1681P - A retrospective real-world study for nimotuzumab plus postoperative adjuvant chemotherapy for resectable pancreatic cancer

Background

Adjuvant chemotherapy offers patients an improved chance of long-term survival, especially for those with R0/R1 resection. In APACT study, the median overall survival (mOS) of adjuvant chemotherapy for resectable pancreatic cancer (RPC) patients ranged from 36.2 to 40.5 months, but further improvement is still needed. As targeted therapy is still a blank in the treatment of RPC, we conducted this study, aiming to explore the clinical benefit of the addition of nimotuzumab to standard adjuvant chemotherapy.

Methods

RPC patients were treated with surgery, postoperative chemotherapy with or without nimotuzumab. Demographic and clinical data were collected from electronic medical records of Ruijin Hospital from May 2016 to July 2022. The primary efficacy endpoint was OS.

Results

We identified 795 patients who underwent surgical resection, of which 57 RPC patients received nimo. Propensity score matching (PSM) was performed to reduce the bias. After 1:1 PSM, we created 32 pairs RPC patients (stage I and II) who received adjuvant chemotherapy with nimo (study arm, Nimotuzumab 400mg, weekly, median exposure was 4 weeks) or without (control arm). Baseline characteristics were balanced after PSM. Median age was 63y, with 66% males. Barthel score 80-100. Median follow-up time was 35.2 (95%CI, 24.8-57.4) months and 37.3 (95%CI, 21.6-42.8) months in the control arm and study arm respectively. Survival analysis showed that study arm with a prolongation survival trend in OS (mOS: 24.5 months vs. 45.1 months) and disease-free survival (mDFS: 13.4 months vs. 15.4 months). Adverse events (AEs, Grade 1-2) were reported by 67% of patients (44 out of 64). The most frequently reported AEs were anemia (37.5%), leukopenia (7.8%), and diarrhea (4.7%), and there were no differences between the two groups. No Grade 3 or above adverse events were observed.

Conclusions

RPC patients were with a prolongation survival trend by the addition of nimotuzumab into current regimens in the postoperative program with good safety profile.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.