Piotr J. Wysocki: OPTICAL trial – another study demonstrating the feasibility and promising efficacy of neoadjuvant chemotherapy in locally advanced colon cancer
Piotr J. Wysocki, Head of the Oncology Department at the
“A phase III OPTICAL study was performed in Chinese patients diagnosed with locally advanced colon cancer (T3 with extramural spread into the mesocolic fat ≥5 mm or T4). Patients (744) were randomly assigned 1:1 to receive six preoperative cycles of mFOLFOX6 or four cycles of CAPOX, followed by surgery and adjuvant chemotherapy (the same regimen as used preoperatively), or immediate surgery (with standard fluoropyrimidine-based adjuvant chemotherapy in stage II, III).
At a median follow-up of 48.0 months, 3-year DFS rates (primary endpoint) were 82.1% in the neoadjuvant group and 77.5% in the upfront surgery group, which translated into a trend towards improved DFS (HR=0.74; 95% CI, 0.54-1.03).
Compared to upfront surgery, neoadjuvant chemotherapy resulted in a significant downstaging – local(pT3-4: 77% v 94%) and regional (pN1-2:
31% v 46%), with 7% of patients experiencing pCR after neoadjuvant treatment.
Three-year OS rates were 95.1% in the neoadjuvant group and 89.6% in the immediate surgery group (HR for death = 0.44; 95% CI, 0.25 to 0.77)and 3-year cancer-specific survival rates 95.7% (95% CI, 93.5 to 97.8) and 89.9% in the neoadjuvant and upfront surgery groups, respectively (HR=0.42; 0.24 to 0.76).
The OPTICAL trial, unlike the similar phase III FOxTROT study, did not confirm a significant improvement in the primary endpoint (DFS). However, the nominal results of both these trials are similar (HRs for DFS—0.74 and 0.72 in OPTICAL and FOxTROT, respectively). Both trials demonstrated that neoadjuvant FOLFOX/CAPOX chemotherapy is safe and feasible and leads to clinical and pathological downstaging. The problems that could have impacted the final outcomes are associated with initial overstaging and less treatment compliance in the neoadjuvant group. Nevertheless, neoadjuvant chemotherapy in locally advanced colon cancer cannot be assumed to be a standard approach but rather a tailored option for well-selected patients.”
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Source: Piotr J. Wysocki/LinkedIn