«Colorectal cancer screening in the regions of the Russian Federation: Stanislav Konovalov Leading expert in HTSA Plus program

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1 «Colorectal cancer screening in the regions of the Russian Federation: Stanislav Konovalov Leading expert in HTSA Plus program

2 Relevance of the problem The structure of mortality rate in Russia from various diseases 1 place 2 place 3 place Diseases of the circulatory system Malignant neoplasms Injuries and poisonings Colorectal cancer (CRC) occupies leading positions in the oncology rates of all developed countries

3 Relevance of the problem Mortality rate from malignant neoplasms among the Russian population (both sexes, 13.6%) Pancreas 5,9 Rectum 5,7 Trachea, bronchi, lungs 17,3 Breast 7,8 Colon 7,9 Stomach 10,3

4 Quantitative immunochemical FOBT (FIT) test HTSA (Hemoglobin Transferrin Simultaneous Assay)* High-performance analyzer Unique specimen collection container (Provides stability of Hb and Tf) Reagent containing colloid gold Fully automated Performance: 300 tests/hour * HTSA (Hemoglobin Transferrin Simultaneous Assay) - a combination of the quantitative detection of fecal hemoglobin (Hb) and fecal transferrin (Tf) currently has the highest accuracy level: 96% for patients with cancer and 88% for patients with precancerous stages.

5 The first pilot project in the Russian Federation in Khanty-Mansiysk region, in which the CRC screening program was launched and has been successfully implemented since км Ханты-Мансийск Нефтеюганск Сургут Нижневартовск

6 Test for Tf confirms false-negative test for Hb Ascending colon Traverse colon Ascending colon Traverse colon Descending colon Descending colon Bleeding Hb, Tf Sigmoid colon Rectum Sigmoid colon Rectum Denatured Hb, Tf Bleeding Hb, Tf Hb, Tf The cancer of the ascending colon is virtually asymptomatic and at its early stages its detection is difficult. This neoplasm occurs mostly among people older than 50, and the incidence rate is growing each year. This calls for a need for new methods of detection of this type of cancer. Transferrin Test (Tf) can be an effective and reliable method for diagnosing colorectal cancer.

7 HTSA Fecal Occult Blood Test using the immunochemical IFOBT/FIT method in Khanty-Mansiysk Region - Yugra Immunochemical fecal occult blood test ifobt/fit DETECTION OCCULT bleeding in various intestine areas Hb Tf Fecal Hemoglobin (Hb) high levels of Hb indicate the damage of lower areas of intestine. Fecal Transferrin (Tf) - high levels of Tf indicate the damage of higher areas of intestine. Besides, Fecal Tf allows avoiding the false-negative results for Hb. Diagnosis Yoshinori Takashima, Takao Shimada, Tamotsu Yokozawa 2015; 2(1): (Hemoglobin Transferrin Simultaneous Assay) a combination of the quantification of fecal hemoglobin (Hb) and fecal transferrin (Tf) has the highest current accuracy level: 96% for patients with cancer and 88% for patients with precancerous conditions.

8 Transferrin in the LOINC system In may 2017 fecal transferrin was introduced to the international database and universal standard for identification of medical doctor s and laboratory examinations LOINC, and it was given a code LOINC is used for standardized presentation of medical terminology in the field of laboratory research and clinical observation for the purpose of electronic exchange and the collection of clinical data obtained from various information systems.

9 Quantitative detection of fecal transferrin and hemoglobin (for occult blood) using a two-day HTSA method in the pilot project "colorectal cancer screening in the Khanty-Mansiysk region - Ugra" on the NS-Plus analyzer Surgut Khanty-Mansiysk Nizhnevartovsk Nefteyugansk TOTAL People examined Positive results («+»), people ,5% ,4% ,6% ,6% ,1% Positive results («+»), tests «+» for Hb (Day 1 and Day 2) ,0% ,4% ,6% ,8% ,2% «+» for Hb Day ,6% ,6% ,0% ,9% ,2% «+» for Hb Day ,4% ,4% ,0% ,1% ,8% «+»for Tf (Day 1 and Day 2) ,0% ,6% ,4% ,2% ,8% «+» for Tf Day ,5% ,9% ,1% ,8% ,0% «+» for Tf Day ,5% ,1% ,9% ,2% ,0% «+» for both markers 449 2,8% 160 3,0% 447 3,6% 145 2,5% ,0% «+»for Hb and Tf Day ,8% ,8% ,7% ,8% ,0% «+»for Hb and Tf Day ,1% ,1% ,6% ,7% ,4% Positive results («+»), people Обследовано People examined человек положительных Positive results результатов положительных Hb positive на Hb положительных Tf positive на Tf Positive results («+»), tests «+» на Hb «+» на Tf из них «+» на Both оба markers маркера ; 14,1% ,8 % 3,0 % 71,2 % 11501

10 3% in year Detection rate of early stages of tumor in Russia in * Malignant neoplasms registered CRC Colon (С18) Rectum, recto-sigmoid junction, anus (С19-21) (56,7%) (43,3%) (56,7%) (43,3%) (56,4%) (43,6%) (56,0%) (44,0%) (56,1%) (43,9%) Of those had the following stage of disease (%): Colon (С18) Rectum, recto-sigmoid junction, anus (С19-21) I ll lll lv l ll lll lv ,0 37,3 25,1 27,7 10,6 40,3 24,2 22, ,4 35,7 26,6 27,7 10,2 38,8 24,8 23, ,8 35,1 27,6 27,6 9,3 38,8 25,1 23, ,7 35,3 27,5 27,5 9,0 38,6 26,0 23, ,6 34,4 28,4 28,0 8,8 39,3 25,2 23,4 Mortality in the first year after making a diagnosis: ,4 23, ,4 24, Colon (С18) 28,4 25, ,6 25, ,5 27,7 Rectum, recto-sigmoid junction, anus (С19-21) * - «Condition of the oncology aid to the population in » - edited by A.D. Caprin, V.V. Starinski, G.V. Petrova - Moscow, Conclusions: In the tables there are data over the 5-year period. In comparison with Khanty-Mansiysk region in Russia the detection rate on the first stage has grown only by 2.4% in colon. In rectum detection rate of malignants has grown by 1.8%.

11 Statistics after implementation of immunochemical ifobt (FIT) test by HTSA method in Khanty-Mansyisk Malignant neoplasms registered Autonomous Okrug Yugra CRC Colon (С18) Rectum, rectosigmoid, anus (С19-21) (54,2%) 268 (45,8%) (54,2%) 218 (45,8%) (55,3%) 214 (44,7%) (55,0%) 201 (45,0%) (50,0%) 195 (50,0%) Of those had the following stage of disease (%): Colon (С18) Rectum, recto-sigmoid junction, anus (С19-21) I ll lll lv l ll lll lv ,6 26,5 17,7 29,3 19,8 33,6 22,8 21, ,8 32,9 21,7 25,6 25,7 27,1 22,0 21, ,6 33,2 19,6 24,9 12,6 33,2 19,6 31, ,6 32,9 15,9 34,1 16,9 38,3 20,4 23, ,2 37,4 23,1 25,1 11,3 40,5 20,0 21,5 Mortality in the first year after making a diagnosis: ,8 15, ,0 23, Colon (С18) 23,3 14, ,9 13, ,3 30,5 Rectum, recto-sigmoid junction, anus (С19-21) * «Condition of the oncology aid to the population in » - edited by A.D. Caprin, V.V. Starinski, G.V. Petrova - Moscow, Conclusions: The data over the 5 year period in Khanty-Mansiysk region are represented above. Due to the 2-days HTSA method use (fecal hemoglobin and transferrin simultaneous assay) detection of colon cancer at the 1 stage has grown three times. Two-days HTSA method helped to increase detection of rectum cancer two times. As a result CRC mortality rate remained at a low level.

12 The test results conducted on a Discrete Automated Clinical Chemistry Analyzer NS-Plus C15 (Japan) in Nizhnevartovsk (2011 to 2018) Results of the two-days immunochemical test - ifobt (FIT) using the HTSA method (fecal hemoglobin (Hb) and transferrin (Tf) simultaneous assay ) (for the entire period). People examined Positive results («+»), people ,6% Positive results («+»), tests «+» for Hb (Day 1 and Day 2) ,6% «+» for Hb Day ,0% «+» for Hb Day ,0% «+»for Tf (Day 1 and Day 2) ,4% «+» for Tf Day ,1% «+» for Tf Day ,9% «+» for both markers 447 3,6% «+»for Hb and Tf Day ,7% «+»for Hb and Tf Day ,6% Positive Results 16,6 % Positive results («+»), tests both

13 Table 2 Quantitative two-days immunochemical test using the HTSA method «+» for Hb «+» for Tf «+» for both markers Day Day Positive results for Hb: Day 1 and Day 2 Hb Day 1 Hb Day 2 Positive results for Tf: Day 1 and Day 2 Tf Day 1 Tf Day 2

14 Appendix 1. Test results. Quantitative simultaneous Hb and Tf tests using the HTSA method (2018) (twodays method) Hb Tf Hb Tf Day 1 Day 1 Day 2 Day 2 Hb Tf Hb Tf Day 1 Day 1 Day 2 Day 2 This patient showed a significant excess of Hb and Tf cut-off in both days. With a positive value in any of the days or both days, the doctor assigns an additional examination (for example, a colonoscopy), and the final diagnosis is reached based on its results.

15 This patient would have been missed when only conducting a one-day Hb test. For small and uneven positive Tf values, the patient is most likely to have an initial form of an upper intestine disease, so additional tests are necessary. For example, a colonoscopy. This patient had positive values only in day 2. With a one-day study, he would have been missed. The doctor assigns an additional examination, which leads to the final diagnosis.

16 Quantitative detection of transferrin and hemoglobin in feces (FOBT) using twodays HTSA method in Moscow Central Polyclinic 474 people were examined. 40 positive cases (8.4%) were detected, including: - Women - 24; - Men Percentage of positive results 8,4% Examination revealed: 1. Polyps - 20 people. (by results of cytology, tubular adenoma of various degrees of dysplasia) 2. Colon cancer - 4 people. 3. Diverticular disease of the large intestine - 6 people. 4. Colitis of various etiology - 5 people. 5. Nonspecific ulcerative colitis - 3 people. 6. Crohn's disease - 2 people. 7,5% 5,0% Полипы 50,0% 12,5% Рак ободочной кишки 15,0% 10,0% Дивертикулярная болезнь толстого кишечника Колиты различной этиологии Неспецифический язвенный колит Болезнь Крона

17 Quantitative detection of transferrin and hemoglobin in feces (FOBT) using twodays HTSA method in Moscow Central Polyclinic Hb «+» Tf «+» Hb Tf «+» Day Day Positive results for Hb 1 day and 2 days 48,7% 51,3% «+» на Hb 1 дня «+» на Hb 2 дня Positive resultsfor Tf 1 day and 2 days 50,0% 50,0% «+» на Tf 1 дня «+» на Tf 2 дня

18 Quantitative detection of transferrin and hemoglobin in feces (FOBT) using twodays HTSA method in Moscow Central Polyclinic Hb Tf Hb Tf 1 день 1 день 2 день 2 день Hb Tf Hb Tf 1 день 1 день 2 день 2 день Выводы: For the final diagnosis, patients underwent a colonoscopy and other examination. cytological tests at the second stage of the

19 Conclusions The immunochemical ifobt (FIT) test by HTSA method will significantly save public funds since detection of patients with early stages of cancer will allow to timely conduct low-cost preventive procedures, to preserve patients health, to improve the quality of their life and to avoid complex and expensive treatment and as a result to reduce the incidence (stage III and IV) and mortality related to colorectal cancer.