2033 - Ten-Year Outcomes of the Phase III ESO-Shanghai 1 Trial: Comparing Paclitaxel Plus Fluorouracil Group vs. Cisplatin Plus Fluorouracil Group in Definitive Chemoradiotherapy for Esophageal Squamous Cell Carcinoma

03:00pm - 04:00pm ET

Poster Hall - Exhibit Hall A

Screen: 21

POSTER

Presenter(s)

Yun Chen, MD - Fudan University Shanghai Cancer Center, Shanghai, Shanghai

Y. Chen¹, T. Tang¹, J. Ye², Z. Zhu¹, W. Zhao¹, J. Zhou³, C. WU⁴, M. Fan¹, L. Li¹, Q. Lin⁵, L. Yunhai⁶, J. Li⁷, M. Mo¹, S. Lu¹, Y. Xu¹, and K. Zhao¹; ¹Fudan University Shanghai Cancer Center, Shanghai, China, ²Jiangsu Cancer Hospital, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China, ³Affiliated Hospital of Jiangnan University, Wuxi, China, ⁴Zhenjiang First People’s Hospital, Zhenjiang, China, ⁵Xiamen Cancer Hospital, The First Affiliated Hospital of Xiamen University, Xiamen, China, ⁶Fudan University Shanghai Cancer Center Minhang Branch Hospital, Shanghai, China, ⁷Fujian province cancer hospital, Fuzhou, China

Purpose/Objective(s):

The phase III ESO-Shanghai 1 trial previously established the non-inferiority of paclitaxel plus fluorouracil (PF) compared to cisplatin plus fluorouracil (CF) in 3-year survival for locally advanced esophageal squamous cell carcinoma (ESCC) patients undergoing definitive chemoradiotherapy (dCRT). This study presents the 10-year follow-up outcomes, including long-term survival, quality of life (QoL), late toxicities, and prognostic biomarker analysis, to comprehensively evaluate the two regimens.

Materials/Methods:

A total of 436 ESCC patients were randomized to receive dCRT (61.2 Gy/34 Fx) with either paclitaxel plus fluorouracil group or cisplatin plus fluorouracil group. Follow-up data were collected up to 2025, ensuring a minimum 10-year follow-up for survivors. Overall survival (OS) and progression-free survival (PFS) were analyzed using Kaplan-Meier and Cox proportional hazards models. Landmark analysis assessed the long-term treatment effect. Quality of life (QoL) was evaluated using the EORTC QLQ-C30 and OES18 scales. Late toxicities were graded using the RTOG/EORTC late radiation morbidity scheme. Pre-treatment plasma proteomics were analyzed for prognostic biomarkers.

Results:

With a median follow-up of 141 months (IQR, 131–150), no significant differences were observed in 10-year OS (28.5% vs. 26.4%, HR 0.925, 95% CI 0.743–1.152, P=0.486) or PFS (22.5% vs. 22.0%, HR 0.979, 95% CI 0.793–1.210, P=0.848) between the two groups. Treatment failure occurred in 344 patients, with no significant difference between groups; locoregional-only recurrence was the primary pattern, accounting for 26.8% (117/436), particularly within the first 2 years. Second primary tumors developed in 10.8% (47/436) of patients. Among 86 ten-year survivors (74.8% response rate), quality of life was excellent, with a mean Global Health Status score of 92.64 (SD, 10.34) and low symptom scores (dysphagia: 2.71, SD 7.80; eating difficulties: 0.78, SD 5.05). Late cardiac toxicities included 14 cardiac deaths (paclitaxel plus fluorouracil group: 6; cisplatin plus fluorouracil group: 8). Pre-treatment CRP signal intensity was significantly associated with OS (HR 1.110, 95% CI 1.016–1.213, P=0.021).

Conclusion:

The 10-year follow-up confirms paclitaxel plus fluorouracil as a viable alternative to cisplatin plus fluorouracil for dCRT in ESCC, with comparable survival and sustained QoL. Baseline CRP may predict long-term survival and warrants further validation.