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Miklos Pless
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Lunch & Poster Display session (ID 58)
- Event: ELCC 2019
- Type: Poster Display session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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199P - Safety meta-analysis of clinical trials delivering TTFields to the upper torso (ID 554)
12:30 - 13:00 | Author(s): Miklos Pless
- Abstract
Background
Tumor Treating Fields (TTFields), a non-invasive, loco-regional, antimitotic treatment approved for glioblastoma (GBM), are delivered via transducer arrays to tumor region. Localized dermatitis underneath the arrays were main adverse events (AEs) reported in phase 3 GBM trials. The safety of TTFields was analyzed in two phase I-II studies in non-small-cell lung cancer (NSCLC) [EF-15, NCT00749346] and malignant pleural mesothelioma (MPM) [STELLAR, NCT02397928].
a9ded1e5ce5d75814730bb4caaf49419 Methods
TTFields studies in this pooled analysis were EF-15 (n=41, advanced NSCLC; plus pemetrexed) and STELLAR (n=80, MPM; plus platinum and pemetrexed). TTFields were applied 12 - 18 hours/day at a frequency of 150 kHz. All patients received standard of care systemic chemotherapy for their disease in addition to TTFields. Severity and frequency of AEs, and association with TTFields treatment were evaluated (CTCAE criteria version 4.0).
20c51b5f4e9aeb5334c90ff072e6f928 Results
Patients were aged 27-78 years: STELLAR: 67 (27-78) and EF-15: 63 (44-78), ECOG 0-1; 7 patients in EF-15 had ECOG 2. The incidence of grade 1-2 gastrointestinal (GI) toxicities was 35%. The most common low grade GI toxicities were: nausea (17%), vomiting (6%), constipation (10%) and diarrhea (6%). Grade 1-2 general disorders (16% fatigue and 11% asthenia) were common. Dyspnea Grade 1-2 (12%) and Grade 3-4 (5%) were considered related to standard chemotherapy or underlying disease. Grade 1-2 cardiovascular AEs were 7%; one case of severe arrhythmia (atrial flutter) was unrelated to TTFields. The only common TTFields-related adverse event was dermatitis below the transducer arrays. 59% patients had dermatological AEs: 53% Grade 1-2 dermatitis, 4% grade 3 dermatitis and 11% Grade 1-2 pruritus.
fd69c5cf902969e6fb71d043085ddee6 Conclusions
Treatment of solid tumors with TTFields 150 kHz to the thorax did not result in serious AEs or treatment-related pulmonary, cardiac, hematological or gastrointestinal toxicities. Expected dermatological toxicity beneath the device transducer arrays was seen in 59% patients, and resolved after a short treatment break or termination of treatment. These safety results and encouraging survival outcomes support the potential use of TTFields therapy in NSCLC and mesothelioma.
b651e8a99c4375feb982b7c2cad376e9 Clinical trial identification
NCT00749346 and NCT02397928.
7a6a3ffa2dadc03a6151ee2c4d6fa383 Legal entity responsible for the study
Novocure.
213f68309caaa4ccc14d5f99789640ad Funding
Novocure.
682889d0a1d3b50267a69346a750433d Disclosure
G.L. Ceresoli: Travel support: Novocure. All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25 -
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56P - CT image standardization is superior to larger but heterogeneous data for robust radiomic models (ID 433)
12:30 - 13:00 | Author(s): Miklos Pless
- Abstract
Background
Radiomics is a promising tool for identification of new prognostic biomarkers. Radiomic models are often based on single-institution data however multi-centric data, highly heterogeneous due to different scanning protocols, reflect better the clinical reality. Robustness studies are crucial to find features robust to e.g. scanner settings. We study if a CT radiomics overall survival (OS) model trained on multi-centric data with robust feature pre-selection can achieve a similar performance as a model on standardized data.
a9ded1e5ce5d75814730bb4caaf49419 Methods
Pre-treatment CT data from 121 IIIA/N2 NSCLC patients from a prospective multi-centric randomized trial (SAKK 16/00, neoadj. chemo- or radiochemotherapy prior to surgery) were used to calculate 1404 radiomic features on the primary tumor. Two OS radiomic models were trained on (1) a sub-cohort with standardized imaging protocol (native CT, standard kernel, n = 84) and on (2) the entire heterogeneous cohort but with robust radiomic feature pre-selection. Robust features were extracted from four robustness studies (contrast, convolution kernel, motion, delineation) using the intra-class correlation coefficient (> 0.9 considered stable). Seperately for each model, principal component (PC) analysis was performed and PCs describing in total 95% data variance were selected. The feature with highest correlation to the PCs were used for the multivariate Cox model with backward selection. Model performances were quantified using Concordance Index (CI), verified with 10-fold cross-validation and compared using bootstrap with resampling.
20c51b5f4e9aeb5334c90ff072e6f928 Results
Robustness studies revealed 113 stable features. The convolution kernel was the largest influence on the feature stability. Final OS model on the entire heterogeneous data consisted of four and on standardized data of six features (all identified as unstable). The model on standardized data showed significant better prognostic performance compared to the model with robust feature pre-selection based on the entire heterogeneous data (CI = 0.64 and 0.61, p < 0.05, resp.).
fd69c5cf902969e6fb71d043085ddee6 Conclusions
For our prognostic NSCLC radiomic models image protocol standardization appears superior to using larger but heterogeneous imaging data combined with robust feature pre-selection.
b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study
The authors.
213f68309caaa4ccc14d5f99789640ad Funding
Swiss National Science Foundation (SNSF) Swiss Group for Clinical Cancer Research SAKK.
682889d0a1d3b50267a69346a750433d Disclosure
M. Guckenberger: Board member: European Society for Therapeutic Radiation Oncology (ESTRO). All other authors have declared no conflicts of interest.
cffcb1a185b2d7d5c44e9dc785b6bb25
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My patient has stage IIIA (N2) disease: Surgery or radiotherapy? (ID 1)
- Event: ELCC 2019
- Type: Multidisciplinary Tumour Board
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 4/10/2019, 14:30 - 16:00, Room B
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Case presentation (ID 1)
14:30 - 16:00 | Presenting Author(s): Miklos Pless
- Abstract
- Presentation
Abstract not provided
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My patient needs surgery upfront followed by adjuvant treatment (ID 3)
14:30 - 16:00 | Presenting Author(s): Miklos Pless
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
