The optimal treatment for locally advanced borderline-resectable squamous cell carcinoma (SCC) of the oesophagus is unclear. This phase II trial assessed the safety and efficacy of paclitaxel in combination with cisplatin and 5-fluorouracil (TPF) induction chemotherapy and subsequent surgery for locally advanced borderline-resectable esophageal SCC (NCT02976909).
Patients with clinical T4 and/or bulky lymphadenopathy that may invade nearby organs were eligible. Treatment started with 2 to 4 cycles of TPF induction chemotherapy (paclitaxel 135mg/m2 on day 1, cisplatin 75mg/m2 on Day 1; 5-fluorouracil 4g/m2 for 120 hours continuous infusion from Day 1 to Day 5), followed by surgery if resectable, or by radical concurrent chemoradiotherapy if unresectable. The primary endpoint was pathologically proven complete resection (R0) rate.
From November 2016 to December 2018, 47 patients were enrolled. After 2 to 4 cycles TPF chemotherapy, surgery was performed in 27 patients (57.4%), 10 (21.3%) patients received radical concurrent chemoradiotherapy. R0 resection was confirmed in 25 patients (53.2%). Pathologic complete response after chemotherapy was confirmed in 4 patients (8.5%). During chemotherapy, the most common grade 3 or 4 toxicities were neutropenia (29.8%), leucopenia (21.3%), febrile neutropenia (4.3%) and stomatitis (4.3%). No serious postoperative complications were observed in patients undergoing surgery.
TPF induction chemotherapy followed by surgery as a multidisciplinary treatment strategy showed promising signs of tolerability and short-term efficacy in patients with locally advanced borderline-resectable esophageal SCC. Long-term survival is still being followed up.
Clinical trial identification
Legal entity responsible for the study
Guangdong Esophageal Cancer institute.
All authors have declared no conflicts of interest.