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Tine Schytte
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EP1.04 - Immuno-oncology (ID 194)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 2
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.04-22 - Efficacy and Safety of Immune Checkpoint Inhibitors in a Danish Real Life Non-Small Cell Lung Cancer Population (Now Available) (ID 1220)
08:00 - 18:00 | Author(s): Tine Schytte
- Abstract
Background
To investigate effect and toxicity of immune check-point inhibition (ICI) in a Danish unselected real life non-small cell lung cancer (NSCLC) population. By including patients underrepresented in clinical trials, such as those with brain metastasis (BM), higher age, more comorbidity, autoimmunity and poorer performance status (ECOG), comparison to pivotal data on clinical trial populations is possible.
Method
Retrospective real life data were gathered from 118 consecutive NSCLC patients with incurable/recurrent disease stage IIIA-C and metastatic stage IV (revised according to the IASLC 8th Edition Lung Cancer TNM Staging) treated with ICI at the Department of Oncology at the University Hospital of Odense, Denmark from September 2015-April 2018. Immune related Adverse Events (irAE) grade 3-5 were registered prospectively during the same period. Patient, tumor and treatment characteristics were obtained from electronic patient records including charlsons comorbidity index score (CCIS). Overall survival (OS), progression free survival (PFS) and best response were assessed using Kaplan Meier estimates and the log-rank test. Cox regression was used for univariate analysis of factors affecting survival. Reasons for termination of ICI including level of irAEs grade 3-5 toxicity leading to termination of ICI was reported as well.
Result
Median age for patients was 66 [IQR 59-71] and 62 [range: 55-64] for those with BM. Females 63%; adenocarcinoma/squamous/others 69%/23%/8%; ECOG ≥ 2 10%; bone/brain/liver metastases 36%/18%/15%; PD-L1 (TPS) <1%/ ≥1%≤ 49%/≥50%/NR: 3%/14%/68%/15%; baseline autoimmunity 10%, Charlsons Comorbidity Index Score (CCIS) ≥ 2 39%, treatment line: 1st/2nd/ ≥3rd 39%/30%/31%. Median OS of all patients and patients with BM comprised 16.1 months [95% CI 10.7-21.5] and 8.2 months [95% CI 1.0-15.5], respectively. Twenty-four percent of patients terminated ICI due to irAE grade 3-5 alone (grade 5, n=1). There was no association of age or BM with irAE grade 3-5.
Conclusion
OS and PFS were comparable to clinical trial reports. Long-lasting remission is possible in patients with BM. Real life populations have higher rates of irAE grade 3-4 than reported in clinical trials, but it does not seem to impact median OS.
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EP1.04-29 - Khorana Score: A Potential New Biomarker for Real Life Non-Small Cell Lung Cancer (NSCLC) Patients Treated with Immunotherapy (Now Available) (ID 1242)
08:00 - 18:00 | Author(s): Tine Schytte
- Abstract
Background
PD-L1 tumor proportion score is presently the only biomarker used for selecting incurable NSCLC patients for immune check point inhibition (ICI). Performance score (ECOG) and comorbidities are useful, but no specified guidelines exist in this regard. New objective biomarkers are warranted.
Khorana score (KS) is a validated tool used to predict venous thromboembolisms (VTE) in out-patients with cancer prior to chemotherapy. For NSCLC patients undergoing chemotherapy KS has recently been associated with prediction of early mortality and not VTE. KS has not previously been investigated in patients undergoing ICI.
Method
Retrospective data from 118 incurable advanced/metastatic NSCLC patients treated with ICI in a single center during the period of September 2015-April 2018 was gathered. Baseline platelet count (PC), leucocyte count (LC), and hemoglobin count (HC) were registered. Baseline body mass index calculations were performed as well as KS (a minimum of KS ≥ 1 due the primary lung cancer disease). Based on follow-up data Kaplan Meier curve estimates of overall survival (OS) and progression free survival (PFS) were performed.
Result
For patient, tumor and treatment characteristics see Table 1. Fourteen percent had known VTE prior to ICI. Two patients died from pulmonary embolisms. KS correlated significantly to OS but not to PFS. A median OS of 18.1 months [CI 12.8-23.4] and 8.4 months [CI 4.3-12-6] was found for groups with KS=1-2 and KS≥3, respectively (log-rank test, p=0.017).
Conclusion
Baseline Khorana Score may represent a new clinical applicable prognostic biomarker for incurable NSCLC patients undergoing ICI. A KS ≥ 3 may be a predictor for early mortality but large prospective studies validating or rejecting this are warranted.
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EP1.11 - Screening and Early Detection (ID 201)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Screening and Early Detection
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.11-19 - Surveillance with PET/CT and ctDNA of Lung Cancer Patients After Completion of Definitive Therapy; A Randomized Trial (Now Available) (ID 2678)
08:00 - 18:00 | Author(s): Tine Schytte
- Abstract
Background
Even after treatment with curative intent lung cancer patients have a high risk of relapse. Patients are currently followed with CT. However, after surgery and especially radiotherapy CT has limited accuracy potentially delaying the diagnosis of a relapse. There is a scarcity in evidence regarding the most efficient follow-up interval as well as maging method. Together with CT the use of PET/CT for follow-up has been increasing and there is a need for improved understanding and perhaps questioning of the role of imaging in surveillance. Relapse of tumour activity can also be reflected by shedding of tumour DNA (ctDNA) into the blood stream. Studies have shown increase in circulating ctDNA months before standard radiologic assessment. Blood sampling and subsequent analysis of ctDNA therefore represent a promising minimally-invasive strategy to assess genomic tumour material and follow its changes. The purpose of this on-going clinical trial is to improve early detection of lung cancer relapse enabling more patients to receive definitive treatment of their relapse, ultimately leading to improved survival.
Method
This national, randomized trial compares two strategies for surveillance of patients with non-small cell lung cancer treated with curative intent (figure 1): standard follow-up +/- imaging with FDG PET/CT. Primary endpoint is frequency of treatable relapse and secondary endpoints includes survival and quality of life, number and type of invasive procedures, adverse events and type of treatment after verification of relapse, as well as use of healthcare resources.Based on samples collected during this randomized trial we will evaluate if monitoring patients with ctDNA enable us to track cancer evolution and detect early signs of relapse, as well as exploring potential new stratification of patient cohort with focus on high-risk and low-risk groups. Hereby, designing an optimal surveillance strategy for individual patients.
Result
The trial has been starting gradually since end-2018 and is now including patients in 4/5 Danish regions. The study aims to include 750 patients by 2021. In order to obtain baseline blood sample for ctDNA patients are included both prior to treatment (by April 2019 n=61) and 3 months after treatment (only patients in complete remission, n=25).
Conclusion
SUPE_R will provide the scientific basis for implementing new ways for surveillance of patients with lung cancer as well as provide knowledge transferable to other groups of cancer patients. This is the first study considering bioinformatics and methodological aspects of liquid biopsies and relating them directly to imaging and clinical benefits for the patients.
