Surgery versus stereotactic body radiation therapy in medically operable NSCLC David H Harpole Jr, MD Professor of Surgery Associate Professor in Pathology Vice Chief, Division of Surgical Services Duke University School of Medicine Durham, North Carolina
90 year old female, 40 pack-year former smoker CAD with drug-eluting stents (clopidogrel bisulfate) 4 cm right upper lobe lung mass PET SUVmax 3.4, Otherwise (-) PFDs FEV1 75%; DLCO 70% ECOG 0-1
Surgery versus stereotactic body radiation therapy in medically operable NSCLC David H Harpole Jr, MD Professor of Surgery Associate Professor in Pathology Vice Chief, Division of Surgical Services Duke University School of Medicine Durham, North Carolina
Disclosure No relevant conflicts of interest to disclose
Stereotactic Body Radiotherapy Multiple radiation beams focused on a single tumor Doses are usually 5-10 times traditional daily radiation doses
Stereotactic Radiosurgery Treated tumor control 85-95% 7
SBRT for early stage NSCLC: Retrospective Single Institution Series Study n Dose (Fractionation) Survival (year) Nagata (Japan) 45 48 Gy (12 Gy 4) 83%- T1 (5) 72%-T2 (5) Local Failure (year) 5%-T1 (5) 0%-T2 (5) Bauman (Sweden) 57 45 Gy (15 Gy 3) 60% (3) 8% (3) Fakiris (Indiana) 70 60-66 Gy(20 22 Gy 3) 43% (3) 12% (3) Ricardi (Italy) 62 45 Gy (15 Gy 3) 57% (3) 12 (3) Bral (Belgium) 40 60 Gy (20 Gy 3)* 60 Gy (15 Gy 4) 52% (2) 16% (2) Hoyer (Denmark) 40 45 Gy (15 Gy 3) 47% (2) 15% (2) Timmerman (RTOG) 55 54 Gy (18 Gy 3)º 56% (3) 2% (3)
SBRT Toxicity: SBRT for early stage NSCLC: Pulmonary Toxicity Bongers E et al. Radiotherapy and Oncology 2013;109:95-99 9
SBRT Toxicity:Centrally Located Tumors Grade 5=6 PNA x 4 Pericardial effusion Hemoptysis Grade 3-4: Decline in PFTs Pleural Effusion Apnea PNA Skin reaction Timmerman R et al. JCO 2006;24:4833-4839
SBRT Toxicity: Centrally Located Tumors Timmerman R et al. JCO 2006;24:4833-4839 2006 by American Society of Clinical Oncology
SBRT: What is the Optimal Dose Schema? RTOG 0915: Randomized Phase II Primary Endpoint: 1 year rate of > Grade 3 definitely, possibly, or probably treatment related toxicity Secondary: 1 year primary tumor control rate, 1 year OS and DFS, FDG PET changes Correlative biomarker for toxicity and control
Surgical Resection vs SBRT for High Risk Operable Early Stage NSCLC Grills I S et al. JCO 2010;28:928-935 2010 by American Society of Clinical Oncology
Surgical Resection vs SBRT for High Risk Operable Early Stage NSCLC Grills I S et al. JCO 2010;28:928-935 2010 by American Society of Clinical Oncology
SBRT for Medically Operable Early Stage NSCLC JCOG 0403: 3 year PFS: 55% 3 year OS: 76% RTOG 0618: Accrual completed Data maturing 15
Surgical Resection vs SBRT for High Risk Operable Early Stage NSCLC ACOSOG Z4099 Limited resection +/- brachytherapy Register/Randomize Peripheral tumor < 4 cm High-risk surgical candidate N=7/420 (goal) SBRT Primary Endpoint: Survival with SBRT < 10% limited resection Secondary: Tumor control, toxicity(pfts, by Charlson CI), DFS
Surgical Resection vs SBRT for Operable Early Stage NSCLC: ROSEL SBRT 18 Gy x 3 Primary Endpoint: Local and Regional Control, Treatment Costs, QOL Secondary:Total Costs, Quality Adjusted Life Years, Overall Survival
Surgical Resection vs SBRT for Operable Early Stage NSCLC: VALOR SBRT: BED > 100 Central 5-8 doses Primary Endpoint: 5 year OS 25 Federal hospitals Resources being allocated at end of 2014
Ablative Radiotherapy (SBRT) Ablative Radiotherapy results in high rates of treated tumor control and survival Toxicity profile varies between central and peripheral tumor locations Randomized comparisons ongoing: Surgery: High risk operable patients Medically operable patients Conventional Radiotherapy Patterns of Progression have changed Distant progression most common 19