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William R. Silveira, M.D., Ph.D.
Department of Radiation OncologyOncology Care ProvidersCommunity Medical Centers
CyberKnife: A New Option In the Treatment of Lung Cancer
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Conventional radiation therapyDevelopment of radiosurgery • Stereotactic body radiosurgery (SBRT)
SBRT for inoperable patients• Early results & Phase II data• Cases/Examples
SBRT for operable patients
Early stage non-small cell lung cancer (NSCLC)
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The Gold Standard for Early Stage Lung Cancer: Surgery
Peripheral T1N0 NSCLC247 patientsLobectomy vs. Limited resection3 year OS ~75-80%Limited resection tripledLocoregional recurrence: 6% → 18%
Ginsberg et al. Annals of Thoracic Surgery (1995) 60:615-623
LCSG 821
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Does conventional radiation therapy help?
The Other End of the Spectrum: The Inoperable Patient
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Does conventional radiation therapy help?
The Other End of the Spectrum: The Inoperable Patient
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Linear Accelerator (Linac)
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Timmerman JCO 32: 2847-2854
2D/3D Conventional Radiation
60 Gy in 30 treatments
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Author Dose 5-year OS 5-year LC Intercurrent death
Dosoretz et al.
60-69 Gy 10% N/A 11%
Krol et al. 60-65 Gy 15% 25% 34%
Kaskowitz et al.
63 Gy 6% 0% 27%
Sibley et al. 55-70 Gy 13% N/A 43%
Graham et al.
60 Gy 13% N/A 28%
Conventional Radiation Therapy for Stage I/II NSCLC
Death: ~30% of distant metastases,~30% of local failure, ~30% intercurrent Sibley GS. Radiotherapy for patients with medically inoperable Stage I nonsmall cell lung carcinoma:
smaller volumes and higher doses--a review. Cancer 1998;82:433-438.
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The Richard L. Roudebush VAMC, Indianapolis, IN
RT ObsMedian Survival (mos) 20 14Death (from cancer) 43% 53%
Conventional RT for Early Stage (I/II) NSCLCIs it better than nothing?
CHEST 2002; 121:1155–1158
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The Richard L. Roudebush VAMC, Indianapolis, INRT Obs
Median Survival (mos) 20 14Death (from cancer) 43% 53%
Conventional RT for Early Stage (I/II) NSCLCIs it better than nothing?
CHEST 2002; 121:1155–1158
SEER (Chest 2005): 4,300 patientsRT improved MS vs. ObsStage I 14 → 21 monthsStage II 9 → 14 months
Didn’t help 5-year CSSStage I 15%Stage II 10%
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An Improvement with Hypofractionation
Slotman et al. (1996)• 31 pts, T1–2N0 tx w/ 4 Gy/day to 48 Gy • Peripheral lesions only, poor PS.• “Postage Stamp Field” – No nodes
• 3-year OS 42%• 3 year DFS 76%• 6% regional failure
Why? Radiobiology
48 Gy in 12 treatments
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Challenge: maximize dose, minimize toxicity
It’s more of a problem in the CNS
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Intracranial Radiosurgery – Gamma Knife
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Gamma Knife
Beautiful plans & excellent outcomes
Cumbersome & limited to the CNS
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What is a “CyberKnife?” Linear accelerator + robotic arm • Sub-mm accuracy• 6 degrees of freedom
Treat anywhere in the body• Stereotactic Body Radiation Therapy• SBRT or SABR
Inventor: Dr. John Adler, Stanford
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What is a “CyberKnife?” Linear accelerator + robotic arm • Sub-mm accuracy• 6 degrees of freedom
Treat anywhere in the body• Stereotactic Body Radiation Therapy• SBRT or SABR
Inventor: Dr. John Adler, Stanford
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CyberKnife by Accuray
Versatile – initially used for CNS disease
Outside the CNS: “There’s plenty of room at the bottom.”
-Richard Feynman
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Small beams, highly targeted
Multiple beams converge
Conformal/Steep fall-off
Hypo-fractionated
Account for motion• 6D skull, fiducials, synchrony,
X-sight spine, X-sight lung
SBRT (SABR) via CK: Another Way to give 60 Gy
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Team effort: from tumor board to
treatment delivery
Planning: Radiation Oncologist & PhD
physicist
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Author Dosing Local control 3-year OS
Onishi et al. Multiple 84% (3 yr) 57%Nyman et al. 15 Gy x3 80% (3.5 yr) 55%Uematsu et al. 50-60 Gy in 5-
1094% (5 yr) 66%
Timmerman et al.
T1: 20 Gy x3T2: 22 Gy x3
88% (3 yr) 43%
Early SBRT Data for Inoperable IA/B NSCLC
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BED >/= 100 Gy was superior• 5 year LC 57% vs. 95%• 5 year OS 30% vs. 71%
Dose ResponseOnishi et al. JTO (2007)
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And then came toxicity…
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Time to Grade 3 to 5 toxicity
Response & Toxicity JCO 24:4833-4839 (2006)
2 year freedom from toxicity: 83% vs. 54%11x higher risk
Phase II: 70 patients, T1-2 NSCLC, inoperable3 month response (PR + CR): 60%, 2-yr LC 95%Median OS 33 months, 2 year OS 55%
(8) Grade 3-4: pericardial effusions, decline in PFTs, pneumonia, effusions, apnea, skin reaction
(6) Grade 5 (death): 4 pneumonia, pericardial effusion, carina w/ hemoptysis
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First major phase II trialRTOG 02-36
Dose: 18 Gy x3T1-3N0 NSCLC, <5 cm, peripheral, 55 pt w/ medical conditions precluding surgery
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3-year Control Rates• Primary tumor control rate: 98%• Local control: 91%• Local & regional control: 87%
• Rate of disseminated failure: 22%• 15% for T1 vs. 47% for T2• 6% for SCC vs. 31% for non-SCC
JAMA. 2010 March 17; 303(11): 1070–1076.
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3-year Survival Rates•Disease-free survival 48.3%•Overall survival 55.8%(18% died of lung cancer)
•Median DFS 34 months31 months if T2
•Median OS 48 months34 months if T2
JAMA. 2010 March 17; 303(11): 1070–1076.
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Toxicity•Grade 3 toxicity: 13%• Severe cough not responsive to
intervention, dyspnea at rest, intermittent O2/steroids needed
•Grade 4 toxicity: 4%• Continuous oxygen or assisted ventilation
•Grade 5 toxicity: No deaths from toxicity
JAMA. 2010 March 17; 303(11): 1070–1076.
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Author Dose Local control 3-year OS
Timmerman et al. 2010
18 Gy x3 98% 56%
Baumann et al.
2009
15 Gy x 3 92% 60%
Ricardi et al. 2010
15 Gy x3 88% 57%
Nagata et al. 12 Gy x 3 98% 83%
Additional Phase II Data for Unresectable IA/B NSCLC
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Comparative Effectiveness of 5 Treatment Strategies for Early-Stage NSCLC in the Elderly (SEER)
IJROBP; 84 (5) 1060-1070
100%
80%
50%
40%
20%
Years
10,923 patients aged ≥66 years Stage IA-IB NSCLC
In the propensity-score matched analysis, survival after SBRT was similar to that after lobectomy
Lobectomy
SBRT
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Increased use of SBRT and a
decline (12%) in the proportion of
untreated elderly patients
Palma et al. JCO 2010
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Overall Survival is increasing (16%) for this
population with historically poor
outcomesPalma et al. JCO 2010
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RTOG 08-13: Phase II• Question: How to treat central tumors
safely?• Dose escalation trial• 9, 10, 11, 12 Gy x5
RTOG 09-15, Phase II• Question: Single session safety?• T1-2 inoperable, peripheral• Randomize: 34 Gy vs. 12 Gy x4• Winning arm to face 20 Gy x3
Pending Data For Inoperable Patients
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A few cases…
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53 M, COPD, cT1aN0M0 (1.3 cm), Stage IA, moderately differentiated adenocarcinoma of the RUL, FEV1 1.45 L, DLCO 23%.
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6 months post treatment
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67 F, COPD, pulmonary HTN, cT2aN0M0 (4.5 cm), Stage IB, poorly diff SCC of the LUL, 2L NC at baseline, wheelchair bound, FEV1 0.6 L, DLCO 11%
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2 months post treatment
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66 F, cT2aN0M0 (4.7 cm), Stage IB, poorly differentiated SCC of the LUL, FEV1 1.3 L, DLCO 50%.
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66 F, cT2aN0M0 (4.7 cm), Stage IB, poorly differentiated SCC of the LUL, FEV1 1.3 L, DLCO 50%.
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6 months post treatment
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12 months post treatment
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Metastatic disease (briefly)
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2 months post treatment
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Operable Early Stage NSCLC
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Retrospective Data: SBRT can approach limited resection & lobectomy
RTOG 06-18 Phase II, operable I/II NSCLC, 18 Gy x3• PRELIMINARY: 2 year LF (primary lobe) 19.2%, OS 84.4%
PHASE III Studies• ROSEL (Dutch): SBRT vs. Surgery, CLOSED EARLY• STARS (Accuray/MDACC): CK vs. Surgery CLOSED EARLY• ACOSOG 4099/RTOG 1021: Sublobar resection +/- brachy vs.
SBRT: CLOSED
Operable Patients
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Retrospective Data: SBRT can approach limited resection & lobectomy
RTOG 06-18 Phase II, operable I/II NSCLC, 18 Gy x3• PRELIMINARY: 2 year LF (primary lobe) 19.2%, OS 84.4%
PHASE III Studies• ROSEL (Dutch): SBRT vs. Surgery, CLOSED EARLY• STARS (Accuray/MDACC): CK vs. Surgery CLOSED EARLY• ACOSOG 4099/RTOG 1021: Sublobar resection +/- brachy vs.
SBRT: CLOSED
Operable Patients
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cT1-2aN0M0, operable NSCLC, 58 pts , SBRT vs. Lobectomy
SABR versus lobectomy for operable stage I NSCLC: A pooled analysis of 2 randomized trials
SBRT Lobectomy
Deaths 1 6 (1 of surgical comp)
3-year OS 95% 86%Local recurrence 1 N/A
Regional recurrence 4 (13%) 1 (4%)Distant metastases 1 2Grade 3/4 toxicity 10% 44%
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Inoperable patients: it’s an easy choice
Operable: Choose wisely – more data is needed• Low risk upfront, likely higher risk of regional recurrence• Consider: tumor size, pathology, full staging
Question remains: What is the role for systemic therapy?
Thoughts on SBRT for Early Stage NSCLC
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Surgery is the standard of care for early stage NSCLC
Conventional radiotherapy fairs poorly for early NSCLC
SBRT/SABR has proven to help tremendously• Higher effective doses to be delivered safely• Increased LC and OS for inoperable early stage NSCLC • Promising for operable early stage NSCLC
We have a lot to learn: Surgery vs. SBRT for operable pts.
Summary
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Oncology Care Providers, Drs. Brent Kane and Uma SwamyPhysics: Dr. Georg Weidlich, Ph.D.CCC Radiation Therapists & NursingLung Nodule ProgramCommunity Medical CentersAll of our referring physicians
Acknowledgements