Phase III Multicenter Randomized Clinical Trial to Evaluate the Safety and Efficacy of CoFactor®/5-Fluorouracil/Bevacizumab Versus Leucovorin/5-Fluorouracil/Bevacizumab as Initial Treatment for Metastatic Colorectal Carcinoma

Saif, Muhammad Wasif; Merritt, James A.; Robbins, Joan M.; Stewart, Jeffrey A.; Schupp, Joachim

doi:10.3816/ccc.2006.n.042

Cited by 6 publications

(9 citation statements)

References 9 publications

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“…Bevacizumab, a humanized antibody directed against the vascular endothelial growth factor (VEGF) that is used as an angiogenesis inhibitor, has been examined in combination with chemotherapeutic agents in several clinical trials in patients with advanced colorectal cancer [1], even as a first-line treatment [2]. The addition of bevacizumab increased the overall response rate and extended median survival.…”

Section: Discussionmentioning

confidence: 99%

Brain microischemic phenomena in a woman receiving bevacizumab treatment: a case report

et al. 2011

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IntroductionSeveral adverse events have been associated with the use of bevacizumab during the treatment of neoplasms such as colorectal cancer, breast cancer, non-small cell lung cancer, pancreatic cancer and renal cell carcinoma. The present case demonstrates how focal neurological symptoms lead to the magnetic resonance imaging-based differential diagnosis between focal parenchymal metastases and microischemic phenomena, with crucial implications for patient management.Case presentationWe describe the case of a 37-year-old Italian Caucasian woman with metastatic colon cancer who developed focal neurological symptoms during a chemotherapy regimen involving the use of bevacizumab. Brain magnetic resonance imaging examination revealed millimetric lesions with restricted diffusion without perilesional edema or contrast enhancement after gadodiamide intravenous injection, suggestive of acute microischemic phenomena. This complication is very rare but clinically significant.ConclusionThe differential diagnosis in patients with cancer undergoing bevacizumab treatment should include microischemic phenomena.

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Section: Discussionmentioning

confidence: 99%

Brain microischemic phenomena in a woman receiving bevacizumab treatment: a case report

et al. 2011

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“…Regarding adverse events reported with the administration of CoFactor/5-FU, the most frequent events are diarrhea, nausea, fatigue, and vomiting, but these are comparable to the adverse events noticed with LV/5-FU regimens [30–32]. Furthermore, it is not possible to distinguish whether these side effects derive from the CoFactor itself or the chemotherapy coadministered.…”

Section: Clinical Studiesmentioning

confidence: 99%

CoFactor: Folate Requirement for Optimization of 5-Fluouracil Activity in Anticancer Chemotherapy

Saif

Makrilia

Syrigos

2010

Journal of Oncology

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Intracellular reduced folate exists as a “pool” of more than 6 interconvertable forms. One of these forms, 5,10 methylenetetrahydrofolic acid (CH2THF), is the key one-carbon donor and reduced folate substrate for thymidylate synthase (TS). This pathway has been an important target for chemotherapy as it provides one of the necessary nucleotide substrates for DNA synthesis. The fluoropyrimidine 5-fluorouracil (5-FU) exerts its main cytotoxic activity through TS inhibition. Leucovorin (5-formyltetrahydrofolate; LV) has been used to increase the intracellular reduced folate pools and enhance TS inhibition. However, it must be metabolized within the cell through multiple intracellular enzymatic steps to form CH2THF. CoFactor (USAN fotrexorin calcium, (dl)-5,10,-methylenepteroyl-monoglutamate calcium salt) is a reduced folate that potentiates 5-FU cytotoxicity. According to early clinical trials, when 5-FU is modulated by CoFactor instead of LV, there is greater anti-tumor activity and less toxicity. This review presents the emerging role of CoFactor in colorectal and nongastrointestinal malignancies.

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“…The eff icacy of bevacizumab has been shown in colorectal cancer, 14 non-small-cell lung cancer (NSCLC) 15,16 renal cancer and ovarian cancer. 17,18 Clinically, bevacizumab has been investigated in combination with a range of chemotherapeutic agents, and the pharmacokinetics and toxicities have generally been non-overlapping.…”

Section: Introductionmentioning

confidence: 99%

“…14,49,50 Perforation typically presented with abdominal pain with constipation and vomiting. Gastrointestinal perforations are rare in patients with breast cancer.…”

mentioning

confidence: 99%

Evidence for the role of bevacizumab in the treatment of advanced metastatic breast cancer: a review

Pories

Wulf

2010

BCTT

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Angiogenesis inhibitors may provide a new approach to the treatment of metastatic breast cancer. Bevacizumab is a monoclonal antibody against pathologic angiogenesis. A pivotal study (ECOG 2100) showed that bevacizumab in combination with paclitaxel increased progression-free survival for patients with metastatic breast cancer by 6 months. Subsequently, several clinical trials have shown that the combination of bevacizumab with a taxane can improve disease-free survival but does not prolong overall survival. While generally well tolerated, bevacizumab is potentially toxic for some patients who develop hypertension, proteinuria, bleeding, impaired wound healing, bowel perforation or thromboembolic events. Here, we review the current evidence for the use of bevacizumab in breast cancer and ongoing studies that address the questions of how to optimize regimens and schedules for the use of anti-angiogenic agents and the identification of those patients who would benefit the most from treatment with regimens that include antiangiogenic therapy.

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Phase III Multicenter Randomized Clinical Trial to Evaluate the Safety and Efficacy of CoFactor®/5-Fluorouracil/Bevacizumab Versus Leucovorin/5-Fluorouracil/Bevacizumab as Initial Treatment for Metastatic Colorectal Carcinoma

Cited by 6 publications

References 9 publications

Brain microischemic phenomena in a woman receiving bevacizumab treatment: a case report

Brain microischemic phenomena in a woman receiving bevacizumab treatment: a case report

CoFactor: Folate Requirement for Optimization of 5-Fluouracil Activity in Anticancer Chemotherapy

Evidence for the role of bevacizumab in the treatment of advanced metastatic breast cancer: a review

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