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M. Garcia
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P2.05 - Poster Session with Presenters Present (ID 463)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiotherapy
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.05-035 - Interim Analysis of the Phase II Trial Dose Risk Adapted FFF Using SBRT in Stage I NSCLC and Lung Metastases (NCT01823003) (ID 4368)
14:30 - 14:30 | Author(s): M. Garcia
- Abstract
Background:
This study is a phase II, prospective, pilot feasibility study designed to evaluate the safety of SBRT in selected patients with stage I NSCLC or metastatic lung cancer lesions using an ablative dose-adapted scheme with Free Flattening Filters (FFF) beams. An interim analysis was planned after enrollment of the first 27 patients. We present our results of this interim analysis.
Methods:
Medically inoperable patients or medically operable patients who refuse surgery with a life expectancy >12 months with lung lesions were candidates. All patients will be treated using FFF beams and the following schedule:
Physical examination, toxicity and clinical response will been performed every three months for the first year and 6 months thereafter. Follow up will include Thoracic CT, pulmonary function, quality of life survey and blood test.Topographical Criteria Dose Distance to Chest Wall Size Distance to main Bronchus Patients A. 34Gy single fr. >1cm < 2cm >2cm 5p (18.5%) C. 50Gy (12 x 5 fr.s)Peripheral <1cm <5cm >2cm 13p (48%) D. 60Gy (7.5Gy x 8fr.)Central >1cm <5cm <2cm 9p (33.3%)
Results:
After median of follow up of 33 months (r 10-45) we analyzed 27p, with median age of 74y (r 83-58), 21 males (78%). Main reasons for inoperability were: 7 (26%) poor respiratory function, 10 (37%) with multiple comorbidities and 6 (22%) who refused surgery. Location was RUL 9 (33%), RLL 6 (22%), LUL 7 (26%), LLL 4 (15%). Lung primaries in 19p (70%) and the main histologies were Squamous Carcinoma (7, 26%) and Adenocarcinoma (7, 26%). T1a (9 , 33%), T1b (7, 26%),T2a (5, 18%) and T3 (2, 7%). Maximum grade of acute toxicity was GIII 1p(asthenia), and for chronic toxicity was GII (asthenia) 4p (15%). Local Control at 30 months was 84% (three local failures, two from metastasis) and overall survival was 100% at this time.
Conclusion:
FFF beams using dose risk adapted schedule seem to be a safe approach with a good response profile. Further analysis with the entire cohort of the trial is needed in order to confirm these early results.
