Clinical effect of sequential therapy of LEN combination with anti-PD1 antibody in uHCC patients who progressed on LEN treatment: A real-world data in China.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16654-e16654
Author(s):  
Yi Chen ◽  
Lan Zhang ◽  
Ningling Ge ◽  
Yanhong Wang ◽  
Zhenggang Ren
Keyword(s):  
Combination Therapy ◽  
Treatment Period ◽  
Combination Treatment ◽  
Real World ◽  
Sequential Therapy ◽  
Complete Response ◽  
Treatment Needs ◽  
Real World Data ◽  
Antibody Treatment ◽  
World Data

e16654 Background: Lenvatinib (LEN) has been used in clinical practice because of its high response rate since administrated in China. However, no recommendation is available as second-line agents after LEN treatment. The combination therapy of anti-programmed death-1(PD1) antibodies with LEN have demonstrated promising clinical efficacy in advanced HCC. Some patients were used this combination treatment after progressed on LEN in real world settings in China. Preclinical studies also showed the immune-moderate effects of LEN. This study was retrospectively analyzed the efficacy and safety of 26 unresectable HCC patients treated with LEN and anti-PD1 antibody after progressed on LEN. Methods: Unresectable HCC (uHCC) patients who treated with the combination of LEN with anti-PD1 antibody after progressed on LEN were enrolled. Patients who combine other loco-treatment and systemic therapy during the LEN combination with PD-1 antibody treatment period were excluded. The efficacy of LEN and anti-PD1 antibody was evaluated by mRECIST criteria after 2 cycles of combination treatment. AE data were recorded during the combination treatment period. Results: From October 2018 to October 2019, 26 patients were finally enrolled. As of January 10, 2020, median follow-up was 6.7±3.19 months. Median age was 56.15±11.9 years old, 80.77% (21/26) was Child-pugh(CP) A while 19.23% (5/26) was CPB7 and 88.5% (23/26) was BCLC stage C. Before combination therapy, 11 patients (42.31%) used LEN only and the other 15 patients (57.69%) were experienced sorafenib/chemotherapy before LEN. Drugs of PD1 antibodies were Keytruda and Toripalimab. The median duration of combination treatment was 6.7±3.15months. The ORR was 26.9% in total 26 cases. 2 cases of them were complete response, and the disease control rate (DCR) was 88.5% (23/26). The most common adverse events (AEs) of combination treatment were hypertension (42.31%), diarrhea (38.46%), hypothyroidism (38.46%) and anorexia (34.62%). Grade 3 or higher AEs occurred in 6 (23.08%) patients. Conclusions: This was the first real-world data of sequential therapy of LEN combination with anti-PD1 followed LEN in uHCC patients. For advanced patients who have progressed after LEN treatment, the results were promising, showing high DCR and well tolerated. 2 cases even achieve complete response. Sequential therapy may be an option for these patients. The efficacy of combination treatment needs random clinical trial to be further studied.

Combination therapy with macitentan and phosphodiesterase type-5 inhibitor (PDE5i) in pulmonary arterial hypertension (PAH): real-world data from OPUS and OrPHeUS

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V McLaughlin ◽  
R Channick ◽  
N.H Kim ◽  
M Flynn ◽  
S Leroy ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Real World ◽  
Patient Characteristics ◽  
Functional Class ◽  
Funding Source ◽  
Real World Data ◽  
World Data ◽  
Start Date ◽  
Phosphodiesterase Type 5 Inhibitor

Abstract Introduction Guidelines for the management of PAH recommend combination therapy for most patients, yet real-world data on treatment patterns in PAH are limited. Purpose To describe the characteristics, safety and clinical outcomes of PAH patients newly treated with double combination therapy with macitentan and PDE5i in the OPsumit® USers (OPUS) Registry and the OPsumit® Historical USers cohort study (OrPHeUS) combined dataset. Methods OPUS is a prospective, US, multicentre, observational drug registry (NCT02126943) ongoing since April 2014. OrPHeUS was a retrospective, US, multicentre chart review (NCT03197688); Oct 2013–Mar 2017. This cohort included patients initiating combination therapy with macitentan and a PDE5i (in any order) ≤60 days apart. Baseline was defined as the start date of the second therapy (i.e., start of combination therapy). Patient characteristics at baseline, changes in 6-minute walk distance (6MWD) and WHO functional class (FC) from baseline to follow-up, safety and outcomes are described. Results Of the 4428 OPUS/OrPHeUS PAH patients initiating macitentan, 2490 received this in combination with a PDE5i; of these patients, 740 (29.7%) initiated macitentan and a PDE5i concurrently (≤60 days apart). Data on disease duration was recorded in 729 patients at baseline; of these, 588 (80.7%) patients were incident (≤6 months since diagnosis) and 141 (19.3%) were prevalent (>6 months since diagnosis); median time from diagnosis to start of combination therapy of was 1.4 (Q1=0.6, Q3=3.6) months. At baseline, median age was 60 (Q1=49, Q3=70) years and 73.6% of patients were female. Mean baseline 6MWD was 264.5 (SD=119.8) m, recorded in 240 (32.4%) patients. WHO FC was recorded at baseline for 347 (46.9%) patients; 263 (75.8%) were in FC III/IV. Median combination therapy exposure was 10.2 (Q1=3.4, Q3=21.8) months, with 58.8% of patients ongoing at data cut. Changes from baseline to follow up in FC and 6MWD are shown in the figure. There was ≥1 adverse event (AE) reported in 455 (61.5%) patients and ≥1 hepatic AE (HAE) in 76 (10.3%) patients. In total, 232 (31.4%) patients discontinued macitentan; 122 (16.5%) due to AEs, 4 (0.5%) due to HAEs, 98 (13.2%) not due to an AE/HAE, and 8 (1.1%) for unknown reasons. Of the 305 patients who discontinued combination therapy, 137 (18.5%) discontinued macitentan only, 73 (9.9%) discontinued PDE5i only, and 95 (12.8%) discontinued both drugs at the same time. Kaplan-Meier estimates (95% CI) showed that 60.7% (56.4, 64.8) of patients were free from hospitalisation and 88.7% (85.7, 91.1) were alive at 12 months. Conclusions In this real-world setting, less than one third of patients treated with macitentan received initial oral combination therapy, despite current expert consensus favouring such therapeutic approaches. Patients initiating macitentan+PDE5i ≤60 days apart had improved 6MWD and WHO FC from baseline to follow-up. Funding Acknowledgement Type of funding source: Other. Main funding source(s): Actelion Pharmaceuticals Ltd

scholarly journals Real World Data of Daclatasvir and Asunaprevir Combination Therapy for HCV Genotype 1b Infection in Patients With Renal Dysfunction

2017 ◽  
Vol 15 (5) ◽  
pp. 787-788 ◽  
Author(s):  
Masatoshi Ishigami ◽  
Kazuhiko Hayashi ◽  
Takashi Honda ◽  
Teiji Kuzuya ◽  
Yoji Ishizu ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Renal Dysfunction ◽  
Real World ◽  
Real World Data ◽  
Hcv Genotype ◽  
World Data ◽  
Genotype 1B

Real-world data on treatment patterns and survival among ALK+ NSCLC patients in Japan.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20505-e20505
Author(s):  
Kaname Nosaki ◽  
Ryo Toyozawa ◽  
Kenichi Taguchi ◽  
Makoto Edagawa ◽  
Shin-ichiro Shimamatsu ◽  
...  
Keyword(s):  
Real World ◽  
Treatment Decision ◽  
Sequential Therapy ◽  
Analysis Data ◽  
Resistance Mechanisms ◽  
Treatment Patterns ◽  
Real World Data ◽  
Optimal Sequence ◽  
World Data ◽  
Nsclc Patients

e20505 Background: Three ALK inhibitors (ALKi) are approved in Japan for treatment of patients with ALK-positive (ALK+) advanced or metastatic non-small cell lung cancer (NSCLC). However, the optimal sequence of therapy with ALKi is unclear. The objective of this study was to provide real-world data on the treatment patterns and survival among ALK+ NSCLC patients. Methods: ALK+ patients treated with ALKi in our institute were included in this retrospective analysis. Data on the treatment patterns and outcomes were collected from medical records. Results: In total, 60 patients were included. The median age at the diagnosis was 52.5 years, with 60% female and 65% non-smokers. The first treatment was chemotherapy in 67% and ALKi in 33%. The median overall survival (OS) was 186 weeks. We found differences in the OS for Crizotinib use at any line (118 weeks; presence vs. NR; absence) and first-line use of an ALKi (127 weeks; Crizotinib vs. 416 weeks; Alecitinib or Ceritinib, p = 0.0048). Conclusions: The role of Crizotinib in the treatment of ALK+ NSCLC is decreasing. Alectinib followed by Ceritinib seems to be promising. Treatment decision-making based on a re-biopsy is immature at present. The development of sequential therapy with ALKi based on resistance mechanisms is urgently needed. [Table: see text]

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.

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