Back to Search
Start Over
Neoadjuvant Chemotherapy With Oxaliplatin and Fluoropyrimidine Versus Upfront Surgery for Locally Advanced Colon Cancer: The Randomized, Phase III OPTICAL Trial.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Sep 01; Vol. 42 (25), pp. 2978-2988. Date of Electronic Publication: 2024 Apr 02. - Publication Year :
- 2024
-
Abstract
- Purpose: The role of neoadjuvant chemotherapy (NAC) in colon cancer remains unclear. This trial investigated whether 3 months of modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine and oxaliplatin (CAPOX) as NAC could improve outcomes in patients with locally advanced colon cancer versus upfront surgery.<br />Patients and Methods: OPTICAL was a randomized, phase III trial in patients with clinically staged locally advanced colon cancer (T3 with extramural spread into the mesocolic fat ≥5 mm or T4). Patients were randomly assigned 1:1 to receive six preoperative cycles of mFOLFOX6 or four cycles of CAPOX, followed by surgery and adjuvant chemotherapy (NAC group), or immediate surgery and the physician's choice of adjuvant chemotherapy (upfront surgery group). The primary end point was 3-year disease-free survival (DFS) assessed in the modified intention-to-treat (mITT) population.<br />Results: Between January 2016 and April 2021, of the 752 patients enrolled, 744 patients were included in the mITT analysis (371 in the NAC group; 373 in the upfront surgery group). At a median follow-up of 48.0 months (IQR, 46.0-50.1), 3-year DFS rates were 82.1% in the NAC group and 77.5% in the upfront surgery group (stratified hazard ratio [HR], 0.74 [95% CI, 0.54 to 1.03]). The R0 resection was achieved in 98% of patients who underwent surgery in both groups. Compared with upfront surgery, NAC resulted in a 7% pathologic complete response rate (pCR), significantly lower rates of advanced tumor staging (pT3-4: 77% v 94%), lymph node metastasis (pN1-2: 31% v 46%), and potentially improved overall survival (stratified HR, 0.44 [95% CI, 0.25 to 0.77]).<br />Conclusion: NAC with mFOLFOX6 or CAPOX did not show a significant DFS benefit. However, this neoadjuvant approach was safe, resulted in substantial pathologic downstaging, and appears to be a viable therapeutic option for locally advanced colon cancer.
- Subjects :
- Humans
Male
Female
Middle Aged
Aged
Capecitabine administration & dosage
Chemotherapy, Adjuvant
Disease-Free Survival
Adult
Neoplasm Staging
Colectomy
Organoplatinum Compounds
Colonic Neoplasms pathology
Colonic Neoplasms drug therapy
Colonic Neoplasms surgery
Colonic Neoplasms mortality
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Neoadjuvant Therapy
Oxaliplatin administration & dosage
Oxaliplatin therapeutic use
Fluorouracil administration & dosage
Leucovorin administration & dosage
Leucovorin therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 42
- Issue :
- 25
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 38564700
- Full Text :
- https://doi.org/10.1200/JCO.23.01889