1430P - Impact of menadione supplementation in the treatment of patients with metastatic gastric cancer: A randomized phase II clinical trial

Background

Preclinical research carried out in vivo and in vitro and phase I clinical trials have demonstrated reduced toxicity and suggested the efficacy of menadione (vitamin K3) in gastric cancer (GC). We evaluated the impact of vitamin K3 supplementation as a first-line adjuvant treatment for advanced or metastatic GC.

Methods

In this phase II clinical trial, patients were randomized 1:1 to treatment with XELOX: capecitabine of 1,000 mg/m2 (orally administered twice a day on days 1-14) and oxaliplatin at 130 mg/m2 (on day 1, as intravenous 2 h boluses); or XELOX plus menadione (K3) 2.5g/m² daily, from June 22, 2021 to May 30, 2022. Toxicities were measured according to CTCAE 5.5 and tumor response through RECIST 1.1.

Results

102 patients were randomized to XELOX, with 51 to each group, which completed four cycles of treatment. The response rate was 37.2% (n=19) in the menadione and 23.5%(n=12) in the XELOX group, whereas the disease control rate (DCR) was 84.3%(n=43) and 72.5%(n=37), respectively. Median overall survival (OS) and progression-free survival (PFS) were 13.2 and 12.5 months for the supplemented patients versus 10.3 and 9.34 months for the non-supplemented (OS, p=0.003; PFS, p=0.017). The XELOX group had a slightly higher frequency of any adverse events (AE) of any grade (94.1 versus 92.1) and grade 3/4 (7.8 versus 1.9), when compared with the menadione group, respectively. Some of them were asthenia (78.4 versus 74.5%), decreased appetite (76.4 versus 68.6%), alopecia (64.7 versus 54.9%), and anemia (29.4 versus 21.5%), respectively. Table: 1430P

Conclusions

Our results indicate that vitamin K3 supplementation combined with adjuvant chemotherapy is capable of significantly improving the clinical outcomes of patients with GC, not only an ORR and DCR in the menadione group, but also a significant benefit for prolonged OS and PFS when compared with the control group.

Clinical trial identification

Brazilian Registry of Clinical Trials (ReBEC): RBR-76j763k.

Editorial acknowledgement

Legal entity responsible for the study

R.M.R. Burbano.

Funding

CNPq.

Disclosure

All authors have declared no conflicts of interest.