Objective

2

To evaluate the real-world effectiveness of the strengthening the spleen， tonifying the kidney， and detoxifying method in the treatment of advanced colorectal cancer.

Methods

2

A multi-center retrospective cohort study was designed. Patients with advanced colorectal cancer receiving western medical treatment were identified from the Surveillance， Epidemiology， and End Results （SEER） database of the National Cancer Institute and assigned to the western medicine group. Patients with advanced colorectal cancer who received standard western medical treatment combined with oral Chinese herbal medicine based on the strengthening the spleen， tonifying the kidney， and detoxifying method for ≥3 months were enrolled from three hospitals in China and assigned to the combined therapy group. Generalized boosted regression modeling （GBM） -based inverse probability weighting （IPW） using propensity scores was applied to eliminate confounding biases. The primary outcome was median overall survival （mOS）. The secondary outcomes included cumulative survival rates at 1， 2， and 3 years. Kaplan-Meier survival method was employed to generate survival curves， and differences in mOS and cumulative survival rates between the two groups were compared before and after IPW adjustment. Subgroup analyses were performed based on characteristics of Chinese herbal medicine intervention， including timing of intervention and duration of oral administration.

Results

2

A total of 2

435 patients were included in the western medicine group， and 360 patients in the combined therapy group. After IPW adjustment， 2

689 patients were included in the western medicine group， and 1

869 patients were included in the combined treatment group. The mOS was 15.3 months in the western medicine group and 26.1 months in the combined treatment group， with significantly longer mOS observed in the combined therapy group （

P

＜ 0.01）. The cumulative survival rates of the combined therapy group at 1， 2， 3 years were higher than that of the western medicine group. In sub

group analyses， the mOS was 29.5 months in the early Chinese herbal intervention group and 24.6 months in the non-early intervention group. Both groups showed longer mOS compared with the western medicine group （

P

＜0.01）， and the early intervention group demonstrated a significantly longer mOS than the non-early intervention group （

P

＜0.05）. According to the duration of Chinese herbal medicine use， the mOS was 14.7 months for 3~6 months， 21.6 months for 6

+

~12 months， and 33.2 months for ＞12 months. The mOS in the western medicine group was significantly lower than that in patients receiving herbal medicine for 6

+

~12 months and ＞12 months （

P

＜0.01）. The mOS for 3~6 months was lower than that for 6

+

~12 months and ＞12 months （

P

＜0.05）， and the mOS for 6

+

~

12 months was lower than that for ＞12 months （

P

＜0.05）.

Conclusion

2

The strengthening the spleen， tonifying the kidney， and detoxifying method as an adjunct to western medical treatment can prolong survival in patients with advanced colorectal cancer. Earlier initiation and longer duration of Chinese herbal medicine use may be associated with better therapeutic outcomes.