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.

scholarly journals Real-World Treatment Patterns and Outcomes Among Patients with Hairy Cell Leukemia

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2125-2125
Author(s):  
Sudeep Karve ◽  
Victoria Divino ◽  
Andrew Gaughan ◽  
Mitch DeKoven ◽  
Guozhi Gao ◽  
...  
Keyword(s):  
Health Plan ◽  
Real World ◽  
Index Date ◽  
Treatment Patterns ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
First Line Therapy ◽  
Line Therapy

Abstract Background and Objective : Hairy cell leukemia (HCL) is a rare condition and accounts for ~2% of all leukemia cases in the US. NCCN guidelines recommend first-line agents including pentostatin and cladribine among patients with HCL. However, a paucity of data exists with regard to real-world treatment patterns among patients with HCL. Current study evaluates treatment patterns and associated clinical outcomes among patients with HCL using a large US administrative claims database. Methods : This retrospective observational study was conducted using the IMS Health PharMetrics Plus Health Plan Claims Database (2006-2014), which includes over 150 million unique health plan members across the US and is nationally representative of the commercially-insured US population. Data includes date stamped medical and pharmacy records along with information on health plan enrollment. Individuals with at least 2 medical claims with a diagnosis for HCL (identified using ICD-9-CM cod: 202.4x) were selected and the first observed claim defined the "index date." Patients <18 years of age at index date or with other malignancies during 6 months (the "pre-index period") prior to index date were excluded. Patients were required at least 90 days of continuous enrollment (the variable "follow-up period") in the health plan post index date with exception of patients who died within 3 months of diagnosis. Patients were followed until death (recorded on inpatient discharge disposition), end of enrollment or end of database, whichever occurred earlier. Study measures including patient demographic and baseline clinical characteristics, line of therapy (LOT), treatment patterns, relapse (receipt of same or new regimen in subsequent LOT following a gap of 365 days) and refractory disease (receipt of same or new regimen where the gap of two adjacent LOTs was <365 days) and post-treatment complications were assessed during the follow-up period. All analyses were descriptive in nature. Results : The study cohort included 749 patients after applying the selection criteria (mean follow-up from diagnosis 32 months). At diagnosis, the mean age (standard deviation) of the study cohort was 56 (10) years and majority of patients were male (77%). Mean baseline comorbidity burden (assessed using Charlson Comorbidity Index score) was 0.8 (1.1) with hypertension (24%) and aplastic anemia (22%) being the two most common co-morbidities. Only 38% (n=282) of patients received first-line chemotherapy post diagnosis. Majority initiated first-line cladribine (76%) as a single agent, while 9% had evidence of single agent pentostatin. Mean time to initiation of first-line therapy from diagnosis was 132 (294) days and average time on first-line therapy was 34 (104) days. Among patients with first-line therapy 14% received second-line therapy and rituximab (53%) and cladribine (21%) were frequently observed second-line agents. Post first-line therapy, mean time to initiation of second-line therapy was 303 (406) days. Among second-line initiators, 76% had refractory disease and 24% had relapsed following first-line. Neutropenia and fever were frequently reported complications while on chemotherapy. Conclusion : The real-world chemotherapy utilization patterns observed in this study are consistent with the NCCN guidelines with cladribine and pentostatin being the agents of choice for first-line therapy. Following diagnosis, more than one-third of patients initiated chemotherapy and only a small proportion of these received second-line chemotherapy suggesting durable response with first-line therapy. Limited follow-up post first-line therapy may have impacted the proportion of patients initiating second-line therapy as well as categorization of refractory and relapse disease. Disclosures Karve: AstraZeneca: Employment. Divino:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gaughan:AstraZeneca: Employment. DeKoven:IMS Health: Employment, Other: IMS Health received funding from AstraZeneca for this study. Gao:MedImmune: Employment. Lanasa:MedImmune: Employment.

scholarly journals Systematic Literature Review on Global Real-World Treatment Patterns of Mantle Cell Lymphoma (MCL)

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5881-5881
Author(s):  
Keri Keri Yang ◽  
Beth Lesher ◽  
Eleanor Lucas ◽  
Tony Caver ◽  
Boxiong Tang
Keyword(s):  
Literature Review ◽  
Adverse Events ◽  
Real World ◽  
Treatment Options ◽  
Treatment Patterns ◽  
Second Line ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy ◽  
Third Line

Introduction: MCL is an aggressive type of non-Hodgkin's lymphoma, and was reported associated with early relapse and poor long-term survival. Treatment options include chemotherapy, immunotherapy, and molecular targeted therapies. As of 2019, molecular targeted therapies available in the United States indicated for the treatment of MCL include the proteasome inhibitor bortezomib, the immunomodulatory drug lenalidomide (following two previous lines of therapy), and the Burton's tyrosine kinase inhibitors (BTKIs) ibrutinib and acalabrutinib (following at least one previous line of therapy). Objective/Methods: To examine the real-world treatment patterns of patients with MCL globally, a systematic literature review was performed (2010-2019) with predefined methodology and inclusion and exclusion criteria. Embase and Medline were searched via ProQuest and the Cochrane Controlled Register of Trials (CENTRAL) via the Cochrane Library. Results: Of the 2207 publications identified, 6 publications (US, n = 4; EU, n = 2) provided information on the first-line treatment of MCL (Table). The most commonly administered first-line treatments were bendamustine-rituximab; high dose cytarabine ± rituximab; and cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) ± rituximab although differences were noted across studies. Most patients received rituximab first-line either in combination with chemotherapy (54.2%-87.5%) or as monotherapy (12.9%-28.9%); although in some studies, rituximab maintenance therapy could not be excluded. The most commonly administered second-line therapies were cytarabine, rituximab monotherapy, and ibrutinib while third-line therapies were rituximab monotherapy, ibrutinib, and temsirolimus. Nine studies provided data on the real-world treatment of MCL with the BTKI ibrutinib (EU, n = 3; US, n = 5; EU/US, n = 1; Table); no real-world studies were identified for acalabrutinib. Six studies enrolled patients only with relapsed or remitting MCL; 3 studies enrolled patients (≤7.5%) who received ibrutinib as first-line therapy. Ibrutinib second-line therapy was administered to 13%-20% of patients and third-line therapy to 21% of patients. Ibrutinib discontinuation rates in 7 studies varied from 38.7%-83.6%. Non-response, including relapse or progression (34.6%-100%), was the main cause of discontinuation, followed by toxicity/adverse events (8.1%-25.6%). Across studies, toxicity/adverse events causing ibrutinib discontinuation included atrial fibrillation, bleeding/hemorrhage, chronic obstructive pulmonary disease, diarrhea, herpes zoster, infection, leukocytosis/ lymphocytosis, lung cancer, myelodysplastic syndrome, and thrombocytopenia. Two studies provided information on ibrutinib dose reductions (16.4% of patients) and ibrutinib dose interruptions (7.8%-30.2% of patients). Treatment options administered post-ibrutinib included rituximab (52.7%), hyper-CVAD + rituximab (16.7%-25.8%), lenalidomide-based regimens (9.7%-41.5%), and bortezomib-based regimens (8.4%-34.4%). Conclusion: Our analyses showed that most patients with MCL received first-line chemoimmunotherapy, although regimens varied across studies. Approximately 13%-21% of patients received ibrutinib following first-line therapy. Most ibrutinib discontinuation was due to progression followed by toxicity/adverse events. Upon discontinuation of ibrutinib, considerable variation in treatments was seen and no standard therapy identified. Given the limitations of current therapies, there is a need for additional second- and third-line treatments for patients with MCL. Quantitative assessments of clinical endpoints from real-world studies evaluating BTKI therapies are also warranted. Disclosures Yang: BeiGene, Ltd.: Employment. Lesher:Pharmerit: Employment. Lucas:Pharmerit: Employment. Caver:BeiGene, Ltd.: Employment. Tang:BeiGene, Ltd.: Employment.

scholarly journals Real-world systemic therapy treatment patterns for squamous cell carcinoma of the head and neck in Canada

2019 ◽  
Vol 26 (2) ◽  
Author(s):  
K. Byrne ◽  
P. Hallworth ◽  
A. Abbas Tahami Monfared ◽  
A. Moshyk ◽  
J. W. Shaw
Keyword(s):  
Squamous Cell Carcinoma ◽  
Clinical Practice ◽  
Drug Treatment ◽  
Real World ◽  
Treatment Patterns ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Line Drug ◽  
First Line Treatment

Background In the present study, we examined real-world treatment patterns for squamous cell carcinoma of the head and neck (scchn) in Canada, which are largely unknown.Methods Oncologists across Canada provided data for disease history, characteristics, and treatment patterns during May–July 2016 for 6–8 consecutive patients receiving first-line or second-line drug treatment for scchn (including locally advanced and recurrent or metastatic disease).Results Information from 16 physicians for 109 patients receiving drug treatment for scchn was provided; 1 patient was excluded from the treatment-pattern analysis. Median age in the cohort was 63 years [interquartile range (iqr): 57–68 years], and 24% were current smokers, with a mean exposure of 26.2 ± 12.7 pack–years. The most common tumour site was the oropharynx (48%). Most patients (84%) received platinum-based regimens as first-line treatment (44% received cisplatin monotherapy). Use of cetuximab-based regimens as first-line treatment was limited (17%). Of 53 patients receiving second-line treatment, 87% received a first-line platinum-based regimen. Median time between first-line treatment with a platinum-based regimen and initiation of second-line treatment was 55 days (iqr: 20–146 days). The most common second-line regimen was cetuximab monotherapy (43%); platinum-based regimens were markedly infrequent (13%).Conclusions Our analysis provides real-world insight into scchn clinical practice patterns in Canada, which could inform reimbursement decision-making. High use of platinum-based regimens in first-line drug treatment was generally reflective of treatment guidelines; cetuximab use in the second-line was higher than anticipated. Additional real-world studies are needed to understand the effect of novel therapies such as immuno-oncology agents on clinical practice and outcomes, particularly for recurrent or metastatic scchn.

Value of Survival Gains In Chronic Myelogenous Leukemia

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 4736-4736
Author(s):  
Wesley Yin ◽  
John R Penrod ◽  
Ross Maclean ◽  
Jeffrey Humphrey ◽  
Erkut Bahceci ◽  
...  
Keyword(s):  
Health Economics ◽  
Real World ◽  
Social Value ◽  
Myelogenous Leukemia ◽  
Second Line ◽  
First Line ◽  
Community Based ◽  
First Line Therapy ◽  
Line Therapy ◽  
Precision Health

Abstract Abstract 4736 Background: Tyrosine Kinase Inhibitors (TKI) are the first line therapies for patients with chronic myelogenous leukemia (CML). The value of survival gains to patients associated with TKI treatment—in aggregate or relative to the cost of treatment—is unknown. Methods: Multivariate Cox proportional hazard models are used to construct real-world, community-based estimates of survival improvements in CML associated with the introduction of first-line TKI therapy, controlling for characteristics of patients which may independently affect survival. We then employ an economic framework following Becker, Philipson and Soares (2005) to calculate social value of infra-marginal improvements in survival gains due to treatment with TKIs. Finally, the value of community-based improvements in CML survival from treatment by newer TKIs used in second line is estimated by combining community-based survival data for first-line TKIs, along with clinical data on health improvements for CML patients receiving a TKI in second line. Results: Introduction of first-line TKIs in 2001 is associated with a real-world decrease in the all-cause mortality hazard rate of 0.183 (p < 0.01) for CML patients. A decrease of this magnitude is associated with an increase in life expectancy from 60 to 110 months for treated CML patients with median survival length in 2001. We estimate that patients place an annual value of $110,000 on first-line treatment with TKIs. This implies that for all patients in present and future CML cohorts, the present social value of first-line TKI therapy is $88bn. The present value of costs is estimated to be $8bn, suggesting that more than 90% of social value of TKIs in first line therapy is retained by patients. In second-line CML therapy, use of newer TKI agents is estimated to have created $47bn in social value, of which roughly 88% is retained by patients. This estimated value of the newer TKIs does not incorporate possible benefits in first-line therapy. Conclusions: In total, the TKI class in first and second-line theray has created over $135bn in social value. Approximately 90% of this value is retained by patients; approximately 10% is recouped by manufacturers. These estimates suggest that at current price levels, the vast majority of value created by new therapies in CML is appropriated by patients. In addition, since our estimates of survival community-based improvements are somewhat smaller than those contained in clinical trial estimates, this suggests the potential value of addressing real-world obstacles to efficacy, such as poor adherence. Disclosures: Yin: Precision Health Economics: Consultancy. Penrod:Bristol-Myers Squibb: Employment. Maclean:Bristol-Myers Squibb: Employment. Humphrey:Bristol-Myers Squibb: Employment. Bahceci:Bristol-Myers Squibb: Employment. Lakdawalla:Bristol-Myers Squibb: Consultancy; Precision Health Economics: Equity Ownership.

Treatment patterns of gastrointestinal neuroendocrine tumors (NET).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 387-387
Author(s):  
Michael S. Broder ◽  
Eunice Chang ◽  
Beilei Cai ◽  
Maureen Neary ◽  
Elya Papoyan ◽  
...  
Keyword(s):  
Disease Status ◽  
Somatostatin Analogues ◽  
Pharmacological Therapy ◽  
Treatment Patterns ◽  
Second Line ◽  
First Line ◽  
Nccn Guidelines ◽  
First Line Therapy ◽  
Line Therapy ◽  
New Treatments

387 Background: NET comprise a broad set of rare tumors. Almost 2/3 arise in the gastrointestinal (GI) tract. NCCN guidelines for unresectable GI NET recommend somatostatin analogues (SSA) first, however, guidelines do not recommend a particular sequence for remaining therapies. Our objective is to describe real world treatment patterns of GI NET. Methods: This retrospective study combined 2 claims databases to examine newly pharmacologically treated patients using tabular and graphical techniques. Treatments included SSA, cytotoxic chemotherapy (CC), targeted therapy (TT), interferon (IF) and combinations. Patients ≥ 18 years, with ≥ 1 inpatient or ≥ 2 outpatient claims for GI NET who received pharmacologic treatment from 7/1/09-6/30/14 were identified. A 6 month clean period prior to first treatment ensured patients were newly treated. Patients were followed until end of enrollment. Results: We identified 2,258 newly treated GI NET patients. 59.6% started first line therapy with SSA monotherapy, 33.3% CC, 3.6% TT, and 0.5% IF. The remainder received combination therapies. Mean follow up was 576 days. Mean duration of first line therapy was 361 days for all newly treated patients (449 SSA, 215 CC, 267 TT). 58.9% of patients had no subsequent pharmarcological treatment after discontinuation of first line therapy.The most common second line was combination therapy with SSA (i.e., CC or TT added). In patients who did not begin with SSA, most received SSA as second line. In graphical pattern analysis, there was no clear pattern visible after first line therapy. Conclusions: More than 1/2 of pharmacologically treated patients began treatment with SSA and 1/3 with CC, with duration of use > 1 year and just over 6 months, respectively. We found treatment patterns after first line were unclear, and more than 1/2 of patients had no subsequent pharmacological treatments after discontinuing first line therapy. It is unclear whether there is underutilization of the pharmacological therapy or this is due to stable disease status after alternative non-pharmacological treatment. Future studies directed at understanding treatment patterns using patient medical records are warranted. As new treatments emerge, reassessment of treatment patterns may be needed.

Patterns of pharmaceutical therapy in advanced melanoma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20014-e20014 ◽  
Author(s):  
Aikaterini Bilitou ◽  
Zhongyun Zhao ◽  
Beth L. Barber ◽  
Genevieve Sian Clapton ◽  
Deborah Saltman
Keyword(s):  
Braf Mutation ◽  
Standard Of Care ◽  
Advanced Melanoma ◽  
Treatment Modalities ◽  
Second Line ◽  
Wild Type ◽  
First Line ◽  
Pharmaceutical Therapy ◽  
First Line Therapy ◽  
Line Therapy

e20014 Background: Since 2011, two therapies that provide novel approaches to the treatment of advanced (unresectable or metastatic) melanoma have been introduced to the market: ipilimumab for second line and vemurafenib for BRAF mutation-positive melanoma. It is not known how the new drugs influence treatment; this study investigated current treatment patterns in advanced melanoma. Methods: A clinician-validated, web-based survey was administered between August and November 2012 to clinicians who treat advanced melanoma in France, Germany, Italy, Spain, and the UK. Respondents were asked about their treatment of patients in the previous 12 months, including treatment modalities and pharmaceutical therapies used, and factors that affect treatment choice. Results: 150 oncologists and dermatologists completed the survey, 30 in each country. Pharmaceutical therapy was more commonly used than other treatment modalities and varied by stage of disease. A high proportion of patients with late stage of disease were treated with pharmaceutical therapy in Germany (85% in M1B) and France (83% in M1C). Among the countries, 51% (Italy) to 87% (France) of respondents test BRAF mutation status. In patients with wild-type BRAF tumors, dacarbazine, which has not been shown to provide any overall survival benefit, was the most commonly used drug for first-line therapy in all countries. In mutated BRAF tumors, vemurafenib was the most commonly used drug in first line therapy in 3 of 5 countries. There was no standard of care in second line for either patients with wild-type or mutated-BRAFtumors; therapies used included fotemustine, temozolomide, interferon, paclitaxel, and ipilimumab. Conclusions: Treatment options for patients with advanced melanoma are limited, particularly for patients with wild-type BRAF disease. In second line, there does not appear to be an established standard of care: a range of treatments are used, including several not indicated for melanoma.

scholarly journals Treatment patterns and overall survival in metastatic non-small-cell lung cancer in a real-world, US setting

2019 ◽  
Vol 15 (30) ◽  
pp. 3491-3502 ◽  
Author(s):  
Jason C Simeone ◽  
Beth L Nordstrom ◽  
Ketan Patel ◽  
Alyssa B Klein
Keyword(s):  
Lung Cancer ◽  
Treatment Patterns ◽  
Small Cell ◽  
Second Line ◽  
Small Cell Lung ◽  
First Line ◽  
Metastatic Nsclc ◽  
First Line Therapy ◽  
Line Therapy ◽  
Third Line

Aim: To conduct a retrospective analysis of electronic medical record data to understand real-world treatment patterns and overall survival (OS) in patients with metastatic non-small-cell lung cancer (NSCLC). Materials & methods: We included n = 9656 adults (≥18 years) with metastatic NSCLC and no prior therapy. Data from 1 January 2013 to 31 January 2017 were analyzed. Results: Carboplatin plus paclitaxel was the most common first-line therapy (18.6%), and nivolumab was the most common second- (31.0%) and third-line (38.4%) therapy; 26.7% of all patients were untreated. Median OS from initial metastatic diagnosis was 11.1 months (95% CI: 10.8–11.5). Second-line immunotherapy extended OS by over 3 months versus second-line chemotherapy. Conclusion: Platinum-based therapy was the most common first-line therapy, and immunotherapy was the most common second- and third-line therapy. Median OS of patients with metastatic NSCLC was <1 year.

scholarly journals Characteristics and treatment patterns of patients with type 2 diabetes in Lebanon: the DISCOVER study

2021 ◽  
Vol 27 (5) ◽  
pp. 509-515
Author(s):  
Sami T. Azar ◽  
Akram Echtay ◽  
Mireille Amm ◽  
Hajar Ballout ◽  
Iskandar Cheaib ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Clinical Practice ◽  
Glycaemic Control ◽  
Treatment Patterns ◽  
Second Line ◽  
First Line ◽  
Second Line Therapy ◽  
First Line Therapy ◽  
Line Therapy

Background: Lebanon is part of the global DISCOVER study, a global, noninterventional, multicentre, prospective study with 3-years of follow-up. Aims: The aim of this study is to describe real-world clinical practice in terms of type 2 diabetes mellitus (T2DM) disease management and treatment patterns within Lebanon. Methods: Baseline demographic and clinical parameters were captured on a standardized case report form, according to routine clinical practice at each clinical site. Results: We recruited 348 patients. At the initiation of second-line therapy, mean duration of diabetes was 6.7 [standard deviation (SD) 6.5] years; mean HbA1c and fasting plasma glucose levels were 8.5% (SD 1.6%) and 178.7 (SD 56.5) mg/dL respectively. Almost half the patients were hypertensive (45.1%) or had dyslipidaemia (48.6%). Metformin monotherapy was used as first-line therapy in 56.9% of the patients and upfront dual therapy in 25%. The primary reason for changing first-line therapy was poor glycaemic control. The main factors in choosing the second-line therapy were efficacy, tolerability and hypoglycaemia. Conclusion: Clinical inertia was evident in this cohort of patients as they had suboptimal glycaemic control at the time of enrolment and the initiation of second-line therapy. Treatment intensification is required to reduce diabetes-related adverse outcomes.

scholarly journals Treatment patterns and clinical outcomes of chemotherapy treatment in patients with muscle-invasive or metastatic bladder cancer in the Netherlands

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Daan J. Reesink ◽  
Ewoudt M. W. van de Garde ◽  
Bas. J. M. Peters ◽  
Paul B. van der Nat ◽  
Maartje Los ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Real World ◽  
Treatment Patterns ◽  
Second Line ◽  
Chemotherapy Treatment ◽  
First Line ◽  
Real World Data ◽  
World Data ◽  
Metastatic Bladder Cancer ◽  
Muscle Invasive

Abstract This retrospective study was performed to evaluate real-world oncological outcomes of patients treated with chemo-based therapy for muscle-invasive or metastatic bladder cancer (MIBC/mBC) and compare results to data from RCTs and other cohorts. Among 1578 patients diagnosed, 470 (30%) had MIBC/mBC. Median overall survival (mOS) for RC alone (47 months), first-line (13 months) and second-line (7 months) chemotherapy, and chemotherapy for recurrent disease (8 months) were similar to literature. Treatment with neoadjuvant and induction chemotherapy (NAIC) was only utilized in 9% of patients, and often in patients with poor disease status, resulting in a lower mOS compared to literature (35 and 20 months, respectively). Patients treated with chemotherapy had many adversities to treatment, with only 50%, 13%, 18% and 7% of patients in NAIC, first-line, salvage after RC, and second-line setting completing the full pre-planned chemotherapy treatment. Real-world data shows NAIC before RC is underutilized. Adversities during chemotherapy treatment are frequent, with many patients requiring dose reduction or early treatment termination, resulting in poor treatment response. Although treatment efficacy between RCTs and real-world patients is quite similar, there are large differences in baseline characteristics and treatment patterns. Possibly, results from retrospective studies on real-world data can deliver missing evidence on efficacy of chemotherapy treatment on older and ‘unfit’ patients.

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