STAGE I INOPERABLE NSCLC RADIOFREQUENCY ABLATION OR STEREOTACTIC BODY RADIOTHERAPY?

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1 STAGE I INOPERABLE NSCLC RADIOFREQUENCY ABLATION OR STEREOTACTIC BODY RADIOTHERAPY? MICHAEL LANUTI, MD American Association of Thoracic Surgeons Minneapolis, MN 2013

2 STAGE I INOPERABLE NSCLC RADIOFREQUENCY ABLATION OR STEREOTACTIC BODY MICHAEL LANUTI, MD RADIOTHERAPY? American Association of Thoracic Surgeons Minneapolis, MN 2013

3 DISCLOSURES Financial None Device RF ablation in lung is considered off label 3

4 HIGH RISK STAGE I NSCLC TREATMENT ALTERNATIVES PERCUTANEOUS ABLATION RADIOFREQUENCY MICROWAVE CRYO Irreversible Electroporation (NanoKnife) STEREOTACTIC BODY RADIOTHERAPY (SABR) STEREOTACTIC ABLATIVE BODY RADIOTHERAPY SUBLOBAR PULMONARY RESECTION NO TREATMENT TIME (MO.) SURVIVAL % Raz D. et al., Chest

5 MODALITY BY ZONE FOR HIGH RISK STAGE I NSCLC PATIENTS Peripheral Zone: SBRT, Sublobar resection Ablation 5 Middle Zone: SBRT Sublobar resection +/- brachy Central Zone: IMRT, Proton SBRT Sublobar resection +/- brachy

6 MANAGEMENT OF STAGE I NSCLC 20-25% of NSCLC patients have stage I (T1/T2aN0) disease The gold standard for treatment of operable patients is surgical resection (anatomic resection segment vs lobe). For high-risk operable patients, typically due to compromised cardiopulmonary function, alternative surgical strategies (such as wedge resection, wedge + brachytherapy, segmentectomy) have been utilized. About 20-30% of patients are medically inoperable and need non-surgical therapy. 6

7 79yo smoker with symptomatic neurovascular disease, ECOG PS=2, DLCO=28% What treatment option would you offer? 7

8 RADIOFREQUENCY ABLATION BACKGROUND Radiofrequency Ablation (RFA) is a local ablative treatment for tumors Lung Application: 2000 Single institution case series Phase I/II study (ACOSOG Z4033) closed to accrual, 2-yr outcomes of high risk patients with stage IA 8

9 EXPECTED CT FINDINGS 1 year later 9 months later 6 months later 3 months later 1month later Before RF ablation 9

10 ELECTRODES Single, cluster or multi-tined array Uninsulated tip Temperature or Impedance based Covidien (Valley Lab) Angiodynamics (RITA) Boston Scientific

11 AUTHOR N AGE ABLATION MEAN TECHNOLOGY SIZE (CM) Beland Covidien 2.5 Stage I 79 ( ) Choe Stage I (20) 3 Lanuti 2009 Stage I REVIEW OF LITERAURE RFA TREATMENT OF STAGE I NSCLC Covidien 4.2 ± ± 1.2 Cryo 70 Covidien 2.0 ± 1.0 ( ) LOCAL DEATHS MED F/U OVERALL RECURRENCE (MO.) SURVIVAL 34/79 (43%) mo (DFS) 24% 14% yr 46% 3-yr 27% 12/38 (31%) 0 17±11 2-yr 78% 3-yr 47% 2-yr DFS 57% Lancioni Stage I 13 Hiraki Stage I 20 Pennathur Stage I 19 Simon Stage I 75 Sano Stage I 30 Dupuy Stage I 24 Fernando Stage I 9 Greico Stage I RITA 2.2 ± 1.6 3/ yr 48% 2-yr 75% Cancer sp 2-yr 92% 76 LeVeen Covidien 78 LeVeen RITA 69 Covidien 2.4 ( ) 7/20 (35%) yr 84% 3-yr 74% Cancer sp 93%, 83% 2.6 ( ) 8/19 (42%) yr 68% 3.0 ( ) NR yr 57% 3-yr 36% 4-yr 27% 63 Covidien LeVeen 2.1 ( ) NR 2* NR NR 76 Covidien 3.4 ( ) 2/24 (8.3%) yr 50% followed by XRT Met dz 9 75 LeVeen 2.8 ( ) 8/21 (38%) 1 14? Covidien Microwave? 12% < 3cm 33% > 3cm 17.6 mo (PFS) yr 70%

12 RFA TREATED STAGE I NSCLC N = 45 patients (55 ablations) RTOG 0236 Median survival = 44.3 mo (48 mo.) 3-Yr survival = 67% (55%) 5-Yr survival = 31% Patients at risk Lanuti M et al. Ann Thorac Surg, 2012 Mar;93(3):921-8

13 LOCOREGIONAL RECURRENCE SIZE THRESHOLD TUMOR SIZE (CM) # LESIONS % LOCOREGIONAL RECURRENCE < % > % 13 Lanuti M et al. Ann Thorac Surg, 2012 Mar;93(3):921-8

14 TUMOR SIZE IN ALL PATIENTS N = 45 patients Median surv. = 59 mo. Median surv. = 29 mo. Patients at risk TUMOR > 3 CM TUMOR < 3 CM Lanuti M et al. Ann Thorac Surg, 2012 Mar;93(3):921-8

15 RADIOFREQUENCY ABLATION LIMITATIONS Large size (> 3cm) Proximity to bronchovascular structures, esophagus, or trachea Regional nodal disease Most frequent complications are pneumothorax (16-54%) and pleural effusion (~19%) 15

16 FAILURE PATTERN AFTER INITIAL RFA 22% (8-43%) LOCAL FAILURE: re-growth in the ablated tumor bed or involved lobe REGIONAL FAILURE: ipsilateral hilar or mediastinal failure 7-25% DISTANT FAILURE: uninvolved lobe and extrathoracic sites NR 16

17 HIGH RISK STAGE I NSCLC TREATMENT ALTERNATIVES RADIOFREQUENCY ABLATION STEREOTACTIC BODY RADIOTHERAPY 17

18 79yo smoker, COPD, CAD, PVD, previous RUL, RLL lung cancer 2 Years Later Nov 2010: SBRT 4 x 12 Gy 18

19 19 TRADITIONAL APPROACH

20 WHAT IS STEREOTACTIC BODY RADIATION THERAPY (SBRT)? SBRT delivers tumor ablative doses with high precision in shorter time SBRT has unique biological characteristics high rates of tumor control. There are multiple, roughly equivalent treatment methods, often called by the brand names of the manufacturers, such as Axesse, CyberKnife, Novalis, Primatom, Synergy, True beam, TomoTherapy, or Trilogy. Proton beam is also being investigated with SBRT* *Westover K, et al. Proton Stereotactic Body Radiation Therapy for Medically Inoperable Stage I NSCLC. J Thor Onc

21 SBRT - INDICATIONS SBRT is rapidly replacing conventional radiation and offers therapy to patients who previously had no good treatment options NCCN Guidelines 2012 for use of SBRT: Medically inoperable N0 status Primary < 5 cm Peripheral location Zone of proximal bronchial tree 21

22 SBRT TREATMENT DOSE AND IMMOBILIZATION TECHNIQUE Dose prescription for peripheral tumors: Standard: 18 Gy x 3 = 54 Gy over ~10 days Alternatives: 12 Gy x 4 = 48 Gy or 10 Gy x 5 = 50 Gy Meticulous normal tissue sparing (esophagus, chest wall) Non-invasive immobilization +/- vacuum + abdominal compression 22

23 SBRT FOR MEDICALLY INOPERABLE STAGE I CLINCIAL TRIALS Baumann et al. 2009, JCO 27, 3290; Bradley et al. 2009, IJROBP Sept 30 Epub; Fakiris et al. 2009, IJROBP 76, 677; ; Grills et al. 2010, JCO 28, 928; Nagata et al. 2005, IJROBP 63, 1427; Timmerman et al. 2010, JAMA 303,

24 SIDE EFFECTS Grade 1-2 reactions: fatigue, rash, radiographic pneumonitis (common, self limited) Grade 3+ toxicity (pulmonary, musculoskeletal) is uncommon (5-10%) No mortality for peripheral tumors Fatal complications have been reported in cases with centrally located tumors (near major bronchus, heart, major blood vessels, trachea) treated to high doses (3 x 20 Gy) gentler fractionation schemes are being explored, such as 5 x Gy (RTOG 0813) 24

25 FAILURE PATTERN AFTER SBRT LOCAL FAILURE: re-growth in the ablated tumor bed or involved lobe 10% REGIONAL FAILURE: ipsilateral hilar or mediastinal failure 5-10% DISTANT FAILURE: uninvolved lobe and extrathoracic sites 22% 25

26 RFA vs. SBRT FOR STAGE I NSCLC Comparison RFA (Chan VO, 2011) SBRT (Onishi H, 2007) SBRT RTOG 0236 (Timmerman R 2010) Number Patients Local recurrence 22.2% 14-16% 9.6% Regional nodal recurrence NR 10-13% 4% 3-yr OS, (DFS) 65% 57% (77%) 56% (48%) 5-yr OS, (DFS) 58% (82%) 47% (73%) NR Median follow up 90 months 38 months 34 months Review of 21 studies (8) examining RFA in stage I NSCLC Chan et al. J Thorac Imaging Multi-institutional Japanese study, Onishi et al. J Thor Oncol, RTOG 0236 Timmerman et al. JAMA,

27 RADIOFREQUENCY ABLATION SUMMARY RFA is reasonable treatment option in high risk stage I NSCLC patients with peripheral lesions < 3cm. There is no consensus on treatment duration or number of treatments. RFA may be considered for tumors > 3cm in combination with radiation therapy. There is no consensus on sequence of therapy. RFA is not indicated for lesions adjacent to major bronchovascular structures, or esophagus. RFA can be used to salvage tumor recurrence after SBRT 27

28 STEREOTACTIC BODY RADIATION THERAPY SUMMARY Despite lack of phase III trials, SBRT is the preferred treatment for medically inoperable patients with peripheral T1/2N0 (< 5 cm) NSCLC Treatment consists of 3-5 treatments delivering a total dose of Gy with various techniques available Local control is 80-95% at 3 years, nodal failures are < 10%. Toxicity for peripheral tumors is uncommon ~ 5-10% risk of grade 3+ side effects A modified SBRT treatment schedule is recommended for tumors within 2cm of the proximal bronchial tree SBRT for operable patients remains investigational 28

29 CONCLUSIONS Pulmonary resection is the preferred approach for early stage disease. Provides tissue for molecular profiling and lymph nodes for staging. As there exist several treatment options for medically inoperable or high risk patients with stage I NSCLC, including sublobar resection, SBRT, and RFA, an individual patient should be carefully evaluated by a multidisciplinary team to identify an approach that minimizes locoregional failure as well as treatment complications and preserve overall survival. 29

30 Q50. In a medically inoperable 78yo, what is your preferred strategy for a 2cm tumor centrally located in the RLL where the PET is negative in the mediastinum? a. Refer to SBRT b. RFA c. Refer for conventional fractionated radiation therapy d. Mediastinoscopy followed by referral to SBRT

31 31

32 RFA vs. SBRT FOR STAGE I NSCLC Scorecard RFA SBRT Peripheral Stage I NSCLC 3cm 5 cm Local recurrence 22.2% 9.6% Regional nodal recurrence 10-25% 4%-25% Preservation of Lung Function Good Good 3-yr OS, (DFS) 65% 56% (48%) 5-yr OS, (DFS) 58% (82%) NR 90-day mortality Low Low Cost (Sher DJ et al. Int J Radiat Oncol Biol Phys. 2011) $5879 $11,014 *More cost effective QALY 32

33 PROSPECTIVE TRIALS OF SBRT OPERABLE STAGE I NSCLC RTOG NCT Phase II, stage I, SBRT (18 Gy x 3) Accrual goal 33 pts, started 2007, closed 2010 ROSEL Netherlands - NCT Phase III, stage IA, anatomical resection vs SBRT (20 Gy x 3 or 12 Gy x 5); Accrual goal 960 pts, started 2008, to be completed in 2015 (terminated) STARS MDACC/Accuray - NCT Phase III, stage I (<4cm), lobectomy vs CyberKnife (20 Gy x 3, 15 Gy x 4) Accrual goal 1030 pts, started 2008, to be completed in 2013 (terminated) RTOG 1021 / ACOSOG - NCT Phase III, stage IA/IB, SBRT (18 Gy x 3) vs sublobar (+/- brachytherapy) Accrual goal 420 pts, started 2011 to be completed in

34 COMPARISON OF ADVERSE EVENTS OF PROSPECTIVE TRIALS 34 Crabtree T et al. JTCVS 2013; 145:

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