Treatment patterns and outcomes of patients with penile squamous-cell carcinoma (PSCC) undergoing inguinal lymph node dissection (ILND): An analysis of a multicenter contemporary database.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5585-5585
Author(s):  
Marco Bandini ◽  
Yao Zhu ◽  
Dingwei Ye ◽  
Antonio Augusto Ornellas ◽  
Nick Watkin ◽  
...  
Keyword(s):  
Real World ◽  
Complete Information ◽  
Treatment Patterns ◽  
Geographical Region ◽  
Inguinal Lymph Node Dissection ◽  
Kaplan Meier ◽  
N Stage ◽  
Penile Squamous Cell Carcinoma ◽  
Collaborative Efforts

5585 Background: PSCC is a rare tumor and the administration of guidelines-based therapies is still problematic in real-world practice. Survival outcomes remain suboptimal in patients (pts) with ILN involvement. Multinational analyses of real-world patterns are needed. Methods: Within an international, multicenter database of 965 PSCC pts who received ILND from 1980-2019, 630 had complete information for the variables of interest, from USA (N=81), Europe (EU, N=355), South America (SA, N=90), and China (Ch, N=104). Descriptive analyses according to geographical and ethnicity/race distribution were made. Comparisons of outcomes were made with Kaplan-Meier analyses and corresponding logrank tests. Results: Median age at diagnosis was 59 yrs, with no differences worldwide and according to ethnicity/race. Pts from SA presented with more advanced cT-stage (cT3-4: 26.7% vs. 17.3% USA vs. 7.6% EU) while EU pts presented with more advanced cN-stage (cN3: 14.9% vs. 11% USA vs. 7.8% SA vs. 5.8% Ch) as well as pathological (p)N-stage: pN3 pts were 53% in EU, 33.3% in USA, 20% in SA, and 18.3% in Ch. Perioperative chemotherapy (pCT) was more frequently administered in EU (53.8%) vs. USA (34.6%) SA (5.6%) Ch (7.7%). cT-stage was more frequently advanced in black pts (cT3-4: 33.3% vs. 12% Caucasian, 6.2% Hispanic/latino, 0% Asian) and the same was for cN-stage (cN3: 25% in black, 13% in Caucasian, 6.2% in Hispanic/latino, 6% in Asian). Conversely, pN3 pts were more frequently Caucasian (45.6%) vs. black (25%), Hispanic/latino (19%), and Asian (18%). pCT was more frequently administered in Caucasian pts (45%) vs. black (8.3%), Hispanic/latino (0), and Asian (8%). No significant differences in overall survival (OS) were observed according to geographical region or ethnicity/race, in the total pts and in the subgroups according to cT, cN, pN-stages and pCT. Median OS after pCT and ILND was 95 months. Bilateral ILN involvement was equally observed regardless of geographical region and ethnicity/race. In the total population, pCT significantly prolonged OS in pts with bilateral ILN (p=0.04), but not in pts with pelvic LN. Conclusions: Treatment patterns for PSCC undergoing ILND remain heterogeneous worldwide, and adherence to guidelines is seemingly poor. However, long-term outcomes with pCT remain uniformly suboptimal with <50% pts alive at 10 yrs. Further collaborative efforts are needed in this orphan disease to harmonize the therapeutic paradigm.

Paclitaxel exposure and long-term mortality of patients treated with the Zilver PTX drug-eluting stent

Vascular ◽  
2020 ◽  
pp. 170853812096437
Author(s):  
Jordan R Stern ◽  
Kenneth Tran ◽  
Venita Chandra ◽  
E John Harris ◽  
Jason T Lee
Keyword(s):  
Real World ◽  
Drug Eluting Stent ◽  
Secondary Patency ◽  
Kaplan Meier ◽  
Drug Eluting ◽  
Lifetime Exposure ◽  
Zilver Ptx ◽  
Long Term Mortality

Objectives Paclitaxel-eluting stents have demonstrated improved patency over balloon angioplasty and bare metal stenting for endovascular interventions in the femoral-popliteal segment. Recently, concerns have arisen regarding the safety of paclitaxel use and its association with mortality. This study aims to examine real-world, long-term mortality, and patency of patients treated with the Zilver PTX drug-eluting stent. Methods Patients treated with the PTX stent after FDA approval between 2013 and 2015 were identified from an institutional database. Demographic, procedural, and device information was collected and initial- and lifetime-exposure dose of paclitaxel was calculated. The primary outcome was all-cause mortality and its association with paclitaxel exposure. Long-term patency was also evaluated. Results Seventy-nine procedures involving PTX placement were performed on 64 individual patients during the study period, with 15 (23.4%) having bilateral procedures. Average age was 70 years, and 71.9% were male. Forty-five patients (70.3%) were claudicants, and 19 (29.7%) had chronic, limb-threatening ischemia. An average of 2.3 PTX stents, totaling 203 mm in length, were placed per procedure. Paclitaxel exposure was 1.87 mg/procedure initially (range 0.38–4.03 mg), and average lifetime exposure was 4.65 mg/patient (range 0.38–27.91 mg). Average follow-up was 59.6 months. Kaplan–Meier estimated survival was 96.9%, 81.2% and 71.7% at one , three, and five years. On multivariate analysis, no specific factors were associated with overall morality including initial paclitaxel dose (HR 0.99, 95% CI 0.99–1.00) and lifetime paclitaxel exposure (HR 0.98, 95% CI 0.89–1.08). Kaplan–Meier primary patency was 76.2%, 60.1%, and 29.3% at one, two, and five years, respectively. Secondary patency was 92.2%, 85.4%, and 75.2% at the same intervals. Conclusions At a mean follow-up of five years, exposure to higher doses of paclitaxel from Zilver PTX does not appear to be associated with increased mortality compared to lower doses in real-world patients. Long-term patency rates confirm the efficacy of Zilver PTX, and further investigation may be warranted before abandoning paclitaxel use altogether.

Real world treatment patterns of first-line combination therapies among BRAF+ metastatic melanoma patients stratified by tumor burden.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 198-198
Author(s):  
Sameer Ghate ◽  
Jackson Tang ◽  
Zhiyi Li ◽  
Antonio Reis Nakasato
Keyword(s):  
Brain Metastasis ◽  
Metastatic Melanoma ◽  
Real World ◽  
Tumor Burden ◽  
Treatment Patterns ◽  
Discontinuation Rate ◽  
First Line ◽  
High Tumor Burden ◽  
Kaplan Meier ◽  
Measured Time

198 Background: For patients (pts) with metastatic melanoma (MM) and BRAF V600 mutation (BRAF+), options for first-line (1L) systemic combination therapy include immunotherapy (IO) or targeted therapy (TT). This study describes real world treatment patterns among BRAF+ MM pts treated with 1L ipilimumab+nivolumab (I+N) or dabrafenib+trametinib (D+T), stratified by tumor burden. Methods: A retrospective observational analysis used Flatiron Health’s electronic health record-derived database from Oct ’15 - Jul ’16. Pts were aged ≥18 years with a MM diagnosis, tested BRAF+ prior to therapy, and treated with ipilimumab+nivolumab (I+N) or dabrafenib+trametinib (D+T) as 1L therapy. Low tumor burden was defined as low/normal LDH (≤ 333 IU/L) and no brain metastasis. High tumor burden was defined as high LDH ( > 333 IU/L) or brain metastasis. Baseline characteristics and treatment patterns were descriptively assessed. Kaplan-Meier (KM) analysis measured time to discontinuation. Results: Among 76 BRAF+ pts, 38% (29) were treated with I+N as 1L, and 62% (47) were treated with D+T as 1L. Of these, 45% (13/29) of I+N vs. 32% (15/47) of D+T had low tumor burden, while 41% (12/29) of I+N vs. 49% (23/47) of D+T had high tumor burden. The two cohorts did not differ by age or gender. Treatment patterns are summarized below. Conclusions: Among pts with low tumor burden, I+N demonstrated shorter time to discontinuation and higher discontinuation rate relative to D+T. Treatment toxicity and progression was the main reason for discontinuation of I+N and D+T, respectively. Among pts with high tumor burden, I+N demonstrated longer time to discontinuation but higher discontinuation rate relative to D+T. Progression was the main reason for discontinuation of both I+N and D+T. [Table: see text]

Real-world treatment patterns and clinical outcomes of advanced melanoma patients following disease progression on anti-PD-1-based therapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e22036-e22036
Author(s):  
Leonel Fernando Hernandez-Aya ◽  
Matthew Burke ◽  
Jenna M Collins ◽  
Dennis Earle ◽  
Melissa Hamilton ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Disease Progression ◽  
Real World ◽  
Treatment Patterns ◽  
Advanced Melanoma ◽  
Pattern Of Care ◽  
Kaplan Meier ◽  
Programmed Cell Death 1 ◽  
Line Of Therapy ◽  
Patients Experience

e22036 Background: Despite the success of anti-programmed cell death-1 (PD-1) based therapies that prolong survival in advanced melanoma, some patients experience disease progression. Real-world treatment patterns and outcomes after progression on anti-PD-1 based regimens are unknown. Methods: Adults with advanced melanoma and a record of disease progression on anti-PD-1 treatment (alone or in combination) between 1 Sept 2014–31 Jan 2019 were selected from the Flatiron Health Oncology electronic medical record (EMR) database for this retrospective study. Index progression date was defined as an event where the treating clinician concluded in the patient record that there had been disease progression. The first subsequent therapy received was identified. Kaplan-Meier methods estimated overall survival (OS) with 95% confidence interval (CI) after the progression date. Analyses were run separately for BRAF mutant (mt) and wild type (wt). Results: Among 2,169 patients with advanced melanoma treated with an anti-PD-1, 213 BRAFmt and 302 BRAFwt had a record of progression following anti-PD-1 initiation and were included; an additional 82 BRAFmt and 138 BRAFwt were excluded due to death without a record of progression. Median age was 64 and 71 years, respectively; 27.7% and 9.9% had >1 line of therapy prior to the anti-PD-1. Among the BRAFmt patients who progressed on anti-PD-1, 94 (44.1%) received no subsequent therapy, 80 (37.6%) BRAF±MEK (± IO), and 16 (7.5%) anti-CTLA4 alone or with anti-PD-1 after progression on the initial anti-PD-1; 11% received other treatments with no clear pattern of care. Median (95% CI) OS from the index progression date for BRAFmt was 11.9 (8.2–16.9) months. In a subgroup of these BRAFmt patients with BRAF treatment prior to or during the first anti-PD-1 line (N = 65), 52.3% had no subsequent therapy and a median OS of 4.0 (2.7–7.5) months. Among the BRAFwt patients who progressed on anti-PD-1, 186 (61.6%) received no subsequent therapy, 46 (15.2%) received anti-CTLA4 alone or with anti-PD-1, 26 (8.6%) switched anti-PD-1s, and 15% received other treatments. Median (95% CI) OS for BRAFwt was 10.1 (8.8–12.5) months. Conclusions: In this real-world retrospective study, > 40% of BRAFmt and > 60% of BRAFwt patients did not initiate a new regimen after progression on anti-PD-1 therapy. Median OS after progression was < 1 year. This may be overestimated, as it excluded patients who died before progression was recorded in the EMR. These findings highlight a need for more effective treatments for advanced melanoma.

Patterns of hedgehog inhibitor (HHI) treatment interruptions and re-initiations among patients with basal cell carcinoma (BCC) in real-world clinical practice.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19349-e19349
Author(s):  
Jessica J. Jalbert ◽  
Chieh-I Chen ◽  
Ning Wu ◽  
Matthew G. Fury ◽  
Emily S Ruiz ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Treatment Duration ◽  
Index Date ◽  
Sensitivity Analyses ◽  
Kaplan Meier ◽  
Treatment Interruptions ◽  
Observational Cohort ◽  
Practice Methods

e19349 Background: HHIs are oral targeted therapies approved for the treatment of advanced BCC but treatment-related adverse events may result in treatment interruptions or discontinuation. The objective of this study was to describe HHI treatment patterns among patients with BCC in real-world clinical practice. Methods: We conducted an observational cohort study using MarketScan Commercial/Medicare databases (01/01/2013–09/30/2018). We identified new users of HHIs (index date = date of the first dispensation), ≥18 years of age who were continuously enrolled for ≥6 months prior to the index date (i.e. baseline) with ≥1 baseline BCC diagnosis. Treatment interruptions (TI) were defined as a lack of dispensation following the exhaustion of days’ supply and allotted grace period (GP). Re-initiation (RI) was defined as ≥1 HHI dispensation after TI. The Kaplan–Meier method was used to estimate risk and time to TI and, among patients with a TI, incidence of RI. HHIs are generally dispensed in 30-days’ supply and indicated as long as a patient derives a clinical benefit; however, since TIs are commonly employed during HHI therapy, sensitivity analyses were conducted using GPs of 14, 30, 60, 90, and 120 days. Results: We identified 469 patients with a BCC diagnosis initiating HHIs. The mean (SD) age was 67.6 (15.8) years, 64.2% were men, 51.2% were covered by commercial insurance, and 99.2% initiated vismodegib. Using a GP of 14, 30, 60, 90, and 120 days, the risk of TI was 79.2%, 68.8%, 60.0%, 55.4%, and 51.4% at 6 months and 94.8%, 91.3%, 88.2%, 83.2%, and 80.2% at 1 year, respectively. Median HHI treatment duration ranged from 94 days (95% CI: 90–109) using a GP of 14 days to 173 days (95% CI: 156–194) using a GP of 120 days. At 6 months following TI, incidence of RI was 35.8%, 19.8%, 11.3%, 6.9%, and 4.9% using a GP of 14, 30, 60, 90, and 120 days, respectively. The incidence of HHI RI at 1-year following TI ranged from 40.8% using a 14-day GP to 13.4% using a 120-day GP. Conclusions: Median HHI treatment duration was approximately 6 months, even after allowing for a 120-day GP. Median treatment duration was considerably shorter than what has been reported in clinical trials. Our results suggest that long-term HHI therapy may be difficult in a real-world setting.

scholarly journals PERsistent Sitagliptin treatment & Outcomes (PERS&O 2.0) study, long-term results: a real-world observation on DPP4-inhibitor effectiveness

2020 ◽  
Vol 8 (1) ◽  
pp. e001507
Author(s):  
Antonio Carlo Bossi ◽  
Valentina De Mori ◽  
Carlotta Galeone ◽  
Davide Pietro Bertola ◽  
Margherita Gaiti ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Repeated Measures ◽  
Long Term Results ◽  
Italian Population ◽  
Drug Survival ◽  
Kaplan Meier ◽  
Significant Difference

IntroductionSitagliptin is a dipeptidyl peptidase 4 inhibitor for the treatment of type 2 diabetes (T2D). Limited real-world data on its effectiveness and safety are available from an Italian population.Research design and methodsWe evaluated long-term clinical data from the single-arm PERsistent Sitagliptin Treatment & Outcomes (PERS&O) study, which collected information on 440 patients with TD2 (275 men, 165 women; mean age 64.1 years; disease median duration: 12 years) treated with sitagliptin ‘add-on’. For each patient, we estimated the 10-year cardiovascular (CV) risk using the UK Prospective Diabetes Study (UKPDS) Risk Engine (RE). Drug survival was evaluated using Kaplan-Meier survival curves; repeated measures mixed effects models were used to evaluate the evolution of glycated hemoglobin (HbA1c) and CV risk during sitagliptin treatment.ResultsAt baseline, most patients were overweight or obese (median body mass index (BMI) (kg/m2) 30.2); median HbA1c was 8.4%; median fasting plasma glucose: 172 mg/dL; median UKPDS RE score: 24.8%, being higher in men (median 30.2%) than in women (median 17.0%) as expected. Median follow-up from starting sitagliptin treatment was 5.6 years. From Kaplan-Meier curves, the estimated median drug survival was 32.8 months when considering discontinuation for any cause and 58.4 months when considering discontinuation for loss of efficacy. A significant improvement in HbA1c was evident during treatment with sitagliptin (p<0.01): the reduction was rapid (median HbA1c after 4–6 months: 7.5%) and continued at longer follow-up. When comparing patients treated with sitagliptin versus those stopping sitagliptin and switching to another antihyperglycemic drug, we detected a significant difference in the evolution of HbA1c in favor of patients who continued sitagliptin treatment. The UKPDS RE score at 10 years and the BMI significantly improved during treatment with sitagliptin (p<0.001). Adverse events were relatively uncommon.ConclusionPatients with T2D treated with sitagliptin achieved an improvement in metabolic control and a reduction in CV risk and did not experience relevant adverse events.

Real-world analysis of treatment patterns and persistence of octreotide LAR and other agents in patients with advanced gastrointestinal neuroendocrine tumors (GI NET): A multicenter study.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 424-424
Author(s):  
Matthew H. Kulke ◽  
Al Bowen Benson ◽  
A. Dasari ◽  
Lynn Huynh ◽  
Beilei Cai ◽  
...  
Keyword(s):  
Real World ◽  
Somatostatin Analogs ◽  
Retrospective Chart Review ◽  
Treatment Patterns ◽  
Treatment Modalities ◽  
Second Line ◽  
First Line ◽  
Primary Tumor Site ◽  
First Line Therapy

424 Background: Limited data are available to document recent treatment paradigms that span NET disease course. This study aims to report long-term, real-world treatment patterns of advanced GI NET patients (pts) based on data from four tertiary cancer centers (Dana-Farber, MD Anderson, UCSF and Northwestern). Methods: Retrospective chart review was conducted in pts diagnosed with advanced, well differentiated GI NET at age ≥18 years and treated with somatostatin analogs (SSAs), targeted therapy (TT), cytotoxic chemotherapy (CC), peptide receptor radiotherapy, liver-directed therapy (LDT) or interferon from 7/2011-12/2014. Eligible pts were followed from advanced NET diagnosis date (earliest recorded diagnosis: 3/1987) to end of follow-up/death (latest recorded date: 5/2017). Analyses of treatment and dosing patterns were performed and persistence of therapy was estimated using Kaplan-Meir analysis. Results: 273 pts were included with mean age of 59 years at advanced NET diagnosis; 64% had functional NET; 57% had ileum as primary tumor site; and 63% had carcinoid syndrome (CS). Most common CS symptoms were diarrhea (87%) and flushing (73%). Majority of pts received octreotide alone (88%) or in combination (2%) with LDT, TT or CC as first-line. Of the 161 pts on second-line, 88% received octreotide alone or in combination; 5 pts (3%) received lanreotide. Most common dose at initiation for octreotide was 30mg/4 weeks (51%) and 20mg/4 weeks (32%); 68% of pts never received > 30mg/4 weeks over the entire treatment course. Median time to treatment discontinuation was 145 months (mos) for octreotide (functional NET: 145; non-functional NET: 117), 13 mos for TT and 6 mos for CC. Conclusions: This study showed that octreotide is the mainstay of treatment for advanced GI NET, as 90% of pts received octreotide alone or in combination with other treatment modalities agents as first-line therapy. 74% continued octreotide alone or in combination with other treatment modalities in the second-line. Most commonly prescribed dose was 30 mg/4 weeks. Pts remained on octreotide long term, with median treatment duration of 12 years.

Treatment patterns and outcomes for metastatic castration-resistant prostate cancer (mCRPC) in a real-world setting: A retrospective study of greater than 2500 patients.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 256-256 ◽  
Author(s):  
Celestia S. Higano ◽  
Cora N. Sternberg ◽  
Fred Saad ◽  
Bertrand F. TOMBAL ◽  
Kurt Miller ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Descriptive Analysis ◽  
Treatment Patterns ◽  
Cross Resistance ◽  
Combination Regimen ◽  
Castration Resistant Prostate Cancer ◽  
Kaplan Meier ◽  
Radium 223 ◽  
Third Line

256 Background: In the era of expanding therapeutic options for mCRPC, there is a growing need to develop an optimal treatment sequence. This real-world study evaluated treatment patterns and outcomes in mCRPC patients. Methods: This retrospective cohort study used the Flatiron prostate cancer core registry (Jan 2013 to Sep 2017) to assess real-world treatment patterns (lines of therapy and transitions to subsequent lines) and outcomes (overall survival, OS) in patients with mCRPC. Descriptive analysis was performed for treatment patterns, and the Kaplan–Meier method was used to analyze OS. Results: This study comprised 2559 patients with mCRPC who received up to three lines of therapy. 23% of patients did not receive a life-prolonging therapy after the initial diagnosis of mCRPC. In the first-line (1L) setting, abiraterone (Abi, 37%) was the most-prescribed therapy, followed by enzalutamide (Enza, 28%) and docetaxel (15%). In the second line (2L), combination therapies were frequent (17%), with rates similar to taxane-based chemotherapy (docetaxel or cabazitaxel). Enza was the most-common 2L therapy used after Abi, and vice versa. Radium-223 (Ra-223) was prescribed as 1L therapy in 5% and 2L therapy in 9% of patients, either as monotherapy or part of a combination regimen. When Ra-223 was used in the 1L setting, similar proportions of patients received subsequent therapy with Enza (14%), Abi (13%), or chemotherapy (11%). Ra-223 was commonly used in the third line (14%), but less frequently than chemotherapy (36%). After each line, ~50% of patients did not receive a subsequent life-prolonging agent. Overall, 66% of patients used bone health agents at any time (denosumab, 48%; zoledronic acid, 24%). The median OS from the diagnosis of mCRPC was 21 months. Conclusions: This real-world study shows that not all patients with mCRPC received a life-prolonging therapy. Among patients who received an anti-cancer therapy, approximately half did not receive a subsequent life-prolonging therapy. Abi and Enza were the most-common 1L therapies, and their back-to-back use was common despite reported cross-resistance and limited benefit.

scholarly journals Treatment patterns and effectiveness of patients with multiple myeloma initiating Daratumumab across different lines of therapy: a real-world chart review study

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Shebli ATRASH ◽  
Philippe THOMPSON-LEDUC ◽  
Ming-Hui TAI ◽  
Shuchita KAILA ◽  
Kathleen GRAY ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Clinical Outcomes ◽  
Real World ◽  
Chart Review ◽  
Response Rate ◽  
Progression Free Survival ◽  
Treatment Patterns ◽  
Free Survival ◽  
Kaplan Meier ◽  
Line Of Therapy

Abstract Background Daratumumab, a CD38 monoclonal antibody, has demonstrated efficacy as monotherapy and combination therapy across several indications, both among newly-diagnosed and refractory patients with multiple myeloma (MM). However, there is limited evidence on treatment patterns and effectiveness of daratumumab in the real-world setting, particularly in first line (1 L). This study aimed to describe real-world treatment patterns and clinical outcomes among patients initiating daratumumab across different lines of therapy. Methods A retrospective chart review of adult patients with MM initiating daratumumab between November 2015 and March 2021 was conducted at two clinical sites in the United States. De-identified patient-level data were abstracted in an electronic case report form. Patient characteristics and treatment patterns were described. Clinical outcomes including overall response rate (ORR), progression-free survival, and time to next line of therapy were reported using descriptive statistics and stratified by line of therapy (1 L, second line [2 L] or third line or later [3 L+]). A sub-group analysis evaluated treatment patterns and ORR among patients re-treated with daratumumab. Results A total of 299 patients were included in the study (mean age: 68 years; 55% male). Among them, 26 were 1 L patients, 66 were 2 L patients, and 207 were 3 L+ patients; 110 patients (36.8%) received a stem cell transplant prior to daratumumab initiation. The mean duration of follow-up was 10 months among 1 L patients and 19 months among 2 L and 3 L+ patients. Patients who initiated daratumumab in 1 L had a 100% ORR, while those initiating in 2 L and 3 L+ had an ORR of 78.8 and 65.2%, respectively. Among re-treated patients, ORR was 66.7% during the first treatment segment, and 52.9% during the second treatment segment. Kaplan-Meier rates of progression-free survival at 12 months were 89.9, 75.2, and 53.1% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Kaplan-Meier rates of time to next line of therapy at 12 months were 94.1, 73.4, and 50.0% among patients who initiated daratumumab in 1 L, 2 L, and 3 L+, respectively. Conclusions These findings suggest that daratumumab-based regimens are an effective treatment option across all lines of therapy, with highest response rate in 1 L.

scholarly journals Comparable Overall Survival with Rituximab-Bendamustine (R-Benda) and Rituximab-Gemcitabine-Oxaliplatin (R-GemOx) When Used As Second-Line (2L) Treatment for Diffuse Large B-Cell Lymphoma (DLBCL): A Real-World Study Using US Veterans Health Administration Data

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1711-1711 ◽  
Author(s):  
Raluca Ionescu-Ittu ◽  
Aijing Shang ◽  
Nancy Vander Velde ◽  
Annie Guérin ◽  
Yilu Lin ◽  
...  
Keyword(s):  
Real World ◽  
Research Funding ◽  
Veterans Health Administration ◽  
Treatment Patterns ◽  
Veterans Health ◽  
Health Administration ◽  
Real World Data ◽  
Analysis Group ◽  
Kaplan Meier

Abstract Introduction: DLBCL is the most common subtype of non-Hodgkin lymphoma. R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) is established as the standard of care for patients (pts) with previously untreated DLBCL, but ~40% of pts will eventually relapse. For relapsed/refractory pts who are ineligible for transplant, clinical guidelines propose a broad spectrum of therapeutic options. However, little is known about treatment patterns and outcomes associated with 2L therapy in routine practice, particularly for pts less suitable for intensive therapy. Therefore, using real-world data, we evaluated 2L treatment patterns in DLBCL pts and overall survival (OS) in those pts who received 2L R-Benda or R-GemOx. We focused on these 2 treatments as they are typically used in the non-transplant setting in pts less suitable for aggressive therapy, and can typically be administered in an outpatient setting. Methods: DLBCL pts receiving care from the US Veterans Health Administration were identified through their electronic medical records and raw oncology domain. Pts diagnosed with DLBCL (and no prior other types of malignancies) between 2004-2016, with ≥1-month follow-up and who received 2L treatment were included. OS (defined as time from the start of 2L therapy until death) was analyzed in pts who received 2L R-Benda or R-GemOx using the Kaplan-Meier method. Surviving pts were censored at data cutoff (December 31, 2017). Univariate and multivariate Cox regression analyses were undertaken to assess the impact of 2L treatment (in particular, R-GemOx vs R-Benda) on OS. Results: A total of 2600 DLBCL pts were identified: 2039 received 1L and 702 received 1L and 2L therapy. Among the 702 pts treated with 2L therapy, regimens included R-ICE (n=77; 11.0%), R-CHOP (n=75; 10.7%), rituximab monotherapy (n=34; 4.8%), R-Benda (n=32; 4.6%), methotrexate (n=24; 3.4%), R-ESHAP (n=23; 3.3%), R-DHAP/R-EPOCH/R-GDP (n=18; 2.6%), rituximab plus cyclophosphamide-doxorubicin-vinblastine-vincristine (n=14; 2.0%), R-CVP (n=11; 1.6%), rituximab plus cyclophosphamide-etoposide-vincristine (n=11; 1.6%), and R-GemOx (n=10; 1.4%). Of the remaining pts, 267 (38.0%) received regimens with agent(s) included in the NCCN guidelines, while 106 (15.1%) received regimens with at least 1 agent not guideline-recommended. Baseline characteristics for pts treated with 2L R-Benda (n=32) or R-GemOx (n=10) are shown in Table 1. There was an imbalance between the 2 cohorts with regard to race, number of involved lymph nodes, B symptoms, Charlson Comorbidity Index score, and abnormal lactate dehydrogenase results. After 24 deaths in the R-Benda cohort and 7 deaths in the R-GemOx cohort, median OS was estimated at 11 and 13 months, respectively (Figure 1). Median follow-up time after start of 2L treatment was 11.3 and 11.7 months, respectively. The Kaplan-Meier curves of the 2 cohorts overlapped at multiple timepoints during follow-up. Respective 1-year OS rates (95% confidence interval [CI]) with R-Benda and R-GemOx were 50.0% (31.9%, 65.7%) and 60.0% (25.3%, 82.7%). Compared with R-Benda, R-GemOx did not significantly predict longer OS in either the univariate (hazard ratio [HR]: 0.94; 95% CI: 0.41, 2.19; p=0.893) or multivariate (HR: 1.07; 95% CI: 0.46, 2.50; p=0.873) analyses. Conclusions: This real-world study highlights the diversity of 2L treatment regimens used in DLBCL pts. There was no apparent difference in OS between R-Benda- and R-GemOx-treated pts and, with a median OS of approximately 1 year after 2L initiation with either regimen, there is clearly an unmet need in this setting. The main limitation of the study relates to the small sample size of each treatment cohort. Further research using other real-world data sources is warranted. Disclosures Ionescu-Ittu: Analysis Group, Inc.: Employment; F. Hoffman-La Roche Ltd: Consultancy, Other: I am an employee of Analysis Group, Inc., which received consulting fees from Roche for the conduct of this study. Shang:F. Hoffmann-La Roche Ltd.: Employment, Other: Ownership interests non-PLC. Guérin:F. Hoffman-La Roche Ltd: Other: I am an employee of Analysis Group, Inc., which received consulting fees from Roche for the conduct of this study; Analysis Group, Inc.: Employment. Shi:F. Hoffman-La Roche Ltd: Research Funding; Bravo4Health: Other: Ownership interests non-PLC; Genentech: Research Funding; Chiasma: Research Funding; Intuitive Surgical: Consultancy. Shi:F. Hoffman-La Roche Ltd: Other: I am an employee of Analysis Group, Inc., which received consulting fees from Roche for the conduct of this study; Analysis Group, Inc.: Employment. Qayum:F. Hoffmann-La Roche Ltd: Employment.

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