Albumin-bound paclitaxel and cisplatin with radiotherapy in locally advanced oesophageal squamous cell carcinoma: a single-arm, phase II trial

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BACKGROUND: We conducted a Phase II study to assess the efficacy and toxicity of nab-paclitaxel (nab-PTX) and cisplatin in combination with concurrent radiotherapy in patients with locally advanced oesophageal squamous cell carcinoma (ESCC). METHODS: Forty-two patients with locally advanced ESCC received nab-paclitaxel (75 mg/m²) and cisplatin (25 mg/m²) on days 1, 8, 15, 22, and 29 of radiotherapy, with total radiation doses ranging from 50 to 64 Gy. The overall response rate (ORR) and disease control rate (DCR) were defined as primary endpoints, while progression-free survival (PFS), overall survival (OS), and treatment-related toxicity were considered secondary endpoints. RESULTS: Between February 2019 and April 2023, 42 patients who met the inclusion criteria participated in the study, 36 (85.7%) of whom were male, with a median age of 62.5 years (IQR: 57.0-66.3). All participants were classified as having clinical stage III or IV disease. Of the 42 patients, 28 (66.7%) completed all planned chemoradiotherapy sessions, whereas 35 (83.4%) completed at least four cycles of chemotherapy, with a median of five cycles (range: 1-5). In the efficacy assessment, the ORR was 73.8%, and the DCR was 90.5%. After a median follow-up of 28.1 months (IQR: 19.9-55.8), the 1-year PFS and 1-year OS rates were 57.1% and 88.0%, respectively. The most common grade 3 or 4 adverse event (AE) was leukopenia (38.1%), with no treatment-related deaths observed. CONCLUSIONS: The combination of nab-paclitaxel and cisplatin, administered on a weekly schedule with concurrent radiotherapy, demonstrated promising antitumour activity and an acceptable safety profile in patients with ESCC. TRIAL REGISTRATION: The trial was registered at https://clinicaltrials.gov under the identifier ChiCTR1900021079 in January 2019.

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