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Comparing Outcomes of SBRT to Outcomes of Surgery

Comparing Outcomes of SBRT to Outcomes of Surgery. Traves Crabtree MD Division of Thoracic Surgery Washington University, St. Louis. Disclosures . Consultant/speakers bureau: Ethicon Endosurgery. How do you interpret this? .

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Comparing Outcomes of SBRT to Outcomes of Surgery

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  1. Comparing Outcomes of SBRT to Outcomes of Surgery Traves Crabtree MD Division of Thoracic Surgery Washington University, St. Louis

  2. Disclosures • Consultant/speakers bureau: Ethicon Endosurgery

  3. How do you interpret this?

  4. How do you interpret these data?Comparisons of SBRT and SurgeryGrills et al. JCO 2010 • 124 pts w/T1-2 N0 NSCLC tx’d w/ SBRT (n=55) or wedge resection (n=69) from 02/03-08/08. • Median potential F/U 30 mo

  5. DEFINITIONS

  6. Criteria for Medically Inoperable Patients Undergoing SBRT (RTOG 0236) Criteria for High Risk Surgical Patient Undergoing Sublobar Resection (ACOSOG Z4032) or Radiofrequency Ablation (ACOSOG Z4033) REQUIRED 1 Major or 2 Minor Criteria Major Criteria: FEV1 < 50% predicted DLCO < 50% predicted Minor Criteria: Age > 75 FEV1 or DLCO 50-60% Pulmonary hypertension (PA systolic > 40 mmHg) LV function < 40% Pa)2 < 55mmHg PCO2 > 45 mmHg REQUIRED Patient deemed medically inoperable by an experienced cancer care physician (thoracic surgeon, oncologist, radiation oncologist, or pulmonologist)  SUGGESTED FEV1 < 40% predicted Postoperative FEV1 < 30% predicted Severely reduced DLCO Hypoxemia Hypercapnia VO2 < 50% predicted Severe pulmonary hypertension Diabetes mellitus with severe end organ damage Severe cerebral, cardiac or PVD

  7. Crabtree et al. JTCVS (In press)

  8. SBRT vs. Sublobar Resection: Propensity Matched Analysis in T1 Tumors • No difference in 30d (OR 2.37 (95% CI: 0.75-9.90) p=0.18) or 90d (OR=1.92(95%CI 0.71-6.08) p=0.25) 3+ AEs. • For sublobar resection, FEV1% was 6.4% higher than the SBRT subjects at 90d follow-up after adjusting for the baseline FEV1% (p=0.024). • In Quintile 1 for Z4032, the median DLCO% and FEV1% was 30% and 39%, with 30-day 3+ AEs of 45%(19/42). In Quintile 5, the median DLCO% and FEV1% was 69% and 56%, with 30-day AEs of 15%(p=0.004). • Thus, for Sublobar resection, perioperative morbidity may be prohibitively high in a subset of patients supporting a role for nonoperative therapy

  9. SBRT vs. Surgery: Overall SurvivalRobinson et al. J ThoracOncol (in press) Crabtree et al. JTCVS 2010 Overall Survival: Unmatched Comparison Overall Survival: Propensity Matched Comparison P<0.0001 P=0.0007

  10. Kaplan-Meier curves for Local Control and Regional Control between the entire cohort of patients treated with lobar resection or SBRTRobinson et al. J ThoracOnc (in press)

  11. Surgical Impact on Staging • Surgery upstaged 35% of patients (161 / 462) • 13.8% had pathologic N1 disease • 3.5% had pathologic N2 disease • With surgical staging, adjuvant chemotherapy was given to 21% of surgery patients and 0% of SBRT patients. Crabtree et al. JTCVS 2010 Robinson et al. ASTRO 2010

  12. SBRT for Inoperable Early Stage Lung Cancer: RTOG 0236Timmerman et al. JAMA 2010 • 55 inoperable pts. 80% T1. • Primary endpoint: Primary tumor control • Primay tumor failure defined as local enlargement at least 20% by CT AND evidence of tumor viability based on PET • Recurrence within the lobe >1cm away from the primary tumor was NOT a primary tumor failure • Local failure defined separately • 3-year primary tumor control 97.6%

  13. Radiation Oncologist “Primary Tumor Control”

  14. Surgical Primary Tumor Control

  15. Different Definitions of Local Recurrence Varlotto et al. Cancer 2010

  16. Recurrence Definitions for Z4099SBRT and Surgery • Local failure • Primary tumor failure • Marginal Failure • Involved lobe failure • Port site/wound recurrence • Regional failure • Non-primary lobe failure • Hilar node failure • Ipsilateral mediastinal node failure

  17. Various Definitions of Survival • Overall survival • Death from any cause • Favors surgery in high risk group • Disease free survival (DFS) • Includes any death AND any recurrence • Disease (cancer) specific survival (DSS) • Does not include recurrence and only counts deaths directly related to cancer • Hard to define COD in high risk population • Most favorable reported outcome for SBRT

  18. Patterns Of Disease Recurrence Following Either Stereotactic Ablative Radiotherapy (sabr) Or Lobectomy By Video-assisted Thoracoscopic Surgery (vats) In Stage I-II Non-small Cell Lung Cancer: Outcomes Of A Propensity Score-matched AnalysisS. Senan1, N. Verstegen1, D. A. Palma2, G. Rodrigues2, F. J. Lagerwaard1, A. van der Elst3, R. Mollema4, A. Warner2, B. J. Slotman1, J. W. Oosterhuis1, 1VU University Medical Center, Amsterdam, Netherlands, 2London Regional Cancer Program, London, ON, Canada, 3Department of Surgery, Spaarne Hospital, Hoofddorp, Netherlands, 4Department of Surgery, Medical Center Alkmaar, Alkmaar, Netherlands • In total 86 VATS- and 527 SABR patients were eligible for matching • The matched cohort consisted of patients with cT1-3N0 NSCLC following SABR (n=64) or VATS-lobectomy (n=64). • Pre-treatment histological confirmation of stage I NSCLC was available in 53% of SABR patients and 50% of VATS patients • SABR patients had a better loco-regional control rates at 1- and 3-years (96.8% and 93.3% vs. 86.9% and 82.6%, respectively, p= .03). • Three-year progression-free survival did not significantly differ between groups (79.3% versus 63.2%, p = .09). Presented at ASTRO Oct. 2012

  19. SUMMARY • Currently published data between SBRT and surgery are limited due to difficulty in matching patients between groups • Tissue confirmation needs to be more consistent • Common definitions of recurrence (local, regional, distant) and survival will need to be more consistent. • Accrual to ACOSOG Z4099/RTOG 1021 is essential to compare efficacy and address current assumptions about the relative benefit of each therapy

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