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.