Baohe Pingwei power plus neoadjuvant chemotherapy for gastric cancer.

BACKGROUND

Neoadjuvant chemotherapy improves the resection rate and reduces postoperative recurrence in gastric cancer (GC) but is often associated with significant toxicity. Traditional Chinese medicine has unique advantages in the treatment of cancer, and Baohe Pingwei powder can help alleviate the side effects of chemotherapy and enhance the therapeutic effect. However, there is no clinical evidence supporting its use in patients who underwent surgery for GC treatment.

AIM

To evaluate the safety and efficacy of Baohe Pingwei powder combined with neoadjuvant chemotherapy in postoperative patients with GC and to provide evidence-based medical evidence for the treatment of postoperative patients with GC with integrated traditional Chinese and Western medicine.

METHODS

A retrospective analysis was conducted on 80 postoperative patients with GC admitted to the Department of Gastroenterology of our hospital and treated between May 2024 and November 2024. According to different treatment methods, they were divided into a control group (54 patients received S-1 + oxaliplatin chemotherapy 4 weeks after surgery) and a study group (26 cases were combined with Baohe Pingwei powder combined with S-1 + oxaliplatin). Clinical data were collected to compare the differences in objective response rate (ORR), disease control rate (DCR), progression-free survival, overall survival, and adverse reactions of patients with GC after surgery under different treatment methods. Further based on the control of GC, patients were divided into an effective group (62 cases) and an ineffective group (18 cases). The relationship between Baohe Pingwei powder and clinical efficacy was analyzed through univariate and multivariate logistic regression analysis as well as a multivariate Cox risk model.

RESULTS

The baseline characteristics including age, gender, and other demographic factors showed no significant differences between the control and observation groups ( > 0.05). In the observation group, there were 24 cases of effective treatment and 2 cases of ineffective treatment, with an ORR of 84.62% and a DCR of 92.31%. In the control group, there were 38 cases of effective treatment and 16 cases of ineffective treatment, with an ORR of 46.30% and a DCR of 70.37%. The treatment effect of the observation group was significantly higher than that of the control group ( < 0.05). The Kaplan Meier curve showed that the risk of tumor recurrence and death in the observation group was significantly reduced compared to the control group (log rank = 0.030 and = 0.035, respectively). Subsequent stratification based on treatment response identified 62 patients in the effective group and 18 in the ineffective group. Intergroup comparison showed that the effective group had a higher proportion of Baohe Pingwei powder ( = 0.000), and there were statistically significant differences in tumor size, differentiation degree, and post-treatment levels of CD3, CD4, CA19-9, CA242, IL-6, IL-10, and TNF-α between the groups ( < 0.05). Further univariate and multivariate logistic analysis revealed that CD3 and CD4 T cell levels were significantly associated with treatment efficacy. The use of Baohe Pingwei powder was a protective factor for effective treatment, while CA19-9 and IL-6 levels were independent risk factors for ineffective treatment ( < 0.05). Multivariate Cox proportional hazards model analysis found that without adjusting the model, the risk of ineffective treatment in patients significantly decreased with the increase of CD3 and CD4 and the decrease of CA19-9 and IL-6 (group 1 as a reference; group 2 hazard ratio: 0.624, 95% confidence interval: 0.437-0.986, = 0.019). After adjusting for confounding factors such as Baohe Pingwei powder in Model 3, Cox regression results showed an increased risk of treatment failure. With the decrease of CD3 and CD4 and the increase of CA19-9 and IL-6, the risk of treatment failure in patients significantly increased (Group 1 as a reference; Group 2 hazard ratio: 1.439, 95% confidence interval: 1.208-1.614, = 0.006).

CONCLUSION

The combination therapy of Baohe Pingwei powder with neoadjuvant chemotherapy demonstrated significant clinical benefits in postoperative patients with GC, including improved the ORR, DCR, extended progression-free survival, and overall survival as well as a reduced incidence of treatment-related adverse events. Furthermore, our finding indicated that decreased CD3 and CD4 levels along with evaluated CA199 and IL-6 levels served as important biomarkers predicting increased risk of treatment failure in this patient population.