scholarly journals Real-World Data on Outcomes in Metastatic Castrate-Resistant Prostate Cancer Patients Treated With Abiraterone or Enzalutamide: A Regional Experience

2021 ◽  
Vol 11 ◽  
Author(s):  
Rachel Raju ◽  
Arvind Sahu ◽  
Myron Klevansky ◽  
Javier Torres
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Burden Of Disease ◽  
Eastern Cooperative Oncology Group ◽  
Response Rates ◽  
The Real ◽  
Real World Setting ◽  
Psa Response ◽  
Visceral Metastases ◽  
The Impact

BackgroundBoth abiraterone and enzalutamide have shown to improve overall survival (OS), progression-free survival (PFS) and prostate-specific antigen (PSA) response in patients with metastatic castration-resistant prostate cancer (mCRPC) regardless of previous treatment with chemotherapy (COU-AA3011, COU-AA3022, AFFIRM3 and PREVAIL4). The data regarding the impact of these treatments in the real world setting is scarce. This study assessed the real world survival and disease outcomes in mCRPC patients in a regional health service in Victoria with the use of abiraterone and enzalutamide.MethodsThis retrospective clinical audit included 75 patients with diagnosis of mCRPC treated with either abiraterone or enzalutamide between January 1, 2014, and December 31, 2019, at Goulburn Valley Health. Patients were stratified according to the drug received, Eastern Cooperative Oncology Group (ECOG) performance status, Gleason score, burden of disease at diagnosis, presence of visceral metastases and use of previous chemotherapy. The primary end point was PSA response (defined as a reduction in the PSA level from baseline by 50% or more). The secondary outcomes were PSA PFS, radiographic PFS, and OS.ResultsThirty-seven patients received enzalutamide, and the other 38 received abiraterone. Only 20% of patients in either group had visceral metastases. 32% of patients receiving enzalutamide had a high burden of disease, compared to 53% receiving abiraterone. 38% of patients in the enzalutamide group and 53% in the abiraterone group had received prior chemotherapy. PSA response rates were higher in the enzalutamide group than abiraterone group (70.3% vs 37.8%). Both PSA and radiographic PFS were longer in the enzalutamide group than abiraterone group; 7 months vs 5 months for both end points. OS was also found to be longer in patients receiving enzalutamide; 30 months compared to only 13 months in patients receiving abiraterone.ConclusionBoth abiraterone and enzalutamide have shown to result in significant PSA response rates, as well as PFS and OS benefit in mCRPC patients in the real world setting. The difference in responses and survival benefit are probably impacted by the unbalanced burden of disease.

Effect of advanced age, elevated bilirubin, and disease extent on outcomes of unresectable pancreatic cancer (UPC) patients receiving first-line chemotherapy: A population-based study.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 325-325 ◽  
Author(s):  
Hannah Marie Cherniawsky ◽  
Ying Wang ◽  
Sunita Ghosh ◽  
Winson Y. Cheung ◽  
Maria Yi Ho
Keyword(s):  
Metastatic Disease ◽  
Real World ◽  
Population Based ◽  
Advanced Age ◽  
Disease Extent ◽  
Population Based Study ◽  
The Real ◽  
Real World Setting ◽  
Elevated Bilirubin ◽  
The Impact

325 Background: Superiority of FOLFIRINOX (FFN) and nab-paclitaxel plus gemcitabine (NG) over standard gemcitabine (GEM) monotherapy for UPC was shown in the PRODIGE and MPACT trials, respectively. However, both trials either excluded or limited enrollment of patients with locally advanced disease, elevated bilirubin and advanced age. We sought to determine the impact of age, bilirubin and disease extent on treatment outcomes in the real-world setting. Methods: We identified all patients newly diagnosed with UPC who received palliative chemotherapy at any 1 of 6 British Columbia Cancer Centers and the Cross Cancer Institute in Alberta from January 2014 to April 2016. Receipt of at least one cycle of chemotherapy represented treatment with group assignment based on the initial regimen delivered. Outcomes were compared while adjusting for age, bilirubin, extent of disease, and other measured confounders. Results: A total of 292 consecutive patients were identified of whom 161 (55%) were aged > = 65 years, 164 (56%) were male, 74 (25%) had elevated bilirubin, and 205 (70%) had metastatic disease at the time of presentation. Patients who received FFN or NG had a longer median overall survival (OS) than those treated with GEM alone after adjusting for age, ECOG, bilirubin and extent of metastatic disease (11 vs 10 vs 4 months, respectively; FFN: HR 0.297, 95% CI 0.199-0.445, p < 0.0001, and NG: HR 0.338, 95% CI 0.236 – 0.485, p < 0.0001). Similarly, FFN and NG patients also had longer progression-free survival (PFS) in comparison to GEM alone (8.8 vs 6.9 vs 2.9 months, respectively; FFN: HR 0.33, 95% CI 0.22-0.499, p < 0.0001, and NG: HR 0.47, 95% CI 0.33 – 0.67, p < 0.0001). Advanced age and elevated bilirubin were not significantly associated with OS and PFS (p > 0.05). Conclusions: The efficacy of FFN and NG were superior when compared to GEM alone for patients with UPC in the real-world setting. This population-based study showed that the benefits of FFN and NG persisted regardless of advanced age and hyperbilirubinemia.

scholarly journals 602P Prevalence of castration-resistant prostate cancer (CRPC) of unknown metastatic status in the real-world setting: The AfrODiTA study

2021 ◽  
Vol 32 ◽  
pp. S646
Author(s):  
M. Rodrigo-Aliaga ◽  
J.L. Álvarez-Ossorio ◽  
A. Rodríguez-Alonso ◽  
Á. García García-Porrero ◽  
A. Quesada-García ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Castration Resistant Prostate Cancer ◽  
The Real ◽  
Castration Resistant ◽  
Real World Setting

Evaluating the impact of bone-targeted agents in the era of novel androgen targeted therapy for metastatic castration-resistant prostate cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e16500-e16500
Author(s):  
Haoran Li ◽  
Dalia Kamel ◽  
Ricardo Fernandes ◽  
Dominick Bosse ◽  
Dong Vo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Targeted Therapy ◽  
Bone Metastases ◽  
Real World ◽  
Smoking History ◽  
Castration Resistant Prostate Cancer ◽  
Psa Response ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant ◽  
The Impact

e16500 Background: Patients with metastatic castrate resistant prostate cancer (mCRPC) often develop bone metastases, resulting in a risk of symptomatic skeletal events (SSE). Bone-targeted agent (BTA) has been integrated into the overall treatment strategy, but its role in the era of novel androgen-targeted therapy (ATT) is still unclear. Methods: A retrospective analysis of real-world practice from 2010 to 2015 was conducted. Patients diagnosed with mCRPC and bone metastases who received systemic therapy (docetaxel/abiraterone/enzalutamide) with or without BTA (zoledronic acid/denosumab/alendronate) were included. Results: We obtained data from 299 patients with a median follow-up of 75.5 months. Compared with no BTA, concomitant BTA was associated with decreased incident of SSE (3.8% vs. 19.2%, p< 0.001), especially in the need for bone radiation (1.9% vs. 15.8%, p< 0.001). Compared to patients without SSE, patients with SSE were more likely to have previous fracture history (10.8% vs. 9.7%, p= 0.047), steroid use history (2.4% vs. 1.4%, p= 0.019), smoking history (53.0% vs. 38.9%, p= 0.009), diabetes (19.3% vs. 8.8%, p= 0.012) and reduced baseline mobility (9.6% vs. 4.2%, p= 0.002). Among those who received first-line novel ATT (n = 152), concurrent ATT+BTA significantly decreased the incident of SSE (2.8% vs. 27.3%, p= 0.004) and prolonged the time to SSE (24.3 vs. 3.2 mo, p< 0.001), when compared to ATT alone. But there was no difference in overall survival between two groups (134.2 vs. 138.9 mo, p= 0.99). In patients who responded to systemic treatment with PSA declining, the SSE rate (2.4% vs. 14.3%, p= 0.037) was lower and the time to SSE was longer (49.6 vs. 32.3 mo, p= 0.026) than those who did not respond. Smoking history (adjusted HR = 1.46, p= 0.013) and PSA response (adjusted HR = 0.19, p< 0.001) are independent risk factors for SSE. Conclusions: This real-world database suggests that concomitant BTA with novel ATT was associated with reducing SSEs. PSA decrease might be used as a predictive factor for those under BTA treatment. Further studies are warranted to validate the role of PSA response.

scholarly journals Management of Patients with Metastatic Castration-Sensitive Prostate Cancer in the Real-World Setting in the United States

2021 ◽  
Author(s):  
Charles J. Ryan ◽  
Xuehua Ke ◽  
Marie-Hélène Lafeuille ◽  
Hela Romdhani ◽  
Frederic Kinkead ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Real World ◽  
The United States ◽  
The Real ◽  
Real World Setting

Trends in Insulin Therapy—A1C and Age at the Time of Insulin Initiation in the Real-World Setting

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 2328-PUB
Author(s):  
RAJIV KOVIL ◽  
MANOJ S. CHAWLA ◽  
PURVI M. CHAWLA ◽  
MIKHIL C. KOTHARI ◽  
AMBARI F. SHAIKH
Keyword(s):  
Insulin Therapy ◽  
Real World ◽  
Insulin Initiation ◽  
The Real ◽  
Real World Setting

The Cost-Effectiveness of Pre-school Peanut Oral Immunotherapy in the Real World Setting

2021 ◽  
Author(s):  
Marcus Shaker ◽  
Edmond S. Chan ◽  
Jennifer LP. Protudjer ◽  
Lianne Soller ◽  
Elissa M. Abrams ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Real World ◽  
Oral Immunotherapy ◽  
The Real ◽  
Real World Setting ◽  
The Cost

PP469 From Theory To Practice: Which Value Framework Is Applied For Onco-Hematology Therapies In Italy? A 5-year Retrospective Analysis

2020 ◽  
Vol 36 (S1) ◽  
pp. 37-37
Author(s):  
Americo Cicchetti ◽  
Rossella Di Bidino ◽  
Entela Xoxi ◽  
Irene Luccarini ◽  
Alessia Brigido
Keyword(s):  
Real World ◽  
Ad Hoc ◽  
Grey Literature ◽  
National Level ◽  
Pharmaceutical Products ◽  
European Medicines Agency ◽  
The Real ◽  
R Process ◽  
The One ◽  
The Impact

IntroductionDifferent value frameworks (VFs) have been proposed in order to translate available evidence on risk-benefit profiles of new treatments into Pricing & Reimbursement (P&R) decisions. However limited evidence is available on the impact of their implementation. It's relevant to distinguish among VFs proposed by scientific societies and providers, which usually are applicable to all treatments, and VFs elaborated by regulatory agencies and health technology assessment (HTA), which focused on specific therapeutic areas. Such heterogeneity in VFs has significant implications in terms of value dimension considered and criteria adopted to define or support a price decision.MethodsA literature research was conducted to identify already proposed or adopted VF for onco-hematology treatments. Both scientific and grey literature were investigated. Then, an ad hoc data collection was conducted for multiple myeloma; breast, prostate and urothelial cancer; and Non Small Cell Lung Cancer (NSCLC) therapies. Pharmaceutical products authorized by European Medicines Agency from January 2014 till December 2019 were identified. Primary sources of data were European Public Assessment Reports and P&R decision taken by the Italian Medicines Agency (AIFA) till September 2019.ResultsThe analysis allowed to define a taxonomy to distinguish categories of VF relevant to onco-hematological treatments. We identified the “real-world” VF that emerged given past P&R decisions taken at the Italian level. Data was collected both for clinical and economical outcomes/indicators, as well as decisions taken on innovativeness of therapies. Relevant differences emerge between the real world value framework and the one that should be applied given the normative framework of the Italian Health System.ConclusionsThe value framework that emerged from the analysis addressed issues of specific aspects of onco-hematological treatments which emerged during an ad hoc analysis conducted on treatment authorized in the last 5 years. The perspective adopted to elaborate the VF was the one of an HTA agency responsible for P&R decisions at a national level. Furthermore, comparing a real-world value framework with the one based on the general criteria defined by the national legislation, our analysis allowed identification of the most critical point of the current national P&R process in terms ofsustainability of current and future therapies as advance therapies and agnostic-tumor therapies.

scholarly journals Trastuzumab-based palliative chemotherapy for HER2-positive gastric cancer: a single-center real-world data

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Tae-Hwan Kim ◽  
Hun Do Cho ◽  
Yong Won Choi ◽  
Hyun Woo Lee ◽  
Seok Yun Kang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Real World ◽  
Group Performance ◽  
Eastern Cooperative Oncology Group ◽  
Conversion Surgery ◽  
Single Center ◽  
Her2 Positive ◽  
Real World Data ◽  
World Data ◽  
The Real

Abstract Background Since the results of the ToGA trial were published, trastuzumab-based chemotherapy has been used as the standard first-line treatment for HER2-positive recurrent or primary metastatic gastric cancer (RPMGC). However, the real-world data has been rarely reported. Therefore, we investigated the outcomes of trastuzumab-based chemotherapy in a single center. Methods This study analyzed the real-world data of 47 patients with HER2-positive RPMGC treated with trastuzumab-based chemotherapy in a single institution. Results With the median follow-up duration of 18.8 months in survivors, the median overall survival (OS) and progression-free survival were 12.8 and 6.9 months, respectively, and the overall response rate was 64%. Eastern Cooperative Oncology Group performance status 2 and massive amount of ascites were independent poor prognostic factors for OS, while surgical resection before or after chemotherapy was associated with favorable OS, in multivariate analysis. In addition, 5 patients who underwent conversion surgery after chemotherapy demonstrated an encouraging median OS of 30.8 months, all with R0 resection. Conclusions Trastuzumab-based chemotherapy in patients with HER2-positive RPMGC in the real world demonstrated outcomes almost comparable to those of the ToGA trial. Moreover, conversion surgery can be actively considered in fit patients with a favorable response after trastuzumab-based chemotherapy.

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