Association of baseline characteristics and survival in patients with advanced non-small cell lung cancer (NSCLC) treated with immune checkpoint inhibitors (CPIs): Real-world evidence.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21625-e21625
Author(s):  
Danielle Crawley ◽  
Kerri Beckmann ◽  
Saranya Ravindra ◽  
Debra Hannah Josephs ◽  
James F. Spicer ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Real World ◽  
Checkpoint Inhibitors ◽  
Definitive Treatment ◽  
Real World Data ◽  
World Data ◽  
Risk Of Death ◽  
Mutational Status ◽  
Increased Risk ◽  
Baseline Characteristics

e21625 Background: CPIs including antibodies to programmed death-1 (PD-1) and its ligand anti PD-L1 are associated with superior overall survival (OS) in NSCLC. PDL1 is an imperfect predictive biomarker. We have examined real world data to identify additional factors associated with clinical benefit. Methods: 96 consecutive NSCLC patients (pts) were treated with CPIs at our institution. Multivariate cox proportional hazard regression models were used to examine the associations between OS and baseline characteristics including age, sex, histology, PDL1 status, performance status (PS), steroid use and brain metastases. Results: 93% (89/96) of pts received pembroluzimab, 6 (6%) nivolumab, and 1 (1%) atezoluzimab. All pts had metastatic disease (68% adenocarcinoma). 15% had PS 0, and 70% PS1. 11 of the 96 pts had brain metastases prior to CPI, 4 (37%) had whole brain radiotherapy, 2 (18%) targeted radiotherapy, 2 (18%) resection with radiotherapy and 3 (27%) had no definitive treatment for brain metastases. After multivariate analysis those with PS 1-2 had an increased risk of death (PS = 1 HR 2.74, 95% CI 1.11-6.72; PS = 2 3.61, 95% CI 1.28-10.15) compared with PS 0. Outcomes for pts receiving corticosteroids at the time of initiation of CPI were also inferior (HR 2.29, 95% CI 1.10-4.74) compared to those who were not. Conversely those who had brain metastasis diagnosed prior to commencing CPI had superior OS (HR 0.29 95% CI: 0.11-0.76). No statistically significant association was seen with age, gender, histology, stage at diagnosis, smoking or mutational status. PDL < 50% compared to > 50% was associated with an increased risk of death (HR 1.53 95% CI: 0.90-2.60) though it was not statistically significant. Conclusions: Here we show, using real world data, that PS and use at baseline of oral corticosteroids are associated with inferior OS with CPI treatment for NSCLC, in line with reports from large clinical trials. We show that baseline brain metastases are associated with improved outcomes. This may be explained by survivor bias, in that those who are successfully treated for brain disease, remain PS ≤2 and are able to commence CPI represent a highly selected group.

scholarly journals Real-world data analyses unveiled the immune-related adverse effects of immune checkpoint inhibitors across cancer types

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Feicheng Wang ◽  
Shihao Yang ◽  
Nathan Palmer ◽  
Kathe Fox ◽  
Isaac S. Kohane ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Real World Data ◽  
World Data ◽  
Data Analyses ◽  
Increased Risk ◽  
Cancer Types

AbstractImmune checkpoint inhibitors have demonstrated significant survival benefits in treating many types of cancers. However, their immune-related adverse events (irAEs) have not been systematically evaluated across cancer types in large-scale real-world populations. To address this gap, we conducted real-world data analyses using nationwide insurance claims data with 85.97 million enrollees across 8 years. We identified a significantly increased risk of developing irAEs among patients receiving immunotherapy agents in all seven cancer types commonly treated with immune checkpoint inhibitors. By six months after treatment initialization, those receiving immunotherapy were 1.50–4.00 times (95% CI, lower bound from 1.15 to 2.16, upper bound from 1.69 to 20.36) more likely to develop irAEs in the first 6 months of treatment, compared to matched chemotherapy or targeted therapy groups, with a total of 92,858 patients. The risk of developing irAEs among patients using nivolumab is higher compared to those using pembrolizumab. These results confirmed the need for clinicians to assess irAEs among cancer patients undergoing immunotherapy as part of management. Our methods are extensible to characterizing the effectiveness and adverse effects of novel treatments in large populations in an efficient and economical fashion.

scholarly journals A real‐world data of Immune checkpoint inhibitors in solid tumors from India

2021 ◽  
Author(s):  
Vanita Noronha ◽  
George Abraham ◽  
Vijay Patil ◽  
Amit Joshi ◽  
Nandini Menon ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Real World Data ◽  
World Data

284 Real World Data of Sequencing Immune Checkpoint Inhibitors (ICI) after Initial ICI

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A310-A310
Author(s):  
Krishna Gunturu ◽  
Muhammad Awidi ◽  
Rojer Ranjit ◽  
Brendan Connell ◽  
Rachel Carrasquillo ◽  
...  
Keyword(s):  
Cell Death ◽  
Programmed Cell Death ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Medical Center ◽  
Clear Understanding ◽  
Real World Data ◽  
World Data

BackgroundICI revolutionized modern Oncology landscape and being utilized in metastatic to adjuvant and neo-adjuvant settings. As Oncologists, we are treating cancer patients with ICI every day, yet there is still a lot that is unknown about these drugs. We don’t have clear understanding of the efficacy and toxicity when sequencing one ICI for another. We conducted a retrospective review of real world data at Lahey Hospital and Medical Center to understand further and to pave path for prospective studies to understand this issue further to improve patient care.MethodsWe retrospectively reviewed Oncology patient charts who received ICI between January1, 2014 to December 18, 2018. Total 483 patients received ICI during this time frame and 22 of these patients received a second ICI either as monotherapy or in combination with other ICI or chemotherapy.ResultsA total of 22 patients received subsequent ICI after the initial ICI as showed in table 1. 15 of the 22 (68%) patients were transitioned from one ICI to another monotherapy. 11 of these patients were transitioned secondary to disease progression (73%), three had immune related adverse events and one was switched per standard of care. One patient had ICI re-challenge. Three patients had a transition from ICI monotherapy to combination ICI therapy. One patient went onto chemo-immunotherapy and 2 patients transitioned from combination ICI to chemo-immunotherapy.Abstract 284 Table 1Real world data of sequencing immune checkpoint inhibitors (ICI) after initial ICIConclusionsICI therapy is evolving and patients are being treated with multiple lines of ICI. In current practices, ICI is frequently being transitioned from cytotoxic T-lymphocyte antigen 4 (CTLA-4) and programmed cell death 1 (PD-1) or its ligand, programmed cell death ligand 1 (PD-L1) classes or combined with chemotherapy or targeted therapy. It would be prudent to explore the effects of sequencing these medications either as a monotherapy or in combination with other therapies to better serve our patients and to prevent financial toxicity.

scholarly journals Brain metastases in primary ovarian cancer: Real-world data

2018 ◽  
Vol 29 ◽  
pp. viii338 ◽  
Author(s):  
E. Ratner ◽  
M. Bala ◽  
M. Louie-Gao ◽  
S. Hazard ◽  
P. Brastianos
Keyword(s):  
Ovarian Cancer ◽  
Brain Metastases ◽  
Real World ◽  
Real World Data ◽  
World Data ◽  
Primary Ovarian Cancer

Temozolomide Alone or Combined with Capecitabine for the Treatment of Metastatic Neuroendocrine Neoplasia: a “Real World” data analysis

2020 ◽  
Author(s):  
Alberto Bongiovanni ◽  
Chiara Liverani ◽  
Flavia Foca ◽  
Valentina Fausti ◽  
Giandomenico Di Menna ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Real World ◽  
Cox Regression ◽  
Propensity Score Analysis ◽  
Objective Response ◽  
Response To Therapy ◽  
Real World Data ◽  
World Data ◽  
Risk Of Death ◽  
Neuroendocrine Neoplasia

Background: Neuroendocrine neoplasia (NEN) are a rare group of tumors with different prognosis and response to therapy. Their heterogeneity is dependent on the site of origin, morphology and Ki67. Temozolomide (TEM) appears to be active in metastatic NENs (mNENs) but there is limited evidence about its efficacy in gastrointestinal NENs. We analyzed “real-world” data on the use of TEM alone or in association with capecitabine (CAPTEM) in patients with mNENs. Patients and Methods: One hundred consecutive patients with advanced NENs treated with TEM or CAPTEM between 2009 and 2019 were included. A pre-treatment tumor growth rate (TGR0) was calculated. Overall survival (OS), progression-free survival (PFS), tolerance, objective response rate (ORR) and disease control rate (DCR) were analyzed. A propensity score analysis and inverse probability of treatment weights for Cox-regression models were used. Results: TEM-based therapy was administered to 95 patients (26.3% CAPTEM and 83.7% TEM) with a median age of 59 years (range 26-85) years. ECOG performance status was 0-2. Carcinoid syndrome was reported in 12 (12.6%) patients. Twenty (21.1%) patients with grade (G) 3 neuroendocrine carcinoma (NEC) and 9 (9.4%) with G3 neuroendocrine tumors (NET) were included in the analysis. Median PFS of the entire group was 10.4 months (95% confidence interval (CI):6.0-11.5). In multivariate analysis, a higher risk of progression was observed for NEC G3 patients (hazard ratio (HR) 2.70, 95%CI:1.25-5.84) and for a TGR ≥19.55 (HR:2.53, 95%CI:1.45-4.40). Median OS was 23.4 months (95%CI: 17.0-29.0) and was similar in both treatment groups (23.9 vs. 20.5 months for TEM and CAPTEM, respectively, p =0.585). In multivariate analysis, TGR ≥19.55 was associated with a higher risk of death (HR:2.18, 95%CI:1.16-4.11) than TGR<19.55, as was NEC G3 (HR: 2.42, 95%CI:1.04-5.59) with respect to NETs. No differences in terms of mPFS or mOS were seen in relation to the primary site of disease. In the 86 patients evaluable for response, ORR was 44.1% and the DCR was 70.9%. Mild adverse events (grade I-II) included anemia, neutropenia and headache. Rare cases of grade 3 neutropenia and thrombocytopenia were recorded. Conclusions: TEM-based regimens are associated with a high DCR and a relatively tolerable toxicity profile in NEN of pancreatic, intestinal and lung origin. Further investigation of these specific NETs is warranted in prospective clinical trials.

scholarly journals Real world data in the era of Immune Checkpoint Inhibitors (ICIs): Increasing evidence and future applications in lung cancer

2020 ◽  
Vol 87 ◽  
pp. 102031 ◽  
Author(s):  
Giulia Pasello ◽  
Alberto Pavan ◽  
Ilaria Attili ◽  
Alberto Bortolami ◽  
Laura Bonanno ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Real World Data ◽  
World Data

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.

Sign in / Sign up

Export Citation Format

Share Document