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B.I. Hiddinga
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OA22 - Novel Trials and Biomarkers in Malignant Pleural Mesothelioma (ID 403)
- Event: WCLC 2016
- Type: Oral Session
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:H. Pass, N. Van Zandwijk
- Coordinates: 12/07/2016, 14:20 - 15:50, Strauss 3
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OA22.01 - STELLAR - Interim Results of a Phase 2 Trial of TTFields with Chemotherapy for First Line Treatment of Malignant Mesothelioma (ID 6034)
14:20 - 14:30 | Author(s): B.I. Hiddinga
- Abstract
- Presentation
Background:
Tumor Treating Fields (TTFields) are an anti-mitotic, regional treatment modality, based on low intensity alternating electric fields delivered non-invasively using a portable, home use, medical device. In-vitro, human mesothelioma cells were found to be highly susceptible to TTFields. TTFields have been shown to extend survival of patients with glioblastoma when added to standard of care chemotherapy.
Methods:
The trial will accrue a total of 80 patients with unresectable, previously untreated mesothelioma. Patients are treated with TTFields in combination with pemetrexed and cisplatin or carboplatin. Continuous TTFields at 150 kHz for a minimum of 18 hours/day are applied to the thorax together with standard dosing of chemotherapy. Inclusion criteria include ECOG 0-1, pathological evidence mesothelioma and at least one measurable lesion according to modified RECIST criteria. Patients are followed q3 weeks (CT scan q6 weeks) until disease progression. The primary endpoint is overall survival (OS) and secondary endpoints are response rate, progression free survival (PFS) and treatment-emergent toxicity. This prospective, single arm study assumes that historical control has an exponential survival distribution and a median survival of 12.1 Months (Vogelzang et al.). The sample size provides 80% power with a two sided alpha of 0.05 to detect a Hazard Ratio of 0.67 for OS, compared to the historical data.
Results:
To date, 42 patients have been enrolled in the trial with an average follow up time of 11.5 months. Median age is 67±9 (range 43-78), 79% are male and 48% smokers. 14% (6 patients) have metastatic disease and 33% (14 patients) have an ECOG score of 1. Median survival has not been reached at this time. The 12-month survival rate is 79.7% (95% CI 57.2-91.2) and median PFS is 7.3 months (95% CI 5.6-NA). No device-related serious adverse events (AEs) have been reported to date. Expected TTFields-related dermatitis was reported in 55% (23 patients). Only 2 patients had grade 3 dermatitis. The following severe (grade 3-4) systemic AEs were reported: hematological (26%), hepatobiliary (2%), respiratory (2%).
Conclusion:
These interim results of the ongoing STELLAR study demonstrated no safety concerns for the combination of TTFields to the thorax together with standard chemotherapy for previously untreated mesothelioma patients. The 12-month survival rate was significantly higher, and PFS longer, than that of historical controls reported by Vogelzang et al. Final analysis of the study will be performed after enrollment and follow up of all 80 patients in the study are completed.
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P1.03 - Poster Session with Presenters Present (ID 455)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.03-028 - Wolf in Sheep's Clothing - Primary Lung Cancer Mimicking Benign Diseases (ID 3937)
14:30 - 14:30 | Author(s): B.I. Hiddinga
- Abstract
Background:
Lung cancer is the biggest cancer killer and typically presents as mass or nodule, round or oval in shape. Recognition and diagnosis of these typical cases is often straightforward, whereas diagnosis of uncommon manifestations of primary lung cancer certainly is far more challenging. The aim of this pictorial essay is to illustrate the Computed Tomography (CT) and histopathology findings of uncommon manifestations of primary lung cancer with focus on these entities that mimic benign diseases.
Methods:
Cases presented were collected during the Multidisciplinary Thoracic Oncology Tumor Board between January 2014 and May 2016 and have histopathologic proof.
Results:
Lung cancer can mimic a variety of benign diseases, including infection, granulomatous disease, lung abscess, postinfectious scarring, mediastinal mass, emphysema, atelectasis and pleural disease. Previous history, clinical and biochemical parameters are certainly helpful and necessary in the assessment of these cases, but often aspecific and inconclusive. Whereas 18FDG-PET is the cornerstone in diagnosis and staging of lung cancer, it’s role in these uncommon manifestations is less straightforward since benign diseases, such as granulomatous and infectious diseases may also present with increased FDG-uptake. Chest CT is the imaging modality of choice and plays a central role in these cases. ‘Irregular air bronchogram sign’ in pneumonia-like lung cancer, ‘drowned lung sign’ in obstructive atelectasis and cortical bone erosion in lung cancer mimicking pleural disease are important signs that point to a malignant etiology. The stippled and eccentric morphology of calcifications in apical lesions aids in differentiating these lesions from postinfectious scarring. Mucinous tumours can mimic a pulmonary abscess and small cell lung cancer can typically present as mediastinal mass without parenchymal abnormalities. Lung cancer presenting with a miliary pattern or cavitating nodules can mimic granulomatous disease. Lung cancer presenting with cystic airspaces and ‘emphysema-like’ morphology is an uncommon entity in which early recognition is crucial since these tumors have an aggressive nature. Key imaging findings and tips and tricks for recognizing these uncommon faces of primary lung cancer will be discussed and illustrated.
Conclusion:
Primary lung cancer can mimic a wide variety of benign entities. Knowledge of these uncommon and atypical manifestations is crucial to avoid delay in diagnosis and treatment. A multidisciplinary approach in these cases is mandatory.
