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Slide 1 ___________________________________ ___________________________________ Hot Lights and Cold Steel vs. Invisible Particle Therapy in Early Stage and High Risk Non-Small Cell Lung Cancer ___________________________________ David Jablons, M.D. Chief, Division of Thoracic Surgery Department of Surgery University of California, San Francisco ___________________________________ BAM 2004 ___________________________________ ___________________________________ ___________________________________ Slide 2 ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ ___________________________________ Slide 3 ___________________________________ Newsflash: Stereotactic Body Radiotherapy (SBRT) is here! ___________________________________ ___________________________________ ___________________________________ BAM 2004 Source: ___________________________________ ___________________________________ ___________________________________

Slide 4 ___________________________________ Why all the excitement about Stereotactic Body Radiotherapy (SBRT)? ___________________________________ ≥ ? ___________________________________ ___________________________________ BAM 2004 Source: ___________________________________ ___________________________________ ___________________________________ Slide 5 ___________________________________ Big Picture – What are we trying to accomplish? Goals SBRT Surgery ___________________________________ Cure cancer Minimize morbidity and mortality Treat all tumor locations Treat all early stage tumors ___________________________________ Assess pathology and staging Perform prognostic and predictive profiling Use proven techniques ___________________________________ Treat patients with poor lung function BAM 2004 Source: ___________________________________ ___________________________________ ___________________________________ Slide 6 ___________________________________ Curing Cancer • Many independent studies have been done on the effectiveness of SBRT. ___________________________________ • A common conclusion of SBRT trials for early stage lung cancer is that it offers • 1. ―Comparable local control‖ • 2. ―Comparable long - term survival‖ ___________________________________ ___________________________________ BAM 2004 Source: ___________________________________ ___________________________________ ___________________________________

Slide 7 ___________________________________ Curing Cancer • Many independent studies have been done on the effectiveness of SBRT. ___________________________________ • A common conclusion of SBRT trials for early stage lung cancer is that it offers • 1. ―Comparable local control‖ • 2. ―Comparable long - term survival‖ ___________________________________ • But don’t believe everything you read ___________________________________ BAM 2004 Source: ___________________________________ ___________________________________ ___________________________________ Slide 8 ___________________________________ Curing Cancer VATS Lobectomy SBRT < 100 Gy ___________________________________ ___________________________________ SBRT < 100 Gy: ___________________________________ 1. Small study populations 2. Worse local control 3. Worse survival (even at 3 years!) BAM 2004 Source: Nguyen et al. Cancer Treatment Reviews 2008; 34: 719-727. Source: ___________________________________ ___________________________________ ___________________________________ Slide 9 ___________________________________ Curing Cancer VATS Lobectomy SBRT > 100 Gy ___________________________________ ___________________________________ SBRT > 100 Gy is better than < 100 Gy, BUT: ___________________________________ 1. Small study populations 2. Overall, worse local control 3. Overall, worse survival BAM 2004 Source: Source: Nguyen et al. Cancer Treatment Reviews 2008; 34: 719-727. ___________________________________ ___________________________________ ___________________________________

Slide 10 ___________________________________ Curing Cancer • Frequently cited study: Onishi, 2007, Japan • Multi-institutional study with 257 pts ___________________________________ • Local control – claimed overall response rate 86.8% • Complete response: Only 25.7% of patients! • Partial response (30% reduction in diameter): 61.1% of patients • ___________________________________ 5-year survival for medically operable patients ~70% ___________________________________ • Survival decreases in pts with stage IB lung ca • Longer-term survival > 5 years worrisome due to lack of compete response BAM 2004 Source: Onishi et al. Journal of Thoracic Surgery 2007; 2: S94-100. Source: ___________________________________ ___________________________________ ___________________________________ Slide 11 ___________________________________ Minimizing Morbidity and Mortality • SBRT is not the only field evolving ___________________________________ ___________________________________ • Nowadays, VATS lobectomy and VATS wedge resection have limited morbidity and mortality at experienced centers • At UCSF, morbidity < 1% and mortality (and reimbursement) close to 0% • Comparative studies biased – compare VATS lobectomy ___________________________________ (not wedge resections) done at all centers vs. SBRT done at specialty centers BAM 2004 Source: ___________________________________ ___________________________________ ___________________________________ Slide 12 ___________________________________ Minimizing Morbidity and Mortality • But don’t worry, radiation is perfectly safe. ___________________________________ ___________________________________ ___________________________________ BAM 2004 Source: ___________________________________ ___________________________________ ___________________________________

Slide 13 ___________________________________ Minimizing Morbidity and Mortality • But don’t worry, radiation is perfectly safe. ___________________________________ ___________________________________ ___________________________________ BAM 2004 Source: ___________________________________ ___________________________________ ___________________________________ Slide 14 ___________________________________ Minimizing Morbidity and Mortality • Many of our patients are elderly with already compromised lung function; SBRT > 100 Gy is not benign in this setting ___________________________________ • SBRT has measurable side-effects ___________________________________ ___________________________________ BAM 2004 Source: Nguyen et al. Cancer Treatment Reviews 2008; 34: 719-727. Source: ___________________________________ ___________________________________ ___________________________________ Slide 15 ___________________________________ Treating All Tumor Locations • Surgery equally effective at treating both peripherally and centrally located tumors, with minimal difference in morbidity ___________________________________ and mortality • Study on SBRT by Timmerman, 2006, UT Southwestern • 11-fold increased risk of severe toxicity with centrally located tumors • 2-fold increased risk of death with centrally located tumors • No clear consensus on safety of SBRT with centrally located tumors ___________________________________ ___________________________________ BAM 2004 Source: Timmerman et al. J Clinical Oncology 2006; 24: 4833-9. Source: ___________________________________ ___________________________________ ___________________________________

Slide 16 ___________________________________ Treating All Early Stage Lung Cancer • Surgery proven effective in treating stage IA, IB, and IIA lung cancer ___________________________________ • Study on SBRT by Onishi, 2007, Japan • 41% increase in local recurrence and 24% increase in regional nodal metastasis for Stage IB vs. IA ___________________________________ • Be careful when recommending SBRT for Stage IB tumors! ___________________________________ BAM 2004 Source: Onishi et al. Journal of Thoracic Surgery 2007; 2: S94-100. Source: ___________________________________ ___________________________________ ___________________________________ Slide 17 ___________________________________ Assessing Pathology and Staging During and After Surgery ___________________________________ ___________________________________ + ___________________________________ 1. You have inspected the lung cavity 2. Disease is in the bucket 3. Disease can be verified by pathology 4. You have adequately staged the patient BAM 2004 Source: ___________________________________ ___________________________________ ___________________________________ Slide 18 ___________________________________ Assessing Pathology and Staging During and After Surgery During and After SBRT ___________________________________ ___________________________________ 1. You have produced a pretty + scar on a picture 2. Disease ―supposed‖ to be gone 3. You don’t know what you have treated with your invisible ___________________________________ particles 1. You have inspected the lung cavity 4. Inadequate staging! 2. Disease is in the bucket 3. Disease can be verified by pathology 4. You have adequately staged the patient BAM 2004 Source: ___________________________________ ___________________________________ ___________________________________