Malignant Mesothelioma Current Approaches to a Difficult Problem. Raja M Flores, MD Thoracic Surgery Memorial Sloan-Kettering Cancer Center

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1 Malignant Mesothelioma Current Approaches to a Difficult Problem Raja M Flores, MD Thoracic Surgery Memorial Sloan-Kettering Cancer Center

2 Malignant Pleural Mesothelioma Clinical Presentation Insidious and nonspecific Dyspnea and chest pain Pleural effusion Cough Bilateral involvement ~ 5%

3 Malignant Pleural Mesothelioma Natural Progression Blunting costophrenic angle Pleura thickens encasing lung Pleural rind fixes the lung, diaphragmatic and intercostal muscles Frozen Chest Dyspnea out of proportion to radiologic findings Shunting, hypoxia, Infection, sepsis, death Adjacent Structures- Dysphagia, SVC syndrome, etc.

4 Survival by Presentation P=0.020 P=0.020 Flores et al JTO, (10):

5 Malignant Pleural Mesothelioma Diagnosis Thoracentesis (cytology) (26%) Closed pleural biopsy (21%) Open pleural biopsy / VATS (98%) Boutin and Rey, Cancer, 1994

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8 Malignant Pleural Mesothelioma Versus Adenocarcinoma Histology Meso Adeno PAS stain Neg Pos Mucicarmine Neg Pos Immunostaining CEA Neg Pos(75%) LeuM-1 Neg Pos Vimentin Pos Neg Cytokeratin Pos Neg Calretinin Pos Neg

9 adenocarcinoma mesothelioma

10 Malignant Pleural Mesothelioma is NOT a frozen section diagnosis

11 Malignant Pleural Mesothelioma Problems with Natural History Diagnostic problems - newer techniques of immunohistochemistry and electron microscopy Imprecise staging - Most studies prior to 1985 (No CT scan) Lack of a well defined, universally applicable, staging system

12 Malignant Pleural Mesothelioma T status T1- T1a- tumor limited to ipsilateral pleura, no involvement of visceral pleura T1b- involvement of visceral pleura T2- Involvement of diaphragmatic muscle, invasion of lung parenchyma T3- Locally advanced but potentially resectable tumor (i.e. pericardium) T4- Locally advanced but potentially unresectable tumor Rusch, Chest 1995

13 Malignant Pleural Mesothelioma N status N0- no regional lymph node involvement N1- Metastasis in the ipsilateral bronchopulmonary or hilar lymph nodes N2- Metastasis in the mediastinal lymph nodes N3- contralateral mediastinal or supraclavicular lymph nodes Rusch, Chest 1995

14 Malignant Pleural Mesothelioma AJCC Staging System Stage I Ia T1aN0M0 Ib T1bN0M0 Stage II T2N0M0 Stage III Stage IV Any T3M0 Any N1M0 Any N2M0 Any T4 Any N3 Any M1 Rusch, Chest 1995

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30 Malignant Pleural Mesothelioma Surgical Options Observation Talc Pleurodesis Palliative pleurectomy Pleurectomy/Decortication Extrapleural Pneumonectomy

31 Malignant Pleural Mesothelioma Supportive care only # patients median survival (mo.) Law Hulks Ruffie Lewis

32 Malignant Pleural Mesothelioma To treat or not to treat? Nihilistic view stems from: 1. Misconception about surgical mortality with extrapleural pneumonectomy 2. Poor overall survival based upon old retrospective studies on heterogeneous patient populations 3. Lack of experience with this uncommon malignancy

33 Malignant Pleural Mesothelioma Surgical History 1976 Butchart, Thorax, 31% mortality with EPP Dismal survival in surgically treated patients. Median survival of 6 months Poor patient selection Technique Diagnosis and Staging (no immunohistochemistry or EM) Imaging ( No CT scan)

34 Malignant Pleural Mesothelioma Mortality of Extrapleural Pneumonectomy # of patients Op. Mortality Balmer % Butchart % Faber % Rusch % Sugarbaker % Flores %

35 Malignant Pleural Mesothelioma Results in 115 EPP and 59 P/D Median survival (mo.) Stage I 30 Stage II 19 Stage III 10 Stage IV 8 Poor prognostic factors Advanced T status Advanced N status Nonepithelial histology Rusch, Ann Thorac Surg, 1999

36 Malignant Pleural Mesothelioma Results in 183 EPP (prognostic variables) Epithelial Histology N2 Status Resection margins 68% 2-year, 46% 5-year survival 31 patients with epithelial histology, negative N2 nodes, and Negative Margins 51 month median survival Sugarbaker, Flores, et al, JTCVS 1999

37 Malignant Pleural Mesothelioma Surgical and Multimodality Rx: Initial experience patients with pleural mesothelioma Epithelioid Sarcomatoid 47 Benign - 21 Surgery- Pleurectomy Additional therapy Adjuvant chemotherapy (cyclophosphamide, adriamycin) Radiation (external beam, I 125 seeds) Survival epithelioid MS 21, Sarcomatoid MS 12 McCormack et al. JTCVS 84: , 1982

38 Malignant Pleural Mesothelioma Brachytherapy and External Beam Radiotherapy Total 105 patients Surgery - Pleurectomy 54 patients implants and external beam ( 192 Ir, 32 P) 41 patients external beam Survival Radioactive implants : MS- 9.9 months No radioactive implants: MS months Local failure Myhalchek et al Endocurie Hypertherm Oncol 1989;5:245 abstr

39 Malignant Pleural Mesothelioma Intrapleural Cisplatin patients enrolled 28 had pleurectomy and IP (Cisplatin 100mg/m2 and mitomycin8mg/m2) 23 patients had IP and systemic chemotherapy Extrapleurals were excluded Rusch et al. J Clin Oncol 1994, 12:

40 Malignant Pleural Mesothelioma Intrapleural Cisplatin MS 17 months Complications 1 postoperative death (UGI bleed, then MSOF) 2 grade 4 renal failure 1 postoperative hemorrhage requiring a pneumonectomy 1 myocardial infarction Rusch et al. J Clin Oncol 1994, 12:

41 Malignant Pleural Mesothelioma Intrapleural Cisplatin Feasible Potential for serious toxicity Local control remains the main problem (80%) Rusch et al. J Clin Oncol 1994, 12:

42 Phase I Trial Sugarbaker 44/61 patients found to be resectable. Pleurectomy/Decortication and 1 hour cisplatin lavage. Dose escalation study (50-250). Operative Mortality 11% Overall Median survival 13 months Epithelioid 19 months Richards,2006 JCO;24:

43 Malignant Pleural Mesothelioma Local control Brachytherapy Photodynamic therapy Postoperative Intrapleural chemotherapy Intraoperative hyperthermic chemotherapy Immunotherapy Gene therapy Surgery is the Foundation

44 Malignant Pleural Mesothelioma Pattern of Recurrence Baldini et al. Ann Thorac Surg patients extrapleural pneumonectomy, CAP chemotherapy, external beam radiotherapy (3000 Gy) Most common site of recurrence was locally,16 patients (35%) total. 67% of all recurrences Problem Local recurrence after surgical resection.

45 Malignant Pleural Mesothelioma Local Control Rusch et al. A phase II trial of surgical resection (EPP) and high dose radiation for malignant pleural mesothelioma. JTCVS 2001:122: Gy to hemithorax 54 patients underwent EPP and adjuvant radiation.

46 Malignant Pleural Mesothelioma Local control Locoregional only 2 Distant only 30 Locoregional and distant 5 Adequate local control (~ 10%) achieved with EPP and high dose adjuvant radiotherapy (5400)

47 Malignant Pleural Mesothelioma Induction chemotherapy followed by EPP and high dose radiotherapy patients with stage III-IV disease Gemcitabine and cisplatin 4 cycles Repeat radiologic imaging Extrapleural pneumonectomy High dose external beam radiation (5400 rads) Flores et al. J Thorac Oncol 2006:

48 Flores et al. J Thorac Oncol 2006:

49 Malignant Pleural Mesothelioma Pemetrexed (ALIMTA) Multi-targeted antifolate Vogelzang et al, JCO Phase III study comparing Premetrexed/Cisplatin versus cisplatin alone. 448 patients randomized Primary endpoint: survival 80% power to detect a hazard ration of.67 based upon alpha= 0.05, 2 sided logrank test

50 Malignant Pleural Mesothelioma Pemetrexed (ALIMTA) Overall survival improved 12.1 versus 9.3 months Overall response rate 41% versus 17% Improved pulmonary function tests Improvement in dyspnea and pain

51 Malignant Pleural Mesothelioma Current Multimodality Approach Locally advanced (T3 or N2) Induction Chemotherapy Extrapleural Pneumonectomy Hemithoracic Radiation Flores et al. J Thorac Oncol 2006:

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67 Malignant Pleural Mesothelioma Surgical pitfalls and considerations Not mesothelioma Subclavian vessels Vena cavae Aorta and intercostal branches Esophagus Intrapericardial left, beware of main PA Recurrent laryngeal Cardiac tamponade Cardiac herniation Not repairing diaphragm, keep diaphragm low

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79 EPP versus P/D in MPM From , 663 consecutive patients Memorial Sloan-Kettering n=448 National Cancer Institute n=96 Karmanos Cancer Institute n=119 Median Follow up 17 months Flores et al JTCVS, : 620-6

80 EPP versus P/D in MPM EPP (n=385) P/D (n=278) p-value Age (mean) <0.001 Male Gender 316 (82%) 220 (79%) Epithelioid Histology 269 (69%) 178 (64%) Early Stage (I + II) 96 (25%) 98 (35%) <0.001 Flores et al JTCVS, : 620-6

81 EPP versus P/D in MPM Results Mortality EPP 7% (n=27/385) P/D 4% (n=13/278) Flores et al JTCVS, : 620-6

82 Proportion Surviving Survival by Histology p< Months Epithelioid n=447 MS 16 Non epithelioid n=216 MS 9

83 Proportion Surviving Survival by AJCC Stage P< Months stage I n=52 MS 38 stage III n=411 MS 11 stage II n=142 MS 19 stage IV n=58 MS 7

84 Proportion Surviving Survival by Procedure P< Months P/D n=278 MS 16 months EPP n=385 MS 12 months

85 Proportion Surviving Survival by Procedure Stage I p= Months P/D n=41 MS 46 months EPP n=11 MS 22 months

86 Proportion Surviving Survival by Procedure Stage II p= Months P/D n=57 MS 18 months EPP n=142 MS 19 months

87 Proportion Surviving Survival by Procedure Stage III p= Months P/D n=136 MS 13 months EPP n=275 MS 10 months

88 Proportion Surviving Survival by Procedure Stage IV p= Months P/D n=44 MS 9 months EPP n=14 MS 4 months

89 EPP versus P/D in MPM Multivariate Model Hazard Ratio Confidence Interval p value EPP 1.2 (1.0, 1.4) p=0.04 Non-epithelioid 1.5 (1.3, 1.8) p<0.001 Stage III/IV 1.9 (1.6, 2.3) p<0.001 Flores et al JTCVS, : 620-6

90 EPP versus P/D in MPM Conclusions Diagnosis requires special stains / EM Surgical mortality for EPP acceptable EPP and P/D similar survival type of surgery dictated by intra-operative findings If an R1 resection is not possible with P/D then an EPP is the procedure of choice If an R2 resection is inevitable at surgical exploration then an EPP should not be performed Decision about procedure type should consider multimodality therapy and protocol options

91 Local Recurrences Ipsilateral chest Pericardium Distant Recurrences Contralateral lung/pleura Peritoneum Peritoneum + chest Abdominal viscera Bone Brain Cutaneous (distant) Other Patterns of Recurrence EPP (n=219) n (%) 73 (33%) 68 (31%) 5 (2%) 146 (66%) 49 (22%) 57 (26%) 17 (8%) 12 (5%) 7 (3%) P/D (n=133) n (%) 86 (65%) 84 (63%) 2 (2%) 47 (35%) 14 (11%) 24 (18%) 1 4 (3%) (2%) Flores et al JTCVS, : 620-6

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93 Patient Characteristics Median Age 63 (range 26-93) Men/Women Laterality Right/Left History of asbestos Histology Epithelioid Non-epithelioid AJCC Stage I + II III + IV Adjuvant Therapy Chemotherapy Radiotherapy Both n (%) 536 (81%) / 127 (19%) 390 (59%) / 273 (41%) 380 (57%) 447 (67%) 216 (33%) 194 (29%) 469 (71%) 186 (28%) 152 (23%) 89 (14%)

94 EPP versus P/D in MPM The optimal procedure for surgical resection is controversial Studies fail to demonstrate significant differences in survival due to small numbers of patients A multi-institutional study was performed to increase statistical power Flores et al JTCVS, : 620-6

95 Malignant Pleural Mesothelioma Role of EPP Lung cancer study group: multi-institutional trial 83 patients Potentially completely resectable disease by CT FEV1 > 1 Medically suitable EPP -20, P/D - 26, limited or no resection - 37 Rusch et al JTCVS 1991;102:1-9

96 Malignant Pleural Mesothelioma Systemic control Chemotherapy Carboplatin / taxol (ineffective) Cyclophosphamide, adriamycin, cisplatin (CAP) (ineffective) Byrne et al, JCO, 1999 Gemcitabine and cisplatin 21 patients 4 cycles 47% response rate

97 Malignant Pleural Mesothelioma Role of EPP Recurrence free survival best for EPP Overall Survival (p>0.05) EPP: MS - 14 mos. P/D: MS - 10 mos. No surgery: MS - 7 mos. EPP better at local control but still not great, and systemic disease is seen in more cases Rusch et al JTCVS 1991;102:1-9

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