From the Guidelines
Stage 2 colon cancer patients with high-risk features should receive adjuvant chemotherapy, such as fluoropyrimidine-based chemotherapy, to improve disease-free survival and overall survival. The treatment of stage 2 colon cancer typically involves surgical removal of the affected part of the colon (colectomy) along with nearby lymph nodes 1. However, for patients with high-risk features such as poorly differentiated tumors, lymphovascular invasion, or fewer than 12 lymph nodes examined, adjuvant chemotherapy may be recommended to reduce the risk of recurrence 1.
High-Risk Features
Some of the high-risk features that may necessitate adjuvant chemotherapy include:
- T4 tumor stage
- Clinical bowel obstruction at the time of diagnosis
- Perforation of the colon at the tumor site
- Poor histologic grade
- Lymphovascular invasion (LVI)
- Fewer than 12 sampled lymph nodes
Adjuvant Chemotherapy
Common chemotherapy regimens for stage 2 colon cancer include:
- FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)
- CAPOX (capecitabine and oxaliplatin) These regimens are typically administered for about 3-6 months 1.
Follow-Up
After treatment, regular follow-up is essential to monitor for recurrence, including:
- Colonoscopies
- CT scans
- Blood tests to monitor CEA levels 1 Lifestyle modifications like maintaining a healthy weight, regular exercise, and a diet rich in fruits and vegetables may also help reduce recurrence risk. According to the most recent guideline update from 2022, the use of adjuvant therapy in stage II colon cancer should be individualized based on the patient's risk of recurrence and other factors 1.
From the FDA Drug Label
The primary objective of the study was to compare disease-free survival (DFS) in patients receiving XELODA to those receiving IV 5-FU/LV alone In this trial, 1987 patients were randomized either to treatment with XELODA 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks) or IV bolus 5-FU 425 mg/m2 and 20 mg/m2 IV leucovorin on days 1 to 5, given as 4-week cycles for a total of 6 cycles (24 weeks) Patients in the study were required to be between 18 and 75 years of age with histologically-confirmed Dukes' stage C colon cancer with at least one positive lymph node and to have undergone (within 8 weeks prior to randomization) complete resection of the primary tumor without macroscopic or microscopic evidence of remaining tumor
The treatment for Stage 2 colon cancer (also known as Dukes' C colon cancer) with capecitabine (PO) is 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks) 2.
- The primary objective of the study was to compare disease-free survival (DFS) in patients receiving XELODA to those receiving IV 5-FU/LV alone.
- The hazard ratio for DFS for XELODA compared to 5-FU/LV was 0.87 (95% C.I. 0.76 – 1.00), indicating that XELODA was non-inferior to 5-FU/LV 2.
- Key points about the study include:
- Patient population: 1987 patients with Dukes' C colon cancer.
- Treatment arms: XELODA 1250 mg/m2 orally twice daily vs IV 5-FU 425 mg/m2 and 20 mg/m2 IV leucovorin.
- Median follow-up: 53 months.
- Disease-free survival rates: 66.0% for XELODA and 62.9% for 5-FU/LV.
From the Research
Stage 2 Colon Cancer Treatment
- The decision to treat a patient with stage II colon cancer with adjuvant chemotherapy can be challenging, and must be made on an individual basis, considering the risks and benefits of treatment 3.
- Several trials have demonstrated the small but absolute benefits of receiving adjuvant chemotherapy for stage II colon cancer for disease-free survival and overall survival 3, 4.
- High-risk characteristics, such as localized intestinal perforation and obstruction, and pT4 lesions, can be used to identify patients who may benefit from adjuvant chemotherapy 4.
- Adjuvant chemotherapy with 5-fluorouracil and leucovorin has been shown to improve overall survival and disease-free survival in patients with high-risk stage II colon cancer 4, 5.
- The addition of oxaliplatin to 5-fluorouracil and leucovorin (FLOX) has been shown to improve overall survival in stage II and III colon cancer patients, particularly in those aged <70 years 6.
- Capecitabine has been associated with a lower rate of emergency room visits and hospitalizations compared to 5-fluorouracil and leucovorin, and FLOX 6.
- The use of high-dose levamisole combined with 5-fluorouracil and leucovorin has not been shown to improve disease-free survival or overall survival in patients with high-risk colon cancer, and is associated with severe gastrointestinal and neurologic side effects 7.
Adjuvant Chemotherapy Regimens
- 5-fluorouracil and leucovorin (5-FU/LV) is a commonly used adjuvant chemotherapy regimen for stage II colon cancer 3, 5.
- Capecitabine is an alternative to 5-FU/LV, and has been associated with a lower rate of emergency room visits and hospitalizations 6.
- FLOX (5-fluorouracil, leucovorin, and oxaliplatin) is a more intensive regimen that has been shown to improve overall survival in stage II and III colon cancer patients 6.
- High-dose levamisole combined with 5-fluorouracil and leucovorin is not recommended due to severe side effects and lack of efficacy 7.
Patient Selection
- Patients with high-risk stage II colon cancer, such as those with localized intestinal perforation and obstruction, and pT4 lesions, may benefit from adjuvant chemotherapy 4.
- Patients aged <70 years, with no comorbidity, and not in the West region, are more likely to use FLOX 6.
- Patients with poorly differentiated histology, lymphovascular invasion, or perineural invasion may not benefit from adjuvant chemotherapy 4.