Background
Phase III RCT (NEOCRTEC5010). 451 patients with resectable T1-4N1M0 or T4N0M0 thoracic esophageal squamous cell carcinoma (SCC) from 8 centers in China. Compared neoadjuvant chemoradiotherapy followed by surgery vs surgery alone. This is a companion Asian SCC-specific trial to the CROSS trial, addressing the predominant histology in Asia.
Interventions and follow up
Arm A: Neoadjuvant CRT (vinorelbine 25 mg/m² days 1 and 8 + cisplatin 75 mg/m² day 1, q3wk × 2 cycles, concurrent with 40 Gy in 20 fractions) followed by esophagectomy
Arm B: Surgery alone
Primary endpoint: Overall survival
mFollow up: Median 59.7 month
Arm B: Surgery alone
Primary endpoint: Overall survival
mFollow up: Median 59.7 month
Results
3-year OS: 69.3% (nCRT+surgery) vs 62.0% (surgery alone), P=.025
5-year OS: 59.9% vs 49.1%, HR 0.71 (95% CI 0.53–0.96), P=.025
pCR rate: 43.2% (nCRT arm)
R0 resection rate: 98.4% vs 91.2%, P<.001
5-year OS: 59.9% vs 49.1%, HR 0.71 (95% CI 0.53–0.96), P=.025
pCR rate: 43.2% (nCRT arm)
R0 resection rate: 98.4% vs 91.2%, P<.001
Adverse events
Main adverse events: Grade 3–4 leukopenia: 46.8% with nCRT. Anastomotic leak: 11.3% vs 12.1% (not significantly different). Postoperative 30-day mortality: 2.2% vs 0.9% (not significantly different). Nausea, radiation esophagitis, and hematologic toxicity were the dominant acute toxicities.
Conclusions
Neoadjuvant chemoradiotherapy followed by surgery significantly improved 3-year and 5-year overall survival compared to surgery alone in thoracic esophageal SCC, with a high pCR rate of 43%. These results support neoadjuvant CRT + surgery as standard of care for resectable esophageal SCC in Asian patients, consistent with CROSS findings in a Western population.
Key Limitations
Key Limitations: Chinese single-country multicenter trial — generalizability to Western populations is reasonable for SCC. Vinorelbine/cisplatin regimen differs from CROSS (carboplatin/paclitaxel) — direct comparison between regimens has not been performed. Lower radiation dose (40 Gy vs 41.4 Gy in CROSS) — clinically similar. Most patients had thoracic SCC; GEJ and adenocarcinoma outcomes not addressed. Surgical technique standardization across centers not explicitly described.
Clinical Context
NEOCRTEC5010 provides the strongest evidence for neoadjuvant CRT in esophageal SCC from an Asian population. Combined with CROSS, it establishes neoadjuvant CRT + surgery as the global standard for resectable esophageal SCC. For Asian SCC patients specifically, both trials are referenced together in NCCN and ESMO guidelines. The high pCR rate in SCC (43%) supports ongoing trials of organ-preservation strategies in complete clinical responders.
References
References: Yang H et al, J Clin Oncol 2018 (NEOCRTEC5010)