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S. Rehman



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    MINI 33 - Radiotherapy and Complications (ID 164)

    • Event: WCLC 2015
    • Type: Mini Oral
    • Track: Treatment of Locoregional Disease – NSCLC
    • Presentations: 1
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      MINI33.01 - Prospective Phase II Trial of SBRT for Centrally-Located Lung Cancer (ID 162)

      18:30 - 20:00  |  Author(s): S. Rehman

      • Abstract
      • Presentation
      • Slides

      Background:
      We report safety and efficacy results for an institutional prospective phase II trial for medically-inoperable patients with centrally-located early-stage non-small cell lung cancers receiving dose escalated SBRT. The Phase II objectives were to determine the overall survival and patterns of local failure.

      Methods:
      Eligible patients with biopsy-proven NSCLC within 2cm of the proximal bronchial tree (RTOG definition) were enrolled on an IRB-approved institutional clinical trial between 2006-2015. All patients were medically inoperable. The Phase I portion consisted of 4 radiation dose levels using 5 fraction regimens. Dose levels were 9, 10, 11, and 12 Gy/fraction. Phase I was previously reported (ASTRO 2011). Based on an early analysis of efficacy, the Phase II radiation dose was 11 Gy x 5 fractions.

      Results:
      64 patients were enrolled to the trial; 23 to Phase I and 41 to Phase II. The median follow up for phase II patients alive is 6.2 months (range 1.3-46.3 months). 41 patients are eligible for toxicity analysis and 37 with at least 1 post-treatment visits are eligible for efficacy. Regarding treatment-related toxicity, 1 patient experienced acute Grade 3 hypoxia (2.4%; 95% CI 0.1-12.8%), 3 patients developed late Grade 3, 2 had late grade 4, and 1 had late grade 5 events. The grade 4 events were lung atelectasis resulting in hospitalization and dyspnea, respectively. The grade 5 event was fatal hemoptysis in a patient with tumor involving the pulmonary artery. The one-year local lobar recurrence rate using 11 Gy x 5 fractions is 4.6% (95% CI 0.7-13.6%). The one-year OS is 81.2% (60.0-91.8%).The predominant causes of death were distant metastasis (N=6), intercurrent illness without recurrence (N=6), and secondary lung cancer (N=2). One patient is alive with gastric cancer. Two patients developed nodal recurrence and two developed local failures.

      Conclusion:
      SBRT for central tumors using 11 Gy x 5 fractions was tolerable, but can contribute to severe toxicity as shown by others where tumor involves the pulmonary vasculature. The lobar tumor control was excellent using 11 Gy x 5 fractions. The results of RTOG 0813, which was methodologically based on this trial, may help to clarify the preferred dose for central lesions.

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