8/22/2016. Major risk factors for the development of lung cancer are: Outline

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1 Carcinomas of the Lung: Changes in Staging, Adenocarcinoma Classification and Genetics Grace Y. Lin, M.D., Ph.D. Outline Background Staging of Lung Cancer: Review of the th Edition of the AJCC Cancer Staging Manual and International Association for the Study of Lung Cancer (IASLC) Proposals for the th Edition Updates in Classification of Lung Adenocarcinoma Genetics of Lung Carcinomas Bronchogenic Carcinoma Most frequently diagnosed major cancer in the world and most frequent cause of cancer mortality world wide Bronchogenic carcinoma occurs most often between the ages of 40 and 70 with peak incidence in the 6th and 7th decades. Currently number one cause of cancer related deaths in industrialized countries in both men and women (surpassed breast cancer in 1987). Bronchogenic Carcinoma The incidence rate for lung cancer in the US in was 61.0 per 100,000 people Males: 73.0/100,000 (compared to prostate cancer: 128.3/100,000) Females: 52.0/100,000 (compared to breast cancer: 122/100,000) The death rate for lung cancer in the US in was 46.0 per 100,000 people Males: 57.9/100,000 (compared to prostate cancer: 20.8/100,000) Females: 37/100,000 (compared to breast cancer: 21.5/100,000) The death rate in women has increased from 4.5 per 100,000 in 1950 reflecting the delayed consequence of increased cigarette smoking among women From the CDC web page Bronchogenic Carcinoma At diagnosis, more than 50% of individuals already have distant metastatic disease, while ~25% have regional lymph node disease 5 year survival rate for all stages of lung cancer combined is ~15%. Even patients with disease localized to the lung have a 5 year survival of ~45%. Bronchogenic Carcinoma Major risk factors for the development of lung cancer are: Tobacco smoking Industrial hazards Air pollution Genetics 1

2 Tobacco Smoking Three types of histologic changes occur in the bronchial epithelium of smokers. (1) loss of cilia sometimes with squamous metaplasia (2) basal cell hyperplasia; (3) dysplasia, sometimes approaching carcinoma in situ. Tobacco smoking is most commonly associated with squamous cell carcinomas and small cell carcinomas Other risk factors Industrial hazards Asbestos: Asbestos workers have 5x increased risk of developing lung cancer. If an individual also smokes the risk is greatly increased by fold. Adenocarcinoma is the most common tumor associated with exposure to asbestos. Ionizing radiation: There is an increased incidence of lung cancer in people exposed to ionizing radiation. Most historical examples are the survivors of the atomic bombs in 1945 AJCC Staging 7 th edition Released in 2010 Staging of Lung Cancer: Updates in the 7 th Edition and Proposed Updates to the 8 th edition of of the AJCC Cancer Staging Manual Changes: Staging system should be applied for NSCLC and SCLC as well as typical and atypical carcinoid tumors Proposals for AJCC Staging 8 th edition Anticipated release later this year and will be applicable after January 1, 2017 Proposals for AJCC Staging 8 th edition Methods: From 1999 to 2010, 77,156 evaluable patients, 70,967 with non small-cell lung cancer, were collected; and 33,115 had either a clinical or a pathological classification, known tumor size, sufficient T information, and no metastases. Survival was measured from date of diagnosis or surgery for clinically and pathologically staged tumors. Tumor-size cutpoints were evaluated by the running logrank statistics. T descriptors were evaluated in a multivariate Cox regression analysis adjusted for age, gender, histological type, and geographic region. 2

3 Proposals for AJCC Staging 8 th edition Survival AJCC Staging: Size AJCC Staging 7 th edition pt1 has been subclassified into T1a ( 2 cm) T1b (>2 but 3 cm) pt2 has been subclassified into T2a (>3 but 5 cm) T2b (>5 but 7 cm) pt3 >7 cm Thus the cutoff points to very carefully measure are ~2 cm, 3 cm, 5 cm and 7cm Proposal for 8 th edition T1 has been subclassified into T1a: 1cm T1b: >1 cm but 2cm T1c: >2 cm but 3 cm T2 has been subclassified into T2a: >3cm but 4cm T2b: >4 cm but 5cm T3 >5 cm but 7cm pt4 >7 cm (J Thorac Oncol. 2015;10: ) Lobectomy Tumor abuts pleura Pleural invasion Pleura layers- normal lung EVG stain Pleural surface Elastic Layer Lung parenchyma AJCC Staging 7 th edition Studies have shown that patients who have involvement of the pleura do worse even with small tumors pt2a if tumor is <3cm but it Invades visceral pleura (PL1 or PL2) PL1=Tumor that extends through elastic layer PL2=Tumor that extends to the surface of the visceral pleura pt3 if tumor is <7 cm but Tumor invades the parietal pleura (PL3) of chest wall 3

4 Pleural invasion Pleura layers- normal lung EVG stain PL0 Chest wall PL3 - pt3 PL2 pt2 PL1 Elastic Layer PL0 PL1 Take home point Please sample tumor abutting or involving pleura carefully. Some pathologists recommend submitting all of the area where it appears to be abutting or involving the pleura Proposals for AJCC Staging 8 th edition Diaphragm Invasion In the 7th edition of the TNM classification, involvement of the diaphragm is classified as T3 Proposal for 8 th edition: In this study, invasion of the diaphragm has a worse prognosis than that assigned to other T3 descriptors, but that prognosis is similar to that of T4 and even worse for those clinically staged. Present data thus support the upstaging of diaphragm invasion to the T4 category. Sample adhesions to the diaphragm carefully! 4

5 AJCC Staging 7 th edition What about multiple tumors? Pneumonectomytumor involves bronchus T3 if separate tumor nodules in the same lobe T4 if separate tumor nodules in different ipsilateral lobe M1a if separate tumor nodule in contralateral lobe Multiple synchronous primaries if they are different histologic cell types or if there are differences in morphology or IHC or molecular studies Stage separately and the highest T category and stage of disease should be assigned and the multiplicity of the tumor should be indicated in parentheses - pt2(m) or pt2(2) Proposals for AJCC Staging 8 th edition Involvement of Main Bronchus In the 7th edition of the TNM classification, involvement of the main bronchus is classified as T2 if it is located 2 cm or more from the carina T3 if it is less than 2 cm from the carina but without its invasion. Proposal for 8 th edition: Data from the new IASLC database revealed that endobronchial tumors either less than 2 or greater than 2 cm from the carina have the same prognosis in the clinical and pathological staging. Classify involvement of the main bronchus as a T2 descriptor, regardless of distance from the carina, but without invasion of the carina Updates in Classification of Lung Adenocarcinoma Panel members included thoracic medical oncologists, pulmonologists, radiologists, molecular biologists, thoracic surgeons and pathologists Panel generated key questions about adenocarcinoma many of these questions were not addressed in the prior 2004 WHO classification although they may have been raised They reviewed literature through 2009, and generated updated terminology along with grading of the strength of the recommendation and evaluating the quality of the evidence These classification changes were incorporated into the 2015 WHO Classification of Tumours of the Lung, Pleura, Thymus, and Heart 5

6 IASLC/ATS/ERS Classification of Lung Adenocarcinoma in Resection Specimens Preinvasive lesions Atypical Adenomatous hyperplasia Adenocarcinoma in situ Minimally invasive adenocarcinoma Invasive adenocarcinoma 2004 WHO Classification of Tumours defined bronchioloalveolar carcinoma pattern as growth of neoplastic cells along pre-existing alveolar structures (lepidic growth) without evidence of stromal, vascular, or pleural invasion Histologic variants included non-mucinous and mucinous New classification of these lesion formerly termed as bronchioloalveolar carcinoma (BAC) Adenocarcinoma in situ Minimally invasive adenocarcinoma Lepidic predominant adenocarcinoma (non-mucinous only) Adenocarcinoma, predominantly invasive with some non-mucinous features Invasive mucinous adenocarcinoma Adenocarcinoma in situ Localized, small ( 3 cm) adenocarcinoma with growth restricted to neoplastic cells along pre-existing alveolar structures (lepidic growth), lacking stromal, vascular or pleural invasion No papillary, micropapillary or intra-alveolar tumor cells Nuclear atypia is absent or inconspicuous Adenocarcinoma in situ What if you see this focus? Virtually all of these cases are non-mucinous Septal widening with sclerosis is common Multiple studies have shown that these lesions should have ~100% disease-free survival if completely resected 6

7 WHO 2004 terminology adenocarcinoma, mixed subtype New terminology Minimally invasive adenocarcinoma (MIA) Small ( 3 cm), solitary adenocarcinoma with predominantly lepidic growth and 5 mm invasion in greatest dimension in any one focus MIA is excluded if there is lymphatic, blood vascular, or pleural invasion or necrosis If multiple microinvasive areas, measure largest (do not sum up) Usually non-mucinous Several papers have shown MIA have nearly 100% disease free 5 year survival if completely resected Lepidic predominant adenocarcinoma Solitary tumors suspected to be AIS or MIA which are larger than 3 cm LPA also used instead of MIA if there is LVI, BVI, pleural invasion or necrosis There is insufficient evidence in the literature to support that these cases will have ~100% disease free survival Recommend comment that clinical behavior is uncertain and/or that an invasive component cannot be excluded (if the lesion has not been entirely submitted) Use for non-mucinous tumors only What is/was this lesion? WHO 2004 bronchioloalveolar carcinoma, mucinous variant New Invasive mucinous adenocarcinoma Differ from the very rare cases of mucinous AIS/MIA by any of the following size >3 cm amount of invasion >5 mm multiple nodules or lack of a circumscribed border with miliary spread into adjacent lung parenchyma Reasons for separating invasive mucinous adenocarcinoma (formerly mucinous BAC) from non-mucinous AIS/MIA/LPA (formerly non-mucinous BAC) Strong tendency for these tumors to show multicentricity, multilobar and bilateral lung involvement which may reflect aerogenous spread Unlike non-mucinous AIS or MIA, these tumors tend to behave poorly with some studies suggesting that even stage I cases have only 76% 5 year disease free survival Other reasons for separating invasive mucinous adenocarcinoma (formerly mucinous BAC) from nonmucinous AIS/MIA/LPA (formerly non-mucinous BAC) Mutations in EGFR have been described to be present in 47-78% of nonmucinous adenocarcinoma with lepidic growth pattern but only 0-22% of invasive mucinous adenocarcinoma. In contrast, mutations in the k-ras oncogene are reported in only 2-17% of nonmucinous adenocarcinoma with lepidic growth pattern but in 67-86% of invasive mucinous adenocarcinoma. 7

8 Take home points Diagnosis of Adenocarcinoma in Situ vs. Minimally Invasive Adenocarcinoma cannot be firmly determined unless tumor is entirely histologically sampled They recommend submission of all of tumors with lepidic growth pattern if less than 3 cm to look for invasive focus If tumors are greater than 3 cm, or if tumors are incompletely sampled, the diagnosis is lepidic predominant adenocarcinoma and the outcome is not known at this time Genetics of Lung Cancer Molecular Testing Guidelines for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors Guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology Jointly published in Archives of Pathology & Laboratory Medicine, Journal of Molecular Diagnostics, and Journal of Thoracic Oncology in June 2013 Some non-small cell lung cancers are thought to be associated with driver mutations Mutations in these genes can lead to constitutive activation of the proteins for which these these genes code 45 These mutations have thus far been identified mostly in cases of adenocarcinoma: EGFR mutation (15-20% of cases of adenocarcinoma) K-ras mutation (25%) EML4-ALK (3-7%) Others include Her2/neu, BRAF, FGFR2, PIK3CA EGFR EGFR=Epidermal growth factor receptor Member of the erbb family of tyrosine kinase receptor proteins Normally, requires binding of epidermal growth factor to EGFR get activation of EGFR and downstream activation of various transcription factors These transcription factors eventually lead to prevention of apoptosis (programmed cell death) or cell proliferation 47 8

9 EGFR and k-ras Extracellular Ligand EGFR P K-RAS Intracellular P P P Cell proliferation EGFR In some lung adenocarcinomas, there are mutations in the sequence of the EGFR genes Short in frame deletions in exon 19 Point mutation in exon 21 of CTG to CGG at nucleotide 2573 which leads to a substitution of leucine by arginine (L858R) Others are known as well These mutations lead to activation of EGFR in the absence of binding of EGF Some cases have increased EGFR gene copy number amplification or polysomy as determined by FISH EML4-ALK Mutations in EGFR gene have been described in lung adenocarcinomas and are more common in Asian, never smokers, and non-mucinous tumors Activating EGFR mutations are a specific target for therapy by EGFR tyrosine kinase inhibitors (TKIs) Mutations in KRAS are most commonly found in non- Asians, smokers and in invasive mucinous adenocarcinoma Inversion of short arm of chromosome 2 leads to an fusion gene between echinoderm microtubule associated protein-like 4 (EML4) and anaplastic lymphoma kinase (ALK) genes More common in never smokers and light smokers Younger age and more commonly male patients Mutually exclusive with EGFR and KRAS mutations Patients with EML4-ALK mutations may benefit from ALK inhibitor therapy When should molecular testing for NSCLC be performed? Which patients should be tested for EGFR mutations and ALK rearrangements? EGFR and ALK molecular testing should be used to select patients for targeted therapy, and patients with lung adenocarcinoma should NOT be excluded from testing on the basis of clinical characteristics (e.g. age, sex, ethnicity, smoking history) because these clinical characteristics are not sensitive nor specific for the mutations Patients who have resected carcinomas without any adenocarcinoma component are not recommended to have EGFR or ALK testing In biopsies and cytology specimens where an adenocarcinoma component cannot be excluded, EGFR and ALK testing may be performed When should molecular testing for NSCLC be performed? Which patients should be tested for EGFR mutations and ALK rearrangements? Either primary tumors or metastases are equally suitable for testing for initial treatment selection (very high concordance between primaries and metastases for these genetic mutations) For patients with multiple, apparently separate, primary lung adenocarcinomas, each tumor may be tested, but testing of multiple different areas within a single tumor is not necessary driver mutations tend to be well maintained through a tumor if they are present although other mutations may show heterogeneity through the tumor 53 9

10 When should molecular testing for NSCLC be performed? When should a patient specimen be tested for EGFR mutation or ALK rearrangement? At the time of diagnosis for patients presenting with advanced-stage disease (Stage IV) who are suitable for therapy or at time of recurrence or progression in patients who originally present with lower-stage disease but were not previously tested Testing for patients presenting with Stage I, II, III disease is optional and should be decided locally in collaboration with the oncology team How rapidly should test results be available? Within 2 weeks of receiving the specimen in the laboratory. (Patients with Stage IV lung cancer have an average life expectancy of ~16 weeks) How should specimens be processed for EGFR testing? Formalin-fixed, paraffin-embedded tissue or fresh, frozen, or alcohol fixed tissues. Avoid heavy metal fixatives, acidic/decalcifying solutions! What are the specimen requirements for EGFR testing? Each laboratory should establish the minimum proportion and number of cells needed for mutation detection during validation Laboratories should use methods that are able to detect mutation in specimens with at least 50% cancer cell content (and encouraged to use or have access to a method that can detect mutations as little as 10% cancer cells) Should detect all individual mutations reported with a frequency of at least 1% of EGFR mutated lung adenocarcinomas KRAS testing is not recommended as a sole determinant for EGFR TKI therapy (direct testing for EGFR mutations is recommended) Most patients with EGFR mutations recur or progress after 8 to 16 months after TKI therapy due to acquired resistance typically due to a second mutation T790M. The panel recommends that any technique used in labs should detect as the resistance mutations in as little as 5% of tumor cells At this time IHC for total EGFR, FISH and CISH are not recommended for selection for TKI therapy ALK testing The panel recommends fluorescence in situ hybridization at this time rather than RT-PCR 1. Because the location of the translocation and translocation partners are variable (e.g. KIF5B-ALK and TFG-ALK). 2. Because of higher failure rate of RNA-based assays in formalin-fixed paraffin-embedded material Thus, the FISH break apart probes at the ALK locus will be more sensitive for identifying a mutation (although it will not identify what the translocation partner is) Other genes? At this time the recommendation is to prioritize EGFR and ALK testing, because there is insufficient data for other molecular targeted therapies to make definitive recommendations. In the future these other molecular targets may play a greater role

11 Summary Staging When grossing, current cutoff points to very carefully measure are ~2 cm, 3 cm, 5 cm and 7cm For 8 th edition, new sub-classifications at each cm essentially Sample tumor abutting or involving pleura and diapphragm carefully. Consider submitting all of the area where it appears to be abutting or involving the pleura/diaphragm Look and palpate carefully for additional small nodules, because their presence may affect the stage Look for endobronchial extension of tumor and how far it is from the margin Summary New classification of lung cancer Diagnosis of Adenocarcinoma in Situ vs. Minimally Invasive Adenocarcinoma cannot be firmly determined unless tumor is entirely histologically sampled They recommend submission of all of tumors with lepidic growth pattern if less than 3 cm to look for invasive focus If tumors are greater than 3 cm, or if tumors are incompletely sampled, the diagnosis is lepidic predominant adenocarcinoma and the outcome is not known at this time Summary Genetic testing of lung cancer Some testing facilities request a piece of tumor measuring at least 5 mm 2 on a glass slide Testing can be performed on formalin-fixed, paraffin-embedded tissue for most the assays Some RNA studies may require snap frozen tissue Ideally want to avoid anything that damages the DNA (decalcification) Fix tissue as soon as possible Any Questions? 11

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