ASBESTOS MANAGEMENT REVIEW A CRITICAL REVIEW OF MEDICAL MANAGEMENT IN MALIGNANT PLEURAL MESOTHELIOMA - AUSTRALIA, 2011

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1 ASBESTOS MANAGEMENT REVIEW A CRITICAL REVIEW OF MEDICAL MANAGEMENT IN MALIGNANT PLEURAL MESOTHELIOMA - AUSTRALIA, 2011 Dr Malcolm Feigen Senior Radiation Oncologist Radiation Oncology Centre Austin Health Heidelberg Repatriation Hospital 300 Waterdale Road, Heidelberg Heights PO Box 5444 Heidelberg West Vic 3081 INTRODUCTION: In regard to the Asbestos Management Review launched by the Australian Government in October 2010, I submit this document to review the medical management in Australia of mesothelioma, the cancer caused by exposure to asbestos that is almost invariably fatal. I wish to assess current management and recent advances in radiotherapy that should lead to significant improvements in treatment over the next few years. Australia is ranked as one of the countries with the world s highest incidence of mesothelioma. Treatment currently is decentralised with many cancer institutions providing various types of surgical excision and chemotherapy with drugs that provide only short term remission. This paper will discuss only malignant pleural mesothelioma and does not include data on peritoneal or other rarer mesothelioma subtypes. 1

2 A. THE MESOTHELIOMA BURDEN IN AUSTRALIA The incidence of mesothelioma in Australia has been rising steadily since the 1980s, with no falloff predicted until 2020 and some 700 new patients currently being diagnosed annually. 1 There is a latency interval of around 40 years following asbestos exposure, and after diagnosis the median survival is 7 months. The five year survival rate of 5%, one of the lowest for any cancer, has remained unchanged since the 1970s. 2 Mesothelioma is probably the only cancer whose cure rate has not significantly benefitted from medical advances in surgery, chemotherapy or radiotherapy, better screening tools and diagnostic imaging. With a new wave of cases being diagnosed after home renovations 3, the problem of finding a medical solution is becoming more pressing. B. MEDICAL MANAGEMENT OF MESOTHELIOMA - AUSTRALIA 2007 A review of the medical management of mesothelioma in Australia is attached in Appendix 1, Clinical Trials in Mesothelioma: Australia by Nowak, Feigen and Pavlakis, Chapter 30 in the book Mesothelioma from Bench Side to Clinic. 4 The current document will provide an update of progress over the past four years, since C. SURGERY Pleural mesothelioma originates in the pleura, the lining surrounding the lung, and the most radical operation to fully remove the disease is called an extrapleural pneumonectomy (EPP). This operation was first described in 1976, and consists of the en bloc resection of the lung and surrounding pleura, removal and reconstruction of the diaphragm and pericardium with synthetic mesh, and lymph node dissection. It has an operative mortality averaging 6% and morbidity of 50%. 5 The debate regarding whether there is a significant benefit from this operation compared to less radical resections has been ongoing for 35 years, and has recently been addressed by the MARS phase III randomised trial, where 50 patients in the United Kingdom underwent chemotherapy with or without an EPP. This study found that patients undergoing EPP had a lower one year survival rate and reduced quality of life compared to the chemotherapy alone arm. 6 At present in Australia only one thoracic surgical team performs EPPs, and other centres offer more palliative treatments including pleurectomy/decortication (where 2

3 the lung remains intact and only the pleura with varying amounts of macroscopic tumour are resected), or pleurodesis, a minor procedure where talc is instilled between the layers of the pleura to prevent re-accumulation of the pleural effusion. The group that has performed the largest number of mesothelioma resections is based at the Royal Prince Alfred Hospital/Baird Institute in Sydney, and recently analysed outcomes from 540 patients treated between 1984 and McCaughan and colleagues have performed about 100 EPPs. Without any further adjuvant treatment, mesothelioma grows back locally within the surrounding chest in 50% or more of these patients, and trials have shown this proportion can be lowered by giving postoperative radiotherapy to the hemithorax, but not with chemotherapy. 8 Most large Australian cancer centres provide pleurectomy/decortication or pleurodesis for their mesothelioma patients, and the majority of these receive postoperative, or occasionally preoperative, chemotherapy. Prophylactic radiotherapy is used in some centres who give three low dose fractions of electron beam radiotherapy that has a very limited benefit of preventing chest wall nodules growing through surgical scars. Any significant improvements in surgical results for mesothelioma likely relate to better patient selection or the addition of adjuvant radiotherapy or chemotherapy. 9 D. CHEMOTHERAPY Chemotherapy for mesothelioma patients is described by Nowak and others. 4,8 Since 2008 the combination of pemetrexed (Alimta) and cisplatin have been subsidised in Australia for palliation of mesothelioma and can be given by any medical oncologist. The standard course is six cycles every 3 weeks, but unfortunately the response rates are lower than in the other cancers for which these drugs are used, with 50% of patients having stable disease for an average of 6 months before progression, while 25% have a better response and 25% do not respond at all. Long-term survivors are rare, and in the series from Royal Prince Alfred Hospital only 2 of 100 patients who had this chemotherapy before their pneumonectomy were found to have no viable tumour on pathological examination. Unfortunately not all such patients are cured, and in my centre we have had one patient with a complete response to chemotherapy who recurred one year later and did not respond to the same drugs at the second attempt, dying of his disease a short time later. The two trials that are detailed in the Nowak article have recently been presented at international oncology conferences with negative results, and neither sunitinib 10 nor thalidomide 11 are any longer considered to be of value in mesothelioma patients, joining a growing list of many other potential chemotherapy and targeting agents 8. A recent analysis of the phase III double-blind placebo-controlled SAHA second line chemotherapy trial has found it does not meet the criteria for further development. 3

4 Vaccines, immunotherapy and gene therapies have made no clinical impact in this disease. Evaluating the response to therapy in mesothelioma is more difficult than in most other cancers, as the growth pattern is often diffuse and irregular, and not easily measurable. There are no specific serum biomarkers that consistently reflect tumour volume, and x-rays or CT scans cannot differentiate active from inactive disease, particularly after therapies that produce tumour fibrosis instead of shrinkage. Over the past decade, PET/CT scanning with 18 FDG, an isotope-labelled glucose marker that identifies functionally active tumour, has been widely adopted to select cancer patients free of metastatic spread who are suitable for radical surgery and to assess responses to chemotherapy. A semi-automated software program developed at Sir Charles Gairdner Hospital in Perth that is described near the end of the Nowak paper has been used to measure responses before and after chemotherapy, by assessing the total glycolytic volume of mesothelioma masses on serial PET scans. Unfortunately, this technique cannot be used in most other institutions as PET scans are not reimbursed for mesothelioma patients (unlike lung, head and neck, oesophageal, gastric, colorectal and ovarian cancers, melanoma and lymphoma), and PET scan assessment has not yet replaced CT scans in the appraisal of new drugs by national regulatory authorities. E. RADIOTHERAPY Clinical research conducted at Austin Health, a major public hospital in Melbourne, over the past eight years has established that radiation is the single most effective targeted cytotoxic agent against mesothelioma. Our early radiotherapy experience is presented in the Nowak article 4, and we have made substantial progress by adopting hemithoracic intensity-modulated radiotherapy and surpassing the barriers we set to avoid excessive toxicities. Most clinicians continue to regard mesothelioma as a radioresistant cancer, based on reports of old studies that used outdated techniques with two dimensional radiological planning and subjective response evaluation. Two meta-analyses examining the role of radical, palliative and adjuvant radiotherapy in mesothelioma have concluded that there was no significant benefit on length or rate of survival compared to other treatment modalities. No effect on long term symptom control was evident and radiation toxicity was not infrequent. 12,13 Consensus treatment guidelines recommend lower doses to avoid severe radiation toxicity, and warn against giving radiotherapy after pleurectomy/decortication. 14 4

5 Low dose radiotherapy is used in many Australian radiation oncology centres for prophylactic irradiation of chest wall procedural sites and for palliation of advanced disease, and very few patients receive high doses to produce long term palliation and maximise local control. None of these treatments has been shown to or improve survival, and the only randomised trials are three small series with chest wall radiotherapy that have found conflicting results, with a meta-analysis concluding they are of no benefit. 14,15 There has been a revolution in radiation oncology following recent major technological advances in radiotherapy planning software and hardware, 3D and 4D- CT simulation, functional imaging with PET/CT scans, computerised multileaf collimators, intensity-modulated radiotherapy (IMRT), image-guided adaptive radiotherapy and helical tomotherapy. Compared to conventional radiotherapy using combinations of photon and low energy electron beams, IMRT reduces dose inhomogeneities by conforming high doses to the target volume and spares adjacent normal tissues, allowing high radiation doses to be delivered with less toxicity and resulting in superior local control. 16 We at the Austin began a program in 2003 that used advanced technologies to target deposits of mesothelioma that were identified on PET scans, irradiating them to high doses while avoiding significant damage to adjacent normal tissues, and analysing post-treatment PET scans to identify patterns of failure. We encountered minimal radiation toxicities and therefore continued to administer the same high doses to larger volumes in patients who had good performance status with mesotheliomas that were confined within an acceptable volume, restricted to the whole of one hemithorax to avoid irradiating the opposite lung. Our series consisted of patients whose tumours were considered surgically unresectable and had mostly progressed on chemotherapy, and who were therefore unlikely to respond to any alternative therapy. Unlike other reported series, we reviewed our responses with PET instead of CT scans. The software program developed in Perth 17 was used to compare total glycolytic volumes on 18 FDG PET/CT scans before and after radiotherapy to calculate a 67% response rate, establishing conclusively that mesothelioma is sensitive to radiotherapy. Our high local control rate has not been equalled in any previous radiotherapy series. 18 We have to date treated 24 patients with high dose IMRT to the entire hemithorax, of whom none have encountered any significant respiratory or other toxicities. 19 Only one patient, our first case, had a prior EPP and two-thirds had only enough tumour removed to establish the diagnosis. On the international scene, only one other institution, the Memorial Sloan-Kettering Cancer Center in New York, is pursuing a similar program to ours, with comparable toxicity results. 20 Following international presentations of our findings, the Austin is being overwhelmed with many referrals to treat local and interstate mesothelioma patients on our program, with several approaches from overseas. 5

6 F. CONCLUSION The recent unexpected findings that radiotherapy is an effective and safe option for treating mesothelioma patients for palliation and optimising locoregional control will reduce the number of major resections performed in this disease and lead to reevaluation of the role and timing of chemotherapy. Current resources in Australia will not meet the anticipated demand for hemithoracic IMRT and there is urgent need for increased funding to promote one or more centres of advanced radiotherapy with state of the art technologies. To select appropriate patients, the subsidisation of PET scanning should be extended to include mesothelioma patients. 6

7 G. REFERENCES 1. Kao SC, Reid G, Lee K, Vardy J, Clarke S, van Zandwijk N. Malignant mesothelioma. Internal Med J 2010;40: Milano MT, Zhang H. Malignant pleural mesothelioma: a population-based study of survival. J Thorac Oncol 2010;5: Olsen NJ, Franklin PJ, Reid A et al. Increasing incidence of malignant mesothelioma after exposure to asbestos during home maintenance and renovation. Med J Aust 2011;195: Nowak AK, Feigen M, Pavlakis N. Chapter 30: Clinical Trials in Mesothelioma: Australia. In: Mesothelioma from Bench Side to the Clinic 2008; Editor Alfonso Baldi. Nova Science Publishers Inc. 5. Cao CQ, Yan TD, Bannon G, McCaughan BC. A systematic review of extrapleural pneumonectomy for malignant pleural mesothelioma. J Thorac Oncol 2010;5: Treasure T, Lang-Lazdunski L, Waller D et al. Extrapleural pneumonectomy versus no extrapleural pneumonectomy for patients with malignant pleural mesothelioma: clinical outcomes of the Mesothelioma and Radical Surgery (MARS) randomised feasibility study. Lancet Oncol 2011;12: Yan YD, Cao CQ, Boyer M et al. Improving survival results after surgical management of malignant pleural mesothelioma: an Australian institution experience. Ann Thorac Cardiovasc Surg 2011;17: Tsao AS, Wistuba I, Roth JA, Kindler HL. Malignant pleural mesothelioma. J Clin Oncol 2009;27: Treasure T, Utley M. Ten traps for the unwary in surgical series: a case study in mesothelioma reports. J Thorac Cardiovasc Surg 2010;133: Nowak AK, Millward M, Francis RJ et al. Final results of a phase II study of sunitinib as second-line therapy in malignant pleural mesothelioma. J Clin Oncol (ASCO Meeting Abstracts) 2010;28: Buikhuisen WA, Vincent A, Van Klaveren RJ et al. A multicenter, randomized phase III maintenance study of thalidomide (Arm A) vs. observation (Arm B) in patients with malignant pleural mesothelioma (MPM) after induction chemotherapy. J 7

8 Thorac Oncol 2011;6 6 Supplement 2: O30.05 S th World Conference on Lung Cancer Amsterdam July 3-7, Ung YC, Yu E, Falkson C et al. The role of radiation therapy in malignant pleural mesothelioma: a systematic review. Radiother Oncology 2006; 80: Chapman E, Garcia Dieguez M. Radiotherapy for malignant pleural mesothelioma. Cochrane Database Syst Rev 2010;4:CD Scherpereel A, Astoul P, Baas P et al. Guidelines of the European Respiratory Society and the European Society of Thoracic Surgeons for the management of malignant pleural mesothelioma. Eur Respir J 2010;35: McAleer MF, Tsao AS, Liao Z. Radiotherapy in malignant pleural mesothelioma. Int J Radiat Oncol Biol Phys 2009;75: Chi A, Liao Z, Nguyen NP et al. Intensity-modulated radiotherapy after extrapleural pneumonectomy in the combined-modality treatment of malignant pleural mesothelioma. J Thorac Oncol 2011; 6: Francis RJ, Byrne MJ, van der Schaaf AA et al. Early prediction of response to chemotherapy and survival in malignant pleural mesothelioma using a novel semiautomated 3-dimensional volume-based analysis of serial 18 F-FDG PET scans. J Nucl Med 2007;48: Feigen M, Lee ST, Lawford C et al. Establishing locoregional control of malignant pleural mesothelioma using high dose radiotherapy and 18 F-FDG PET/CT scan correlation. J Med Imaging Rad Oncol 2011;55: Feigen M, Knight S, Mitchell P, Wright G, Lee ST, Hamilton C. Controversies in the management of malignant pleural mesothelioma: the case for conservative surgery and high-dose hemithoracic radiotherapy. J Thorac Oncol 2011; 6 6 Suppl 2: MO07.14 S th World Conference on Lung Cancer Amsterdam July 3-7, Zauderer MG, Rimner A, Rosenzweig K et al. Creating a new multimodality treatment paradigm for malignant pleural mesothelioma using intensity modulated radiation therapy to the pleura. J Thor Oncol 2011;6 6 Suppl 2:MO07.13, S th World Conference on Lung Cancer Amsterdam July 3-7,

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