الفهرس 
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Abstract
Previous studies have suggested that metformin may be associated with improved outcomes in DLBCL. Therefore, we aimed to determine if the addition of metformin to the treatment regimen could enhance response rates and survival in these patients. The purpose of this study was to investigate the correlation between adding metformin and response rate and survival outcomes in patients with DLBCL. The study included 100 newly diagnosed patients from the Clinical Oncology Department at Menoufia University, with 50 patients included in the trial arm and 50 in the control arm. The median age at diagnosis was 54.5 years in the trial arm and 56 years in the control arm.
There is no significant difference regarding demographics characteristics among studied group except for gender.
There is no significant difference regarding patient characteristics.
There is no significant difference regarding laboratory data.
There is no significant difference regarding type of molecular pathology.
Regarding the toxicity profile, there were no statistically significant differences between the two groups in terms of neutropenia, anemia, thrombocytopenia, diarrhea, mucositis, hypoglycemia, vomiting, neuropathy, metallic taste, and other side effects (p>0.05). The most common grade 3-4 toxicity observed was neutropenia, affecting 28% of patients in the trial arm and 24% in the control arm, but again, this difference was not statistically significant (p=0.064). However, it’s worth noting that nausea was significantly higher in the metformin group compared to the control group (p=0.008). Although this is a known side effect of metformin, it is generally manageable and may be outweighed by the clinical benefits.
The primary endpoint of the study was the response rate, which was significantly higher in the trial arm, with 92% of patients achieving complete response compared to 74% in the control arm (P=0.017). Additionally, the combination of R-CHOP with metformin led to a significant improvement in mean progression-free survival (PFS) – 24.6 months for the trial arm and 18.8 months for the control arm. Overall survival (OS) also showed a significant benefit in favor of adding metformin to R-CHOP, with a mean OS of 26 months for the trial arm and 22.5 months for the control arm (p=0.013). The median OS was not reached due to the short follow-up time and a high percentage of surviving patients (88%) at the end of the study.
Both treatment with metformin and the type of molecular pathology were independently associated with the development of relapse, as revealed by both univariate and multivariate analysis.