|The following article features coverage from the ASCO Gastrointestinal Cancers Symposium 2022. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
Adding docetaxel to neoadjuvant cisplatin and fluorouracil prolonged overall survival (OS) for patients with locally advanced esophageal squamous cell carcinoma (ESCC), according to results from the phase 3 JCOG1109 NExT trial.
These results suggest that neoadjuvant docetaxel, cisplatin, and fluorouracil (DCF) “represents a new standard treatment for locally advanced ESCC,” according to Ken Kato, MD, PhD, of the National Cancer Center Hospital in Tokyo.
Dr Kato presented results from the JCOG1109 NExT trial at the ASCO Gastrointestinal Cancers Symposium 2022.
For this trial, researchers compared neoadjuvant DCF, cisplatin plus fluorouracil (CF), and CF plus radiotherapy (RT). The trial included 601 patients with stage IB-III ESCC. Their median age was 65 (range, 30-75) years, 63% had stage III (non-T4) disease, and 88% were men.
The patients were randomly assigned 1:1:1 to receive DCF (202 patients), CF-RT (200 patients), or CF (199 patients). In the DCF arm, patients received 3 courses of DCF every 2 weeks. In the CF-RT arm, patients received 2 courses of CF every 4 weeks with RT (41.4 Gy). In the CF arm, patients were treated with 2 courses of CF every 3 weeks.
After neoadjuvant treatment, 185 patients in the CF arm, 183 in the DCF arm, and 178 in the CF-RT arm proceeded to surgery.
At a median follow-up of 4.2 years, the median OS was not reached in the DCF arm, 7.0 years in the CF-RT arm, and 5.6 years in the CF arm. The 3-year OS rates were 72.1%, 68.3%, and 62.6%, respectively.
For DCF compared with CF, the hazard ratio (HR) for death was 0.68 (95% CI, 0.50-0.92; P =.006). For CF-RT compared with CF, the HR for death was 0.84 (95% CI, 0.63-1.12; P =.12).
The median progression-free survival was not reached in the DCF arm, 5.3 years in the CF-RT arm, and 2.7 years in the CF arm. The HR for DCF compared with CF was 0.67 (95% CI, 0.51-0.88). The HR for CF-RT compared with CF was 0.77 (95% CI, 0.59-1.01).
The proportion of patients who achieved R0 resection was 94.5% in the DCF arm, 98.9% in the CF-RT arm, and 90.3% in the CF arm.
Grade 3-4 adverse events that were more common in the DCF arm than in the CF and CF-RT arms included neutropenia (85.2%, 23.4%, and 44.5%, respectively), febrile neutropenia (16.3%, 1.0%, and 4.7%), and hyponatremia (26.0%, 6.2%, and 11.0%).
Grade 3-4 esophagitis was more common in the CF-RT arm than in the CF and DCF arms — 8.9%, 1.0%, and 1.0%, respectively
Treatment-related deaths occurred in 4 patients in the DCF arm, 2 patients in the CF-RT arm, and 3 patients in the CF arm.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
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Kato K, Ito Y, Daiko H, et al. A randomized controlled phase III trial comparing two chemotherapy regimen and chemoradiotherapy regimen as neoadjuvant treatment for locally advanced esophageal cancer, JCOG1109 NExT study. Presented at ASCO GI 2022; January 20-22, 2022. Abstract 238.