PET/CT-Guided Neoadjuvant Tislelizumab Plus Chemotherapy/Chemoradiotherapy for Resectable Esophageal Squamous Cell Carcinoma: RATIONALE-213 Final Analysis - PubMed
6 hours ago
- #Neoadjuvant therapy
- #Esophageal cancer
- #Immunotherapy
- PET/CT-guided neoadjuvant tislelizumab plus chemotherapy/chemoradiotherapy assessed for resectable esophageal squamous cell carcinoma (ESCC).
- Study design: Multicenter, open-label, two-cohort phase II trial (RATIONALE-213) with 70 patients.
- Patients categorized as PET responders (≥35% SUV decrease) or nonresponders (<35%) after one induction chemotherapy cycle.
- All patients received three cycles of tislelizumab (200 mg IV). PET responders got chemotherapy, nonresponders received chemoradiotherapy before surgery.
- Primary endpoint: Pathological complete response (pCR) rate.
- pCR rates: 30.0% in PET responders, 34.4% in nonresponders. Higher pCR linked to higher baseline PD-L1 TAP scores.
- 1-year DFS rates: 79.0% (responders), 74.2% (nonresponders). EFS rates: 87.1% vs. 67.8%.
- TRAEs: Any-grade in 93.3% (responders), 97.5% (nonresponders); grade ≥3 in 50.0% vs. 82.5%. Most common grade ≥3 TRAE: decreased neutrophil count.
- Conclusion: Promising pCR and survival outcomes with tolerable safety in both PET-guided groups.