scholarly journals Immunotherapy in Nonendemic Nasopharyngeal Carcinoma: Real-World Data from Two Nonendemic Regions

Cells ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. 32
Author(s):  
Panagiota Economopoulou ◽  
Anastasios Pantazopoulos ◽  
Aris Spathis ◽  
Ioannis Kotsantis ◽  
Anastasios Kyriazoglou ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Real World ◽  
Complex Disease ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Complete Response ◽  
Lower Probability ◽  
Real World Data ◽  
World Data ◽  
Ebv Dna

Background: nasopharyngeal carcinoma (NPC) is a complex disease entity that mainly predominates in endemic regions. Real-world data with immunotherapy from nonendemic regions are limited. Methods: we collected data from patients with recurrent/metastatic (R/M) NPC treated at a center in Greece and 8 centers in Italy. Between 2016 and 2021, 46 patients who were treated with at least one cycle of immune checkpoint inhibitors (ICI) were identified. Herein, we present our results and a review of the literature. Results: assessment of response was available in 42 patients. Overall, 11 patients responded to immunotherapy (Overall Response Rate-ORR 26.2%). Three patients had complete response (CR), and 8 patients had partial response (PR). Disease control rate (DCR) was 61.9%. Median Progression Free Survival (PFS) was 5.6 months and median Overall Survival (OS) was 19.1 months. Responders to ICI improved PFS and OS as compared to that of nonresponders. A lower probability of responding to ICI was shown in patients with more than three metastatic sites (p = 0.073), metastatic disease at initial diagnosis, (p = 0.039) or EBV DNA positive before ICI initiation, (p = 0.074). Decline in EBV DNA levels was found to be statistically significant associated with best response to ICI (p = 0.049). Safety was manageable. Conclusions: among 46 patients with R/M NPC treated with immunotherapy in two nonendemic regions, ORR was 26.2% and durable responses were observed. Low disease burden could serve as a biomarker for response to ICI.

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 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

Retrospective study to assess the efficacy and safety of checkpoint inhibitors in advanced urothelial carcinoma in real-world setting.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17043-e17043
Author(s):  
Elena Sevillano Fernandez ◽  
Javier Puente ◽  
Natalia Vidal ◽  
Alvaro Pinto ◽  
Lourdes Garcia Sanchez ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Urothelial Carcinoma ◽  
Real World ◽  
Checkpoint Inhibitors ◽  
Progression Free Survival ◽  
Complete Response ◽  
Molecular Study ◽  
Collaborative Group ◽  
First Line ◽  
Advanced Urothelial Carcinoma

e17043 Background: Checkpoint Inhibitors (CPI) have become a new standard of treatment in advanced urothelial carcinoma. However, little is known regarding the outcome of patients in daily practice.We aimed to assess tumor response and toxicity of CPIs in a cohort of patients treated in “real world” conditions. In parallel, a comprehensive molecular study in tumor samples from these patients, is ongoing. Methods: We designed an observational retrospective study within the “Grupo Centro” collaborative group. Adult patients diagnosed of metastasic urothelial carcinoma (mUC) and treated with CPIs between 2011-2019 in any of the 20 centers of the group, were eligible. Results: Up to date 100 patients have been included (82% males) with a median age of 74 years (48 -96). In 82% patients primary was bladder cancer. Most common metastasic sites were bone (26%) and liver (16%).With a median follow up of 10,6 months(mo) median progression free survival (mPFS) was 6,6mo (1,4-95,4 range) and median Overall Survival (mOS) was 21.3mo (3,8-121,8). 38% of patients received CPIs in first line(L): atezolizumab:27, pembrolizumab: 10, nivolumab:1. The median number of cycles was 8,2. Up to 51% received platinum-based combinations in first line. 69% (69/100) pts received 2L treatment: 68% with CPIs, 27,5% with chemotherapy and 4% with FGFR inhibitors (as part of a clinical trial). 2L mPFS was 3,5 mo (1,9-25.9). 23% (23/100) patients received 3L, of them 26% (6/23) were treated with CPIs. 3L mPFS:8,3mo(0,4-43,8). As a whole, patients treated with CPI accross different lines, achieved complete response in 8% of the cases, partial response in 18% and stable disease in 15%. Up to 44% of cases presented progressive disease as best response and evaluation was not available in 15%. Most common G1-2 AEs related to immunotherapy were: asthenia:31%,pruritus:16% and anorexia: 9%.10% pts experienced G3-4 toxicity: asthenia G3: 4, diarrhea G3: 1, erythrodysesthesia G3:1, arthromyalgia G3: 1, cardiac arrest G4:1,pneumonitis G4:1,anemia G3:1. Conclusions: This study confirms the efficacy and security of CPIs in real world. Response rates and toxicity profile were comparable to those reported in clinical trials.

Value of cabozantinib in the treatment of advanced metastatic clear cell renal cell carcinoma (ccRCC): Real-world data from a single Korean institution.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16578-e16578
Author(s):  
Seoyoung Lee ◽  
Seul-Gi Kim ◽  
Sejung Park ◽  
Jeehyun Lee ◽  
Seung-Hoon Beom ◽  
...  
Keyword(s):  
Real World ◽  
Response Rate ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Cancer Center ◽  
Second Line ◽  
Real World Data ◽  
World Data ◽  
Third Line ◽  
Grade 3

e16578 Background: Cabozantinib is a multitarget tyrosine kinase inhibitor and getting attention in these days through its combination with immune checkpoint inhibitors. In this article, we analyze the efficacy of cabozantinib in patients with metastatic ccRCC in Korean who had progression after 1 or more VEGFR TKI therapies. Methods: Seventy-five patients from Jan.2019 to Dec. 2021 at Yonsei Cancer Center who had received cabozantinib treatment in second to fourth line of therapy were retrospectively reviewed. The primary endpoint was PFS. The secondary outcomes were the response rate, disease control rate (DCR), and OS. The evaluable subjects for efficacy were those who had at least one response evaluation. Results: Among 75 patients, 57 (76.0%) were male and median age was 59 years (range 33-81). Median follow up time was 12.1 months. There were 22 (29.3%) patients of second line, 38 (50.7%) of third line and 15 (20.0%) of fourth line of treatment. Median PFS was 5.6 months (95% CI, 4.6-6.6). Median OS was 13.6 months (95% CI, 5.0-22.2). The PFS based on the line of treatment was 4.7 months for second line, 5.6 months for third line and 12.0 months for 4th line. Proportion of patients who were previously treated with ICI was different between treatment line groups and showed increasing trend toward later line; 13.6% of second line, 31.6% of third line, and 66.7% of fourth line, respectively. The objective response rate was 8.0% with 6 patients of partial response. The DCR was 69.3%. The major toxicities were similar with the western population and most of them were less than CTCAE grade 3. Most common grade 3 or 4 AEs were anemia, hand-foot syndrome, fatigue, and stomatitis. There were no grade 5 AEs. Conclusions: Our results demonstrate that cabozantinib is an effective treatment option after first line TKI in Korean ccRCC patients with manageable toxicities. Notably, its tolerability in the advanced line of treatment and synergy with ICIs are suggested in this study despite heterogeneous patients of real world setting. This is the first real world data with cabozantinib in Asian patients.

Lessons learned from the reimbursement policy for immune checkpoint inhibitors and real-world data collection in Taiwan

2020 ◽  
pp. 1-5
Author(s):  
Li Ying Huang ◽  
Churn-Shiouh Gau
Keyword(s):  
Health Insurance ◽  
National Health Insurance ◽  
National Health ◽  
Real World ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Reimbursement Policy ◽  
Real World Data ◽  
World Data

Abstract This paper describes the reimbursement policy for immune checkpoint inhibitors in Taiwan and provides a perspective to improve the quality, consistency, and transparency of decision making. Global trends for cancer treatment have shifted from chemotherapies to targeted therapies and immuno-oncology (IO) medicine, leading to significant increases in treatment costs. To enhance the accessibility of advanced therapy, the Taiwan National Health Insurance Administration announced two pathways for high-cost medicine: the managed entry agreement and a set of general rules of reimbursement submission for high-cost drugs. To further manage the financial burden on Taiwan's national health insurance system, the policy makers introduced novel inhibitory drugs for cancer immune checkpoints, subject to a maximum annual budget of NT$800 million (≈US$26.7 million). In April 2019, a national registry was established for patients undergoing cancer immunotherapy. Clinical characteristics, treatment duration, toxicity, and the outcome of the postcheckpoint inhibitor treatments were recorded. By analyzing real-world data, we assess the therapeutic effect of IO treatment in Taiwanese patients, thereby enabling payers to adjust payment regulations and rules for reimbursement. The Health Technology Assessment Team plays an important role in drawing upon the evidence to support policy making. Under an implemented cost-management mechanism, Taiwan's high-cost drug policy has enabled patients to access new medicines and maximized patient benefits.

scholarly journals Real World Outcomes of Check Point Inhibitors Immunotherapy in Renal and Urothelial Cancers in a Teratiary Care Cancer Center in India

2019 ◽  
Vol 4 ◽  
pp. 63-66
Author(s):  
Vineet Talwar ◽  
Sneha Jatan Bothra ◽  
Varun Goel ◽  
Prasanta Kumar Dash ◽  
Ankush Jajodia ◽  
...  
Keyword(s):  
Real World ◽  
Immune Checkpoint ◽  
Renal Cell ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Common Adverse Effect ◽  
Cancer Center ◽  
Real World Data ◽  
World Data ◽  
Metastatic Rcc

AIMS: The real-world data regarding the response rates, tolerability, and toxicities of immunotherapy is very limited. The aim of this study is to analyze these characteristics in patients who have received immunotherapy for metastatic renal cell carcinoma (RCC) or urothelial cancer (UC). Methods: Retrospective review of patients over a year from 2017–2018 diagnosed with metastatic RCC and UC in our institute who received checkpoint inhibitors was done. PFS and OS were calculated. Results: A total of 16 patients, 11 with metastatic RCC and 5 patients with Metastatic UC were included in this study. All patients were male and Median age was 57.5 years. Median Number of cycles administered was 6. 50% of patients had a partial response to treatment, 16.6% of patients had stable disease and 33.3% of patients had progressive disease. There were no complete responses to therapy. Median Follow up was 9 months. The median PFS of the whole cohort was 6 months, while in RCC was 6 months and in UC was 1 month. Median OS of the whole cohort is 7 months, while the median OS for RCC and UC were 7 months and 3 months respectively. Fatigue was the most common adverse effect noted and Anaemia was the most common hematological side effect seen with immunotherapy in this study. Conclusion: This is real-world data of the use of the immune checkpoint inhibitors in the resource-limited setting. The benefit of Immune checkpoint inhibitors may in advanced renal cell cancers and Urothelial cancers may be different from that seen in the Western population.

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