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Randomized Controlled Trial
. 2025 Mar 5;25(1):401.
doi: 10.1186/s12885-024-13372-6.

Comprehensive evaluation of tumor response better evaluates the efficacy of neoadjuvant chemotherapy and predicts the prognosis in gastric cancer - a post hoc analysis of a single-center randomized controlled trial

Xuejun Gan #  1 , Yongning Jia #  2 , Fei Shan #  2 , Xiangji Ying  1 , Shuangxi Li  1 , Yan Zhang  1 , Fei Pang  1 , Ziyu Li  3
Affiliations
Randomized Controlled Trial

Comprehensive evaluation of tumor response better evaluates the efficacy of neoadjuvant chemotherapy and predicts the prognosis in gastric cancer - a post hoc analysis of a single-center randomized controlled trial

Xuejun Gan et al. BMC Cancer. .

Abstract

Background: Perioperative chemotherapy combined with D2 radical gastrectomy has been proven to be the standard treatment for local advanced gastric cancer. However, tumor regression grading (TRG) is the only neoadjuvant chemotherapy (NACT) response evaluation criterion recommended by the NCCN guideline for gastric cancer (GC). Given TRG's limitations, we aim to explore a better comprehensive response evaluation method in this study.

Methods: Clinical information of 96 GC patients who received NACT was collected prospectively. Clinicopathological variables predictive of the response to NACT were identified by comparing the pre- and post-NACT examination results. The correlations between the response mode and long-term survival rate were assessed.

Results: Univariate Cox regression analysis showed that CT-based evaluation of the primary lesion thickness (CT-thickness) and tumor markers (TMs) were significantly associated with prognosis. The comprehensive evaluation method, including CT-thickness, TRG, and TMs, was constructed and proved to have a higher Harrell's C index. Significant differences in overall survival (OS) and recurrence-free survival (RFS) were observed between responders and non-responders distinguished by the comprehensive evaluation method.

Conclusions: The combination of CT-thickness, TRG, and TMs could be used to construct a pragmatic NACT efficacy evaluation method with both high sensitivity and specificity, which could facilitate clinical decision-making, NACT-related clinical research conduction, and efficacy predictive biomarker exploration.

Keywords: Gastric cancer; Neoadjuvant chemotherapy (NACT); Response evaluation; Tumor marker (TM); Tumor regression grading (TRG).

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Declaration of Helsinki of 1964 and its later versions. The study was approved by the Peking University Cancer Hospital Ethics Committee. Informed consent was obtained from all individual participants included in the study. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
The changes of CT-thickness before and after NACT were associated with disease outcomes. (A-B) Kaplan-Meier estimates of overall survival and recurrence-free survival between different response groups confirmed by CT-thickness (log-rank test). PR, partial response; SD, stable disease; PD, progressive disease; CT, computed tomography
Fig. 2
Fig. 2
The predictive value of TMs. (A-B) Kaplan–Meier estimates for overall survival and recurrence-free survival between different TMs groups. (C) The distribution of TMs in different CT-thickness, TRG and recurrence status groups. TMs, tumor markers; CT, computed tomography; TRG, tumor regression grade; PR, partial response; SD, stable disease; PD, progressive disease
Fig. 3
Fig. 3
The predictive value of TRG. (A) The three representative response cases included: TRG3&PR, the patient was identified as TRG3 by pathological evaluation while showing partial response on CT images; TRG0&SD, the patient showed stable disease using CT scan while identified as TRG0 by pathological evaluation; TRG1&PR, the patient showed a consistent response through either histopathological and radiographic evaluation. (B) The responders were identified by CT-thickness and TRG. (C-D) Kaplan-Meier estimates of overall survival and recurrence-free survival for different TRG groups. TRG, tumor regression grade; CT, computed tomography; PR, partial response; SD, stable disease
Fig. 4
Fig. 4
The predictive and prognostic ability of the combination tool (A) The detailed method of the comprehensive combination tool (left) and the Venn diagram shows the intersect of different evaluation method (right). (B-C) The prognostic capacity of the combination of CT-thickness, TRG and TMs. (D) The overview table of all patients. Black arrows represent discordant cases between clinical outcomes and comprehensive evaluation results. NACT, neoadjuvant chemotherapy; CT, computed tomography; TRG, tumor regression grade; TMs, tumor markers; PR, partial response; SD, stable disease; PD, progressive disease
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