Here's the bottom line, no pun intended: Colonoscopy is still the most effective screening method for colorectal cancer (CRC), but too many adults who should be screened refuse to have it done as a primary screening method.
Innovators have spent the past decade or so developing various alternative colorectal cancer (CRC) screening methods. None of those alternatives currently on the market are as effective as the traditional colonoscopy, but gastroenterologists generally agree that the best CRC screening test is the one that gets done.
The key word here is screened, not diagnosed. Colonoscopy is still the only procedure that can actually diagnose cancer because a CRC diagnosis requires a biopsy. All of the non-invasive CRC tests currently on the market are designed to be a first line screening tool. If that turns up positive, then the patient is referred for a colonoscopy.
Earlier this week, the NCI-sponsored cancer intervention and surveillance modeling network (CISNET) published a study in the Journal of the National Cancer Institute comparing the incremental cost-effectiveness of alternative CRC screening methods on the market. Specifically, the study evaluated computed tomography colonography (CTC; also known as virtual colonoscopy), PillCam, mtSDNA (Cologuard) and mSEPT9 (Epi proColon).
From a cost-effectiveness standpoint, the researchers concluded that of all the aforementioned techniques, annual screening with Epi proColon landed at the top of the list. Developed by Berlin, Germany-based Epigenomics, the is a blood-based screening test for the detection of colorectal cancer. The test was developed based on the company's DNA methylation biomarker technology. The screening test is on the market in the United States, Europe, and China.
The study found that annual screening with Epi proColon had an incremental cost-effectiveness ratio (ICER) of $63,253 per quality-adjusted-life-years gained (QALYG). Other efficient strategies were CTC screening every five years (ICER: $1,092 per QALYG) and annual mtSDNA screening (ICER: $214,974 per QALYG), which were not optimal given the willingness-to-pay threshold ($100,000 per QALYG), according to the researchers.
“CISNET microsimulation models are the gold-standard by which the American Cancer Society, United States Preventative Services Task Force, and other clinical societies base their guideline recommendations for CRC screening," said Jorge Garces, president and chief scientific officer at Epigenomics. "This study supports the findings from another recent study published in Cancer Medicine and adds to the mounting evidence indicating that Epi proColon administered annually can reduce the incidence and mortality of colorectal cancer as effectively or better than other approved methods and most importantly highlights the opportunity for the Epi proColon blood test to serve as the test of choice for those currently resistant to colonoscopy and stool-based screening methods.”
The JNCI publication analyzed the clinical effectiveness and performance of various screening strategies under five different scenarios:
- Screening from age 50 through 75 years in an-average risk population, with perfect adherence to screening, diagnostic follow-up and surveillance recommendations.
- Assuming screening from age 45 to age 75 with outcomes presented per 1,000 45-year olds at 100% adherence.
- Using the model version that was used to inform the 2016 USPSTF screening guidelines, in which screening starts at 50 years of age and does not account for the increasing incidence. 100% adherence assumed.
- Assuming that 90% of the people that participated in a previous round would participate in a subsequent round, and 15% of the people that did not participate in the previous round would participate in the subsequent round. An 80% adherence to diagnostic follow-up and surveillance was assumed.
- Assuming 12% of advanced adenomas and 18% of colorectal cancers are systematically missed by the mSEPT9.