An Experiment Involving 1.1 Million People That Nearly Halved Colorectal Cancer Mortality
Colorectal cancer remains one of the most common and deadly oncological diseases in the world today. However, in modern medicine, there is a small list of diseases that can be prevented not only through early diagnosis but also through the timely detection and treatment of precancerous changes. Colorectal cancer belongs to exactly this group of diseases.
Today, as healthcare systems increasingly focus on prevention and population-based approaches, the program implemented by the American healthcare giant Kaiser Permanente Northern California, which has established a completely new standard for organizing colorectal cancer screening over the past two decades, is attracting particular attention.
Colorectal Cancer — An Invisible Threat
Colorectal cancer includes malignant tumors of the colon and rectum and holds one of the leading positions among the most frequently diagnosed oncological diseases worldwide. According to GLOBOCAN 2022 data, approximately 1.9 million new cases of the disease were recorded globally, while the mortality rate exceeded 900,000. These figures firmly place colorectal cancer as the second leading cause of cancer-related deaths.
The particular danger of the disease lies in the fact that it is often asymptomatic in its early stages. This is why patients often consult a doctor only when the disease is already clinically apparent. Among the most common symptoms are changes in bowel habits, blood in the stool, abdominal pain and persistent bloating, unexplained weight loss, general weakness, and iron-deficiency anemia.
However, the most important feature of this disease is that colorectal cancer is considered a preventable disease. Through screening, it is possible not only to detect tumors at an early stage but also to identify precancerous conditions early and combat them in a timely manner.
Risk Factors and Their Management
Both genetic and environmental factors play an important role in the development of colorectal cancer. Modifiable risk factors include a diet rich in red meat and low in fiber, low physical activity, overweight and obesity, as well as tobacco and alcohol use.
As for non-modifiable factors, the leading ones are age (especially after 50), family history, Lynch syndrome, familial adenomatous polyposis (FAP), and a personal history of polyps or colorectal cancer.
Early Diagnosis and New Standards
Numerous international studies confirm that regular screening significantly reduces both the incidence of colorectal cancer and its associated mortality. For years, the traditional fecal occult blood test (FOBT) was used as the primary screening method, but in recent years it has been actively replaced by a more modern method — the fecal immunochemical test (FIT).
The advantage of the fecal immunochemical test is obvious: it is characterized by almost twice the sensitivity in detecting colorectal cancer, provides a better opportunity to detect precancerous adenomas, does not require preliminary dietary restrictions, requires only a single sample, and has fewer false-positive results. It was this effective method that formed the basis of one of the most successful population-based programs in the world.
The Kaiser Permanente Experiment
In 2006, Kaiser Permanente Northern California launched a large-scale organized screening program targeting the population aged 50 to 75. The project involved the annual mailing of FIT tests, electronic medical record analysis, an automated reminder system, and timely colonoscopy in the event of a positive test.
By 2019, the program covered data from more than 1.1 million people. The results were quite impressive: the screening participation rate increased from 37.4% to 79.8%, the incidence of colorectal cancer decreased by approximately 30–33%, and the disease mortality rate fell by 50–52%.
Given how significant the Kaiser Permanente experiment proved to be, we decided to obtain additional information about the research process and results directly from the primary source. We present an exclusive interview with Theodore R. Levin, Associate Director of the Research Division at Kaiser Permanente Northern California and Clinical Lead of the Colorectal Cancer Screening Program at The Permanente Medical Group.
Interview with Theodore R. Levin
— How did it all start, and why was the choice made specifically for the FIT test?
— The creation of the program was preceded by years of experience using flexible sigmoidoscopy. During our research, we discovered that screening rates were not at all at the level we expected. At the same time, we studied patients’ experiences with the FIT test, and the results prompted us to build the program on a completely new model. There are more than 4 million people in our system. FIT is easily mailed to patients, and its processing is simple to organize on a large scale.
— Can you describe the overall structure of the colorectal cancer screening program and the population involved in the analysis?
— We created a system that automatically checks patients’ electronic medical records to determine what types of tests members have had and who is due for screening in the current year. Every week, a portion of these patients are sent a reminder letter stating that it is time for their annual screening, along with a FIT kit.
If a member is becoming eligible for FIT screening for the first time, they first receive a letter explaining the screening process, followed by the FIT kit. If the kit is not returned to the center within three weeks, the patient receives a text message or an automated phone call reminder. If, after another 2–3 weeks, the test is still not returned, a second letter is sent to the screening participant, and at the same time, primary care physicians, their support staff, or local quality managers get involved to encourage the completion of the test.
— How were false-positive and false-negative FIT results managed in clinical practice?
— A false-positive is considered a case where the FIT result is positive, but the subsequent colonoscopy is negative, meaning it rules out the presence of a colorectal tumor. Such patients can postpone their next screening for 10 years. False-negative results are only identified when a patient is ultimately diagnosed with cancer. However, everyone who has a negative result undergoes screening again the following year, as recommended.
— The program showed a significant reduction in colorectal cancer mortality. In your opinion, which mechanisms were most important in achieving this result?
— The most crucial factor is the correct selection of patients who must undergo colonoscopy. It is worth noting that the FIT test has higher sensitivity compared to the traditional FOB test; however, a FIT-based program alone cannot reduce mortality unless a positive result is followed by a colonoscopy. Colonoscopy is essential for diagnosing cancer. In addition, it makes it possible to detect and remove advanced adenomatous polyps before they transform into malignant growths.
— Do you think mail-in FIT-based population screening should become a national preventive strategy?
— We believe that a national screening program will reduce mortality from colorectal cancer. However, this is only possible if the appropriate infrastructure exists: laboratories must be able to perform tests quickly, patients must receive information about results in a timely manner, and timely colonoscopy must be accessible to individuals with a positive result.
— Will artificial intelligence become a future tool for screening?
— In the next decade, Kaiser Permanente plans to integrate artificial intelligence. We want to create a more personalized reminder system. AI navigators will provide individual communication with patients and further increase engagement in screening.
— Do you predict that the fecal immunochemical test will remain the primary screening method, or do you expect new technologies to replace this test?
— FIT is a relatively cheap, simple, and effective method. Currently, new technologies such as stool DNA tests, which are directly consumer-oriented, are being intensively promoted in the US. However, it is not yet clear whether their effectiveness exceeds that of the FIT test.
— Can Georgia implement a similar model?
— I am not familiar with Georgia’s healthcare system in detail, but if quality databases, appropriate human resources, and colonoscopy capabilities exist, implementing such a program is completely possible.
— If you were creating this program today, based on current evidence, what would you change or improve?
— If we were creating the program today, we would use more advanced computing technologies, which would allow us to create an improved monitoring system to ensure timely colonoscopy for all patients with a positive FIT result. We would also create a more personalized reminder system tailored individually to each member. The experience of Kaiser Permanente clearly showed that success in the fight against colorectal cancer is determined not only by modern tests but by a well-organized system.
Where is Georgia Today?
Georgia has a state colorectal cancer screening program, under which men and women aged 50–70 can undergo an FOBT test based on fecal occult blood. If necessary, a colonoscopy and histomorphological examination of biopsy material are also performed.
As specialists point out, regular screening saves lives — the earlier the disease is detected, the more favorable the final clinical outcome.
Article author – Mariam Kukhalashvili, MD, Clinical Oncologist; Co-author – Mariam Chirakadze, MD
