Case History
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Transcript of Case History
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Case History
84-year-old with poor pulmonary function, smoking history, and recent thromboembolic event
Underwent serial CT scans with these findings
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CP1066773-47
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Case History
PET Positive there at SUV 10.1
OK elsewhere
FNA performed: Result C/W NSCLC
Patient considered unsuitable for lobectomy due to co-morbidities
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Treatment Options
1. Observation?
2. Wedge Resection (VATS or Not)?
3. Radiofrequency Ablation?
4. Systemic Therapy?
Chemo or Oral TKI?
5. Radiosurgical Ablation?
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Subsequent Course
The patient received SBRT at 18 Gy times 3 without difficulty. On six -month follow-up, CT chest revealed a new moderate-sized ipsilateral pleural effusion and “scarring” at the primary tumor.
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Final Question
This pleural effusion should be:
1.Tapped
2.Drained and Treated
3.Evaluated with PET
4.Evaluated with Thoracoscopy
5.Treated with Chemotherapy
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Walter J Curran, Jr, MDExecutive DirectorWinship Cancer Institute of Emory University
Group ChairmanRadiation Therapy Oncology Group
Stereotactic RT in Early Stage Lung Cancer Current and Future Applications???
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Technology Enabling SBRT
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What is SBRT?
• Potentially highly effective
• Potentially extremely dangerous
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RT Fractionation Options• Conventionally Fractionated RT
- small daily doses- go to very high cumulative doses- tolerable for most normal tissues
• Hypofractionated RT- larger daily doses (3-8 Gy)- used mostly for palliation
• Ablative RT (Stereotactic)- very high daily doses (8-20 Gy)- overwhelm tumor repair- causes “late” effects that may be intolerable
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Ablative Treatments (Stereotactic)Must Exclude Normal Tissue
• Requirements for ablative hypofractionation:–Abandon prophylactic treatment–Account for organ motion–Achieve sharper dose fall-off gradients to normal
tissue (mimic radiosurgery)
• These requirements need advanced technology
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Phase I Dose Response for Local Control
0
20
40
60
80
100
0 20 40 60 80
Total Dose (Gy) in 3 Fractions
17 Month
Local Control (%)
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• First North American cooperative group trial testing SBRT
• Non-small cell lung cancer - biopsy proven• T1, T2 ( 5 cm) and T3 (chest wall only, 5 cm),
N0, M0• Medical problems precluding surgery
(e.g. emphysema, heart disease, diabetes)• No other planned therapy
Robert Timmerman, MD; Rebecca Paulus, BS; James Robert Timmerman, MD; Rebecca Paulus, BS; James Galvin, PhD; Jeffrey Michalski, MD; William Straube, Galvin, PhD; Jeffrey Michalski, MD; William Straube, PhD; Jeffrey Bradley, MD; Achilles Fakiris, PhD; Jeffrey Bradley, MD; Achilles Fakiris, MD; Andrea Bezjak, MD; Gregory Videtic, MD;David MD; Andrea Bezjak, MD; Gregory Videtic, MD;David Johnstone, MD; Jack Fowler, PhD; Elizabeth Gore, Johnstone, MD; Jack Fowler, PhD; Elizabeth Gore, MD; Hak Choy, MD MD; Hak Choy, MD
:RTOG 0236:RTOG 0236:RTOG 0236:RTOG 0236
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Compact Dose Deposition
Pulmonary VeinPulmonary VeinPulmonary VeinPulmonary VeinBronchusBronchusBronchusBronchus
EsophagusEsophagusEsophagusEsophagus
CordCordCordCord SkinSkinSkinSkin
ChestwallChestwallChestwallChestwall
LungLungLungLung
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Local Tumor Control Rate: RTOG 0236
• 1 failure within PTV, 0 within 1 cm of PTV• 36 months local control = 98% (CI: 84 -100%)
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Regional and Disseminated Recurrence: RTOG 0236
• 2 patients have reported a regional failure, both after 2 years (2.8 and 3.0 years)
• Eleven patients (20%) have experienced disseminated failure
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n=55
Complete Response 23 (42%)
Partial Response 22 (40%)
Stable 9 (16%)
Not evaluated 1 (2%)
RTOG 0236 : Best Observed Response
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Post-SBRT Treatment Lung Reaction
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Grade 3-5 Toxicity: Location, Location
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• RTOG 0618: SBRT for Operable Stage I NSCLC: Accrual complete
• RTOG 0813: SBRT for Central Early Stage NSCLC: Nearly done
Other RTOG Phase I/II Trials SBRT
0
20
40
60
80
100
0 20 40 60 80
Total Dose (Gy) in 3 Fractions
17 Month Local Control
Future PlansFuture Plans
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Japanese Pooled Retrospective Experience with SBRT in
OPERABLE Patients
• Stage IA (n=63), 5y OS 75% (95% CI 63-87%)
• Stage IB (n=24), 5y OS 70% (95% CI 49-90%)
• Stage IA (n=63), 5y OS 75% (95% CI 63-87%)
• Stage IB (n=24), 5y OS 70% (95% CI 49-90%)
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Legitimate Alternative to Lobectomy for Stage I NSCLC??????
• Requirements:- Local control 90% or more at 5 years (actuarial)- Survival 60-80% at 5 years (actuarial)- Grade III or higher toxicity <15-20%- Ideally less invasive than thoracotomy- Ideally more convenient- Ideally less costly- All proven by prospective testing
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Phase III Study of Sublobar Resection (SR) versus SBRT in High Risk Patients with Stage I NSCLC
Z4099 / R1021
• Joint Trial between ACOSOG and RTOG• To ascertain whether patients treated by SBRT have 3-
year overall survival (OS) rate that is no more than 10% less than patients treated with Surgery.
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Phase III Study of Sublobar Resection versus SBRT in High Risk Patients with Stage I NSCLC
Z4099 / R1021
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Phase III Study of Surgery vs SBRT in High Risk Pts with Stage I NSCLC: Z4099 / R1021
• Non-Inferiority Survival Design: 80% +/-10%• 420 Pts to be Enrolled• Activated 3/11• Brachytherapy with Sublobar Resection
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What is the Real Debate Question?
• Are American Docs Disciplined Enough to Enroll and Randomize Patients into this Surgery vs SBRT Trial?
• Historic Record is Spotty• Likely Possible at Lower Velocity than Projected • NCI Early Stopping Rules will be an Issue!
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Summary
• SBRT is a new Standard for Medically Inoperable Stage I NSCLC
• Operable Patients: Data from Phase II and Phase III Trials Necessary
• Central Lesions: Data on RT Dose Pending
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Sunday, February 12, 2012Hollywood, Florida
Co-ChairsRogerio C Lilenbaum, MDMark A Socinski, MD
Co-Chair and ModeratorNeil Love, MD
Faculty
Walter J Curran Jr, MDDavid Jablons, MDMark G Kris, MD
Suresh Ramalingam, MDAlan B Sandler, MD