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V. Gondi
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-093 - A Phase III Study of Radiosurgery with TTFields for 1-10 Brain Metastases from NSCLC (ID 1690)
09:30 - 09:30 | Author(s): V. Gondi
- Abstract
Background:
Tumor Treating Fields (TTFields) are a novel, non-invasive regional anti-mitotic treatment modality, based on low intensity alternating electric fields. Efficacy of TTFields in non-small cell lung cancer (NSCLC) has been demonstrated in multiple in vitro and in vivo models, and in a phase I/II clinical study. TTFields treatment to the brain was shown to be safe and effective in glioblastoma patients. Local treatment options for patient with brain metastases (BM) are limited to neuro-surgery (NS), stereotactic radiosurgery (SRS) or whole brain radiotherapy (WBRT) or a combination thereof. In patients treated with NS or SRS, intracranial recurrence remains high, since the rest of the brain is not treated. The addition of WBRT, can improve intracranial control either alone or when added to SRS but at the risk of severe neurocognitive and other complications. Thus, new therapeutic options are needed, particularly ones that allow for greater intracranial control while minimizing the risk of neurocognitive and other adverse events.
Methods:
The METIS Clinical Trial 240 patients with 1-10 BM from NSCLC will be randomized in a ratio of 1:1 to receive SRS followed by either TTFields or supportive care alone. Patients are followed-up bimonthly until 2[nd] intracerebral progression. Patients in the control arm may cross over to receive TTFields at the time of 1[st] intracerebral progression. Objectives To test the efficacy, safety and neurocognitive outcomes of TTFields in this patient population. Endpoints Time to intracerebral progression (primary); time to first/second intracerebral progression for patients with 1-4 and 5-10 BM; 2, 4, 6, 8, 10, 12-month first/second intracerebral progression rate; intracerebral progression free survival; overall survival; time to neurocognitive failure; rate of decline in cognitive function; neurocognitive failure-free survival; radiological response; safety (secondary). Treatment Continuous TTFields at 150 kHz will be applied to the brain using the NovoTTF-100M System within 7 days of SRS. The System is a portable medical device allowing normal daily life activities. The device delivers alternating electric fields to the brain using 4 Transducer Arrays, which may be covered by a wig or a hat for cosmetic reasons. Patients will receive the best standard of care for their systemic disease. Statistical Considerations This is a prospective, randomized, multicenter study for 240 patients. The trial is designed to detect an increase in the time to intracerebral progression from 7.7 to 13.4 months (hazard ratio 0.57). This sample size assessment takes into consideration a competing risk (death prior to intracerebral progression) of 0.08252 per month in both treatment arms. The competing risk is based on a predicted median overall survival of 8.4 months mainly due to systemic disease progression. The trial has 80% power at a two sided alpha of 0.05. The sample size was calculated using a log-rank test (based on Lakatos 1988 and 2002) with the competing risk taken as loss to follow up (patients will be censored at time of death if it occurs prior to intracerebral progression).
Results:
not applicable
Conclusion:
not applicable
