Neoadjuvant therapy of bevacizumab in combination with oxaliplatin and capecitabine (XELOX) for patients with metastatic colorectal cancer with unresectable liver metastases: a phase II, open-label, single-arm, noncomparative trial
| Autor: | Chieh Han Chuang, Jen Yi Wang, Joe Bin Chen, Jen Kou Lin, Mei Ching Liu, Chung Rong Changchien, Hong-Hwa Chen |
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| Rok vydání: | 2017 |
| Předmět: |
Male
medicine.medical_specialty Organoplatinum Compounds Oxaloacetates Bevacizumab Colorectal cancer medicine.medical_treatment Deoxycytidine Gastroenterology Capecitabine 03 medical and health sciences 0302 clinical medicine Unresected Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Adverse effect Neoadjuvant therapy Chemotherapy business.industry Liver Neoplasms General Medicine Middle Aged medicine.disease Neoadjuvant Therapy Oxaliplatin Surgery Oncology 030220 oncology & carcinogenesis Female 030211 gastroenterology & hepatology Fluorouracil Colorectal Neoplasms business medicine.drug |
| Zdroj: | Asia-Pacific Journal of Clinical Oncology. 14:61-68 |
| ISSN: | 1743-7555 |
| Popis: | Aim This phase II, open-label study evaluated the efficacy and safety of neoadjuvant therapy with bevacizumab plus XELOX (capecitabine and oxaliplatin) for untreated metastatic colorectal cancer with unresectable liver metastases and assessed conversion of unresectable to resectable metastases after neoadjuvant treatment. Methods Patients received bevacizumab 5 mg/kg and oxaliplatin 85 mg/m2 on day 1, and capecitabine 1000 mg/m2 twice daily on days 1–5 followed by 2 days of rest in a 14-day cycle for 12 cycles; bevacizumab was excluded in cycles 6 and 7. Patients were later divided into resected and unresected groups, depending upon whether they underwent curative resection after chemotherapy. Efficacy and safety were evaluated. Results Of 45 patients enrolled, 17.8% completed the study. The resection rate of liver metastases after neoadjuvant therapy was 42.2%. The median time to disease progression was 10.1 and 8.7 months in the resected and unresected groups, respectively (P = 0.1341). Response rate was significantly higher in the resected (47.4%) versus the unresected group (34.6%; P = 0.0010), and seven patients achieved complete response (resected group). Overall, 94.3% of adverse events were of mild or moderate severity, and grade ≥3 adverse events occurred in 4.3% and 7.3% of patients in the resected and unresected groups, respectively. The most common adverse events in both groups were palmar-plantar erythrodysesthesia syndrome, decreased appetite, thrombocytopenia, peripheral neuropathy, fatigue, diarrhea, vomiting, proteinuria and nausea. Conclusion Neoadjuvant therapy with bevacizumab plus XELOX was well tolerated and effective in previously untreated metastatic colorectal cancer patients with initially unresectable liver metastases. |
| Databáze: | OpenAIRE |
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