Shortening the duration of adjuvant chemotherapy to 3 months improves safety and does not compromise efficacy for patients with stage III colon cancer, according to a phase 3 trial published in the Journal of Clinical Oncology.
Researchers observed similar 5-year disease-free survival (DFS) and overall survival (OS) rates with 3 months or 6 months of adjuvant chemotherapy. In addition, shortening the duration of treatment significantly reduced the risk of peripheral sensory neuropathy (PSN).
The researchers also found no significant differences in efficacy outcomes between patients who received capecitabine plus oxaliplatin (CAPOX) and those who received modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6). However, there was a numerically lower rate of PSN with CAPOX.
The phase 3 ACHIEVE trial enrolled 1313 patients at 244 centers across Japan. Patients were randomly assigned to 3 months or 6 months of adjuvant chemotherapy with mFOLFOX6 or CAPOX, as selected by the physician.
Ultimately, 1291 patients started adjuvant chemotherapy, with 641 receiving 6 months of treatment and 650 receiving 3 months of treatment. Overall, more patients received CAPOX (n=969) than mFOLFOX6 (n=322).
The 5-year DFS rate was 75.2% in the 3-month treatment group and 74.2% in the 6-month group (hazard ratio [HR], 0.95; 95% CI, 0.77-1.18; P =.64).
The 5-year DFS rates were comparable between the 3-month and 6-month groups for mFOLFOX6 (HR, 1.04; P =.82) and CAPOX (HR, 0.91; P =.49) recipients as well as for patients with low-risk disease (HR, 0.85; P =.39) or high-risk disease (HR, 1.04; P =.75).
The 5-year OS rate was 87.0% in the 3-month treatment group and 86.4% in the 6-month treatment group (HR, 0.91; 95% CI, 0.69-1.20; P =.51).
As with DFS, the 5-year OS rates were comparable between the 3-month and 6-month groups for mFOLFOX6 (HR, 0.99; P =.95) and CAPOX (HR, 0.87; P =.42) recipients as well as for patients with low-risk (HR, 0.86; P =.52) or high-risk disease (HR, 0.96; P =.82).
During treatment, the rate of PSN was significantly lower in the 3-month treatment group than in the 6-month group — 73% and 82%, respectively (odds ratio [OR], 0.589; P <.0001). The rate of long-lasting PSN was significantly lower in the 3-month group as well — 8% and 16%, respectively (OR, 0.424; P =.0016).
PSN of any grade lasting more than 5 years was slightly more common with mFOLFOX6 than with CAPOX — 14% and 11%, respectively — but this difference was not significant (OR, 1.380; P =.27).
Based on these findings, the researchers concluded that 3 months of CAPOX is an appropriate treatment option for this patient population, especially those with low-risk disease.
Disclosures: This research was supported, in part, by Yakult Honsha Co, Ltd. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Yoshino T, Oki E, Misumi T, et al. Final analysis of 3 versus 6 months of adjuvant oxaliplatin and fluoropyrimidine-based therapy in patients with stage III colon cancer: The randomized phase III ACHIEVE trial. J Clin Oncol. Published online May 05, 2022. doi:10.1200/JCO.21.02628