The incidence of breastcancer in India is on the rise and is rapidlybecoming the number one cancer in females pushing the cervical cancer to thesecond spot. The seriousness of the situation is apparent after going throughrecent data from Indian Council of Medical Research (ICMR).
The rise is being documented mainly in the metros, but it can be safely saidthat many cases in rural areas go unnoticed. It is reported that one in 22women in India is likely to suffer from breast cancer during her lifetime,while the figure is definitely more in America with one in eight being a victimof this deadly cancer. The problem with preventing breast cancer is that thereis no one cause that can be pinpointed as being the culprit. Of coursescreening for the presence of BRCA1 and BRCA2 mutations is available though itmust be admitted of being of little use in the Indian context. It is here thatthe task of spreading the awareness of the prevalence of this cancer andadvising women on undertaking self-breast examination comes into the picture Procedureslike mammography and Fine Needle Aspiration Cytology (FNAC) and biopsy need to be publicized so that women are aware of exactly what they are lettingthemselves in for.
RISK FACTORS FOR BREAST CANCER
A riskfactor is anything that makes it more likely you'll get a particular disease.But having one or even several risk factors doesn't necessarily mean you'lldevelop cancer — many women who develop breast cancer have no known riskfactors other than simply being women.
Factorsthat are associated with an increased risk of breast cancer include:
Being female. Women are much more likely than men are to develop breast cancer.
Increasing age. Your risk of breast cancer increases as you age. Women older than 55 have a greater risk than do younger women.
A personal history of breast cancer. If you've had breast cancer in one breast, you have an increased risk of developing cancer in the other breast.
A family history of breast cancer. If you have a mother, sister or daughter with breast cancer, you have a greater chance of being diagnosed with breast cancer. Still, the majority of people diagnosed with breast cancer have no family history of the disease.
Inherited genes that increase cancer risk. Certain gene mutations that increase the risk of breast cancer can be passed from parents to children. The most common gene mutations are referred to as BRCA1 and BRCA2. These genes can greatly increase your risk of breast cancer and other cancers, but they don't make cancer inevitable.
Radiation exposure. If you received radiation treatments to your chest as a child or young adult, you're more likely to develop breast cancer later in life.
Obesity. Being overweight or obese increases your risk of breast cancer because fat tissue produces estrogen that may help fuel certain cancers.
Beginning your period at a younger age. Beginning your period before age 12 increases your risk of breast cancer.
Dr.Mamta Pande
DCP,MD
About Onko-Sure
Believe it or not,universally 20,000 people die from cancereveryday BUT there is a U turn,the countdown is now in your hands!
40 years of tough research and development has introduced
ONKO-SURE --the first Pan Tumour Marker in India ( Now at Mamta Pathology and Ultasound Centre) that screens 13different types of cancer
(Liver,stomach,ovarian,lung,pancreatic,colorectal,tongue,breast )
from a simple blood test without any prior fasting.
Individuals having greater risk profile for cancer should bescreened for it every year.
Dr.Mamta Pande
DCP,MD
In medical terms, it measures Fibrin/Fibrinogen Degradation Products (FDP) in the blood serum. If these elements are found to be present, the physician can use this information to better plan and focus the post-diagnosis treatment program. Identifying colorectal cancer recurrences earlier and treating it properly can lead to a better survival rate and quality of life.1
Note: Onko-Sure® is available in the United States for monitoring of CRC treatment and recurrence.
For the last 25 years, Carcinoembryonic Antigen (CEA) (sensitivity of 38-69%) and CA 19-9 (sensitivity of 23-65%) have been available blood biomarkers for colorectal cancer (CRC) treatment and follow-up monitoring. However, similar to any other biomarker, they have their own limitations.1 DR-70® (sensitivity of 54-87%) is the most recent biomarker cleared by the US FDA for the monitoring of colorectal cancer treatment and recurrence. It has been shown by two recent clinical studies performed in the UK and US in 2010 that combining CEA and DR-70® improves the test sensitivity to 55% higher than that of CEA alone.
FDP level measurement is routinely performed for the detection of coagolopathies. However, the current assays for FDP measurement usually detect only one out of the many FDP components (D-dimer).5 There have been many publications studying the D-dimer level measurement in different malignancies including CRC6-9; however, it is not approved for detecting or monitoring malignancies.
Onko-Sure® is the first blood test available for the monitoring of colorectal cancer treatment and recurrence based on FDP measurement. It is an ELISA-based test that uses DR-70® polyclonal antibody against the full array of FDP. Onko-Sure® detects all of the breakdown products of Fibrin and Fibrinogen, including a unique cancer-related breakdown product, Initial Plasmin Degradation Product (IPDP).10
Clinical data supports the medical utilization of Onko-Sure® for the monitoring of colorectal cancer. In these seven clinical studies, Onko-Sure® was used to measure DR-70 levels in about 6,000 patients and the results positively correlated with the progression of CRC.1,10-14 Furthermore, as reported by six other studies, the D-dimer level was also linked to CRC progression in about 500 patients.2,6-9
Figure 1. Comparison of Onko-Sure® with CEA. A large number of CRC patients have low CEA values (Concordance with Clinical Findings (%)
In general, it has been found that a combination of several biomarkers provides more accurate information for CRC monitoring. Therefore, it is recommended that both CEA and Onko-Sure® are used in combination for the monitoring of post-surgery CRC recurrence21.
More clinical studies are ongoing to verify the beneficial effect of CEA combination with Onko-Sure®. Furthermore, Onko-Sure® should be used in conjunction with other clinical modalities considered to be the standard of care for CRC disease progression monitoring.
For the last 25 years, CEA has been the main routine biomarker for CRC monitoring. DR-70 is the most recent biomarker cleared by the US FDA for the monitoring of colorectal cancer treatment and recurrence. It is recommended to use these two tests in combination to increase the test sensitivity for the monitoring of CRC treatment and recurrence (supported by 2 clinical studies in 2011).
The information on this website is intended for healthcare professionals practicing in the US. If you or a loved one want to know more about Onko-Sure, we encourage you to discuss it with your physician or other healthcare professional.
2. Okholm M, Iversen, LH, Thorlacius-Ussing O, Ejlerson E, Boesby S. Fibrin and fibrinogen degredation products in plasma of patients with colorectal adenocarcinoma. Dis Colon Rectum. 1996;39:1102-1106.
3. Hatton MW. Fibrinogen catabolism within the procoagulant VX-2 tumor of rabbit lung in vivo: Effluxing fibrin(ogen) fragments contain antiangiogenic activity. J Lab Clin Med. 2004;143:241-254.
4. Hatton MW. Relationships among tumor burden, tumor size, and the changing concentrations of fibrin degredation products and fibrinolytic factors in the pleural effusions of rabbits with VX2 lung tumors. J Lab Clin Med. 2006; 147:27-35.
5. Ieko M, Nakabayashi T, Tarumi T, Naito S, Yoshida M, Kanazawa K, Mizukami K, Koike T. Soluble fibrin monomer degradation products as a potentially useful marker for hypercoagulable states with accelerated fibrinolysis. Clin Chim Acta. 2007;386(1-2):38-45.
6. Blackwell K, Hurw´itz H, Liebe´rman G, Novotny W, Snyder S, Dewhirst M, Greenberg C. Circulating D-dimer levels are better predictors of overall survival and disease progression than carcinoembryonic antigen levels in patients with metastatic colorectal carcinoma. cancer. 2004;101(1):77-82.
7. Kilic M, Yoldas O, Keskek M, Ertan T, Tez M, Gocmen E, Koc M. Prognostic value of plasma D-dimer levels in patients with colorectal cancer. Colorectal Dis. 2008;10(3):238-41.
8. Oya M, Akiyama Y, Yanagida T, Akao S, Ishikawa H. Plasma D-dimer level in patients with colorectal cancer: its role as a tumor marker. Surg Today. 1998;28(4):373-8.
9. Xu G, Ya-Li Zhang, Wen Huang. Relationship between plasma D-dimer levels and clinicopathologicparameters in resectable colorectal cancer patients. World J Gastroenterol. 2004;10(6):922-923.
10. Rucker P, Antonio SM and Braden B. Elevated Fibrinogen-Fibrin Degradation Products (FDP) in Serum of Colorectal Cancer Patients. Analytical Letters. 2004;37:2965-2976.
11. Kerber A, TrojanJ, Herrlinger K, Zgouras D, Caspary WF, Braden B. The new DR-70 immunoassay detects cancer of the gastrointestinal tract: a validation study. Aliment Pharmacol Ther. 2004;20:983-098.
12. Small-Howard A, Harris H. Advantages of the AMDL-ELISA DR-70 (FDP) Assay over Carcinoembryonic Antigen for Monitoring Colorectal Cancer Patients. J Immunoassay Immunochem. 2010;31(2):131-147.
13. Wu D, Zhou X, Yang G, et al. Clinical performance of the AMDL DR-70 immunoassay kit for cancer detection. J Immunoassay 1998;19(1):63-72.
14. Lee KH, Cho DH, Kim KM, et al. Meaning of the DR-70 immunoassay for patients with the malignant tumor. Immune Network 2006;6(1):43-51.
15. Charalabopoulos K. CEA levels in serum and BAL in patients suffering from lung cancer: correlation with individuals presenting benign lung lesions and healthy volunteers. Med Oncol. 2007;24:219-225.
16. Graffner H, Hultberg B, Johansson B, Moller T, Petersson BG. Detection of recurrent cancer of the colon and rectum. J Surg Oncol. 1985;28:156-159.
17. Ladenson JH, McDonald JM, Landt M, Schwartz MK. Colorectal carcinoma and carcinoembryonic antigen (CEA). Clin Chem. 1980;26:1213-1220.
18. Wang JY, Tang R, Chiang JM. Value of carcinoembryonic antigen in the management of colorectal cancer. Dis Colon Rectum. 1994;37:272-277.
19. Wang WS. Preoperative carcinoembryonic antigen level as independent prognostic factor in colorectal cancer. Taiwan experience. Jpn J Clin Oncolo. 2000;30:12-16.
20. Kantrowitz M. False Positives and False Negativesin Tumor Marker Blood Tests. Cancer Points.http://www.kantrowitz.com/cancerpoints/tumormarkerfalsepositives.html[01/06/2010 11:59:54 PM].
21. Shimwell NJ, Wei W, Wilson S, et al. Assessment of novel combinations of biomarkers for the detection of colorectal cancer. Cancer Biomark. 2010;7(3):123-132.
The rise is being documented mainly in the metros, but it can be safely saidthat many cases in rural areas go unnoticed. It is reported that one in 22women in India is likely to suffer from breast cancer during her lifetime,while the figure is definitely more in America with one in eight being a victimof this deadly cancer. The problem with preventing breast cancer is that thereis no one cause that can be pinpointed as being the culprit. Of coursescreening for the presence of BRCA1 and BRCA2 mutations is available though itmust be admitted of being of little use in the Indian context. It is here thatthe task of spreading the awareness of the prevalence of this cancer andadvising women on undertaking self-breast examination comes into the picture Procedureslike mammography and Fine Needle Aspiration Cytology (FNAC) and biopsy need to be publicized so that women are aware of exactly what they are lettingthemselves in for.
RISK FACTORS FOR BREAST CANCER
A riskfactor is anything that makes it more likely you'll get a particular disease.But having one or even several risk factors doesn't necessarily mean you'lldevelop cancer — many women who develop breast cancer have no known riskfactors other than simply being women.
Factorsthat are associated with an increased risk of breast cancer include:
Being female. Women are much more likely than men are to develop breast cancer.
Increasing age. Your risk of breast cancer increases as you age. Women older than 55 have a greater risk than do younger women.
A personal history of breast cancer. If you've had breast cancer in one breast, you have an increased risk of developing cancer in the other breast.
A family history of breast cancer. If you have a mother, sister or daughter with breast cancer, you have a greater chance of being diagnosed with breast cancer. Still, the majority of people diagnosed with breast cancer have no family history of the disease.
Inherited genes that increase cancer risk. Certain gene mutations that increase the risk of breast cancer can be passed from parents to children. The most common gene mutations are referred to as BRCA1 and BRCA2. These genes can greatly increase your risk of breast cancer and other cancers, but they don't make cancer inevitable.
Radiation exposure. If you received radiation treatments to your chest as a child or young adult, you're more likely to develop breast cancer later in life.
Obesity. Being overweight or obese increases your risk of breast cancer because fat tissue produces estrogen that may help fuel certain cancers.
Beginning your period at a younger age. Beginning your period before age 12 increases your risk of breast cancer.
Dr.Mamta Pande
DCP,MD
About Onko-Sure
Believe it or not,universally 20,000 people die from cancereveryday BUT there is a U turn,the countdown is now in your hands!
40 years of tough research and development has introduced
ONKO-SURE --the first Pan Tumour Marker in India ( Now at Mamta Pathology and Ultasound Centre) that screens 13different types of cancer
(Liver,stomach,ovarian,lung,pancreatic,colorectal,tongue,breast )
from a simple blood test without any prior fasting.
Individuals having greater risk profile for cancer should bescreened for it every year.
Dr.Mamta Pande
DCP,MD
About Onko-Sure®
When you know, you can act.
Onko-Sure® is a simple, non-invasive and FDA cleared in vitro diagnostic (IVD) blood biomarker test used both for monitoring colorectal cancer (CRC) during treatment and afterwards for recurrence monitoring. It helps CRC patients and their healthcare team of physicians plan a pro-active treatment program and follow-up plan for patients after a CRC diagnosis.In medical terms, it measures Fibrin/Fibrinogen Degradation Products (FDP) in the blood serum. If these elements are found to be present, the physician can use this information to better plan and focus the post-diagnosis treatment program. Identifying colorectal cancer recurrences earlier and treating it properly can lead to a better survival rate and quality of life.1
Note: Onko-Sure® is available in the United States for monitoring of CRC treatment and recurrence.
Onko-Sure® offers some specific advantages over other approaches:
- Simple, non-invasive blood test
- Clinically proven in 12 published studies for monitoring of colorectal cancer treatment and recurrence
- Floats freely in blood (which makes it more effective even in lower concentrations of the marker)
For the last 25 years, Carcinoembryonic Antigen (CEA) (sensitivity of 38-69%) and CA 19-9 (sensitivity of 23-65%) have been available blood biomarkers for colorectal cancer (CRC) treatment and follow-up monitoring. However, similar to any other biomarker, they have their own limitations.1 DR-70® (sensitivity of 54-87%) is the most recent biomarker cleared by the US FDA for the monitoring of colorectal cancer treatment and recurrence. It has been shown by two recent clinical studies performed in the UK and US in 2010 that combining CEA and DR-70® improves the test sensitivity to 55% higher than that of CEA alone.
How Onko-Sure® Works
The production of Fibrin and Fibrinogen Degradation Products (FDP) is restricted in healthy individuals by normal cells. However, cancer cells release proteolytic enzymes such as plasmin and thrombin as they grow and metastasize. They also redirect the coagulation cascade which leads to overproduction of FDP in the process of carcinogenesis.2-4FDP level measurement is routinely performed for the detection of coagolopathies. However, the current assays for FDP measurement usually detect only one out of the many FDP components (D-dimer).5 There have been many publications studying the D-dimer level measurement in different malignancies including CRC6-9; however, it is not approved for detecting or monitoring malignancies.
Onko-Sure® is the first blood test available for the monitoring of colorectal cancer treatment and recurrence based on FDP measurement. It is an ELISA-based test that uses DR-70® polyclonal antibody against the full array of FDP. Onko-Sure® detects all of the breakdown products of Fibrin and Fibrinogen, including a unique cancer-related breakdown product, Initial Plasmin Degradation Product (IPDP).10
Clinical data supports the medical utilization of Onko-Sure® for the monitoring of colorectal cancer. In these seven clinical studies, Onko-Sure® was used to measure DR-70 levels in about 6,000 patients and the results positively correlated with the progression of CRC.1,10-14 Furthermore, as reported by six other studies, the D-dimer level was also linked to CRC progression in about 500 patients.2,6-9
Comparison of Onko-Sure® with CEA
CEA, an adhesion molecule, is firmly attached to cancer cells.15 Therefore, it is less abundant in blood and more difficult to be measured. However, DR-70 antigen is freely diffusible in blood and therefore easy to measure even in low concentrations in lower stages of the cancer. Approximately 35% of all CRC patients experience recurrence.16 Of those, half of them have low CEA values not detectable by CEA test.17-19 For this reason, Onko-Sure® has advantages over CEA in detecting lower levels of this biomarker leading to an early detection of recurrence.Figure 1. Comparison of Onko-Sure® with CEA. A large number of CRC patients have low CEA values (Concordance with Clinical Findings (%)
The Concentration of Biomarker (ng/ml)
(CEA = Carcinoembryonic Antigen)
CEA has approximately a 20% chance of false positive in smokers20 while Onko-Sure® measurements are not affected by smoking.In general, it has been found that a combination of several biomarkers provides more accurate information for CRC monitoring. Therefore, it is recommended that both CEA and Onko-Sure® are used in combination for the monitoring of post-surgery CRC recurrence21.
More clinical studies are ongoing to verify the beneficial effect of CEA combination with Onko-Sure®. Furthermore, Onko-Sure® should be used in conjunction with other clinical modalities considered to be the standard of care for CRC disease progression monitoring.
Summary
Onko-Sure® is a simple, non-invasive, patent-pending blood test used both for monitoring colorectal cancer (CRC) during treatment and for post-treatment CRC recurrence. It is an ELISA-based assay that measures the accumulation of Fibrin/Fibrinogen Degradation Products (FDP) in the serum using a polyclonal antibody (DR-70) as a blood biomarker.For the last 25 years, CEA has been the main routine biomarker for CRC monitoring. DR-70 is the most recent biomarker cleared by the US FDA for the monitoring of colorectal cancer treatment and recurrence. It is recommended to use these two tests in combination to increase the test sensitivity for the monitoring of CRC treatment and recurrence (supported by 2 clinical studies in 2011).
The information on this website is intended for healthcare professionals practicing in the US. If you or a loved one want to know more about Onko-Sure, we encourage you to discuss it with your physician or other healthcare professional.
References
1. Anthony T. Colorectal cancer follow-up in 2005. Surg Oncol Clin N Am. 2006;15:175-193.2. Okholm M, Iversen, LH, Thorlacius-Ussing O, Ejlerson E, Boesby S. Fibrin and fibrinogen degredation products in plasma of patients with colorectal adenocarcinoma. Dis Colon Rectum. 1996;39:1102-1106.
3. Hatton MW. Fibrinogen catabolism within the procoagulant VX-2 tumor of rabbit lung in vivo: Effluxing fibrin(ogen) fragments contain antiangiogenic activity. J Lab Clin Med. 2004;143:241-254.
4. Hatton MW. Relationships among tumor burden, tumor size, and the changing concentrations of fibrin degredation products and fibrinolytic factors in the pleural effusions of rabbits with VX2 lung tumors. J Lab Clin Med. 2006; 147:27-35.
5. Ieko M, Nakabayashi T, Tarumi T, Naito S, Yoshida M, Kanazawa K, Mizukami K, Koike T. Soluble fibrin monomer degradation products as a potentially useful marker for hypercoagulable states with accelerated fibrinolysis. Clin Chim Acta. 2007;386(1-2):38-45.
6. Blackwell K, Hurw´itz H, Liebe´rman G, Novotny W, Snyder S, Dewhirst M, Greenberg C. Circulating D-dimer levels are better predictors of overall survival and disease progression than carcinoembryonic antigen levels in patients with metastatic colorectal carcinoma. cancer. 2004;101(1):77-82.
7. Kilic M, Yoldas O, Keskek M, Ertan T, Tez M, Gocmen E, Koc M. Prognostic value of plasma D-dimer levels in patients with colorectal cancer. Colorectal Dis. 2008;10(3):238-41.
8. Oya M, Akiyama Y, Yanagida T, Akao S, Ishikawa H. Plasma D-dimer level in patients with colorectal cancer: its role as a tumor marker. Surg Today. 1998;28(4):373-8.
9. Xu G, Ya-Li Zhang, Wen Huang. Relationship between plasma D-dimer levels and clinicopathologicparameters in resectable colorectal cancer patients. World J Gastroenterol. 2004;10(6):922-923.
10. Rucker P, Antonio SM and Braden B. Elevated Fibrinogen-Fibrin Degradation Products (FDP) in Serum of Colorectal Cancer Patients. Analytical Letters. 2004;37:2965-2976.
11. Kerber A, TrojanJ, Herrlinger K, Zgouras D, Caspary WF, Braden B. The new DR-70 immunoassay detects cancer of the gastrointestinal tract: a validation study. Aliment Pharmacol Ther. 2004;20:983-098.
12. Small-Howard A, Harris H. Advantages of the AMDL-ELISA DR-70 (FDP) Assay over Carcinoembryonic Antigen for Monitoring Colorectal Cancer Patients. J Immunoassay Immunochem. 2010;31(2):131-147.
13. Wu D, Zhou X, Yang G, et al. Clinical performance of the AMDL DR-70 immunoassay kit for cancer detection. J Immunoassay 1998;19(1):63-72.
14. Lee KH, Cho DH, Kim KM, et al. Meaning of the DR-70 immunoassay for patients with the malignant tumor. Immune Network 2006;6(1):43-51.
15. Charalabopoulos K. CEA levels in serum and BAL in patients suffering from lung cancer: correlation with individuals presenting benign lung lesions and healthy volunteers. Med Oncol. 2007;24:219-225.
16. Graffner H, Hultberg B, Johansson B, Moller T, Petersson BG. Detection of recurrent cancer of the colon and rectum. J Surg Oncol. 1985;28:156-159.
17. Ladenson JH, McDonald JM, Landt M, Schwartz MK. Colorectal carcinoma and carcinoembryonic antigen (CEA). Clin Chem. 1980;26:1213-1220.
18. Wang JY, Tang R, Chiang JM. Value of carcinoembryonic antigen in the management of colorectal cancer. Dis Colon Rectum. 1994;37:272-277.
19. Wang WS. Preoperative carcinoembryonic antigen level as independent prognostic factor in colorectal cancer. Taiwan experience. Jpn J Clin Oncolo. 2000;30:12-16.
20. Kantrowitz M. False Positives and False Negativesin Tumor Marker Blood Tests. Cancer Points.http://www.kantrowitz.com/cancerpoints/tumormarkerfalsepositives.html[01/06/2010 11:59:54 PM].
21. Shimwell NJ, Wei W, Wilson S, et al. Assessment of novel combinations of biomarkers for the detection of colorectal cancer. Cancer Biomark. 2010;7(3):123-132.
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