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Evaluating Stereotactic Body Radiotherapy vs. Surgery for Early Stage Lung Cancer: Insights and Trials

This document discusses the current landscape of clinical trials comparing Stereotactic Body Radiotherapy (SBRT) to surgery for early-stage lung cancer. It highlights key studies, including RTOG 0236 and ACOSOG trials, that have shown promising outcomes for SBRT in terms of local control and low mortality rates. The challenges in decision-making due to tumor heterogeneity and patient comorbidities are emphasized, alongside the need for randomized trials to support evidence-based treatment choices. Surgeons are encouraged to participate in these trials for improved patient outcomes.

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Evaluating Stereotactic Body Radiotherapy vs. Surgery for Early Stage Lung Cancer: Insights and Trials

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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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