Postsurgical Disease Recurrence in Stage I to III Colorectal Cancer May Be Predicted by ctDNA
- 3 years ago
Patients with stage I to III colorectal cancer and a high risk for disease recurrence may be identified by serial testing of circulating tumor DNA (ctDNA) after resection, according to a study in which ctDNA was more reliable than carcinoembryonic antigen (CEA) surveillance or standard radiologic imaging.
“Patients with ctDNA detected immediately after surgery had a high risk of recurrence, and longitudinal monitoring increased the predictive power of ctDNA,” said Tenna V. Henriksen, a doctoral student at Aarhus University in Denmark, who presented the findings during the 2021 Gastrointestinal Cancers Symposium (Abstract 11).
Molecular recurrence, as identified on ctDNA, was detected a median of 8 months before radiologic detection of disease, and longitudinal testing with ctDNA greatly outperformed CEA for prediction as well, she said.
This work was a collaboration between researchers at Aarhus University and the INCLIVA Institute in Spain, which together provided data on 260 patients with stage I to III colorectal cancer, and the Natera company in the United States, which created the ctDNA detection strategy used in the study (Signatera, which was granted a Breakthrough Device designation by the U.S. Food and Drug Administration).
The ctDNA tool is a “custom-built, tumor-informed” blood-based next-generation sequencing assay that traces the 16 most frequent tumor-specific single-nucleotide variants exclusive to each patient.
Study Design and Key Findings
The 260 patients in the study included 166 with stage III disease, 90 with stage II disease, and 4 with stage I disease; all patients underwent tumor resection, and 165 patients also received adjuvant treatment. Relapse occurred in 48 patients. Plasma samples (n = 1,503) were collected at various time points (30 days, 3 months, and then every 3 months postsurgery for 3 years) for a median time of 29.9 months.
The presence or absence of ctDNA identified two distinct prognostic groups at multiple time points. Postresection, 80% of patients with detectable ctDNA after surgery experienced disease recurrence, as compared with only 13% of patients with undetectable ctDNA, translating to an 11-fold increase in the risk for relapse (P
“Patients with ctDNA detected immediately after surgery had a high risk of recurrence, and longitudinal monitoring increased the predictive power of ctDNA,” said Tenna V. Henriksen, a doctoral student at Aarhus University in Denmark, who presented the findings during the 2021 Gastrointestinal Cancers Symposium (Abstract 11).
Molecular recurrence, as identified on ctDNA, was detected a median of 8 months before radiologic detection of disease, and longitudinal testing with ctDNA greatly outperformed CEA for prediction as well, she said.
This work was a collaboration between researchers at Aarhus University and the INCLIVA Institute in Spain, which together provided data on 260 patients with stage I to III colorectal cancer, and the Natera company in the United States, which created the ctDNA detection strategy used in the study (Signatera, which was granted a Breakthrough Device designation by the U.S. Food and Drug Administration).
The ctDNA tool is a “custom-built, tumor-informed” blood-based next-generation sequencing assay that traces the 16 most frequent tumor-specific single-nucleotide variants exclusive to each patient.
Study Design and Key Findings
The 260 patients in the study included 166 with stage III disease, 90 with stage II disease, and 4 with stage I disease; all patients underwent tumor resection, and 165 patients also received adjuvant treatment. Relapse occurred in 48 patients. Plasma samples (n = 1,503) were collected at various time points (30 days, 3 months, and then every 3 months postsurgery for 3 years) for a median time of 29.9 months.
The presence or absence of ctDNA identified two distinct prognostic groups at multiple time points. Postresection, 80% of patients with detectable ctDNA after surgery experienced disease recurrence, as compared with only 13% of patients with undetectable ctDNA, translating to an 11-fold increase in the risk for relapse (P