Oncology
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Multicenter Study
Cetuximab plus FOLFOX-4 in untreated patients with advanced colorectal cancer: a Gruppo Oncologico dell'Italia Meridionale Multicenter phase II study.
FOLFOX-4 and FOLFIRI are considered equivalent in terms of activity and efficacy as first-line chemotherapy in metastatic colorectal cancer (mCRC). The monoclonal antibody (mAb) cetuximab showed intrinsic activity as a single agent in mCRC and was approved in combination with CPT-11 for patients who failed previous CPT-11-based treatment. The purpose of this phase II study was to evaluate the activity and safety of FOLFOX-4 plus cetuximab in untreated mCRC patients. ⋯ These results suggest that the combination of FOLFOX-4 plus cetuximab is very active and obtains long TTP with an acceptable toxicity profile. Indeed, our results are in line with recent findings from phase II and phase III randomized studies providing strong evidence that the efficacy of anti-EGFR mAb is confined to patients with wild-type KRAS mCRC. Investigation of other predictive biomarkers may be useful to further define the responder population.
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Infusional 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) plus bevacizumab chemotherapy is commonly implemented in the first-line treatment of metastatic colorectal cancer. A stop and go oxaliplatin strategy has been recommended to reduce oxaliplatin-associated neuropathy. Despite the acceptance of this strategy by community and academic practices, efficacy data with this approach are limited. ⋯ Elective withdrawal of oxaliplatin after 8 cycles in the setting of FOLFOX and bevacizumab does not appear to compromise the activity of this regimen. A stop and go approach of FOLFOX plus bevacizumab is effective and may reduce treatment costs and toxicity in comparison with a continuous FOLFOX treatment strategy.
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Multicenter Study
A prospective, multicenter, phase 2 study of imatinib mesylate in korean patients with metastatic or unresectable gastrointestinal stromal tumor.
This prospective, multicenter, phase 2 study evaluated the efficacy and safety of imatinib mesylate and assessed KIT and PDGFRA gene mutation status in Korean patients with gastrointestinal stromal tumors (GISTs). ⋯ Imatinib is effective and safe in Korean patients with metastatic or unresectable GIST.
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Review Meta Analysis
Risk of high-grade skin rash in cancer patients treated with cetuximab--an antibody against epidermal growth factor receptor: systemic review and meta-analysis.
Cetuximab, a chimeric antibody against epidermal growth factor receptor has emerged as an effective therapy for advanced colorectal cancer (CRC) and head-neck cancer. However, severe skin toxicity may limit its use. Its efficacy in the treatment of other cancers is also undergoing extensive investigation. We performed a systemic review and meta-analysis of published clinical trials to quantify the overall incidence and risk of severe skin rash. ⋯ Cancer patients who received cetuximab have a substantial risk of developing high-grade skin rash. The risk may be particularly increased in patients with CRC. Further studies are strongly recommended for the prevention and treatment of high-grade skin rash.
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Monoclonal antibodies targeting the epidermal growth factor receptor (EGFR) have improved outcomes for patients with metastatic colorectal carcinoma. Among patients not carrying activating mutations in the KRAS gene, only a limited number will experience tumor response to these therapeutic agents. The role of BRAF mutations in determining resistance to this treatment is emerging through preclinical and clinical studies. ⋯ However, the absence of KRAS mutations is not sufficient to assure clinical response to cetuximab and panitumumab. We need to discover further molecular biomarkers of impairment in this or other signaling pathways to identify responders more specifically. Preclinical rationale is available for combined therapies, which simultaneously target EGFR and the RAS/RAF/MAPK signaling pathways for metastatic colorectal cancer.