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U. Weinberg
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-015 - Designing Transducer Arrays for the Delivery of TTFields Whilst Maximizing Patient Comfort and Field Intensity in the Thorax (ID 4897)
14:30 - 15:45 | Author(s): U. Weinberg
- Abstract
Background:
Tumor Treating Fields (TTFields) are an anti-mitotic therapy that utilizes low intensity electric fields in the intermediate frequency range to disrupt cell division. A study to test the efficacy of TTFields in combination with chemotherapy for the treatment of mesothelioma is underway, and a pivotal study testing the efficacy of TTFields in treating NSCLC is planned. TTFields are delivered via two pairs of transducer arrays placed on the patient's skin. The transducer arrays comprise a set of ceramic disks that make electric contact with the skin through a thin layer of conductive medical gel. The disks in the arrays currently in use are arranged in an almost rectangular pattern. One pair of arrays is placed on the posterior and anterior sides of the patient’s thorax. The other pair is placed on the lateral and contralateral aspects of the patient. This configuration has several limitations: The array placed on the chest may not adhere well to body curvature, leading to sub-optimal electric contact that reduces field intensity in the tumor. In females and obese individuals, fields generated by arrays placed on the anterior and posterior have to traverse thick layers of adipose in the breast. The high resistivity of these layers damps the intensity of TTFields in the lungs. Here we present novel array designs intended to overcome these limitations.
Methods:
Multiple concepts for arrays designed to adhere comfortably to the body, whilst avoiding regions of high adipose were proposed. Finite element simulations using realistic computational phantoms were used to evaluate the field distribution generated by these arrays, and optimize their design.
Results:
Novel array designs for delivering TTFields to the lungs were developed. These arrays are not designed as large patches, but comprise sets of interconnected small patches that adhere to the natural contours of the patient's bodies. Simulations showed that these arrays deliver uniform field distributions to the lungs. A particularly noteworthy design is a pair of arrays in which one array was shaped as a circular ring placed around the neck and shoulders, and the second array was shaped as a belt placed on the lower torso. This design yielded a highly uniform and intense field directed longitudinally throughout the torso.
Conclusion:
The arrays presented in this study deliver high field intensities to the thorax whilst maintaining patient comfort. These designs could help to improve the outcome of TTFields therapy.
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P2.06 - Poster Session with Presenters Present (ID 467)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.06-036 - LUNAR - A Phase 3 Trial of TTFields in Combination with PD-1 Inhibitors or Docetaxel for 2nd Line Treatment of Non-Small-Cell Lung Cancer (NSCLC) (ID 6063)
14:30 - 15:45 | Author(s): U. Weinberg
- Abstract
Background:
Tumor Treating Fields (TTFields) is a novel, non-invasive, anti-mitotic treatment modality, based on low intensity alternating electric fields. TTFields predominantly affect two phases of mitosis: metaphase – by disrupting the mitotic spindle, and cytokinesis – by dielectrophoretic dislocation of organelles. TTFields were shown to extend the survival of newly diagnosed glioblastoma patients when combined with temozolomide. Efficacy of TTFields in non-small cell lung cancer (NSCLC) of all histologies has been demonstrated multiple preclinical models as well as in a phase I/II study in combination with pemetrexed, where overall survival was extended in more than five months compared to historical controls.
Methods:
The hypothesis of the study is that the addition of TTFields to standard of care second line therapies in advanced NSCLC will increase OS compared to treatment with standard second line alone. 512 patients with either squamous or non-squamous NSCLC will be enrolled in this prospective, randomized study. Patients will be stratified based on: 1) second line therapy (either PD-1 inhibitor or docetaxel), histology (squamous Vs. non-squamous) and geographical region. The main eligibility criteria are first disease progression (per RECIST Criteria 1.1), ECOG score of 0-1, no prior surgery or radiation therapy, no electronic medical devices in the upper torso and absence of brain metastasis. Docetaxel or PD-1 inhibitors (nivolumab or pembrolizumab) will be administered at the standard dose. TTFields will be applied to the upper torso using a small, portable medical device for at least 18 hours/day at home, allowing patients to maintain daily activities. TTFields will be continued until progression in the thorax and/or liver according to the immune-related response criteria (irRC). Follow up will be performed once q6 weeks, including a CT scan. Following progression in the upper torso, patients will be followed monthly for survival. The primary endpoint will be superiority in overall survival (OS) between patients treated with TTFields in combination with either docetaxel or PD-1 inhibitors, compared to docetaxel or PD-1 inhibitors alone. A co-primary endpoint will compare the OS in patients treated with TTFields and docetaxel to those treated with PD-1 inhibitors alone in a non-inferiority analysis. Secondary endpoints include progression-free survival, radiological response rate based on the irRC, quality of life based on the EORTC QLQ C30 questionnaire and severity & frequency of adverse events. The sample size is powered to detect a Hazard Ratio of 0.75 of TTFields-treated patients compare to the control group.
Results:
Trial Progress
Conclusion:
Trial Progress
