Capecitabine in combination with oxaliplatin and bevacizumab (AXELOX) as 1st line treatment for fit and vulnerable elderly patients (aged >70 years) with metastatic colorectal cancer (mCRC): a multicenter phase II study of the Hellenic Oncology Research Group (HORG)
| Autor: | John Souglakos, Vassilis Georgoulias, Alexios Matikas, Stelios Kakolyris, Aris Polyzos, Lambros Vamvakas, Dora Hatzidaki, Ioannis Boukovinas, Athanasios Karampeazis, Charalampos Christophylakis |
|---|---|
| Rok vydání: | 2014 |
| Předmět: |
Male
Oncology Cancer Research medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Organoplatinum Compounds Bevacizumab Colorectal cancer health care facilities manpower and services Phases of clinical research Antibodies Monoclonal Humanized Deoxycytidine Disease-Free Survival Capecitabine Surgical oncology Internal medicine Antineoplastic Combined Chemotherapy Protocols Genetics medicine Humans XELOX Neoplasm Metastasis neoplasms Aged Aged 80 and over business.industry Age Factors social sciences medicine.disease digestive system diseases humanities Oxaliplatin Elderly patients Clinical trial Treatment Outcome mCRC Fluorouracil Female Colorectal Neoplasms business Research Article medicine.drug |
| Zdroj: | BMC Cancer |
| ISSN: | 1471-2407 |
| DOI: | 10.1186/1471-2407-14-277 |
| Popis: | Background Colorectal cancer (CRC) is a disease of the elderly. However, geriatric patients are often excluded from clinical trials. The combination of capecitabine, oxaliplatin and bevacizumab (XELOX/BEV) has not been assessed in an elderly population. Methods We conducted a phase II study of XELOX plus bevacizumab combination as first line treatment in elderly patients with metastatic CRC. Treatment consisted of capecitabine 750 mg/m2 twice a day during days 1–7, oxaliplatin 85 mg/m2 and bevacizumab 5 mg/kg on day 1. Treatment was repeated every 14 days. The primary endpoint was overall response rate. Results In the 48 enrolled patients response rate according was 46.8% (95% CI: 32.54%–61.07%), while 13 patients had stable disease, for an overall disease control rate of 74.4% (95% CI: 57.8–91.2). Progression free survival was 7.9 months (95% CI: 5.9–9.8 months) and the median overall survival 20.1 months (95% CI: 15.6–25.7 months). Response rate and progression free survival has been correlated with baseline albumin and haemoglobin levels. There was one treatment-related death. Grade 3–4 toxicities were asthenia (4.2%), neurotoxicity (2.1%) and diarrhea 6.3%). Conclusions The combination of capecitabine, oxaliplatin and bevacizumab is an effective and safe combination for the treatment of elderly patients with metastatic CRC. Trial registration Clinical trials NCT01024504, 26 November 2010. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|