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Stratified treatment of localized cervical esophageal squamous cell carcinoma induced by neoadjuvant immunotherapy plus chemotherapy (SCENIC).
Li, Chunguang; Li, Bin; Yang, Yang; Liu, Jun; Zhang, Ming; Zhang, Huojun; Tan, Lijie; Shen, Xiaoyong; Li, Zhigang.
Affiliation
  • Li C; Department of Thoracic Surgery, Section of Esophageal Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
  • Li B; Department of Thoracic Surgery, Section of Esophageal Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
  • Yang Y; Department of Thoracic Surgery, Section of Esophageal Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
  • Liu J; Department of Radiation Oncology, Shanghai Jiao Tong University, Shanghai, China.
  • Zhang M; Department of Integrative Medicine, Shanghai Jiao Tong University, Shanghai, China.
  • Zhang H; Department of Radiation Oncology, Changhai Hospital Affiliated to Naval Medical University, Shanghai, China.
  • Tan L; Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Shen X; Department of Thoracic Surgery, The Affiliated Huadong Hospital of Fudan University, Shanghai, China.
  • Li Z; Department of Thoracic Surgery, Section of Esophageal Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
J Thorac Dis ; 14(9): 3277-3284, 2022 Sep.
Article in En | MEDLINE | ID: mdl-36245591
ABSTRACT

Background:

Definitive chemoradiation is the preferred treatment for cervical esophageal carcinoma (CEC), per the National Comprehensive Cancer Network (NCCN) guidelines. However, in treatment failures, salvage surgery poses significant technical challenges. If non-responders could be identified, prior to chemoradiation, these patients may benefit from primary esophagectomy. Programmed cell death protein 1 (PD-1) inhibitor is widely used and recognized as an effective treatment method in various cancers including esophageal cancer. Therefore, we propose to screen for treatment response to neoadjuvant immunotherapy plus chemotherapy to select patients who are radiosensitive and potential candidates for laryngeal preservation. While non-responders are likely to be insensitive to chemoradiation would be offered radical esophagectomy.

Methods:

A total of 36 patients with histopathologically-confirmed locally advanced CEC have been enrolled in our study. All participants will receive 2 cycles of induction therapy, which was tislelizumab combined with paclitaxel and carboplatin. Patients will be classified into 3 groups according to their response to induction therapy a remarkable response (RR) group, limited partial response (LPR) group, and poor response (POR) group. Stratified patients will receive the following follow-up treatments those in the RR group will receive dCRT, and those in the LPR and POR groups will undergo radical surgery. Then, participants in the RR group will be administrated with tislelizumab alone for 1 year. The choice of postoperative treatment for patients in the LPR and POR groups will depend on the patient's condition, including chemotherapy, radiotherapy, immunotherapy, or follow-up. The primary endpoint of the study is the 2-year event-free survival (EFS). The secondary endpoints are disease-free survival (DFS), regression-free survival (RFS), objective response rate (ORR), and 5-year overall survival (OS). At the same time, we will assess the patient's quality of life (QoL).

Conclusions:

Screening CEC patients after immune-induction therapy combined with chemotherapy using different treatment strategies might lead to improvements in their QoL and OS time. No relevant double-endpoint studies have been reported until now. Our study is the first multicenter, prospective, exploratory study to seek the optimal treatment for locally advanced CEC patients. The results may offer high-level evidence for future CEC treatment. Trial Registration Chictr.Org identifier ChiCTR2200057732.
Key words

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials / Guideline Aspects: Patient_preference Language: En Journal: J Thorac Dis Year: 2022 Document type: Article Affiliation country: China

Full text: 1 Collection: 01-internacional Database: MEDLINE Type of study: Clinical_trials / Guideline Aspects: Patient_preference Language: En Journal: J Thorac Dis Year: 2022 Document type: Article Affiliation country: China