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AATS Focus on Thoracic Surgery : Lung Cancer November 16, 2012 Session II: Managing Small Tumors SBRT, RFA, Cryo and other Technologies. James D. Luketich MD, FACS Henry T. Bahnson Professor and Chairman, Department of Cardiothoracic Surgery

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AATS Focus on Thoracic Surgery :

Lung Cancer

November 16, 2012

Session II: Managing Small Tumors

SBRT, RFA, Cryo and other Technologies

James D. Luketich MD, FACS

Henry T. Bahnson Professor and Chairman,

Department of Cardiothoracic Surgery

University of Pittsburgh Medical Center


Presenter DisclosureJames D. Luketich MD The following relationships exist related to this presentation:

Accuray- Grant/Research Support


Background
Background

  • Lung Cancer is the most common cause of cancer related mortality in the United States

  • Surgical Resection is the standard of care for patients with resectable disease but the aging population and the lay public at large are seeking less morbid options

  • CT screening promises to identify smaller and smaller cancers whereby less than lobectomy may be quite an adequate oncologic option

  • Thoracic Surgeons must become leaders in performing this technology and in clinical trial design and outcomes


This is just another example of advanced diagnostics ct guided fna becoming destination therapy
This is Just Another Example of Advanced Diagnostics (CT-Guided FNA) Becoming Destination Therapy!

  • Cardiac Cath labs (need I say more?)

  • Esophagoscopy and now Endomucoosal Resection is the new paradigm for Barretts high grade dysplasia and early stage cancers

  • Stents, PDT, laser for palliation of esopahgeal cancer

  • Interventional angiography and now percutaneous stents for peripheral vascular and aortic diseases

  • Ultrasound guided biopsy and now US-guided RFA for liver tumors


This Innovative Approach is Working in Pittsburgh, Our Clinical Volume of ThoracicSurgical Procedures

2012 volumes:

> 15,000

1994 volumes

300 annually


Comparison of modalities for stage i nsclc
Comparison of Modalities for Stage I NSCLC Clinical Volume of Thoracic


External beam radiation for stage i lung cancer in high risk patients
External Beam Radiation for Stage I Lung Cancer in High Risk Patients

  • External beam radiation has been the standard treatment in non operable patients.

  • Kaskowitz reported 3 and 6 year survival of 19% and 3% in 53 Stage I patients

  • Sibley et al: 156 patients 2 and 5 year survival of 39% and 13%.


New options in high risk patients radiofrequency ablation
New Options in High Risk Patients: Radiofrequency Ablation Patients

  • Radio Frequency Ablationis a thermal energy delivery system which may provide an alternative approach in high risk patients

  • Radiofrequency energy generator is utilized to generate an alternating current

  • Alternating current generates ionic agitation creating heat

  • Delivered though a needle electrode.

  • Percutaneous insertion under CT guidance into the tumor


Multiple tines for applying Patients

RF energy



Results tumor response after rfa
Results- Tumor Response PatientsAfter RFA

Pre-RFA

1 month post-RFA

3 months post-RFA


Why are thoracic surgeons not doing rfa for lung tumors
Why Are Thoracic Surgeons not Doing RFA for Lung Tumors? Patients

  • Not recognizing the previous paradigms of advanced diagnostics becoming destination therapy

  • Practical Issues: No CT scan in the O.R.

    • Liver surgeons do them all with Ultrasound

  • NEED CT scan and there is a turf battle to access Interventional CT

    • Some centers allow thoracic surgeons

  • Thoracic surgeons have little experience with CT-guided diagnostic and interventional cases in training

  • Navigational bronchoscopy and flexible RFA or Cryo delivery systems will likely change all of this

  • Vascular Surgery field, Surgical Oncology, Urology, etc, etc, etc


Rfa patient characteristics
RFA : Patient Characteristics Patients

  • Total 19 medically inoperable patients with Stage I NSCLC

  • IA 13 patients; IB 6 patients

  • Size of tumor: Mean 2.6 cm (Range 1.6 -3.8)

  • Gender Male : Female - 8 : 11

  • Age Range – 68 – 88 Median – 78 yrs


Morbidity
Morbidity Patients


RFA Results : Tumors Rarely Just Disappear, Response Defined by a Decrease in Size, density and SUV. Intense Follow-up Required!

  • Complete Response 2 (10.5%)

  • Partial Response 10 (53% )

  • Stable Disease 5 (26%)

  • Progressive Disease 2 (10.5%)

  • Initial Response - 63.5 % (CI 38 – 84)

  • Initial Local Control - 89.5 % ( CI 67 – 99)


Rfa results progression
RFA Results : Progression by a Decrease in Size, density and SUV. Intense Follow-up Required!

  • Local Progression 42%

  • Median TTP - 27 months (CI 4 –NR)


Rfa results survival
RFA Results : Survival by a Decrease in Size, density and SUV. Intense Follow-up Required!

  • 13/19 patients alive at mean follow-up of 29 months (Range 6 – 51 m)

  • Estimated probability of overall 1 year survival – 95%

  • Median Survival has not been reached


Overall survival
Overall Survival by a Decrease in Size, density and SUV. Intense Follow-up Required!

Pennathur A, Luketich JD, Abbas GA et al. JTCVS 2007


Conclusions rfa
Conclusions: RFA by a Decrease in Size, density and SUV. Intense Follow-up Required!

  • Our preliminary experience suggests that Radiofrequency Ablation is safe in this high risk group of medically inoperable patients

  • Surgery continues to offer the best chance of cure for resectable patients.

  • Radiofrequency Ablation offers a good alternative in patients not fit for surgery

  • Larger Prospective studies and evolution of technique will improve outcomes of Radiofrequency Ablation


Stereotactic radiosurgery srs stereotactic body radiation therapy sbrt
Stereotactic Radiosurgery (SRS)/Stereotactic Body Radiation Therapy (SBRT)

  • Conventional RT associated with poor local control, up to 65 to 70 gy maximum dosing

  • Stereotactic Radiosurgery provides precise delivery of beams from multiple collimated paths

    • Maximizes the delivery to the tumor

    • Minimizes the exposure of normal tissue

    • Typically use 3-4 fractions

  • SRS allows up to 110gy, bioequivalent dosing compared to 60-70 gy with conventional RT


Fiducial placement
Fiducial Placement Therapy (SBRT)


Stereotactic radiosurgery system
Stereotactic Radiosurgery System Therapy (SBRT)

  • CyberKnife System: FDA approved frameless SRS delivery system

  • Lightweight linear accelerator mounted on a robotic arm

  • Image tracking system which monitors patient position during the treatment & adjusts the treatment beams accordingly



Baseline ct scan
Baseline CT Scan Therapy (SBRT)



American Association for Thoracic Surgery Therapy (SBRT)

87th Annual Meeting , Washington, DC

May 7, 2007

General Thoracic Surgery Scientific Session

Stereotactic Radio Surgery For The Treatment Of

Stage I Non-small Cell Lung cancer In

High-Risk Patients

Arjun Pennathur, James D. Luketich, Steve A. Burton,

Ghulam Abbas, Mang Chen, Dwight E. Heron,

William E. Gooding, Cihat Ozhasoglu,

Rodney J. Landreneau, Neil A. Christie

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania


Srs patient characteristics
SRS : Patient Characteristics Therapy (SBRT)

  • Total 21 medically inoperable patients with Stage I NSCLC

  • IA 14 patients; IB 7 patients

  • Size of tumor: Mean 2.24cm (Range 0.9 – 5.5 )

  • Gender Male : Female - 9 : 12

  • Age Range – 61 – 85 Median – 71 yrs


Results stereotactic radiosurgery

Complications Therapy (SBRT)

Fiducial Placement

Pneumothorax requiring chest tube 10 pts (47%)

- Prolonged Air Leak in 1 patient

- One patient admitted for COPD exacerbation

Mortality: 0

Results: Stereotactic Radiosurgery


Results initial treatment response
Results: Initial Treatment Response Therapy (SBRT)

  • All potentially Curative! 81%

    • Complete Response 7 ( 33%)

    • Partial Response 5 ( 24%)

    • Stable Disease 5 ( 24%)

  • Progressive Disease 3 ( 14%)

  • Not Evaluable 1 ( 5%)

  • Initial Response - 57 %

  • Initial Local Control - 81 %


Results progression
Results : Progression Therapy (SBRT)

  • Local Progression 9/21 (42%)

  • Median Time to Progression

    12.3 months (95% confidence interval 6.8 –Not reached)


Overall Survival Therapy (SBRT)


Summary of cyberknife results
Summary of Cyberknife Results Therapy (SBRT)

Initial local control : 81%

Local progression occurred in 42% of patients.

Median Time To Progression 12.3 months

11 patients are alive at median follow-up of 21 months

Median Survival: 26.4 months

Probability of 1 year survival in Stage 1 NSCLC was estimated to be 81% (CI 95% 57- 92)


Japanese multi institutional study
Japanese Multi-institutional Study Therapy (SBRT)

  • 245 patients with Stage I NSCLC

  • Stage I A 155, I B 90

  • Median Age 76 years

  • Median Biologically effective dose 108 Gy

  • Inoperable158 patients; Operable 87 patients

  • Median follow-up 24 months

Onishi H et al Cancer, 2004


Japanese study results progression
Japanese Study: Results Progression Therapy (SBRT)

  • Local progression (all Patients) 13.5%

  • BED <100 Gy: Local Progression 26.4%

    IA 16.3%; IB: 44%

  • BED >100 BED: Local progression 8.1%


Overall survival rate in medically operable patients
Overall survival rate in medically operable patients Therapy (SBRT)

Onishi H et al 2004


Japanese study results
Japanese Study: Results Therapy (SBRT)

  • Overall Survival 3 and 5 years was 56% and 47%

  • Survival was analyzed in terms of medical operability, BED, and Stage

  • Inoperable patients: Estimated overall 2 year survival was 65%

  • Operable patients

  • < 100 Gy 3 year survival 69%

  • >100 Gy:Estimated overall three and five year survival of 88%

    IA: 90% , I B 84%


CyberKnife SRS Multicenter Study for Stage I medically inoperablein Progress – Initial Results Presented at ASTRO 2012

University of Pittsburgh- PI site (PI: Luketich MD) and 16 other sites

Primary Aims:

  • To assess clinical response rate, local control, progression-free survival and overall survival, following CyberKnife SRS for patients with early stage NSCLC.

  • Peripheral lesion-accrual complete; Central-ongoing

    Dose : Peripheral Lesion: 60 Gy in 3 fractions

    Central Lesion: 48 Gy in 4 fractions


Microwave ablation for lung tumors
Microwave Ablation for Lung Tumors inoperable

  • Mechanism: Electromagnetic waves interact with molecules, leads to vigorous movement of water molecules and an increase in temperature to 120 degrees C and Cell Death

  • Potential Advantages

    • Higher Tumor temperature

    • Larger ablation volume

    • Faster ablation time

    • No grounding pads


Microwave ablation clinical studies
Microwave Ablation Clinical Studies inoperable

Limited clinical studies

50 patients (NSCLC n=27, small cell n=3; metastatic n=20)

Mean follow up 10 months

26% (13/ 50) of patients had residual disease at the ablation site, associated with size > 3 cm (P=.01).

Another 18 % (9 of 50) of patients had recurrent disease in the same lobe during follow-up

Overall Survival at 1,2,3 yrs = 65%,55%,45%

Wolf, Grand et al 2008


Percutaneous cryo ablation for lung cancer
Percutaneous Cryo ablation for lung cancer inoperable

Bronchoscopic cryoablation has been reported previously

Percutaneous cryoablation for lung tumors relatively newer Modality of ablation

A unique safety feature of cryotherapy is thought to be the preservation of the collagenous architecture

Limited clinical data is available


Findings of immediate and short term cryotherapy induced cavitation
Findings of immediate and short-term cryotherapy-induced cavitation

Wang et al; Radiology 2005


Transverse CT images obtained during cryotherapy for treatment of a small pulmonary mass and during follow-up

Wang et al; Radiology 2005


Percutaneous cryo ablation for lung cancer1
Percutaneous Cryo ablation for lung cancer treatment of a small pulmonary mass and during follow-up

  • Yamaguchi treated 160 patients with cryoablation (3 cycles of freezing -130 degree C

  • Reported results in 22 patients with Stage I NSCLC with more than one year follow-up

  • Pneumothorax in 28%

  • Follow-up median 23 months.

  • Local tumor progression was observed in one tumor (3%).

  • The overall 2- and 3-year survivals were 88% and 88%, respectively

Yamaguchi et al. PLoS ONE 2012


Local progression free interval after cryoablation
Local progression-free interval after cryoablation treatment of a small pulmonary mass and during follow-up

Yamauchi et al; PLoS ONE 2012


Conclusions
Conclusions treatment of a small pulmonary mass and during follow-up

  • Ablative Therapies for lung cancer are out of the research realm and up and running clinically, they are already competitive with wedge resection, for the most part there is little major morbidity

  • Thoracic Surgeons at large are grossly ill-equipped to compete in this arena and stand to lose the majority of early stage lung cancer referrals and metastasectomies as well

  • For the short run, Surgery continues to be the standard of care for resectable patients and for me and other gray hairs in the audience, we may be lucky enough to ride our current horse to the end of our careers

  • For the younger generation of CT surgeons, you must gain the ability to perform, not just observe and participate in these ablative clinical therapies

  • Prospective studies with long term follow-up are needed to further investigate the role of Stereotactic Radiosurgery

  • Because of cost and convenience, non-radiation ablative therapies may be a winner for Thoracic surgeons, especially if deliverable by navigational bronchoscopy in the O.R.


Conclusions 2
Conclusions-2 treatment of a small pulmonary mass and during follow-up

  • Do not follow the paradigm of surgeons before us who have ignored advanced diagnostic testing, it virtually always leads to definitive therapy eventually

  • Multiple examples:

    • Coronary revascularization with angioplasties and now stents, perc valves

    • Interventional vascular surgery and now many of our aortic colleagues are up and running

    • Endomucosal resection is becoming the standard for Barretts HGD and early stage esophageal cancer

    • Ultrasound guided RFA and cryo by surgical oncologists for liver neoplasms

  • WAKE UP CALL, Surgery will not be the first line therapy for early stage lung cancer within the next decade, this is already the case in some countries


Dinosaurs dominated the Earth for over 165 million years, Failed to Evolve to Changing Environment Led to Extinction!

Surgeons have dominated the treatment of Lung

cancer for only about 50 years……


This is the future of Open Surgery! Surgeons must evolve and develop less morbid procedures and embrace new technology!


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