Exploratory analysis of trifluridine/tipiracil in late-stage metastatic colorectal cancer (mCRC): Prognostic factors.

24 Background: Trifluridine/Tipiracil (FTD/TPI) is effective in pts with refractory mCRC. Enrollment into in the RECOURSE trial was allowed only for pts with ECOG < 1 pts, while real world pts may have a lower ECOG. In addition, predictive markers for the efficacy of FTD/TPI at late stage are open. This exploratory analysis assessed outcome of mCRC pts (including ECOG PS ≥ 2) upon FTD/TPI treatment by prognostic factors in the real world setting. Methods: This cohort included mCRC pts who were treated with FTD/TPI from 01/2016 until 08/2019 at two large volume CRC centers in Germany. Pts were classified with good prognosis characteristics (GPC) according to Tabernero et al. (abstract 677, ASCO-GI 2019) defined by 1 or 2 metastatic sites and time since diagnosis of first metastases ≥ 18 mo. Pts of this group without liver metastases had the best prognostic characteristics. Pts with poor prognostic characteristics (PPC) were characterized by ≥ 3 metastases sites and time since diagnosis of first metastases ≤ 18 mo. Results: A total of 44 mCRC pts were included in this analysis (mean age 62.5 yrs; 22 males and 22 females). Within the GPC population (n=28; median age 67 yrs; KRAS wt n= 21; KRAS mt n= 7; ECOG 0-1 n= 23; ECOG ≥ 2n=7) 6 pts were alive up to 08/2019 and 4 were lost to FU. Four pts of the GPC were without liver metastases. Within the PPC group (n=16; median age 59 yrs; KRAS wt n= 6; KRAS mt n= 10; ECOG 0-1 n= 15; ECOG ≥ 2 n=1) 2 pts were alive and 2 were lost to FU. The mPFS and mOS of the GPC group (n=18) were 2,15 mo (range 0,62-10,13) and 4,63 mo (range 0,95-14,39), respectively. The mPFS and mOS of the PPC group (n=12) were 1,31 mo (range 0,76-9,72) and 4,72 mo (range 0,76-16,61), respectively. Pts with an ECOG ≥ 2 had a mOS of 2,76 mo (range 0,95-6,92), and a mPFS 1,67 mo (range 0,53-1,77). Conclusions: GPC and PPC group pts treated with FTD/TPI differed with respect to mPFS, but these pts had a comparable mOS in the real world setting. PFS and OS were lower when compared to the Tabernero analysis of the RECOURSE trial, which may reflect the real world setting. Inclusion of pts with an ECOG of ≥ 2 was feasible but showed poor survival data in the third line. Nevertheless, all pts with mCRC benefited from FTD/TPI treatment.

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Deterioration of liver function after transarterial chemoembolization (TACE) in hepatocellular carcinoma (HCC): An exploratory analysis of OPTIMIS—An international observational study assessing the use of sorafenib after TACE.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.4_suppl.368 ◽

2018 ◽

Vol 36 (4_suppl) ◽

pp. 368-368 ◽

Cited By ~ 5

Author(s):

Masatoshi Kudo ◽

Jean-Luc Raoul ◽

Han Chu Lee ◽

Ann-Lii Cheng ◽

Keiko Nakajima ◽

...

Keyword(s):

Liver Function ◽

Real World ◽

International Normalized Ratio ◽

Exploratory Analysis ◽

The Real ◽

Optimal Outcomes ◽

Real World Setting ◽

Selection For ◽

B 52 ◽

Clinical Trial Information

368 Background: TACE is commonly used for patients (pts) with unresectable HCC, and appropriate pt selection is important to obtain optimal outcomes. However, there is no globally accepted consensus on unsuitability and refractoriness to TACE. Retrospective studies suggest that continuing TACE after refractoriness or failure is harmful and may cause pts to become ineligible for further treatments because of liver function deterioration. This exploratory analysis of OPTIMIS evaluated the real-world incidence of liver function deterioration by baseline liver characteristics after first TACE. Methods: OPTIMIS enrolled 1670 pts with HCC for whom a decision to treat with TACE was made at the time of study entry. Liver function deterioration was defined as worsening of CTCAE grade compared with baseline for any of these parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, albumin, and prothrombin international normalized ratio (INR). All analyses are descriptive. Results: A total of 977 pts received TACE. The incidence of liver deterioration was higher in pts with BCLC stage C vs stage B (52% vs 44%, respectively), in pts exceeding the up-to-7 criteria compared with those within (49% vs 43%, respectively), and in those deemed unsuitable for TACE at baseline versus those deemed eligible (53% vs 44%, respectively) (Table). Conclusions: Deterioration of liver function parameters was observed after TACE in pts with HCC in the real-world setting. Therefore, appropriate pt selection for TACE and preserving liver function are important to optimize the benefit of TACE and subsequent treatments. Clinical trial information: NCT01933945. [Table: see text]

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

Diabetes ◽

10.2337/db18-2328-pub ◽

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

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

The Journal of Allergy and Clinical Immunology In Practice ◽

10.1016/j.jaip.2021.02.058 ◽

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

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Performance Characteristics of Breezhaler® and Aerolizer® in the Real-World Setting

Clinical Drug Investigation ◽

10.1007/s40261-021-01021-w ◽

2021 ◽

Author(s):

Mathieu Molimard ◽

Ioannis Kottakis ◽

Juergen Jauernig ◽

Sonja Lederhilger ◽

Ivan Nikolaev

Keyword(s):

Real World ◽

Performance Characteristics ◽

The Real ◽

Real World Setting

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Trends in Chemotherapy Patterns and Survival of Patients with Advanced Gastric Cancer Over a 16-year Period: Impact of Anti-HER2-Targeted Agent in the Real-World Setting

Cancer Research and Treatment ◽

10.4143/crt.2020.725 ◽

2020 ◽

Author(s):

Dong-Hoe Koo ◽

Min-Hee Ryu ◽

Mi-Yeon Lee ◽

Heejung Chae ◽

Eo Jin Kim ◽

...

Keyword(s):

Gastric Cancer ◽

Advanced Gastric Cancer ◽

Real World ◽

The Real ◽

Real World Setting ◽

Targeted Agent

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Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-221915 ◽

2022 ◽

pp. annrheumdis-2021-221915

Author(s):

Farzin Khosrow-Khavar ◽

Seoyoung C Kim ◽

Hemin Lee ◽

Su Been Lee ◽

Rishi J Desai

Keyword(s):

Rheumatoid Arthritis ◽

Real World ◽

Fixed Effects ◽

Safety Concern ◽

Specific Effect ◽

Routine Care ◽

Cardiovascular Outcomes ◽

The Real ◽

Real World Setting ◽

Increased Risk

ObjectivesRecent results from ‘ORAL Surveillance’ trial have raised concerns regarding the cardiovascular safety of tofacitinib in patients with rheumatoid arthritis (RA). We further examined this safety concern in the real-world setting.MethodsWe created two cohorts of patients with RA initiating treatment with tofacitinib or tumour necrosis factor inhibitors (TNFI) using deidentified data from Optum Clinformatics (2012–2020), IBM MarketScan (2012–2018) and Medicare (parts A, B and D, 2012–2017) claims databases: (1) A ‘real-world evidence (RWE) cohort’ consisting of routine care patients and (2) A ‘randomised controlled trial (RCT)-duplicate cohort’ mimicking inclusion and exclusion criteria of the ORAL surveillance trial to calibrate results against the trial findings. Cox proportional hazards models with propensity score fine stratification weighting were used to estimate HR and 95% CIs for composite outcome of myocardial infarction and stroke and accounting for 76 potential confounders. Database-specific effect estimates were pooled using fixed effects models with inverse-variance weighting.ResultsIn the RWE cohort, 102 263 patients were identified of whom 12 852 (12.6%) initiated tofacitinib. The pooled weighted HR (95% CI) comparing tofacitinib with TNFI was 1.01 (0.83 to 1.23) in RWE cohort and 1.24 (0.90 to 1.69) in RCT-duplicate cohort which aligned closely with ORAL-surveillance results (HR: 1.33, 95% CI 0.91 to 1.94).ConclusionsWe did not find evidence for an increased risk of cardiovascular outcomes with tofacitinib in patients with RA treated in the real-world setting; however, tofacitinib was associated with an increased risk of cardiovascular outcomes, although statistically non-significant, in patients with RA with cardiovascular risk factors.Trial registration numberNCT04772248.

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