Paclitaxel plus cisplatin and 5-fluorouracil induction chemotherapy for locally advanced borderline-resectable esophageal squamous cell carcinoma: a phase II clinical trial.

Purpose: This phase II trial aimed to assess the safety and efficacy of paclitaxel in combination with cisplatin and 5-fluorouracil (TPF) induction chemotherapy followed by surgery for locally advanced borderline-resectable esophageal squamous cell carcinoma (BR-ESCC).
Methods: Patients with primary tumor or bulky lymph nodes that might invade nearby organs were eligible. Treatment started with 2-3 cycles of TPF induction chemotherapy, followed by surgery if the tumor was assessed resectable, or by radical concurrent chemoradiotherapy if unresectable. The primary endpoint was pathologically proven complete resection (R0) rate.
Results: From July 2014 to February 2019, a total of 47 patients were enrolled. After TPF chemotherapy, 27 patients (57.4%) received surgery and 11 patients (23.4%) received radical concurrent chemoradiotherapy. R0 resection was confirmed in 25 patients (53.2%, 95% confidence interval (CI) 38.9-67.5%). Pathologic complete response was confirmed in four patients (8.5%). The median overall survival (OS) and progression-free survival (PFS) for all patients were 33.3 months and 20.3 months, respectively. The median OS was significantly more favorable in surgery group than in chemoradiotherapy and chemotherapy alone group [33.3 months vs 14.1 months, hazard ratio 0.32 (95% CI 0.12-0.88), p = 0.027]. During induction chemotherapy, the most common grade 3 or 4 toxicities were neutropenia (29.8%), leucopenia (21.3%) and stomatitis (4.3%). No serious postoperative complications were observed in patients undergoing surgery.
Conclusions: The treatment strategy of induction chemotherapy followed by surgery is promising for patients with locally advanced BR-ESCC. To further improve the R0 resection rate, more effective induction chemotherapy regimens need to be explored.
Trial Registration: ClinicalTrials.gov identifier: NCT02976909.
(© 2021. The Japan Esophageal Society.)