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The Impact of Metformin Administration on the Clinical Outcome of Stage IV Colon Cancer

ABSTRACT: Design: Prospective, randomized controlled trial Setting: Clinical Oncology and Nuclear Medicine, Ain Shams University Condition: Colorectal cancer Patients will be randomized into one of two groups: Group A: Patients will receive standard therapy FOLFOX PROTOCOL Group B: Patients will receive metformin (500 mg twice daily or 1000 mg once daily) on top of standard therapy Assessment: Baseline Assessment: * Patient Full History: Age, sex, smoking history, occupational history, medical history, concurrent diseases and medications. * Laboratory data: * Complete blood test * Liver functional test * Renal function test * Inflammatory Markers: Interleukin (IL)-6 EVERY 3 MONTH: CT/MRI /PET scan to detect the response to chemotherapy and progression , Quality of life by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30. (EORTC QLQC30), Assessment of chemotherapy toxicity using CTACE 4.0 . Every 2 CYCLE: Lab examination (CBC, Liver function, Kidney function),CTACE SIDE EFFECTS EXAMINATION AFTER 6 MONTH : iL-6 LEVELS AFTER 1 YEAR : PFS AND OS

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 64754 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Background: Systemic-Onset Juvenile Idiopathic Arthritis (SJIA) is a rare disease associated with dysregulated interleukin (IL)-1 activity. Objectives: To assess the efficacy and safety of Anakinra, an IL-1 receptor antagonist in SJIA and its effects on gene expression profiling. Methods: We conducted a multicenter, randomized, double-blind placebo-controlled trial. The primary objective was to compare the efficacy of a one-month treatment with anakinra (2 mg/kg subcutaneoulsy daily, maximum 100 mg) to a placebo between 2 groups of 12 SJIA patients each. Response was defined by a 30% improvement of the pediatric American College of Rheumatology criteria for JIA, resolution of systemic symptoms and a decrease of at least 50% of both C-reactive protein and erythrocyte sedimentation rate compared to baseline. An intention-to-treat analyze was performed. After Month 1 (M1), patients taking placebo were switched to Anakinra. Secondary objectives included tolerance and efficacy assessment for 12 months. Results: At M1, concluding the randomized trial, there was a significant difference in the response rate between patients treated with Anakinra (8/12 responders) and placebo (1/12) (p=0.003). The number of adverse events, mainly pain to injections, was similar between both groups. Ten patients from the placebo group switched to Anakinra at M1; nine were responders at M2. Between M1 and M12, six patients stopped treatment for an adverse event (Crohn’s disease, hepatitis), a lack of efficacy or a disease flare (2 cases each). Blood gene expression profiling at enrollment and upon follow-up allowed us to identify one set of dysregulated genes that reverted to normal values in the clinical responders and a second set, including interferon-inducible genes, that was induced by Anakinra. Conclusion: Anakinra is an effective treatment of SJIA. Its effect is associated with normalization of blood gene expression profiles in clinical responders and de novo induction of an interferon signature. (Clinical trials registration number: NCT00339157)

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The Impact of Metformin Administration on the Clinical Outcome of Stage IV Colon Cancer

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