Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA)...
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Transcript of Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA)...
![Page 1: Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA) Jeffrey D. Bradley, M.D. S. Lee Kling Professor of.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e245503460f94b12028/html5/thumbnails/1.jpg)
Approaching Early-Stage Disease: Strategizing Various Therapeutic
Options (Surgery vs. SBRT vs. RFA)
Jeffrey D. Bradley, M.D.S. Lee Kling Professor of Radiation Oncology
Alvin J Siteman Cancer Center
![Page 2: Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA) Jeffrey D. Bradley, M.D. S. Lee Kling Professor of.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e245503460f94b12028/html5/thumbnails/2.jpg)
Department of Radiation Oncology
Disclosures
• No financial relationships to disclose
• Chair of NRG Oncology Lung Cancer Committee (modest stipend)
![Page 3: Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA) Jeffrey D. Bradley, M.D. S. Lee Kling Professor of.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e245503460f94b12028/html5/thumbnails/3.jpg)
Department of Radiation Oncology
Case 1: LB
• Referred by cardiologist to Dr. Meyers for evaluation of a LUL lung nodule
• Recent drug-eluting stent placed in coronary artery. On clopidrogel
• FDG-PET showed moderately increased FDG uptake with max SUV of 2.5. No other findings
• PFTs showed FEV1 of 2.64 (83%) and FEV1/FVC of 74.7 (100%)
• CT-guided needle Bx: NSCLC favor SCCA
![Page 4: Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA) Jeffrey D. Bradley, M.D. S. Lee Kling Professor of.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e245503460f94b12028/html5/thumbnails/4.jpg)
Department of Radiation Oncology
LB SABR Images
![Page 5: Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA) Jeffrey D. Bradley, M.D. S. Lee Kling Professor of.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e245503460f94b12028/html5/thumbnails/5.jpg)
Department of Radiation Oncology
LB: 5 Year Follow-up Images
![Page 6: Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA) Jeffrey D. Bradley, M.D. S. Lee Kling Professor of.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e245503460f94b12028/html5/thumbnails/6.jpg)
Department of Radiation Oncology
Stage I NSCLC - Options
• Surgery• Lobectomy/ pneumonectomy• Sublobar resection
(segmentectomy, wedge)
• Radiation• SBRT• EBRT
• Observation
Medically operable
Medically inoperable
Borderline medically operable
Wouldn’t touch with a 10-foot pole
???
??
?
![Page 7: Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA) Jeffrey D. Bradley, M.D. S. Lee Kling Professor of.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e245503460f94b12028/html5/thumbnails/7.jpg)
Department of Radiation Oncology
Results of Surgery
• IASLC project – AJCC 7th addition• 100,869 patients from 46 sources from
19 countries• 67,725 NSCLC treated between 1990-
2000
• American College of Surgeons Z4032• Randomized Phase III study of sublobar
resection +/- brachytherapy in high-risk patients with NSCLC, 3 cm or smaller (ongoing)
![Page 8: Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA) Jeffrey D. Bradley, M.D. S. Lee Kling Professor of.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e245503460f94b12028/html5/thumbnails/8.jpg)
Department of Radiation Oncology
![Page 9: Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA) Jeffrey D. Bradley, M.D. S. Lee Kling Professor of.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e245503460f94b12028/html5/thumbnails/9.jpg)
Department of Radiation Oncology
![Page 10: Approaching Early-Stage Disease: Strategizing Various Therapeutic Options (Surgery vs. SBRT vs. RFA) Jeffrey D. Bradley, M.D. S. Lee Kling Professor of.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649e245503460f94b12028/html5/thumbnails/10.jpg)
Department of Radiation Oncology
Stage I NSCLC - OptionsStage I NSCLC - Options• Surgery
5y LR(LCSG 1995)
6%
18%
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Department of Radiation Oncology
ACOSCOG Z0432ACOSCOG Z0432
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Department of Radiation Oncology
Stereotactic Body Radiation Stereotactic Body Radiation TherapyTherapy
• Not a machine, but a type of radiation delivery.
• Stereotactic = precise positioning of the target volume in 3 dimensions.
• Has become synonymous with high dose per fraction.
• Different delivery techniques (arcs, static fields, protons)
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Department of Radiation Oncology
Loca
l Con
trol (
%)
0
25
50
75
100
Months after Start of SBRT0 6 12 18 24 30 36
0
25
50
75
100
0 6 12 18 24 30 36
Patientsat Risk 55 54 47 46 39 34 23
Fail: 1Total: 55
/ / / / / /// / / // / // / / / / / // / // // // //
Challenges?......What Challenges?RTOG 0236
• 1 failure within PTV, 0 within 1 cm of PTV
36 month
Primary tumor control = 98% (CI: 84-100%)
Lobar tumor control = 94%
Timmerman et al. JAMA 2010
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Department of Radiation Oncology
Thermal Ablation for lung cancersThermal Ablation for lung cancers
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Department of Radiation Oncology
Radiofrequency Ablation – Schneider et al. 2013Radiofrequency Ablation – Schneider et al. 2013
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Department of Radiation Oncology
Radiofrequency AblationRadiofrequency Ablation
• Follow up data are now projecting 5-year results for percutaneous thermal ablation
• Pneumothorax and chest drain rates are very high
• Local recurrence rates are poor (11-57%)• Industry and investigators are evaluating
bronchoscopic ablation techniques• Consider for SBRT failures?• First-line RFA cannot be recommended
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Department of Radiation Oncology
Randomized Trials comparing surgery to SBRT
• Lobectomy• Netherlands ROSEL Trial – closed due to lack of accrual• Accuray Cyberknife – closed due to lack of accrual
• High Risk• ACOSOG Z4099/RTOG 1021 – closed due to lack of
accrual• TMSC rejected amendment for cluster randomization
(5/9/13)
• One last hope?VA Medical System – VALOR TrialLobectomy vs SBRTDrew Moghanaki - PI
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Department of Radiation Oncology
Histological confirmation NSCLC
and confirmatio
n N2/N3 negative lymph nodes
Registration and
Randomization
ARM 1:Sublobar
Resection ± Brachythera
py (SR)
ARM 2:Stereotactic
Body Radiation Therapy
(SBRT) 18 Gy X 3 = 54
Gy
FOLLOW
UP
ACOSOG Z4099/RTOG 1021 ACOSOG Z4099/RTOG 1021 Phase III Trial for High-risk patientsPhase III Trial for High-risk patientsOpened June 2011Opened June 2011
Endpoint: 3 year OS
Accrual = 420 patients
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Department of Radiation Oncology
Histological confirmation NSCLC
and confirmatio
n N2/N3 negative lymph nodes
Registration and
Randomization
ARM 1:Sublobar
Resection ± Brachythera
py (SR)
ARM 2:Stereotactic
Body Radiation Therapy
(SBRT) 18 Gy X 3 = 54
Gy
FOLLOW
UP
ACOSOG Z4099/RTOG 1021 ACOSOG Z4099/RTOG 1021 Phase III Trial for High-risk patientsPhase III Trial for High-risk patientsOpened June 2011Opened June 2011
Endpoint: 3 year OS
Accrual = 420 patients
Closed
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Department of Radiation Oncology
SBRT vs. surgery for SBRT vs. surgery for clinical stage I NSCLCclinical stage I NSCLC
• Rough comparison of OS
cT1N0 cT2N0
3y OS 5y OS 3y OS 5y OS
Surgery AJCC 6th ed 71% 61% 46% 38%
AJCC 7th ed ~68% (1a)
~58% (1b)
53% (1a)
47% (1b)
~50% (2a)
~45% (2b)
~30% (3; ≥ 7 cm)
43% (2a)
36% (2b)
26% (3; ≥ 7 cm)
SBRT RTOG 0236 (60Gy/3)
(55.8%; T1/T2)
? (55.8%; T1/T2)
?
U. Indiana (60-66Gy/3)
~50% ~20% ~35% ?
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Department of Radiation Oncology
SBRT vs. surgery for SBRT vs. surgery for clinical stage I NSCLCclinical stage I NSCLC• Problem #1. . .
• Treatment groups are inherently different!
Vs.
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Department of Radiation Oncology
SBRT vs. surgery for SBRT vs. surgery for clinical stage I NSCLCclinical stage I NSCLC• Problem #2. . .
• Definition of “medically operable”?
???FEV1
Diabetes
Cardiac Co-morbidity
DLCOPerformance Status
Predicted Postoperative Pulmonary Reserve
SmokingFVC
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Department of Radiation Oncology
SBRT vs. surgery for SBRT vs. surgery for clinical stage I NSCLCclinical stage I NSCLC
• Medically operable• Uematsu, IJROBP 2001• Onishi, J Thorac Oncol 2007 / IJROBP 2010
• Medically inoperable / High risk operable• William Beaumont
• Grills, JCO 2010 - Wedge vs. SBRT• Cornell
• Parashar, Cancer 2010 – Wedge+Brachy vs. SBRT• Wash U
• Crabtree, J Thorac Cardiovasc Surg 2010 - Any surgery vs. SBRT
• Robinson, JTO 2012– Lobectomy/Pneumonectomy vs. SBRT
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Department of Radiation Oncology
SBRT vs. surgery for SBRT vs. surgery for clinical stage I NSCLCclinical stage I NSCLCMedically operable - Onishi, J Thorac Oncol 2007
• Median F/U 38 mo (2-128 mo)
OS by medical operability
3y ~40%, 5y 35%
3y ~70%, 5y 64.8%
All 257 pts
3y 5y
OS 56.8% 47.2%
CSS 76.9% 73.2%
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Department of Radiation Oncology
SBRT vs. surgery for SBRT vs. surgery for clinical stage I NSCLCclinical stage I NSCLCMedically operable - Onishi, J Thorac Oncol 2007
≥ 100Gy = 64.8%
5y overall survival 19.7% 53.9% sig
Control rates by BED10 for all pts
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Department of Radiation Oncology
What dose for peripheral lung cancers?
Medically operable - Onishi, J Thorac Oncol 2007
5y OS by BED10 in medically operable
<100Gy3y ~65%, 5y ~50%
≥100 Gy3y 80.4%, 5y 70.8%
BED = nd(1+d//)Schemes >100 Gy:16 Gy x 312 Gy x 410 Gy x 5
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Department of Radiation Oncology
SBRT vs. surgery for SBRT vs. surgery for clinical stage I NSCLCclinical stage I NSCLCMedically operable - Onishi, IJROBP 2010
• 87 pts w/medically operable, path proven T1 (n=65) or T2 (n=22) N0 NSCLC tx’d w/SBRT to BED > 100Gy from 1995-2004 at 14 Japanese institutions.• Subset from original 2007 study with longer follow-
up.• SBRT was 42-72.5 Gy / 3-10 fx via a variety of
stereotactic techniques.• No chemo
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Department of Radiation Oncology
SBRT vs. surgery for SBRT vs. surgery for clinical stage I NSCLCclinical stage I NSCLCMedically operable - Onishi, IJROBP 2010
• Median F/U 55 mo
Local control Overall survival
5y LC 86.7% (All) 5y OS 69.5% (All) CSS 76.l%
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Department of Radiation Oncology
Local Recurrence by Prescription Dose
• 2-year LR of 15% for low dose vs 4% for high dose• Grills IS et al. JTO 2012;7(9):1382-93• Elekta Consortium
1.0
0.8
0.2
0.4
0.6
0
0 4 6 82Time (Years)
Local
Recu
rren
ce
Rx BED10 ≥ 105 Gy
Rx BED10 < 105 Gy
p<0.001
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Department of Radiation Oncology
SBRT vs. surgery for clinical stage I NSCLCMedically operable - Onishi, IJROBP 2010
• Median F/U 55 mo
Local control Overall survival
5y LC 86.7% (All) 5y OS 69.5% (All) CSS 76.l%
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Department of Radiation Oncology
SBRT vs. surgery for SBRT vs. surgery for clinical stage I NSCLCclinical stage I NSCLCMedically inoperable / High risk operable - Grills, JCO
2010 • Median potential F/U 30 mo
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Department of Radiation Oncology
J Thorac Oncol 2013; 8:192-201
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Department of Radiation Oncology
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Department of Radiation Oncology
RTOG 0915 Overall Survival
Videtic et al. ASTRO and IASLC 2013
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Department of Radiation Oncology
Centrally-located lung cancersCentrally-located lung cancers
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Department of Radiation Oncology
Reported Toxicity for Central Lung Reported Toxicity for Central Lung CancersCancers
Timmerman R. et al JCO 2006
Timmerman et al. JCO 2006
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Department of Radiation Oncology
RTOG 0813 - SBRT Dose LevelsRTOG 0813 - SBRT Dose LevelsTrial completed, await f/uTrial completed, await f/u
Level 1 10 Gy x 5 50 GyLevel 2 10.5 Gy x 5 52.5 GyLevel 3 11 Gy x 5 55 GyLevel 4 11.5 Gy x 5 57.5 GyLevel 5 12 Gy x 5 60 GyDesign: Continual Reassessment Monitoring (CRM)Endpoints:
Phase I – Any Tx-related Grade 3 or greater toxicity
Phase II – 2-year primary tumor control rate
Phase I/II Dose Escalation study (N=94)
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Department of Radiation Oncology
WU Data on Local ControlWU Data on Local Control
Olsen, Robinson, Bradley et al. IJROBP 2011
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Department of Radiation Oncology
Conclusions: Surgery versus SBRTConclusions: Surgery versus SBRT
• Surgery is the gold standard for operable patients
• For inoperable or marginally operable patients with Stage I lung cancer, SBRT offers excellent local control and similar survival to surgical approaches
• SBRT results will be similar, regardless of delivery device. Differences are method of imaging, +/- fiducials, treatment time, etc.
• Randomized trials have failed to accrue for various reasons; patients and surgeons