient visits; and was less likely to have an ER visit or hospitalization relative to RCHOP patients. Over the first 6 months of therapy, controlling for baseline differences, the BR group experienced significantly lower costs and fewer outpatient visits. The BR cohort was also significantly less likely to be admitted to the ER or experience a hospitalization. Conclusions: The results of this analysis suggest that, in general, the healthcare costs and utilization of FL patients receiving BR is significantly lower than for RCHOP patients. These results support the emerging prominence of BR as an effective and safe first-line treatment option for FL patients.

Serious infections and cardiovascular complications among patients with chronic lymphocytic lymphoma treated with first-line ibrutinib or bendamustine/rituximab.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19503-e19503
Author(s):  
Debra E. Irwin ◽  
Stephen Thompson ◽  
Rinat Ribalov ◽  
Azhar Choudhry
Keyword(s):  
Real World ◽  
Index Date ◽  
Cardiovascular Complications ◽  
Administrative Claims ◽  
First Line ◽  
Real World Data ◽  
World Data ◽  
Serious Infections ◽  
Baseline Characteristics

e19503 Background: Clinical trials have shown positive outcomes associated with ibrutinib monotherapy (IM) and bendamustine / rituximab combination (BR) therapy in patients with chronic lymphocytic lymphoma (CLL) compared to other standard treatments, but limited real-world data exist. This study evaluated serious infections and cardiovascular complications in CLL patients treated with first-line IM or BR therapy using US real-world data. Methods: Administrative claims from the MarketScan® Research Databases were used to identify adult patients enrolled in commercial or Medicare supplemental insurance plans based on a first prescription fill of IM or BR therapy (the index date) from 2/1/14 to 9/1/19. Patients were diagnosed with CLL, treatment naïve, and continuously enrolled for ≥12 months prior to and following the index date. Serious infections and cardiovascular complications requiring hospitalization (diagnosis code in any position) were evaluated during a fixed 12-month follow-up period. Statistical differences in outcome distributions between the treatment groups were tested. Multivariate logistic regression models for lower respiratory tract infection (LRTI) and atrial fibrillation (AF) were also conducted to determine the adjusted odds of hospitalization. Results: Of 2,138 CLL patients, 810 had IM and 512 had BR as index therapy with ≥12 months of follow-up data. Patients receiving IM were older and more likely to have had an LRTI during baseline compared to BR patients, otherwise both groups had similar baseline characteristics. Hospitalization for serious infections was more common during follow-up among IM patients than BR patients (17.7% vs. 13.1%; p = 0.027). Specifically, 10.2% of IM patients had a bacterial infection hospitalization compared to 5.7% of BR patients (p = 0.004) and 10.7% of IM patients had a LRTI hospitalization compared to 6.6% of BR patients (p = 0.012). After adjusting for baseline characteristics, IM patients did not have significantly higher odds of a LRTI hospitalization (OR = 1.51; p = 0.069). Hospitalization for cardiovascular complications was more common during follow-up among IM patients than BR patients (18.3% vs. 11.9%; p = 0.002). Specifically, 8.4% of IM patients had an AF-related hospitalization versus 2.7% of BR patients (p < 0.001). After adjusting for baseline characteristics, IM patients were more likely to have a hospitalization for AF versus BR patients (OR = 3.89; p < 0.001). Conclusions: In a real-world setting, serious infections and cardiovascular complications were more common among CLL patients treated with first-line IM compared to BR during 12 months of follow-up. IM patients were more likely than BR patients to have an inpatient admission due to AF after adjusting for other patient characteristics.

scholarly journals Real-World Treatment Patterns, Health Care Utilization, and Costs Among Relapsed/ Refractory Multiple Myeloma (rrMM) Patients

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3555-3555 ◽  
Author(s):  
Changxia Shao ◽  
Matthew Monberg ◽  
Xiting Cao ◽  
Wei Zhou ◽  
Yichen Zhong ◽  
...  
Keyword(s):  
Health Care ◽  
Real World ◽  
Cost Evaluation ◽  
Care Utilization ◽  
Administrative Claims ◽  
Cell Transplant ◽  
Duration Of Treatment ◽  
Real World Data ◽  
Line Of Therapy

Abstract Background: Carfilzomib (Car, 2012), pomalidomide (Pom, 2013), and panobinostat (Pano, 2015) were approved for the treatment of rrMM patients after failure of at least two prior standard therapies. There is limited real-world data on utilization of these medications, health care resource utilization (HCRU) and costs in patients with rrMM at the US population level. This study aimed to describe treatment pattern, HCRU, and costs in rrMM patients who received at least two prior therapies using a large administrative claims database. Methods: This was a retrospective database analysis using the Truven Health MarketScan Commercial and Medicare Database. Patients (pts) were included if they were diagnosed with MM between Jan 1, 2006 and May 31, 2015, were ≥18 yrs, had no claim for stem cell transplant, and had ≥6 mos continuous enrollment before and ≥1 mos after the 1st MM diagnosis (index date) and treatment initiation (TI). Only patients who had ≥6 mos continuous enrollment after TI were included in HCRU and cost evaluation. If two or more drugs started within 90 days, they were considered as 1 regimen. End of a line of therapy (LOT) was defined when a new treatment was introduced or there was a treatment gap >90 days or end of follow-up, whichever occurred first. Third line of therapy (3L) was identified following 2 prior lines of therapy. Time to next treatment (TTNT) was defined from initiation of the LOT to initiation of subsequent LOT. Duration of treatment (DOT) and TTNT were estimated based on Kaplan-Meier method. Regimens were classified into 6 mutually-exclusive categories, including bortezomib (Bor), lenalidomide (Len), Pom, Car, thalidomide (Thal), and Other based therapies. HCRU and cost (per patient per month, PPPM) were calculated. The total costs included inpatient costs, outpatient costs and pharmacy costs. Results: A total of 9,960 pts were identified with initiation of 1L therapy. Median age was 67 yrs. And 57.4% were male. During an average of 20.0 mos follow-up post TI, 3,282 (33.0%), 1,103 (11.1%) and 400 (4%) pts initiated 2L, 3L, and 4L therapies, respectively. During 3L therapy, Bor (43.5%, including 10.5% for Bor-Len) and Len based regimens (29.8%) were most commonly observed. Median DOTs ranged from Car (3.7 mos) to Len (8.1 mos) based regimens. Median TTNT from short to long was Car, Pom, Bor, Len, Other, and Thal based regimens. On average, each patient with rrMM had 4.5 outpatient visits, 0.1 inpatients visits, 0.1 ER visits and 0.004 hospice care visits per month. The average PPPM costs were $14,286, $13,377, $11,919, for Bor, Len, Thal based regimens and $25,850 and $21,180 for Pom and Car based regimens, respectively. Conclusions: Although novel agents were added to rrMM treatment, Bor and/or Len based regimens remained the most commonly used therapies in 3L setting. Compared to Bor, Len and Thal based therapies, PPPM costs were higher for Pom and Car based regimens. These data could be useful for treatment consideration and economic evaluation. Table Table. Disclosures Shao: Merck & Co., Inc.: Employment. Monberg:Merck & Co.: Employment. Cao:Merck & Co.: Employment. Zhou:Merck & Co.: Employment. Zhong:Merck & Co., Inc.: Employment. Marinello:Merck & Co., Inc.: Employment.

Real-world treatment patterns and outcomes in patients with follicular lymphoma in the United States.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19534-e19534
Author(s):  
Jamie T. Ta ◽  
Taha Itani ◽  
Sheila Shapouri ◽  
Stella Arndorfer ◽  
Cristina Julian ◽  
...  
Keyword(s):  
Follicular Lymphoma ◽  
Clinical Outcomes ◽  
Real World ◽  
The United States ◽  
Aggressive Lymphoma ◽  
Trial Participation ◽  
Low Grade ◽  
Cell Transplant ◽  
The Us

e19534 Background: Despite the availability of new therapies for follicular lymphoma (FL), there are limited data on the real-world treatment (tx) of FL in a contemporary cohort of patients (pts). We examined tx patterns and outcomes in pts who received FL therapy in the US. Methods: This retrospective cohort study used the nationwide Flatiron Health electronic health record-derived de-identified database. During the study, the de-identified data originated from ̃280 cancer clinics (̃800 sites of care) in the US. We selected pts aged ≥18 years, with an initial FL diagnosis (ICD-9-CM: 202.0x; ICD-10-CM: C82.0x) between January 2011 and July 2020, who had received ≥1 line of therapy (LOT) for FL (follow-up ended September 2020). The initiation date of a LOT was considered the index date for analyses by LOT. Pts with evidence of clinical trial participation during the study period, high-grade (3b) FL at diagnosis, transformed aggressive lymphoma at any time before first-line (1L) FL tx, or chemotherapy/immunotherapy or stem cell transplant 12 months before 1L FL tx, were excluded. Pt characteristics at diagnosis were assessed using descriptive statistics. Tx patterns and clinical outcomes (time to next tx [TTNT] and overall survival [OS]) were reported by LOT. Median TTNT and OS were estimated using Kaplan–Meier methods. Results: Overall, 2383 pts met all eligibility criteria. Median age at FL diagnosis was 66 years; 49.2% were male, 77.5% had low-grade (1–2) FL, and 75.2% had advanced stage (III/IV) FL at diagnosis. Median follow-up was 43.1 months, and median time from diagnosis to 1L FL tx was 38 days. Most pts received up to 2 LOTs (n=2258 [94.8%]). The most common regimens across all LOTs were rituximab-bendamustine (R-benda; n=1256 [52.7%]), R monotherapy (n=812 [34.1%]), R-CHOP (n=483 [20.3%]), R-CVP (n=172 [7.2%]), and obinutuzumab (G)-benda (n=77 [3.2%]). The use of newer FL therapies was limited across all LOTs, but more common in the third-line onwards (3L+): chemotherapy-free combinations (R-/G-lenalidomide): 2.3% (all LOTs) and 19.2% (3L+); and phosphoinositide 3-kinase inhibitors: 1.6% (all LOTs) and 21.6% (3L+). In total, 111 (4.7%) pts received G-based regimens. Median TTNT after 1L and second-line onwards (2L+) was 79.4 months and 38.3 months, respectively. Median OS was not reached (NR) and 82.9 months after 1L and 2L+, respectively (Table). Conclusions: We provide a comprehensive update on real-world tx patterns and clinical outcomes in pts with FL in the US. Chemoimmunotherapy remains the standard of care across all LOTs, though the shorter durations of TTNT and OS in 2L+ may support the role of novel therapies in this setting. Tx outcomes by LOT.[Table: see text]

scholarly journals Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative

2021 ◽  
Author(s):  
Scott R. Evans ◽  
Dianne Paraoan ◽  
Jane Perlmutter ◽  
Sudha R. Raman ◽  
John J. Sheehan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Real World Data ◽  
Eligibility Criteria ◽  
World Data ◽  
Study Planning ◽  
Efficiency And Effectiveness ◽  
Multi Stakeholder ◽  
Functional Teams ◽  
Data Driven Decisions

AbstractThe growing availability of real-world data (RWD) creates opportunities for new evidence generation and improved efficiency across the research enterprise. To varying degrees, sponsors now regularly use RWD to make data-driven decisions about trial feasibility, based on assessment of eligibility criteria for planned clinical trials. Increasingly, RWD are being used to support targeted, timely, and personalized outreach to potential trial participants that may improve the efficiency and effectiveness of the recruitment process. This paper highlights recommendations and resources, including specific case studies, developed by the Clinical Trials Transformation Initiative (CTTI) for applying RWD to planning eligibility criteria and recruiting for clinical trials. Developed through a multi-stakeholder, consensus- and evidence-driven process, these actionable tools support researchers in (1) determining whether RWD are fit for purpose with respect to study planning and recruitment, (2) engaging cross-functional teams in the use of RWD for study planning and recruitment, and (3) understanding patient and site needs to develop successful and patient-centric approaches to RWD-supported recruitment. Future considerations for the use of RWD are explored, including ensuring full patient understanding of data use and developing global datasets.

scholarly journals Leveraging Real-World Data for the Selection of Relevant Eligibility Criteria for the Implementation of Electronic Recruitment Support in Clinical Trials

2021 ◽  
Vol 12 (01) ◽  
pp. 017-026
Author(s):  
Georg Melzer ◽  
Tim Maiwald ◽  
Hans-Ulrich Prokosch ◽  
Thomas Ganslandt
Keyword(s):  
Data Warehouse ◽  
Real World ◽  
Chart Review ◽  
Patient Recruitment ◽  
Real World Data ◽  
Eligibility Criteria ◽  
Health Records ◽  
World Data ◽  
Paper Chart ◽  
Data Elements

Abstract Background Even though clinical trials are indispensable for medical research, they are frequently impaired by delayed or incomplete patient recruitment, resulting in cost overruns or aborted studies. Study protocols based on real-world data with precisely expressed eligibility criteria and realistic cohort estimations are crucial for successful study execution. The increasing availability of routine clinical data in electronic health records (EHRs) provides the opportunity to also support patient recruitment during the prescreening phase. While solutions for electronic recruitment support have been published, to our knowledge, no method for the prioritization of eligibility criteria in this context has been explored. Methods In the context of the Electronic Health Records for Clinical Research (EHR4CR) project, we examined the eligibility criteria of the KATHERINE trial. Criteria were extracted from the study protocol, deduplicated, and decomposed. A paper chart review and data warehouse query were executed to retrieve clinical data for the resulting set of simplified criteria separately from both sources. Criteria were scored according to disease specificity, data availability, and discriminatory power based on their content and the clinical dataset. Results The study protocol contained 35 eligibility criteria, which after simplification yielded 70 atomic criteria. For a cohort of 106 patients with breast cancer and neoadjuvant treatment, 47.9% of data elements were captured through paper chart review, with the data warehouse query yielding 26.9% of data elements. Score application resulted in a prioritized subset of 17 criteria, which yielded a sensitivity of 1.00 and specificity 0.57 on EHR data (paper charts, 1.00 and 0.80) compared with actual recruitment in the trial. Conclusion It is possible to prioritize clinical trial eligibility criteria based on real-world data to optimize prescreening of patients on a selected subset of relevant and available criteria and reduce implementation efforts for recruitment support. The performance could be further improved by increasing EHR data coverage.

scholarly journals Real-world comparative effectiveness of nab-paclitaxel plus gemcitabine versus FOLFIRINOX in advanced pancreatic cancer: a systematic review

2019 ◽  
Vol 11 ◽  
pp. 175883591985036 ◽  
Author(s):  
Elena Gabriela Chiorean ◽  
Winson Y. Cheung ◽  
Guido Giordano ◽  
George Kim ◽  
Salah-Eddin Al-Batran
Keyword(s):  
Systematic Review ◽  
Pancreatic Cancer ◽  
Real World ◽  
Controlled Trial ◽  
Safety Data ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
First Line ◽  
Eligibility Criteria ◽  
Grade 3

Background: No clinical trial has directly compared nab-paclitaxel/gemcitabine (nab-P/G) with FOLFIRINOX (fluorouracil/leucovorin/oxaliplatin/irinotecan) in metastatic or advanced pancreatic cancer (mPC or aPC). We conducted a systematic review of real-world studies comparing these regimens in the first-line setting. Methods: Embase and MEDLINE databases through 22 January 2019, and Gastrointestinal Cancers Symposium 2019 abstracts were searched for real-world, retrospective studies comparing first-line nab-P/G versus FOLFIRINOX in mPC or aPC that met specific parameters. Studies with radiotherapy were excluded. Study quality was assessed using the Newcastle–Ottawa Scale. Results: Of 818 records initially identified, 35 were duplicates and 749 did not meet the eligibility criteria, mostly because they were either not comparative ( n = 356) or not first line ( n = 245). The remaining 34 studies (21 mPC; 13 aPC) assessed >6915 patients who received nab-P/G or FOLFIRINOX. In the studies identified, the median overall survival (OS) reached 14.4 and 15.9 months with nab-P/G and FOLFIRINOX, respectively, and median progression-free survival reached 8.5 and 11.7 months, respectively. Safety data were reported in 14 studies (2205 patients), including 8 single-institutional studies. In most single-institutional studies that reported safety data, rates were higher with FOLFIRINOX versus nab-P/G for grade 3/4 neutropenia (five of six studies) and febrile neutropenia (all three studies), while rates of grade 3/4 peripheral neuropathy were higher with nab-P/G in four of seven studies. Conclusions: Although FOLFIRINOX was associated with slightly longer median OS in more studies, the differences, when available, were not statistically significant. Therefore, a randomized, controlled trial is warranted. Toxicity profile differences represent key considerations for treatment decisions.

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