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F. Pino



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    P2.05 - Poster Session with Presenters Present (ID 463)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Radiotherapy
    • Presentations: 1
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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): F. Pino

      • Abstract
      • Slides

      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:

      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%)
      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.

      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.

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