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

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...

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Bibliographic Details
Published in:Asia-Pacific journal of clinical oncology 2018-02, Vol.14 (1), p.61-68
Main Authors: Chen, Hong‐Hwa, Lin, Jen‐Kou, Chen, Joe‐Bin, Chuang, Chieh‐Han, Liu, Mei‐Ching, Wang, Jen‐Yi, Changchien, Chung‐Rong
Format: Article
Language:English
Subjects:
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Appetite loss
Bevacizumab
Bevacizumab - administration & dosage
Biopsy
Cancer therapies
Capecitabine - administration & dosage
Chemotherapy
Colorectal cancer
Colorectal carcinoma
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - pathology
Colorectal Neoplasms - surgery
Deoxycytidine - administration & dosage
Deoxycytidine - analogs & derivatives
Diarrhea
Fatigue
Female
Fluorouracil - administration & dosage
Fluorouracil - analogs & derivatives
Humans
Immunotherapy
Liver
Liver cancer
liver metastases
Liver Neoplasms - drug therapy
Liver Neoplasms - secondary
Liver Neoplasms - surgery
Male
Metastases
Metastasis
metastatic colorectal cancer
Middle Aged
Monoclonal antibodies
Nausea
Neoadjuvant Therapy
Organoplatinum Compounds - administration & dosage
Oxaliplatin
Peripheral neuropathy
Proteinuria
Targeted cancer therapy
Thrombocytopenia
Vomiting
XELOX
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Summary: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.
ISSN:1743-7555
1743-7563
DOI:10.1111/ajco.12692