Overview
Mesothelioma is a rare cancer that is estimated to occur in approximately 2500 people in the United States every year.1,2 These NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) focus on malignant pleural mesothelioma (MPM), which is the most common type; mesothelioma can also occur in other sites (e.g., peritoneum, pericardium, tunica vaginalis testis). The disease is difficult to treat;
NCCN Clinical Practice Guidelines in Oncology for Malignant Pleural Mesothelioma
NCCN Categories of Evidence and Consensus
Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.
Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate.
All recommendations are category 2A unless otherwise noted.
Clinical trials: NCCN believes that the best management for any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. median overall survival is only approximately 1 year. MPM occurs mainly in older men (median age, 72 years) who have been exposed to asbestos, although it occurs decades after exposure (20-40 years later).3,4
The incidence of MPM is leveling off in the United States, because asbestos use has decreased since the 1970s; however, the United States still has more cases than anywhere else in the world.5,6 Although asbestos is no longer mined in the United States, it is still imported.6 The incidence of MPM is increasing in other countries, such as Russia, Western Europe, China, and India.1,5,7-11 Mortality rates from MPM are highest in the United Kingdom, Netherlands, and Australia, and are increasing in several other countries, such as Japan, Argentina, and Brazil.7 Although most mesothelioma is linked to asbestos exposure, reports suggest that it may also be caused by radiotherapy,12-16 and recent data suggest that erionite (a mineral that may be found in gravel roads) is associated with the disease.17 Genetic factors may also play a role in MPM.18
The histologic subtypes of mesothelioma include epithelioid (most common); biphasic or mixed; and sarcomatoid.2 Patients with epithelioid histology have better outcomes than those with either mixed (biphasic) or sarcomatoid histologies. Some patients who have been exposed to asbestos only have benign pleural disease, although they may have significant chest pain.19,20 Although screening for mesothelioma has been studied in high-risk patients (i.e., those with asbestos exposure), these guidelines do not currently recommend screening for MPM.21-23 Note that the recent results about screening for lung cancer with low-dose computed tomography do not apply to malignant mesothelioma.24 The NCCN Non-Small Cell Lung Cancer panel developed this guideline for MPM in 2010.
NCCN Clinical Practice Guidelines in Oncology: Malignant Pleural Mesothelioma Version 2:2012
Version 2.2012, 10-04-11 ©2012 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®
Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 10, 1; 10.6004/jnccn.2012.0006
NCCN Clinical Practice Guidelines in Oncology: Malignant Pleural Mesothelioma Version 2:2012
Version 2.2012, 10-04-11 ©2012 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®
Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 10, 1; 10.6004/jnccn.2012.0006
NCCN Clinical Practice Guidelines in Oncology: Malignant Pleural Mesothelioma Version 2:2012
Version 2.2012, 10-04-11 ©2012 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®
Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 10, 1; 10.6004/jnccn.2012.0006
NCCN Clinical Practice Guidelines in Oncology: Malignant Pleural Mesothelioma Version 2:2012
Version 2.2012, 10-04-11 ©2012 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.
Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 10, 1; 10.6004/jnccn.2012.0006
NCCN Clinical Practice Guidelines in Oncology: Malignant Pleural Mesothelioma Version 2:2012
Version 2.2012, 10-04-11 ©2012 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.
Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 10, 1; 10.6004/jnccn.2012.0006
NCCN Clinical Practice Guidelines in Oncology: Malignant Pleural Mesothelioma Version 2:2012
Version 2.2012, 10-04-11 ©2012 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.
Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 10, 1; 10.6004/jnccn.2012.0006
NCCN Clinical Practice Guidelines in Oncology: Malignant Pleural Mesothelioma Version 2:2012
Version 2.2012, 10-04-11 ©2012 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.
Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 10, 1; 10.6004/jnccn.2012.0006
NCCN Clinical Practice Guidelines in Oncology: Malignant Pleural Mesothelioma Version 2:2012
Version 2.2012, 10-04-11 ©2012 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.
Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 10, 1; 10.6004/jnccn.2012.0006
NCCN Clinical Practice Guidelines in Oncology: Malignant Pleural Mesothelioma Version 2:2012
Version 2.2012, 10-04-11 ©2012 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®.
Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 10, 1; 10.6004/jnccn.2012.0006
Diagnosis
Patients with suspected MPM often have symptoms (e.g., dyspnea and chest pain) and can also have pleural effusion, cough, chest wall mass, weight loss, fever, and sweating.25 In patients with recurrent pleural effusion and/or pleural thickening, the recommended initial evaluation for suspected MPM includes 1) CT of the chest with contrast, 2) thoracentesis for cytologic assessment, and 3) pleural biopsy (e.g., thoracoscopic biopsy [preferred]; see Initial Evaluation, page 28).26,27 However, cytologic samples are often negative even when patients have MPM. Talc pleurodesis or pleural catheter may be needed for management of pleural effusion.28-31 Serum mesothelin-related peptide levels may also be assessed, and these levels may correlate with disease status32-34; osteopontin does not seem to be as useful for diagnosis.35-39
It can be difficult to distinguish malignant from benign pleural disease and also to distinguish MPM from other malignancies, such as metastatic adenocarcinoma, sarcoma, or other metastases to the pleura.8,40,41 On CT, thymoma can mimic MPM; however, pleural effusion does not typically occur with thymoma. Diagnosis is difficult, because cytologic samples of pleural fluid are often negative.42 Calretinin, WT1, D240, and cytokeratin 5/6 are useful immunohistochemical markers for diagnosing MPM, as are markers that typically are positive in pulmonary adenocarcinoma and negative in mesothelioma (e.g., thyroid transcription factor 1, carcinoembryonic antigen; see also the College of American Pathologists' Protocol for the Examination of Specimens from Patients with Malignant Pleural Mesothelioma at http://www.cap.org/apps/docs/committees/cancer/cancer_protocols/2011/Mesothelioma_11protocol.pdf).40
Management
These guidelines recommend that patients with MPM be managed by a multidisciplinary team with experience in MPM. Treatment options for patients with MPM include surgery, radiotherapy, and/or chemotherapy2; select patients (clinical stages I-III, medically operable, good performance status) are candidates for multimodality therapy.43-47 Definitive radiotherapy alone is not recommended for unresectable MPM (see the algorithm).48,49 Appropriate patients should be evaluated by radiation oncologists, surgeons, medical oncologists, diagnostic imaging specialists, and pulmonologists to assess whether they are candidates for multimodality treatment.
Pretreatment evaluation for patients diagnosed with MPM is performed to stage patients and assess whether they are candidates for surgery. This evaluation includes chest and abdominal CT with contrast and 18F-fluorodeoxyglucose (FDG)-PET/CT. Video-assisted thoracic surgery can be considered if contralateral disease is suspected. If possible, PET/CT scans should be obtained before pleurodesis, because talc causes pleural inflammation, which can affect the FDG avidity (i.e., false-positive result).50-52 If surgical resection is being considered, mediastinoscopy or endobronchial ultrasonography fine-needle aspiration of the mediastinal lymph nodes is recommended.53,54 The following tests may be performed if suggested by imaging: 1) laparoscopy to rule out transdiaphragmatic extension (e.g., extension to the peritoneum indicates stage IV [unresectable] disease) and 2) chest MRI.
Staging is performed using the International Mesothelioma Interest Group TNM staging system, which was approved by the American Joint Committee on Cancer.55 Most patients have advanced disease at presentation. Accurately staging patients before surgery is difficult, and understaging is common with PET/CT.52,56 However, PET/CT is useful for determining whether metastatic disease is present.56,57 Patients with clinical stage I through III MPM can be evaluated for surgery using pulmonary function tests, perfusion scanning (if FEV1 < 80%), and cardiac stress tests (see Surgical Evaluation, page 29). Surgical resection is recommended for patients with clinical stage I through III MPM who are medically operable and can tolerate the surgery. Trimodality therapy (i.e., chemotherapy, surgery, and radiotherapy) is recommended for patients with clinical stages I through III MPM who are medically operable. Chemotherapy alone is recommended for those who are not operable, those with clinical stage IV MPM, or those with sarcomatoid histology (see Chemotherapy, page 31).
Pleural effusion can be managed using thoracoscopic talc pleurodesis or placement of a drainage catheter.31,58-60 Therapeutic thoracentesis can also be used to remove pleural fluid and thus decrease dyspnea either before treatment or in patients who are not candidates for more aggressive treatment.
Surgery
Patients must undergo a careful assessment before surgery. Surgical resection for patients with MPM can include either pleurectomy/decortication (P/D; also known as total pleurectomy and lung-sparing surgery), which is complete removal of the involved pleura and all gross tumor; or extrapleural pneumonectomy (EPP), which is enbloc resection of the involved pleura, lung, ipsilateral diaphragm, and often the pericardium (see Principles of Surgical Resection, page 31).61 Radical (or extended) P/D refers to the resection of the diaphragm and pericardium in addition to total pleurectomy.61 Mediastinal nodal dissection is recommended in patients having either P/D or EPP. In medically operable patients, the decision whether to perform a P/D or an EPP may not be made until surgical exploration.
The choice of surgery for MPM is controversial, because data from randomized controlled trials are not available.2,62-65 EPP often would be required to remove all gross tumor in patients with stages II through III MPM.25 In addition, neither EPP nor P/D will yield an R0 resection.2,66 However, EPP is associated with higher morbidity and mortality; therefore, P/D (i.e., lung-preserving surgery) may be a better option for some patients.67-72 A retrospective analysis (N = 663) found that the type of surgery did not affect survival regardless of whether patients had early-stage or advanced-stage disease.2,69 In addition, because data from randomized trials are not available, surgery has not been shown to improve survival when compared with systemic therapy.64
A recent feasibility trial (Mesothelioma and Radical Surgery [MARS]) in 50 patients assessed whether EPP improves survival when compared with chemotherapy treatment alone.73,74 Results suggest that EPP is not beneficial and is associated with morbidity when compared with chemotherapy.73,75 However, a retrospective study (N = 540) reported that several factors yielded increased survival for select patients, including EPP, surgeon experience, and pemetrexed.76 The NCCN Guidelines panel and other clinicians recommend EPP for select good-risk patients (i.e., good performance status, absence of comorbidities) but not for those with comorbid conditions.62,77
For patients with operable early-stage disease (confined to the pleural envelope [stage I], no N2 lymph node involvement), EPP may be the best option for those with favorable histology (i.e., epithelioid), good performance status, and no comorbidities.47,69,70,78 PD may be a better choice for those with operable advanced disease (stages II-III), mixed (biphasic) histology, and/or high-risk factors (poor performance status, comorbidities).79 The NCCN Guidelines panel does not recommend surgery for patients with stage IV MPM or sarcomatoid histology; chemotherapy is recommended for these patients (see next section and Clinical Assessment, page 29).
Chemotherapy
Chemotherapy is recommended either alone for patients with medically inoperable MPM, or as part of a regimen for those with medically operable MPM (see Principles of Chemotherapy, page 31, for specific regimens). Patients with medically operable stage I through III MPM can receive chemotherapy either before or after surgery. Chemotherapy alone is recommended for patients with medically inoperable stages I through IV MPM and those with sarcomatoid histology.80,81
A combined first-line regimen using cisplatin and pemetrexed (category 1) is considered the gold standard for MPM, and is currently the only regimen approved by the FDA for malignant mesothelioma.82,83 A phase III randomized trial assessed cisplatin/pemetrexed versus cisplatin alone in patients who were not candidates for surgery; the combined regimen increased survival when compared with cisplatin alone (12.1 vs. 9.3 months; P = .02).82 Other acceptable first-line combination chemotherapy options recommended by NCCN include pemetrexed and carboplatin, which was assessed in 3 large phase II studies (median survival, 12.7, 14, and 14 months, respectively),84-86 or gemcitabine and cisplatin, which was also assessed in phase II studies (median survival, 9.6-11.2 months).87,88 Gemcitabine and cisplatin may be useful for patients who cannot take pemetrexed. A comparison of 1704 patients with medically inoperable MPM treated with cisplatin/pemetrexed or carboplatin/pemetrexed as part of an expanded access trial found that outcomes with the regimens were similar.89 The carboplatin/pemetrexed regimen is a better choice for patients with poor performance status and/or comorbidities.
Acceptable first-line single-agent options include pemetrexed or vinorelbine.90-92 Second-line chemotherapy options include pemetrexed (if not administered first-line), vinorelbine, or gemcitabine.93-95 Limited data are available to guide second-line therapy.96
Recently, trimodality therapy using chemotherapy, surgery, and hemithoracic radiotherapy has been used in patients with MPM,43-46 with a median survival of up to 29 months reported.44 Nodal status and response to chemotherapy can affect survival.44,47 A small retrospective series showed that trimodality therapy using EPP did not improve survival over therapy without EPP.66
Radiation Therapy
The principles of radiation therapy are described in the algorithm (pages 32 and 33) and are summarized here; the algorithm in the NCCN Guidelines for Non-Small Cell Lung Cancer is also a useful resource (available at www.NCCN.org). In patients with MPM, radiotherapy can be used as part of a multimodality regimen; however, radiotherapy alone is not recommended (see next paragraph). Radiotherapy can also be used as palliative therapy for relief of chest pain or metastases in bone or brain (see also the NCCN Guidelines for Central Nervous System Cancers, available at www.NCCN.org).48 The dose of radiation should be based on the purpose of treatment. The most appropriate timing for delivering radiotherapy (i.e., after surgical intervention, with or without chemotherapy) should be discussed by a multidisciplinary team.
After EPP, adjuvant radiotherapy has been shown to significantly reduce the local recurrence rate.97,98 Patients who are candidates for radiotherapy have good performance status, pulmonary function, and kidney function (see Principles of Radiation Therapy, pages 32 and 33). However, in patients who have limited or no resection of disease (i.e., in the setting of an intact lung), highdose radiotherapy to the entire hemithorax has not been shown to improve survival, and the toxicity is significant.48 Radiotherapy can also be used to prevent instrument-tract recurrence after pleural intervention.45,66,98-101
CT simulation-guided planning with conventional photon/electron radiotherapy is recommended. The clinical target volumes should be reviewed with the thoracic surgeon to ensure coverage of all volumes at risk. The total doses of radiation are described in the algorithm (see Principles of Radiation Therapy, pages 32 and 33). A dose of 60 Gy or more should be delivered to macroscopic residual tumors, if the doses to normal adjacent structures are limited to their tolerances (see the NCCN Guidelines for Non-Small Cell Lung Cancer). In addition to covering the surgical bed within the thorax, the volume of postoperative radiation should also include the surgical scars and biopsy tracks in the chest wall,102-104 although this is controversial.105-107
Intensity-modulated radiotherapy (IMRT) allows a more conformal high-dose radiotherapy and improved coverage to the hemithorax at risk.48,108 The NCI/ASTRO IMRT guidelines are recommended (http://www.astro.org/Research/ResearchHighlights/documents/Imrt.pdf). The ICRU83 (International Commission on Radiation Units & Measurements Report 83) guidelines are also useful (http://www.icru.org/index.php?option=com_content&task=view&id=171). Radiation to the contralateral lung should be minimized,48,108,109 because the risk of fatal pneumonitis with IMRT is excessively high if strict limits are not applied.110-112 The mean lung dose should be kept as low as possible, preferably less than 8.5 Gy. The volume of contralateral lung receiving low-dose radiotherapy (e.g., 5 Gy) should be minimized.113 For patients with chest pain from mesothelioma, total doses of 20 to 40 Gy seem to be effective in relieving pain102,103; however, the optimal dose of radiotherapy for palliative purposes remains unclear.114
Individual Disclosures of the NCCN Malignant Pleural Mesothelioma Panel
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