lung cancer profiles understanding lung cancer … · any time during your treatment journey. ......

1
UNDERSTANDING LUNG CANCER How molecular profiles are changing the way we look at the disease...and what it means for YOU Our understanding of lung cancer has evolved considerably. Doctors used to think lung cancer was one singular disease. 5,6 Now doctors may be able to test the molecular makeup of some patients’ tumors in hopes of identifying the molecular profiles driving them. Tumor tissue is tested from a biopsy or surgery. While there are many factors to consider and molecular testing may not be appropriate for everyone, knowing the molecular driver of the cancer can help guide treatment decisions. Three professional organizations, CAP, IASLC and AMP, have developed a guideline to establish recommendations supporting standard molecular testing for the ALK and EGFR biomarkers in advanced adenocarcinoma patients. 9 Today, we know that isn’t true. Doctors understand that there are two major types of lung cancer, the most common being non-small cell lung cancer (NSCLC). In NSCLC classified as adenocarcinoma, researchers have now identified more than 15 genetic mutations that may cause cells to become cancerous — redefining the disease. 7,8 4 QUESTIONS about molecular testing to ask when diagnosed with lung cancer 1. What type of lung cancer do I have? Previously thought of as one disease, doctors now understand that there are different types of lung cancer, which can be driven by different molecular profiles. Molecular testing, which is usually determined by testing tumor tissue samples, can help doctors tailor treatment plans for certain individuals based on the molecular makeup of their tumors. In fact, three professional organizations joined together to publish an evidence-based guideline recommending all advanced adenocarcinoma patients get tested for ALK and EGFR biomarkers in order to help better diagnose and treat patients. 2. Can I get a molecular test to determine my tumor type? Molecular testing is available via doctors’ offices and cancer centers of all sizes. Talk to your doctor to see if it’s right for you. 3. Based on my tumor type, what treatments may be appropriate for me? Some drugs have been developed to treat specific types of lung cancer based on the tumor’s molecular profile. Some are approved by the U.S. Food and Drug Administration, while others are being studied in clinical trials. Both the presence and absence of specific molecular drivers may be taken into consideration when determining an appropriate treatment plan, including participation in a clinical trial. 4. When is the best time to test my tumor for genetic mutations? Testing for clinically relevant biomarkers during treatment planning is important to patients with metastatic NSCLC. According to the 2013 CAP-ISALC-AMP guideline, doctors should order EGFR mutation and ALK rearrangement testing at the time of adenocarcinoma diagnosis for patients who present with metastatic NSCLC, regardless of their clinical history. However, your doctor may decide to order molecular testing at any time during your treatment journey. If you have not been tested, talk to your doctor to see if molecular testing may be right for you. www.LungCancerProfiles.com If you or someone you know has lung cancer, ASK YOUR DOCTOR ABOUT MOLECULAR TESTING. For more information, visit: are expected to be diagnosed in the U.S. in 2016 1 That’s enough to fill over 3 professional football stadiums* *Based on average stadium capacity of 70,000 2 An estimated 224,390 new cases of lung cancer 1. American Cancer Society. Cancer Facts & Figures 2016. Atlanta: American Cancer Society; 2016. 2. Stadiums of Pro Football. NFL Stadium Comparisons. http://www.stadiumsofprofootball.com/comparisons.htm. Accessed July 24, 2012. 3. Subramanian J, Govindan R. Lung Cancer in Never Smokers: A Review. J Clin Oncol. 2007;561:1-3. 4. Ramalingam S, Pawlish K, Gadgeel S, Demers R, Kalemkerian GP. Lung Cancer in Young Patients: Analysis of a Surveillance, Epidemiology, and End Results Database. J Clin Oncol. 1998;651-657. 5. Janssen-Heijnen MLG, Coebergh JWW. The changing epidemiology of lung cancer in Europe. Lung Cancer. 2003;41:245-258. 6. Paik PK, Johnson ML, D’Angelo SP, et al. Driver Mutations Determine Survival in Smokers and Never-Smokers With Stage IIIB/IV Lung Adenocarcinomas. Cancer. 2012. 10.1002/cncr.27637. 7. Kris MG, Johnson BE, Kwiatkowski DJ, et al. Identification of driver mutations in tumor specimens from 1000 patients with lung adenocarcinoma: The NCI’s Lung Cancer Mutation Consortium (LCMC). J Clin Oncol. 2011. 29(suppl; abstr CRA7506). Page 10. http://meetinglibrary.asco.org/content/81670-102. Accessed October 24, 2014. 8. Takeuchi K, Soda M, Togashi Y, et al. RET, ROS1 and ALK fusions in lung cancer. Nat Med. 2012;18(3):378-381. Doi:10.1038/nm.2558. 9. Wigle DA, Jurisica I, Radulovich N, et al. Molecular profiling of non-small cell lung cancer and correlation with disease-free survival. Cancer Res. 2002;62:3005-3008. 10. Mendelsohn J. Targeting the Epidermal Growth Factor Receptor for Cancer Therapy. J Clin Oncol. 2002;20(18 Suppl):1S-13S. 11. Santos E, Martin-Zanca D, Reddy EP, et al. Malignant activation of a K-ras oncogene in lung carcinoma but not in normal tissue of the same patient. Science. 1984;223(4637):661-664. 12. Yuasa Y, Gol RA, Chang A. Mechanism of activation of an N-ras oncogene of SW-1271 human lung carcinoma cells. Proc Natl Acad Sci U S A. 1984;81(12):3670-3674. 13. Davies H, Bignell G, Cox C, et al. Mutations of the BRAF gene in human cancer. Nature. 2002;417:949-954. 14. Samuels Y, Wang Z, Bardelli A, et al. High Frequency of Mutations of the PIK3CA Gene in Human Cancers. Science. 2004;304:554. 15. Tengs T, Lee J, Guillermo P, et al. A transforming MET mutation discovered in non-small cell lung cancer using microarray-based resequencing. Cancer Letters. 2006;239:227-233. 16. Shigematsu H, Gazdar A. Somatic mutations of epidermal growth factor receptor signaling pathway in lung cancers. Int J Cancer. 2006;118:257-262. 17. Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nat Med. 2012;18(3):382-384. 18. Marks J, Gong Y, Chitale D, et al. Novel MEK1 Mutation Identified by Mutational Analysis of Epidermal Growth Factor Receptor Signaling Pathway Genes in Lung Adenocarcinoma. AACR.2008; 68:14. Cancer Res. 2008;68:5524-5528. 19. Bergethon K, Shaw AT, Ou SHI, et al. ROS Rearrangements Define a Unique Molecular Class of Lung Cancers. J Clin Oncol. 2012;30(8):863-870. 20. Lipson D, Capelletti M, Janne PA, et al. Identification of new ALK and RET gene fusions from colorectal and lung cancer biopsies. Nat Med. 2012;18(3):382-384. 21. Gamez-Pozo A, Sanchez-Navarro I, Calvo E, et al. PTRF/Cavin-1 and MIF Proteins Are Identified as Non-Small Cell Lung Cancer Biomarkers by Label-Free Proteomics. PLOS ONE. 2012. 22. Lovly C, Horn L, Pao W. 2013. AKT1 Mutations in Non-Small Cell Lung Cancer (NSCLC). My Cancer Genome. http://www.mycancergenome.org/content/disease/lung-cancer/akt1/. Updated September 9. Accessed October 20, 2014. 23. Paik P. 2013. DDR2 Mutations in NSCLC. My Cancer Genome http://www.mycancergenome.org/content/disease/lung-cancer/ddr2/ (Updated June 24). Accessed October 20, 2014. 24. Sos M, Thomas R. 2012. FGFR1 Mutations in NSCLC. My Cancer Genome. http://www.mycancergenome.org/content/disease/lung-cancer/fgfr1/. Updated June 1. Accessed October 20, 2014. 25. Lovly C, Horn L, Pao W. 2013. NRAS Mutations in Non-Small Cell Lung Cancer (NSCLC). My Cancer Genome. http://www.mycancergenome.org/content/disease/lung-cancer/nras/. Updated April 4. Accessed October 20, 2014. 26. Lovly C, Horn L, Pao W. 2012. PTEN Mutations in Non-Small Cell Lung Cancer (NSCLC). My Cancer Genome. http://www.mycancergenome.org/content/disease/lung-cancer/pten/. Updated July 31. Accessed October 20, 2014. 27. ClinicalTrials.gov. 525 studies found for: KRAS OR EGFR OR ALK OR PIK3CA OR HER2 OR BRAF OR ROS OR RET OR NRAS OR MET | lung cancer. https://clinicaltrials.gov/ct2/results?term=KRAS+OR+EGFR+OR+ALK+OR+PIK3CA+OR+HER2+OR+BRAF+OR+ROS+OR+RET+OR+NRAS+OR+MET&recr=Open&rslt=&type=&cond=lung+cancer &intr=&titles=&outc=&spons=&lead=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&rcv_s=&rcv_e=&lup_s=&lup_e=. Accessed February 8, 2016. Lung Cancer 52% are male are female 1 48% In fact, MORE THAN HALF of adenocarcinoma cases have an identifiable molecular driver causing the cancer to grow. 6,7,8 PP-XLK-USA-0203-01 ©2016 Pfizer Inc. All rights reserved. February 2016. UNITED WE TEST QUEST In the past few years, there has been an evolution in the molecular understanding of non-small cell lung cancer. United We Test Quest is a national mapping project that calls on lung cancer survivors, their families, friends, advocates and health care professionals to amplify awareness around the importance of molecular testing. Visit LungCancerProfiles.com to place a pin on the United We Test Quest map. LUNG CANCER PROFILES ≈10% of people with lung cancer NEVER SMOKED 3 but up to 10% are diagnosed in patients less than 55 years of age 4 Most cases of lung cancer occur in men and women ages 60-80 biopsy performed doctor assessment doctor & patient discuss treatment guidance lab testing Currently, there are MORE THAN 500 TRIALS 27 examining the role of molecular profiles in lung cancer tumors. In the past decade, the number of clinical trials exploring treatments in different molecular profiles of lung cancer has grown significantly. While treatments are not available for every molecular driver, NEW DISCOVERIES are continually being made to help improve our understanding of the disease. 10-26 1981 EGFR NRAS KRAS 1984 BRAF 2002 PIK3 CA 2004 HER2 MET DDR2 2005 ALK AKT1 2007 2008 MEK1 RET ROS1 2011 MIF PTRF/ cavin-1 2012 SO WHAT DOES THIS MEAN FOR YOU? LUNG CANCER CAN AFFECT ANYONE It’s estimated that of new lung cancer cases: PTEN 1996 2010 FGFR1 #UWTQ HER2 DDR2 BRAF ALK AKT ROS1 RET PTEN PIK3CA2 NRAS MET MEK1 KRAS Unknown FGFR1 EGFR

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UNDERSTANDINGLUNG CANCER

How molecular profiles are changing the way welook at the disease...and what it means for YOU

Our understanding of lung cancer hasevolved considerably. Doctors used to think

lung cancer was one singular disease.5,6

Now doctors may be able to test the molecular makeup of somepatients’ tumors in hopes of identifying the molecular profiles driving them.

Tumor tissue is tested from a biopsy or surgery. While there are many factorsto consider and molecular testing may not be appropriate for everyone,

knowing the molecular driver of the cancer can help guide treatmentdecisions. Three professional organizations, CAP, IASLC and AMP,

have developed a guideline to establish recommendations supportingstandard molecular testing for the ALK and EGFR biomarkers in

advanced adenocarcinoma patients.9

Today, we know that isn’t true. Doctors understand that there are two major

types of lung cancer, the most common being non-small cell lung cancer(NSCLC). In NSCLC classified as

adenocarcinoma, researchers havenow identified more than 15 genetic

mutations that may cause cells to become cancerous — redefining the disease.7,8

4 QUESTIONSabout molecular testing to ask when diagnosed with lung cancer

1. What type of lung cancer do I have? Previously thought of as one disease, doctors now understand that there are different types of lung cancer, which can be driven by different molecular profiles. Molecular testing, which is usually determined by testing tumor tissue samples, can help doctors tailor treatment plans for certain individuals based on the molecular makeup of their tumors. In fact, three professional organizations joined together to publish an evidence-based guideline recommending all advanced adenocarcinoma patients get tested for ALK and EGFR biomarkers in order to help better diagnose and treat patients.

2. Can I get a molecular test to determine my tumor type?

Molecular testing is available via doctors’ offices and cancer centers of all sizes. Talk to your doctor to see if it’s right for you.

3. Based on my tumor type, what treatments may be appropriate for me? Some drugs have been developed to treat specific types of lung cancer based on the tumor’s molecular profile. Some are approved by the U.S. Food and Drug Administration, while others are being studied in clinical trials. Both the presence and absence of specific molecular drivers may be taken into consideration when determining an appropriate treatment plan, including participation in a clinical trial.

4. When is the best time to test my tumor for genetic mutations? Testing for clinically relevant biomarkers during treatment planning is important to patients with metastatic NSCLC. According to the 2013 CAP-ISALC-AMP guideline, doctors should order EGFR mutation and ALK rearrangement testing at the time of adenocarcinoma diagnosis for patients who present with metastatic NSCLC, regardless of their clinical history. However, your doctor may decide to order molecular testing at any time during your treatment journey. If you have not been tested, talk to your doctor to see if molecular testing may be right for you.

www.LungCancerProfiles.com

If you or someone you know has lung cancer,

ASK YOUR DOCTOR ABOUT MOLECULAR TESTING.For more information, visit:

are expected to be diagnosed in the U.S. in 20161

That’s enough to fill over 3 professional football stadiums**Based on average stadium capacity of 70,0002

An estimated 224,390 new cases of lung cancer

1. American Cancer Society. Cancer Facts & Figures 2016. Atlanta: American Cancer Society; 2016.2. Stadiums of Pro Football. NFL Stadium Comparisons. http://www.stadiumsofprofootball.com/comparisons.htm. Accessed July 24, 2012.3. Subramanian J, Govindan R. Lung Cancer in Never Smokers: A Review. J Clin Oncol. 2007;561:1-3.4. Ramalingam S, Pawlish K, Gadgeel S, Demers R, Kalemkerian GP. Lung Cancer in Young Patients: Analysis of a Surveillance, Epidemiology, and End Results Database. J Clin Oncol. 1998;651-657.5. Janssen-Heijnen MLG, Coebergh JWW. The changing epidemiology of lung cancer in Europe. Lung Cancer. 2003;41:245-258. 6. Paik PK, Johnson ML, D’Angelo SP, et al. Driver Mutations Determine Survival in Smokers and Never-Smokers With Stage IIIB/IV Lung Adenocarcinomas. Cancer. 2012. 10.1002/cncr.27637.7. Kris MG, Johnson BE, Kwiatkowski DJ, et al. Identification of driver mutations in tumor specimens from 1000 patients with lung adenocarcinoma: The NCI’s Lung Cancer Mutation Consortium

(LCMC). J Clin Oncol. 2011. 29(suppl; abstr CRA7506). Page 10. http://meetinglibrary.asco.org/content/81670-102. Accessed October 24, 2014.8. Takeuchi K, Soda M, Togashi Y, et al. RET, ROS1 and ALK fusions in lung cancer. Nat Med. 2012;18(3):378-381. Doi:10.1038/nm.2558.9. Wigle DA, Jurisica I, Radulovich N, et al. Molecular profiling of non-small cell lung cancer and correlation with disease-free survival. Cancer Res. 2002;62:3005-3008.10. Mendelsohn J. Targeting the Epidermal Growth Factor Receptor for Cancer Therapy. J Clin Oncol. 2002;20(18 Suppl):1S-13S.11. Santos E, Martin-Zanca D, Reddy EP, et al. Malignant activation of a K-ras oncogene in lung carcinoma but not in normal tissue of the same patient. Science. 1984;223(4637):661-664.12. Yuasa Y, Gol RA, Chang A. Mechanism of activation of an N-ras oncogene of SW-1271 human lung carcinoma cells. Proc Natl Acad Sci U S A. 1984;81(12):3670-3674.13. Davies H, Bignell G, Cox C, et al. Mutations of the BRAF gene in human cancer. Nature. 2002;417:949-954.14. Samuels Y, Wang Z, Bardelli A, et al. High Frequency of Mutations of the PIK3CA Gene in Human Cancers. Science. 2004;304:554.15. Tengs T, Lee J, Guillermo P, et al. A transforming MET mutation discovered in non-small cell lung cancer using microarray-based resequencing. Cancer Letters. 2006;239:227-233.16. Shigematsu H, Gazdar A. Somatic mutations of epidermal growth factor receptor signaling pathway in lung cancers. Int J Cancer. 2006;118:257-262.17. Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nat Med. 2012;18(3):382-384.18. Marks J, Gong Y, Chitale D, et al. Novel MEK1 Mutation Identified by Mutational Analysis of Epidermal Growth Factor Receptor Signaling Pathway Genes in Lung Adenocarcinoma.

AACR.2008; 68:14. Cancer Res. 2008;68:5524-5528.19. Bergethon K, Shaw AT, Ou SHI, et al. ROS Rearrangements Define a Unique Molecular Class of Lung Cancers. J Clin Oncol. 2012;30(8):863-870.20. Lipson D, Capelletti M, Janne PA, et al. Identification of new ALK and RET gene fusions from colorectal and lung cancer biopsies. Nat Med. 2012;18(3):382-384.21. Gamez-Pozo A, Sanchez-Navarro I, Calvo E, et al. PTRF/Cavin-1 and MIF Proteins Are Identified as Non-Small Cell Lung Cancer Biomarkers by Label-Free Proteomics. PLOS ONE. 2012.22. Lovly C, Horn L, Pao W. 2013. AKT1 Mutations in Non-Small Cell Lung Cancer (NSCLC). My Cancer Genome. http://www.mycancergenome.org/content/disease/lung-cancer/akt1/. Updated

September 9. Accessed October 20, 2014.23. Paik P. 2013. DDR2 Mutations in NSCLC. My Cancer Genome http://www.mycancergenome.org/content/disease/lung-cancer/ddr2/ (Updated June 24). Accessed October 20, 2014.24. Sos M, Thomas R. 2012. FGFR1 Mutations in NSCLC. My Cancer Genome. http://www.mycancergenome.org/content/disease/lung-cancer/fgfr1/. Updated June 1. Accessed October 20, 2014.25. Lovly C, Horn L, Pao W. 2013. NRAS Mutations in Non-Small Cell Lung Cancer (NSCLC). My Cancer Genome. http://www.mycancergenome.org/content/disease/lung-cancer/nras/. Updated

April 4. Accessed October 20, 2014.26. Lovly C, Horn L, Pao W. 2012. PTEN Mutations in Non-Small Cell Lung Cancer (NSCLC). My Cancer Genome. http://www.mycancergenome.org/content/disease/lung-cancer/pten/. Updated

July 31. Accessed October 20, 2014.27. ClinicalTrials.gov. 525 studies found for: KRAS OR EGFR OR ALK OR PIK3CA OR HER2 OR BRAF OR ROS OR RET OR NRAS OR MET | lung cancer.

https://clinicaltrials.gov/ct2/results?term=KRAS+OR+EGFR+OR+ALK+OR+PIK3CA+OR+HER2+OR+BRAF+OR+ROS+OR+RET+OR+NRAS+OR+MET&recr=Open&rslt=&type=&cond=lung+cancer&intr=&titles=&outc=&spons=&lead=&id=&state1=&cntry1=&state2=&cntry2=&state3=&cntry3=&locn=&gndr=&rcv_s=&rcv_e=&lup_s=&lup_e=. Accessed February 8, 2016.

Lung Cancer

52%are male

are female148%

In fact,

MORE THAN HALFof adenocarcinoma cases have an

identifiable molecular drivercausing the cancer to grow.6,7,8

PP-XLK-USA-0203-01 ©2016 Pfizer Inc. All rights reserved. February 2016.

UNITED WE TEST QUESTIn the past few years, there has been an evolution in

the molecular understanding of non-small cell lung cancer.

United We Test Questis a national mapping project that calls on lung cancer survivors, their families, friends, advocates and health care professionals to amplify awareness around the importance of molecular testing.

Visit LungCancerProfiles.comto place a pin on the United We Test Quest map.

LUNG CANCER PROFILES

≈10%of people with lung cancer

NEVER SMOKED3 but up to 10%

are diagnosed in patientsless than 55 years of age4

Most cases of lung canceroccur in men and women

ages 60-80

biopsyperformed

doctorassessment

doctor & patient discusstreatment guidance

labtesting

Currently, there are MORE THAN 500 TRIALS27 examining the role of molecularprofiles in lung cancer tumors.

In the past decade, the number of clinical trials exploring treatments in different molecular profiles of lung cancer has grown significantly.

While treatments are not available for every molecular driver,NEW DISCOVERIES are continually being made to help improve our understanding of the disease.10-26

1981

EGFRNRAS

KRAS

1984

BRAF

2002

PIK3CA

2004

HER2

MET

DDR2

2005

ALK

AKT1

2007 2008

MEK1 RET

ROS1

2011

MIF

PTRF/cavin-1

2012

SO WHAT DOES THIS MEAN FOR YOU?

LUNG CANCER CAN AFFECT ANYONEIt’s estimated that of new

lung cancer cases:

PTEN

1996 2010

FGFR1

#UWTQ

HER2

DDR2

BRAFALK

AKTROS1RET

PTEN

PIK3CA2NRAS

METMEK1

KRAS

Unknown

FGFR1

EGFR