Single-center phase 3 trial of neoadjuvant paclitaxel plus platinum versus 5-fluorouracil plus platinum for locally advanced esophageal/GEJ squamous cell carcinoma

The standard neoadjuvant chemotherapy (NACT) for locally advanced esophageal/gastroesophageal junction squamous cancer (LAEGSC) is 5-fluorouracil (5-FU) plus platinum. This therapy is associated with toxicities and is logistically challenging. A phase 3 trial at Tata Memorial Hospital (Mumbai, India) compared neoadjuvant paclitaxel plus platinum versus 5-FU plus platinum for LAEGSC. Significantly more patients in the paclitaxel group received all three planned NACT cycles than in the 5FU group (92.3% versus 85.9%; p=0.009). Grade 3 or higher toxicities were seen in 69.7% of patients in the 5FU group versus 51.9% of patients in the paclitaxel group (p=0.001). Surgery was performed in 66.2% of patients in the paclitaxel group versus 62.4% of patients in the 5FU group (p=0.415). Pathologic complete response was seen in 21.9% of patients in the paclitaxel group and 12.4% of patients in the 5FU group (p=0.053). Median overall survival was 27.5 months in the paclitaxel group and 27.1 months in the 5FU group (p=0.346). The authors conclude that paclitaxel plus platinum should replace 5FU plus platinum as NACT of choice for resectable LAEGSC.