Real-World Study of anti-PD-1 Combined with Regorafenib and Raltitrexed as Third-Line Therapy in Colorectal Cancer.

PURPOSE: This studyaimed to assess the effectiveness of combining the anti-PD-1 drug with regorafenib and raltitrexed as a third-line treatment for mCRC.

METHODS

We conducted a retrospective analysis of patients diagnosed with metastatic colorectal cancer between December 2021 and December 2022, who had previously failed treatment and subsequently received anti-PD-1 drugs combined with regorafenib and raltitrexed as third-line therapy. The primary efficacy endpoints were the objective response rate (ORR) and progression-free survival (PFS), while secondary endpoints included the disease control rate (DCR) and overall survival (OS).

RESULTS

A total of 57 patients were enrolled in the study. The ORR and DCR were 14.1% (95% confidence interval [CI]: 5.1–23.1) and 50.9% (95% CI: 37.9–63.9), respectively. No patient achieved CR, 8 (14.1%) patients exhibited PR, 21 (36.8%) patients had SD, and 28 (49.1%) patients experienced PD. At the data cutoff, 23 (40.4%) deaths had occurred; with a median follow-up of 11 months (range 1-32.6). The median PFS was 4.2 months (95% CI: 1.7 to 6.7), and the median OS was 10.5 months (95% CI: 3.0 to 18.0). Treatment-related adverse events (TRAEs) of any grade occurred in 50 (87.7%) patients, with the most common being palmar-plantar erythrodysesthesia (25, 43.9%), followed by a rash (7, 12.3%), and hypertension (5, 8.8%).

CONCLUSIONS

The combination of anti-PD-1 drugs, regorafenib, and raltitrexed demonstrated promising antitumor efficacy and acceptable safety in patients with metastatic CRC, offering an alternative approach to optimize combination strategies in the management of refractory metastatic colorectal cancer.