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Presentation Transcript
slide1

Please note, these are the actual video-recorded proceedings from the live CME event and may include the use of trade names and other raw, unedited content. Select slides from the original presentation are omitted where Research To Practice was unable to obtain permission from the publication source and/or author. Links to view the actual reference materials have been provided for your use in place of any omitted slides.

case history
Case History

84-year-old with poor pulmonary function, smoking history, and recent thromboembolic event

Underwent serial CT scans with these findings

case history1
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

treatment options
Treatment Options

1. Observation?

2. Wedge Resection (VATS or Not)?

3. Radiofrequency Ablation?

4. Systemic Therapy?

Chemo or Oral TKI?

5. Radiosurgical Ablation?

subsequent course
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.

final question
Final Question

This pleural effusion should be:

Tapped

Drained and Treated

Evaluated with PET

Evaluated with Thoracoscopy

Treated with Chemotherapy

stereotactic rt in early stage lung cancer current and future applications
Stereotactic RT in Early Stage Lung Cancer Current and Future Applications???

Walter J Curran, Jr, MD

Executive Director

Winship Cancer Institute of Emory University

Group Chairman

Radiation Therapy Oncology Group

what is sbrt
What is SBRT?

Potentially highly effective

Potentially extremely dangerous

rt fractionation options
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
ablative treatments stereotactic must exclude normal tissue
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
slide14
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

:RTOG 0236

Robert Timmerman, MD; Rebecca Paulus, BS; James Galvin, PhD; Jeffrey Michalski, MD; William Straube, PhD; Jeffrey Bradley, MD; Achilles Fakiris, MD; Andrea Bezjak, MD; Gregory Videtic, MD;David Johnstone, MD; Jack Fowler, PhD; Elizabeth Gore, MD; Hak Choy, MD 

slide15

Compact Dose Deposition

Pulmonary Vein

Bronchus

Lung

Esophagus

Chestwall

Cord

Skin

slide16

Local Tumor Control Rate: RTOG 0236

  • 1 failure within PTV, 0 within 1 cm of PTV
  • 36 months local control = 98% (CI: 84 -100%)
slide17

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
other rtog phase i ii trials sbrt
Other RTOG Phase I/II Trials SBRT
  • RTOG 0618: SBRT for Operable Stage I NSCLC: Accrual complete
  • RTOG 0813: SBRT for Central Early Stage NSCLC: Nearly done

Future Plans

slide22

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%)
legitimate alternative to lobectomy for stage i nsclc
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
slide24
Phase III Study of Sublobar Resection (SR) versus SBRT in High Risk Patients with Stage I NSCLCZ4099 / 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.
slide25
Phase III Study of Sublobar Resection versus SBRT in High Risk Patients with Stage I NSCLCZ4099 / R1021
phase iii study of surgery vs sbrt in high risk pts with stage i nsclc z4099 r1021
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
what is the real debate question
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!
summary
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
sunday february 12 2012 hollywood florida

Sunday, February 12, 2012Hollywood, Florida

Co-Chairs

Rogerio C Lilenbaum, MD

Mark A Socinski, MD

Co-Chair and Moderator

Neil Love, MD

Faculty

Walter J Curran Jr, MD

David Jablons, MD

Mark G Kris, MD

Suresh Ramalingam, MD

Alan B Sandler, MD

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