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AATS Focus on Thoracic Surgery : Lung Cancer November 16, 2012

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

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  1. 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

  2. Presenter DisclosureJames D. Luketich MD The following relationships exist related to this presentation: Accuray- Grant/Research Support

  3. 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

  4. 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

  5. This Innovative Approach is Working in Pittsburgh, Our Clinical Volume of ThoracicSurgical Procedures 2012 volumes: > 15,000 1994 volumes 300 annually

  6. Comparison of Modalities for Stage I NSCLC

  7. 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%.

  8. New Options in High Risk Patients: Radiofrequency Ablation • 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

  9. Multiple tines for applying RF energy

  10. CT Guided Ablation

  11. Results- Tumor ResponseAfter RFA Pre-RFA 1 month post-RFA 3 months post-RFA

  12. Why Are Thoracic Surgeons not Doing RFA for Lung Tumors? • 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

  13. RFA : Patient Characteristics • 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

  14. Morbidity

  15. 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)

  16. RFA Results : Progression • Local Progression 42% • Median TTP - 27 months (CI 4 –NR)

  17. RFA Results : Survival • 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

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

  19. Conclusions: RFA • 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

  20. 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

  21. Fiducial Placement

  22. Stereotactic Radiosurgery System • 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

  23. Stereotactic Radiosurgery

  24. Baseline CT Scan

  25. Post Stereotactic Radiosurgery

  26. American Association for Thoracic Surgery 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

  27. SRS : Patient Characteristics • 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

  28. Complications 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

  29. Results: Initial Treatment Response • 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 %

  30. Results : Progression • Local Progression 9/21 (42%) • Median Time to Progression 12.3 months (95% confidence interval 6.8 –Not reached)

  31. Overall Survival

  32. Summary of Cyberknife Results 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)

  33. Japanese Multi-institutional Study • 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

  34. Japanese Study: Results Progression • 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%

  35. Overall survival rate in medically operable patients Onishi H et al 2004

  36. Japanese Study: Results • 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%

  37. 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

  38. Microwave Ablation for Lung Tumors • 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

  39. Microwave Ablation Clinical Studies 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

  40. Percutaneous Cryo ablation for lung cancer 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

  41. Findings of immediate and short-term cryotherapy-induced cavitation Wang et al; Radiology 2005

  42. Transverse CT images obtained during cryotherapy for treatment of a small pulmonary mass and during follow-up Wang et al; Radiology 2005

  43. Percutaneous Cryo ablation for lung cancer • 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

  44. Local progression-free interval after cryoablation Yamauchi et al; PLoS ONE 2012

  45. Conclusions • 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.

  46. Conclusions-2 • 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

  47. 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……

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

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