Is Resection Superior to SBRT for Stage I Lesions. Traves Crabtree MD Professor of Surgery Southern Illinois University School of Medicine
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1 Is Resection Superior to SBRT for Stage I Lesions Traves Crabtree MD Professor of Surgery Southern Illinois University School of Medicine
2 I have nothing pertinent to disclose.
3 Patterns of Recurrence for SBRT Adapted from Crabtree. Lung Ca Management 2012 Study N Median Overall Survival Local Regional f/u (OS) failure Failure Uematsu mo 66% 3 yr OS 6% 4% Distant Failure Onishi mo 47% 5 yr OS 13.5% 8.2% 14.7% Nyman mo 30% 5 yr OS 20% 4.4% Timmerman mo 54.7% 2 yr OS 5% Lagerwaard mo 64% 2 yr OS 3% 9% 15% Baumann mo 65% 2 yr OS 3.2% 3.2% 11.7% Fakiris mo yr OS 11.9% 8.6% Ricardi mo 57.1% 3 yr OS 6.5% 12.9% 24.2% Timmerman mo 55.8% 3 yr OS 7.3% 3.6% Crabtree mo 32% 3 yr OS 11% Robinson mo 34% 4 yr OS 13% 19% Andratschke mo 38% 3 yr OS 10.9% 18.5% Martini 1995 (surgery) yrs 7% 20%
4 RCTs: Surgery vs. SBRT Trial Eligibility Endpoints ROSEL STARS ACOSOG Z4099 VALOR (VA study) Operable noncental IA Operable IA or IB ( 4cm) High risk operable, Stage I (< 3cm) Operable (<5cm) Locoregional control, QOL, cost OS, DSS, Local PFS OS, LRR, DFS, toxicity OS, QOL, patterns of failure Planned Accrual STABLEMATES High risk stage I OS 218 Actual 22 (2.4%) CLOSED 36 (3.5%) CLOSED 10 (2.4%) CLOSED
5 Study N Median Surgery SBRT f/u Overall Survival Overall Survival Crabtree JTCVS mo 55% 5 yr OS 32% 3 yr OS Local failure Robinson Int J Radiat Oncol Biol Phys mo 68% 4 yr OS 34% 4 yr OS (p<0.001) 4 yr 6% surgery vs. 13% SBRT (p=0.02) Grills et al JTO wedge vs. SBRT 30 mo 85% 5 yr OS 70% 5 yr OS (p=0.02) 5% SBRT vs. 24% wedge Verstegen et al. Annals of Oncology 2013 Crabtree et al. JTCVS 2014 Port el al. ATS 2014 Cornell Matsuo et al. Eur J Cancer 2014 Kyoto Zheng et al Int J Radiat Oncol Biol Phys 2014 (meta-analysis) Puri et al JTO 2015 Puri et al JTO VATS lobe 527 SBRT 458 surgery 151 SBRT 164 Wedge vs. SBRT 180 SBRT vs. Sublobar 24 mo 80% 3 yr OS 76% 3 yr OS 3 yr LRR 6.7% SBRT vs. 17.4% VATS lobe (P=0.04) 2-3 yrs 68% 3 yr OS 52% 3 yr OS (p=0.05) LR 2.6% surgery vs. 10.7% SBRT 35 mo 3 yr RFS 88% 3 yr RFS 59% (p=0.001) 5-7 yrs 55.6% 5 yr OS 40.4% 5 yr OS (p=0.124) mo 66.1% 5 yr OS (lobe) 71.7% 5 yr OS (sublobar) All Resections (NCDB) Sublobar 4555 (NCDB) Hamaji et al ATS 2015 Kyoto 517 VATS lobectomy vs SBRT Yu et al. Cancer SEER Mokhles et al. Lung Cancer 2015 Netherlands Rosen et al JTCVS 2016 Yale (NCDB) 41.2% 5 yr OS (unadjusted) 36.5 mo 62.3 mo 33.1 mo 48.3 mo 33.9 mo 48 mo 68.5% 5 yr OS 37.3% 5 yr OS (p=0.0016) 77.7% 2 yr OS 2 yr OS 59.9% 577 lobectomy vs. SBRT mo 80% 5 yr OS 53% 5 yr OS (p=0.089) 59% 5 yr OS 29% 5 yr OS (p<0.001) LR 2% lobe vs. 24% SBRT (p<0.001) Wang et al Medicine 2016 Beijing mo 67.8% 5 yr OS 47.4% 5 yr OS (p=0.07) 5 yr LRR 21.3% surgery vs. 47.9% SBRT (p=0.001) Yerokun et al. JTCVS 2017 Duke Cornwell et al. JTCVS 2017 VA system 6295 (NCDB) Wedge vs. SBRT 183 VATS lobe vs. SBRT 49.9% 5 yr OS 31.0% 5 yr OS (p<0.001) 82.8% 3 yr RFS 38.5% 3 yr RFS
6 Study N Median Surgery SBRT f/u Overall Survival Overall Survival Crabtree JTCVS mo 55% 5 yr OS 32% 3 yr OS Local failure Robinson Int J Radiat Oncol Biol Phys mo 68% 4 yr OS 34% 4 yr OS (p<0.001) 4 yr 6% surgery vs. 13% SBRT (p=0.02) Grills et al JTO wedge vs. SBRT 30 mo 85% 5 yr OS 70% 5 yr OS (p=0.02) 5% SBRT vs. 24% wedge Verstegen et al. Annals of Oncology 2013 Crabtree et al. JTCVS 2014 Port el al. ATS 2014 Cornell Matsuo et al. Eur J Cancer 2014 Kyoto Zheng et al Int J Radiat Oncol Biol Phys 2014 (meta-analysis) Puri et al JTO 2015 Puri et al JTO VATS lobe 527 SBRT 458 surgery 151 SBRT 164 Wedge vs. SBRT 180 SBRT vs. Sublobar 24 mo 80% 3 yr OS 76% 3 yr OS 3 yr LRR 6.7% SBRT vs. 17.4% VATS lobe (P=0.04) 2-3 yrs 68% 3 yr OS 52% 3 yr OS (p=0.05) LR 2.6% surgery vs. 10.7% SBRT 35 mo 3 yr RFS 88% 3 yr RFS 59% (p=0.001) 5-7 yrs 55.6% 5 yr OS 40.4% 5 yr OS (p=0.124) mo 66.1% 5 yr OS (lobe) 71.7% 5 yr OS (sublobar) All Resections (NCDB) Sublobar 4555 (NCDB) Hamaji et al ATS 2015 Kyoto 517 VATS lobectomy vs SBRT Yu et al. Cancer SEER Mokhles et al. Lung Cancer 2015 Netherlands Rosen et al JTCVS 2016 Yale (NCDB) 41.2% 5 yr OS (unadjusted) 36.5 mo 62.3 mo 33.1 mo 48.3 mo 33.9 mo 48 mo 68.5% 5 yr OS 37.3% 5 yr OS (p=0.0016) 77.7% 2 yr OS 2 yr OS 59.9% 577 lobectomy vs. SBRT mo 80% 5 yr OS 53% 5 yr OS (p=0.089) 59% 5 yr OS 29% 5 yr OS (p<0.001) LR 2% lobe vs. 24% SBRT (p<0.001) Wang et al Medicine 2016 Beijing mo 67.8% 5 yr OS 47.4% 5 yr OS (p=0.07) 5 yr LRR 21.3% surgery vs. 47.9% SBRT (p=0.001) Yerokun et al. JTCVS 2017 Duke Cornwell et al. JTCVS 2017 VA system 6295 (NCDB) Wedge vs. SBRT 183 VATS lobe vs. SBRT 49.9% 5 yr OS 31.0% 5 yr OS (p<0.001) 82.8% 3 yr RFS 38.5% 3 yr RFS
7 Local Recurrence NO Recurrence Local Recurrence Regional Recurrence Distant Recurrence Surgery 77.7% 2.6% 7.0% 12.7% SBRT 66% 10.7% 10% 13.3%
8 Propensity Matched Comparison: Overall Survival Surgery: 55% 5-yr OS P< SRT: 29% 5-yr OS
9 Local Recurrence NO Recurrence Local Recurrence Regional Recurrence Distant Recurrence Surgery 77.7% 2.6% 7.0% 12.7% SBRT 66% 10.7% 10% 13.3% Hamaji et al ATS 2015 Kyoto 517 VATS lobectomy vs SBRT 48 mo LR 2% lobe vs. 24% SBRT (p<0.001)
10 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
11 Assumptions Made with SBRT Primary tumor control = local control Higher local failure has negligible impact on outcome Pathologic staging both in terms of intralobar disease and nodal disease adds negligible benefit relative to clinical staging Adjuvant therapy based on identification of occult disease provides little survival benefit
12 Radiation Oncology Consensus Recommendations Presented at ASTRO 2017
13 Assumptions Made with a Bad Wedge Resection Higher local failure has negligible impact on outcome Pathologic staging both in terms of intralobar disease and nodal disease adds negligible benefit relative to clinical staging Adjuvant therapy based on identification of occult disease provides little survival benefit
14 Quality Measures in Clinical Stage I Non-Small Cell Lung Cancer: Improved Performance is Associated With Improved Survival Pamela Samson, MD, MPHS, Traves Crabtree, MD, Stephen Broderick, MD, Daniel Kreisel, MD, PhD, A. Sasha Krupnick, MD G. Alexander Patterson, MD, Bryan Meyers, MD, MPH, Varun Puri MD, MSCI
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16 Medically operable High risk operable Medically inoperable Surgery? SBRT Complications Mortality Morbidity Cancer free survival Functional status Maintaining independence Quality of life
17 Current State of Affairs A minimally invasive, anatomic R0 resection, with adequate hilar and mediastinal lymphadenectomy remains the standard of care for early stage NSCLC SBRT should be viewed as an additional tool to be utilized by the physician treating NSCLC in inoperable and potentially high risk patients
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