ROBOT SURGEY AND MINIMALLY INVASIVE TREATMENT FOR LUNG CANCER

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ROBOT SURGEY AND MINIMALLY INVASIVE TREATMENT FOR LUNG CANCER Giulia Veronesi European Institute of Oncology Milan Lucerne, Samo 24 th - 25 th January, 2014

DIAGNOSTIC REVOLUTION FOR LUNG CANCER - Imaging advancement and early detection programs > more than 80% stage I and II - Less invasive treatment - Modern medicine: from the maximum tolerable treatment to the minimum effective treatment Stage of screening detected lung cancers COSMOS STUDY 17; 13% 7; 5% 9; 7% 95; 75% I II III IV

IMPROVEMENT OF DIAGNOSTIC TOOLS (SCREENING) = EVOLUTION OF SURGICAL TREATMENT Posterolateral Thoracotomy Lateral Muscle Sparing Thoracotomy VATS Approach Robotic Approach

VATS LOBECTOMY - Introduction of the minimally invasive approach marks one of the great advances in surgery and the advantages of VATS lobectomy are well accepted - Shortcomings: - limited visual information - limited freedom of movement - poor ergonomics - Challenge for surgeons and potential danger for patients - Significant learning curve to develop and maintain advanced skills The majority of advanced thoracoscopic cases are performed by a small number of surgeons

ROBOTIC SYSTEM Advantages: To overcome vats limitations, micromechanic and robotic technology was introduced in the mid-1990. Natural movements of the surgeon s hands are traslated into precise instrument movements inside the patient with tremor filtration. Three dimensional view offers a visual magnification that compensate the absence of haptic feedback Robotic system can made advanced thoracoscopic surgery accessible to surgeons who do not have advanced videoendoscopic training. Expand indications. Advantages for patients.

ROBOT vs. CONVENTIONAL VIDEOSURGERY INSTRUMENTS: ADVANTAGES AND DISADVANTAGES ADVANTAGES 1. Intuitive movements 2. Tremor filtration 3. Increased degrees of freedom 4. Motion scaling 5. Stereoscopic vision 6. Stable camera platform 7. Equivalence between the dominant and non-dominant hands 8. Motion analysis 9. Eye-hand-target alignment 10. Possibly shorter learning curve DISADVANTAGES 1. Costs 2. Loss of tactile feedback 3. Limited instrumentation available 4. Significant system set-up time 5. Need of at least one experienced assistant 6. Possible delayed response by the surgeon in case of catastrophic event As every evolving technology, robotic has many limitations, however entrance of competitor companies into the market and extended use of the robot will reduce costs

ROBOTIC LOBECTOMIES: CASE SERIES Lead Author Year No. Pts MOT LOS Compl. Mortality Conversion (min) (Days) (%) (%) RAL Park 2006 30 218 4.5 26 0 12 Melfi 2004 107 220 5 na 1 na Gharagozloo 2009 100 216 4 21 3 13 Veronesi 2010 54 224 4.5 20 0 9.4 Park, Melfi, Veronesi 2011 325 210 5 25 na 8 Veronesi 2012 91 213 5 20 0 10 CPRL / CPRS Dylewski 2011 165 / 35 90 3 26 0 1.5 Cerfolio 2011 106 /16 132 2 27 0 10 CPRL Complete port robotic lobectomy CPRS Complete port robotic segmentectomy RAL Robotic assisted lobectomy

ROBOTIC LOBECTOMIES Acceptable learning curve? Adequate oncological radicality?

Characteristic CASE CONTROL STUDY: Robotic lobectomy N=54 Open Lobectomy N=54 Men Women 38 16 34 20 0.41 <55 55-59 60-64 65+ 8 12 19 15 11 13 14 16 0.54 95 (19) 95 (49-141) 95 (20) 90 (66-169) 0.91 0.48 20 4 30 21 2 31 0.70 45 9 48 6 0.40 51 2 1 0 51 2 0 1 0.80 11 37 6 10 34 10 0.41 1 24 24 5 1 25 21 7 0.91 48 6 46 8 0.57 2 18 34 2 17 35 0.98 P value Sex Age (years) Objective: To evaluate learning curve and surgical radicality of robotic lobectomies in early stage NSCLC patients Method: 54 cases were performed by a single surgeon, using the da 4 arms Vinci system We used the propensity score matching, a statistical method that mimics randomization Control group (n=54) patients with the same characteristics submitted to open lobectomy FEV1% predicted Mean (standard deviation) Median (range) Lobe Lower Middle Upper Clinical tumor stage ct1 ct2 Clinical lymph node status cn0 cn1 cn2* cn3* ASA score 1 2 3 BMI Less than 18.5 18.5-25 25-30 30 or more Cardiac comorbidity No Yes Smoking status Never smoke Ex-smoker Current smoker

Learning curve The median time of robotic lobectomy decreased by 43 minutes between the first and the last two series of interventions (p=0.01) Overall it last in median 1 hour more than open surgery.

ROBOTIC LOBETCOMY Mean duration: 220 min Plateau reached after the first 18 cases Veronesi Innovation 2011 VATS LOBECTOMY Mean duration: 206 minutes Plateau reached after 50 cases HS Lee AATS 2009

LEARNING CURVE - SAFETY - RADICALITY ROBOT (54) OPEN (54) p value p value I II III I vs II+III II+III vs Open ------------------------------------------------------------------------------------------------------------------------------Complications 33% 22% 6% 19% 0.04 0.77 Operative time 260 213 235 154 0.02 <0.0001 Postop days 6 days 5 days 4 days 6 days 0.002 0.002 Median N LN 15 17 17 18 0.24 0.72 ---------------------------------------------------------------------------------------------------------------------------1) Learning curve include 18 pts, complications, postoperative days and operative time declines with experience 2) Postoperative stay was SHORTEN after robotic than open procedures 3) Complications and N lymph nodes removed were comparable in open and robotic lobectomies Veronesi 2010 JTCS

ROBOTIC LOBECTOMY FOR NON-SMALL CELL LUNG CANCER (NSCLC): LONGTERM ONCOLOGIC RESULTS B.J. Park, F. Melfi, P. Maisonneuve, L. Spaggiari, R Da Silva, G. Veronesi Journal of Thoracic and Cardiovascular Surgery 2011 Pathologic stage IA IB IIA IIB IIIA 325 176 72 41 15 21 (54%) (22%) (13%) (5%) (6%)

Ann Thorac Surg 2012;93:1598 165 Case-control evaluation: 53 Robotic and 35 VATS Similar surgical and postoperative outcomes Significantly shorter duration of narcotic use and earlier return to normal activities after robotic approach The ability to perform mediastinal lymph node dissection was similar in the VATS and robotic approaches, however robotics gave greater confidence in dissecting N1 lymph nodes adjacent to the pulmonary artery, allowing easier and safer passage of the stapler

ROBOTIC LOBECTOMIES: TECHNIQUES Number of arms: 3 versus 4 Insufflation C02 Timing of utility incision Site of utility incision and other ports

4 ARMS ROBOTIC LOBECTOMY: SURGICAL TECHNIQUE Lateral position Robot at the head posteriorly Four incisions including a small utility incision Camera arm: VII space mid axillary line No rib spreading Individual ligation of hilar elements

ROBOTIC SEGMENTECTOMY

J Thorac Cardiovasc Surg 2006;132:769-75 Nonrandomized study for patients with a peripheral ct1n0m0 NSCLC < 2 cm able to tolerate a lobectomy Sublobar resection group (n 305) compared with lobar resection group (n 262) Conclusion: Extended segmentectomy should be considered as an alternative for patients with ct1n0m0 NSCLC of 2 cm or smaller

Thoracoscopic segmentectomy is a safe and feasible procedure for experienced TS, comparing favorably with OS by reducing hospital length of stay

Robotic anatomic lung segmentectomy is feasible, safe and reproducible in different centres Robotic system, by improving ergonomic, surgeon view and precise movements, may make minimally invasive segmentectomy easier to adopt and perform

Robotic segmentectomy: technique

Clinical case GE, F, 65 yy, Non solid nodule 16 mm RUL, SUV 1.1 FEV1 103%, Dlco/va 73%

Patient position Wedge resection Measure of nodule size and distance from margin As the nodule was >1 cm and PET positive > lymph node sampling Frosen section of margins and nodule (tumor type) Robot docking

Lymph node sampling R10 R2/R4 7 Negative frozen section R Limited resection Hystology: Adenocarcinoma G1 lepidic pattern 12 mm, margin 15 mm postoperative stay: 3 days

PERSONAL EXPERIENCE Robotic lung resection N Tumor mean size Conversions Oncological reason Anatomical reason Bleeding Technical Other Complications Minor Major 200 20 mm (4-80mm) 19 (10%) 3 9 1 2 1 51 (25%) 41 10 Mean duration surgery Duration POS 170 minutes (last 30 cases) 4-5 days Learning curve 20 cases 80% of screen detected tumors resected with robotic approach

VATS AND ROBOTIC LYMPH NODE DISSECTION

RADICAL LYMPH NODE DISSECTION : GOLD STANDARD FOR THE TREATMENT OF LUNG CANCER Despite the recent results of the randomized trial that showed the adequacy of lymph node sampling, many surgeons favor complete resection of the mediastinal nodes. The randomized trial in fact only studied patients who were lymph node negative on frozen section for stations 4R, 7, and 10R on the right and for stations 5, 7, and 10L on the left. Darling GE American College of Surgery Oncology Group Z0030 trial. J Thorac Cardiovasc Surg 2011

A recent study from the STS database demonstrated that nodal Upstaging after lobectomy was significantly lower after VATS than after thoracotomy The study by Licht confirmed that N1 Upstaging was higher during Vats compared to open but number of station dissected and adjusted survival was not different

but is it feasible and safe during Robotic Lobectomy?

LEARNING CURVE - SAFETY - RADICALITY ROBOT (54) OPEN (54) p value p value I II III I vs II+III II+III vs Open ------------------------------------------------------------------------------------------------------------------------------Complications 33% 22% 6% 19% 0.04 0.77 Operative time 260 213 235 154 0.02 <0.0001 Postop days 6 days 5 days 4 days 6 days 0.002 0.002 Median N LN 15 17 17 18 0.24 0.72 ---------------------------------------------------------------------------------------------------------------------------1) Complications, postoperative days and operative time declines across the 3 robotic tertiles 2) Postoperative stay was SHORTEN after robotic than open procedures 3) N lymph nodes removed were comparable in open and robotic lobectomies

N1 AND N2 UPSTAGING DURING SURGERY Stage Robotic (Park) VATS STS OPEN STS --------------------------------------------------------------------------------------------------------Clinical Pathological Upstaging Upstaging Upstaging ---------------------------------------------------------------------------------------------------------N0 310 248 N1 14 56 13% 6.7% 9.3% N2 1 21 6.4% 4.9% 5% N1 Upstaging after robotic lobectomy is similar or even higher compared to upstaging after open lobectomy

J Thorac Cardiovasc Surg. 2011 Retrospective results : 107 completely portal (no utility incision) 4-arm robotic lobectomies, compared to 318 propensity-matched cases undergoing nerve- and rib-sparing thoracotomy. Robotic group : lower morbidity and mortality, improved mental quality of life and shorter HS than the thoracotomy group. It shows similar total number of lymph nodes removed or in the median number of N2 or N1 lymph node stations assessed Cerfolio et al included cases with large tumours, N1 disease, or previous chemoradiation for nodal involvement. They have extended indications for minimally invasive lung cancer resection, as the robotic approach allows R0 resection for tumours up to 9.4 cm, and outstanding mediastinal and lymph node resection.

COSTS 30% VATS lobectomy from The Society of Thoracic Surgeons voluntary database 6% VATS lobectomy from nonvoluntary databases Higher costs of Robotics versus Vats will be justified if robotics will allow an higher transition from thoracotomy to minimally invasive surgery for early stage lung cancer

We analysed a consecutive series of clinical N0 screening detected lung malignancy to identify predictive criteria of nodal involvement. Preoperative PET scan c-stage T1-2N0M0 lung cancer 10mm / SUV <2 10mm / SUV 2 >10mm / SUV < 2 >10mm / SUV 2 < 3 cm Ø Anatomical resection + lymphadenectomy SCREENING pn0 pn+ (91) 25 0 23 0 14 0 29 6 (17.1%) no prior treatment CLINIC pn0 pn+ (159) 14 0 9 0 20 1 (2.3%) 116 33 (22.2%) In cases of tumors larger than 1 cm and PET positive 17 to 22% 22% had hilar or mediastinal lymph node unexpected metastases

IEO Randomised Trial limited resection vs standard lobectomy Preoperative criteria: Suspicious or proven NSCLC; Lung nodules 2 cm; N0 at preoperative PET/CT; N0 prior treatment for lung cancer Intraoperative criteria: Diagnosis of NSCLC; Lesion suitable for a limited resection; No lymph node at FS when size > 1 cm and SUV positive; Negative margins Stratification Nodule Size ( 1 versus > 1 cm) PET on nodule (positive versus negative) Wedge or segmentectomy R Lobectomy with SND

SUMMARY 1 Randomized controlled trials are not available Robot-assisted approaches to lung cancer resection and lymph node dissection appear to offer comparable radicality and safety to VATS/open surgery. Learning curve is around 18 cases More intuitive movements, greater flexibility and high-definition threedimensional vision, render surgery easier for the surgeon, with shorter learning curve than VATS Radicality obtained at mediastinal level will probably extend indication of minimally invasive procedures to N1-N2 disease and post chemotherapy lobectomies. N1 upstaging after robotics is similar to open surgery High capital and running costs, limited instrument availability and long operating times are important disadvantages

SUMMARY 2 LR CONCLUSIONS SUMMARY Limited resections seems indicated in stage 1a disease and RCT are ongoing Vats anatomical segmentectomy are rarely reported due to demanding technique Early data show that robotic segmentectomy is feasible, safe and reproducible in different centres Robotic offers an excellent 3D view of the operative field and high precision of robotic Instruments, thus major bleeding is rare The four arm technique offers the possibility of an easy control of major vessel bleeding with the free Cadiere, and represents a safe procedure for major minimally invasive lung resection