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Disclosures

Disclosures. EES: speaker, advisory board Varian: speaker, advisory board. Current Trials Comparing SBRT to Surgery Should you be involved?. Bryan F. Meyers MD MPH Patrick and Joy Williamson Professor of Surgery. Stereotactic Body Radiotherapy (SBRT/SABR/SRS).

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Disclosures

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  1. Disclosures • EES: speaker, advisory board • Varian: speaker, advisory board

  2. Current Trials Comparing SBRT to SurgeryShould you be involved? Bryan F. Meyers MD MPH Patrick and Joy Williamson Professor of Surgery

  3. Stereotactic Body Radiotherapy(SBRT/SABR/SRS) • Multiple non-coplanar radiation beams • High fractional dose (15-20 Gy) • Short treatment (3 doses) • Maximizes radiation dose to tumor • Minimizes radiation to surrounding structures • Reported 5-year local control 84.2% Onishi et al. J ThoracOncol 2007

  4. SBRT and Sublobar Resection NCI studies • RTOG 0236 (n=55) • medically inoperable Median FU 24.8m • Local failure 5% • Loco-regional failure 12.8% • Grade 3 or higher toxicity 16% • Mortality 0% • Z4032 (n=222) • High-risk operable • Median FU TBD • Local failure (TBD) • Loco-regional failure (TBD) • Grade 3 or higher toxicity 27.9% (30 days) • Mortality 1.4%

  5. Science News • ... from universities, journals, and other research organizations • “Experts Find SBRT to Be Good Alternative to Surgery in Some Lung Cancer Patients”

  6. Challenges to Decision Making • Heterogeneity of tumors: • Size • Location • Heterogeneity of patient comorbidities • Selection bias for each modality • Lack of randomized trials • Multiple descriptive “endpoints” and definitions for “control”

  7. Multiple Endpoints: Pick Your Yardstick! • Overall survival • Cancer Specific Survival • Cancer Free Survival • Freedom from Local Recurrence • Freedom from Locoregional Recurrence • Freedom from death or recurrence

  8. SBRT selection bias: Bronchial Tree Diagram

  9. Criteria for selecting procedure Courtesy of Bilfinger, Stony Brook

  10. Clinical Trials • Viewed by some as the only way to have solid evidence • Expensive • Developed with compromises throughout: like politics and lawmaking • The better the focus, the more difficult it is to generalize result

  11. Long and Slow Process Workshop in July 2003 led to two trials evaluating lung cancer therapy: ACOSOG 4032 ACOSOG 4033 Eight years later, both trials are completed, but no outcome published yet!

  12. Dutch ROSEL Trial

  13. Dutch ROSELTrial • Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer (ROSEL) • This study has been terminated. • (Poor recruitment) • Sponsor: VU University Medical Center

  14. STARS Trial

  15. STARS TRIALObjectives: • Primary Goal: • To compare overall survival at 3 years • Secondary goals: • 1. To compare disease specific survival at 3 years. • 2. To compare 3 year progression free survival at the treated primary tumor site • 3. To compare grade 3 and above acute and/or chronic toxicities. • 4. To evaluate predictive value of pre and post treatment PET scan in clinical outcome.

  16. STARS STATUS • Many sites open for >2 years • Accrual slow as of the start of 2012 • Last DSMB December 2011, lack of subsequent DSMB activity suggests slow accrual continues

  17. ACOSOG Z4099/RTOG 1021: A Randomized Phase III Study of Sublobar Resection versus Stereotactic Body Radiation Therapy in High Risk Patients with Stage I Non-Small Cell Lung Cancer (NSCLC) Accrual: 5 subjects currently enrolled (goal 420 – 210 in each arm)

  18. Current Status Z-4099 • Ongoing persistence in jeapordy due to poor accrual • Ten patients total since opening in May 2011 • Trial adjusted to allow more liberal inclusion criteria: • Larger tumors to 4 cm • Omission of mandatory biopsy

  19. Likely Outcome of Study • Unlikely to succeed or persist in current configuration • Possibility exists to alter design markedly to allow novel strategy • Alternative will be to close due to poor accrual

  20. SUMMARY • Clinical trials for stage I lung cancer are tough to accrue, especially with disparate therapies • Open trials have laudable goals, but the successful completion is not assured • Surgeons are encouraged to be part of the solution by enrolling patients and advocating for trial participation by colleagues

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