Colon!
CIRCULATE-US (NRG-GI008)
Stage IIB, IIC, or any stage III colon cancer post-R0 resection------Cohort A NO ctDNA Detected
* Arm 1-- CAPOX/FOLFOX
* Arm 2--Surveillance with serial ctDNA
Arm 2 pts who become ctDNA +ve may cross-over to Cohort B
Cohort B cTDNA detected
* Arm 3--CAPOX/FOLFOX
* Arm 4--FOLFIRINOX
Cohort A: ctDNA negative • Phase II: Time to ctDNA+ • Phase III: DFS
Cohort B: ctDNA positive • Phase II/III: DFS
(ONGOING?)
--> With a median follow-up at 16.74 months, post-surgical ctDNA positivity at 4 weeks after surgery is associated with higher recurrence risk. It also identified patients with Stage II/III CRC who would benefit from adjuvant chemotherapy.
Alascca Trial
3508 patients were screened for PI3K pathway alterations, rectal I-III and colon II-III.
Group A (PIK3CA Exon 9 or 20)
Group B (PIK3R1/PTEN/other PI3CA)
Aspirin 160 mg led to a significantly lower incidence of colorectal cancer recurrence compared to the placebo among patients with PIK3CA hotspot mutations in exon 9 or 20. It appeared to confer a similar benefit among those with other somatic alterations in PI3K pathway genes. Also, improved DFS at 3 years.
Per NCCN, for colon stage II/III and PIK3CA mutation, add aspirin x 3 years.
CO21 Study
Patients with resected stage II or high risk stage II who completed adjuvant chemo within 2-6 months