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C01-TFunctionalProg: stage II colorectal cancer recurrence risk test and select effective personalized adjuvant drugs

Carbon Logic Biotech C01-TFunctionalProg test recurrence risk of stage II colorectal cancer and selects effective personalized adjuvant drugs for stage II colorectal cancer patients who have a high risk of recurrence. C01-TFunctionalProg was validated on formalin-fixed, paraffin-embedded(FFPE) samples of 222 high quality stage II microsatellite stable(MSS) colorectal cancer patients(median follow-up=41 months, main endpoint recurrence-free survival. Stage II colorectal cancer patients who had no recurrence but received adjuvant/neoadjuvant chemotherapy/radiotherapy were excluded from this cohort). C01-TFunctionalProg low-risk group of stage II colorectal cancer patients have 3-years recurrence free survival >92% and may consider forgoing adjuvant therapy. C01-TFunctionalProg high-risk group of stage II colorectal cancer patients have 3-years recurrence free survival <60% (Figure 1,2), and C01-TFunctionalProg proposes personalized rational adjuvant drugs for these high-risk patients.

Different from ctDNA-based prognostic biomarkers that are used as indicators of minimal residual disease, C01-TFunctionalProg aims to dissect the underlying biology of recurrence of stage II colorectal cancer and subgroups of epithelial mesenchymal transition. Therefore, C01-TFunctionalProg provides several different features and a different modality for the management of stage II CRC:

       (1) The observed sensitivity of C01-TFunctionalProg of predicting the recurrence of stage II colorectal cancer is between 70% (Figure 1A.Independent validation) - 85% (Figure 1B.Leave-One-Out cross validation), and this sensitivity is higher than the observed sensitivity of postoperative ctDNA-based prognostic biomarkers for predicting recurrence of stage II colorectal cancer in clinical trials^# (Tie J, et al. N Engl J Med. 2022; Reinert T, et al. JAMA Oncol. 2019; Chen G, et al. J Hematol OncolJ Hematol Oncol. 2021)

       (2) C01-TFunctionalProg utilizes standard 5 µm/10 µm formalin-fixed, paraffin-embedded(FFPE) slides that can be stored at room temperature, thus the operation cost is significantly lower.

       (3) C01-TFunctionalProg is a prognostic assay with integrated functions that indicate chemotherapy response (Figure 3) and select personalized adjuvant drugs for stage II colorectal cancer patients who have a high risk of recurrence.

	Figure 1. Independent validation of C01-TFunctionalProg on FFPE samples		Figure 2. Leave-One-Out cross validation of C01-TFunctionalProg on FFPE samples		Figure 3. Folfox resistance score of C01-TFunctionalProg high-risk subgroups

# Sensitivity of postoperative ctDNA-based prognostic biomarkers of predicting reccurence of stage II colorectal cancer is estimated as TP/(TP+FN):
TP=Number of stage II colorectal cancer patients that developed recurrence and are correctly detected as ctDNA-positive (recurrence of stage II colorectal cancer patients in ctDNA-positive group)
FN=Number of stage II colorectal cancer patients that developed recurrence but are not detected as ctDNA-positive (recurrence of stage II colorectal cancer patients in ctDNA-negative group)





Fulong Wang. et al., (2023) Dissected subgroups predict the risk of recurrence of stage II colorectal cancer and select rational treatment. Front. Immunol. DOI: 10.3389/fimmu.2023.1103741. PMID: 37033948