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Feasibility study of adjuvant chemotherapy with FOLFOX(or XELOX) for 3 months followed by oral anticancer drug for 3 months in patients with completely resected colorectal cancer

ABSTRACT: Interventions: mFOLFOX6 therapy(or XELOX therapy) for 3 months followed by capecitabine for 3 months mFOLFOX6 therapy Day1 L-OHP 85mg/m2,l-LV 200mg/m2 Day1 bolus 5FU 400mg/m2 Day1~2 Infusional 5FU 2400mg/m2 XELOX therapy Day1 L-OHP 130mg/m2 Day1~14(b.i.d. at the end of meal) capecitabine 2000mg/m2/day Capecitabine therapy Day1~14(b.i.d. at the end of meal) Capecitabine 2500mg/m2/day Primary outcome(s): Frequency and Grade of peripheral neuropathy(CTCAE v4 and PNQ) Study Design: Single arm Non-randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2620377 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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A phase II study of resection followed capecitabine + oxaliplatin for liver metastasis of colorectal cancer. [REX study]

Project description:Interventions: Surgical hepatectomy followed by chemotherapy (XELOX)8cycles. <XELOX> (L-OHP 130 mg/m2 day1 , Capecitabine 2,000mg/m2/day day1-14) Primary outcome(s): 3-year Disease-Free Survival Study Design: Single arm Non-randomized

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Gene expression profiling of biopsy and resection samples from the DEBIOC phase 1 trial of oxaliplatin and capecitabine +/- AZD8931 in oesophageal cancer

Project description:The Dual Erb B Inhibition in Oesophago-gastric Cancer (DEBIOC) trial reported an acceptable safety profile for neoadjuvant Oxaliplatin and Capecitabine (Xelox) +/- AZD8931 in oesophageal adenocarcinoma (OAC) but limited efficacy. We evaluated the impact of neoadjuvant Xelox +/-AZD8931 on biological pathways using a unique software-driven solution. Transcriptomic profiles from 25 pre-treatment FFPE OAC biopsies and 17 matched resection specimens, treated with Xelox+AZD8931 (n=16) and Xelox alone (n=9), were analysed using the Almac claraT total mRNA report. Tumour Infiltrating Lymphocytes (TILs) were assessed digitally using QuPath software. Hierarchical clustering identified three molecular subgroups classified by activation of innate immune signalling. The Immune High subgroup was associated with HER2 positivity, increased pathological response and a marked reduction in immune signalling and TILs following neoadjuvant therapy. The Immune Low cluster was pre-dominantly HER2/EGFR negative and EGFR positivity was associated with the Immune Mixed subgroup. Neoadjuvant therapy induced angiogenesis and EMT signalling and a reduction in DNA repair signatures with AZD8931 also promoting an immunosuppressive microenvironment. OAC may be subdivided into three immune-related subgroups which undergo modulation in response to neoadjuvant therapy with marked suppression of the immune microenvironment in HER2 positive/Immune High tumours.

2024-09-01 | E-MTAB-13741 | biostudies-arrayexpress

Randomized phase II study of adding steroid for prevention of venous pain in colorectal cancer patients who are receiving oxaliplatin through peripheral vein (APOLLO)

Project description:Interventions: XELOX Oxaliplatin 130mg/m2 day1 Capecitabine 2,000mg/m2 day1-14 every 3 weeks SOX Oxaliplatin 130mg/m2 day1 S-1 80-120mg/m2 day1-14 every 3 weeks Oxaliplatin is combined with dexamethasone (2 mg). XELOX Oxaliplatin 130mg/m2 day1 Capecitabine 2,000mg/m2 day1-14 every 3 weeks SOX Oxaliplatin 130mg/m2 day1 S-1 80-120mg/m2 day1-14 every 3 weeks Primary outcome(s): The incidence of venous pain:Grade>=2 Study Design: Parallel Randomized

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Pure Estrogen Receptor Antagonists Potentiate Capecitabine Activity in ESR1-mutant Breast Cancer

Project description:The ESR1 ligand binding domain activating mutations are the most prevalent genetic mechanism of acquired endocrine resistance in metastatic hormone receptor-positive breast cancer. These mutations confer endocrine resistance that remains estrogen receptor (ER) dependent. We hypothesized that in the presence of the ER mutations, continued ER blockade with endocrine therapies that target mutant ER is essential for tumor suppression even with chemotherapy treatment. Here, we conducted comprehensive pre-clinical in vitro and in vivo experiments testing the efficacy of adding fulvestrant to fluorouracil (5FU) and the 5FU pro-drug, capecitabine, in models of wild-type (WT) and mutant ER. Our findings revealed that while this combination had an additive effect in the presence of WT-ER, in the presence of the Y537S ER mutation there was synergy. Notably, these effects were not seen with the combination of 5FU and selective estrogen receptor modulators, such as tamoxifen, or in the absence of intact P53. Likewise, in a patient derived xenograft (PDX) harboring a Y537S ER mutation the addition of fulvestrant to capecitabine potentiated tumor suppression. Moreover, multiplex immunofluorescence revealed that this effect was due to decreased cell proliferation in all cells expressing ER and was not dependent on the degree of ER expression. Taken together, these results support the clinical investigation of the combination of ER antagonists with capecitabine in patients with metastatic hormone receptor-positive breast cancer who have experienced progression on endocrine therapy and targeted therapies, particularly in the presence of an ESR1 activating mutation.

2024-06-01 | GSE266932 | GEO

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