Main Session
Sep 30
QP 36 - From Brachy to Beams to Biologics: Innovations in Esophageal and Liver Cancer

1212 - Consolidation Chemotherapy after Definitive Concurrent Chemoradiotherapy in Patients with Locally Advanced, Inoperable Esophageal Squamous Cell Carcinoma: A Multicenter, Randomized, Non-inferiority, Phase 3 Trial

08:10am - 08:15am ET
Room 162

Presenter(s)

ChengCheng Fan, MD - Affiliated Cancer Hospital of Zhengzhou university, Zhengzhou, HeNan

C. Fan1, F. Liu1, X. Zheng1, L. Guo2, F. Liu1, Z. Feng1, Y. Sun1, Y. Jiang1, X. Liu1, W. Xu1, Y. Liu1, J. Liu1, C. He1, X. Wu1, S. Wu3, G. Chen3, Y. Zhang4, L. Jin4, and H. Ge1; 1Department of Radiation Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, Henan, China, 2Henan Cancer Hospital, Zhengzhou, China, 3Xinyang Hospital Affiliated to Zhengzhou University & Xinyang Central Hospital, Xinyang, Henan, China, 4Anyang Cancer Hospital, Anyang, Henan, China

Purpose/Objective(s):

Consolidation chemotherapy was often administered after definitive concurrent chemoradiotherapy (dCCRT) for locally advanced, inoperable esophageal squamous cell carcinoma (ESCC). However, its necessity remains controversial. This study aims to evaluate the role of consolidation chemotherapy after dCCRT.

Materials/Methods:

This is a multicenter, prospective, open-label, non-inferiority, phase 3 randomized controlled trial. Patients were enrolled and randomly assigned in a 1:1 ratio to receive either dCCRT alone (Observation group) or consolidation chemotherapy after dCCRT (Consolidation group). The primary endpoint was overall survival (OS), with a prespecified non-inferiority margin of 15%. Participants were analyzed according to the intention-to-treat principle (ITT) and the per-protocol set principle (PPS), respectively. This trial was registered with chictr.org.cn, ChiCTR1800017646.

Results:

Between August 2018 and March 2023, 200 patients were enrolled and randomly assigned to Observation group (n = 99) or Consolidation group (n = 101). After a median follow-up of 47.36 months, the 2-year OS was 66.7% in the Observation group versus 67.1% in the Consolidation group according to the ITT analysis, with a difference of -0.4% (95% CI: -13.44% to 12.64%). It remained non-inferior in the PPS analysis(65.2% in the Observation group vs. 65.7% in the Consolidation group), with a difference of -0.5% (95% CI: -14.28% to 13.28%). The incidence of grade =3 treatment-related toxicities (according to CTCAE 4.0) was comparable between the two groups [ITT: 20.2% (n=20/99) vs. 25.7%(n=26/101), p = 0.352; PPS: 20.6%(n=19/92) vs. 22.0%(n=20/91), p=0.827].

Conclusion:

The dCCRT alone demonstrated non-inferiority survival outcomes and a comparable toxicity profile compared to consolidation chemotherapy after dCCRT for patients with locally advanced inoperable ESCC.