학술논문

Phase II study of biweekly XELOX (capecitabine and oxaliplatin) as first line chemotherapy in elderly patients with metastatic colorectal cancer.
Document Type
Academic Journal
Source
Journal of Clinical Oncology (J CLIN ONCOL), 5/21/2009 Supplement Part 1 of 2; 27: e15053-e15053. (1p)
Subject
Language
English
ISSN
0732-183X
Abstract
e15053 Background: Analysis of efficacy and toxicity of biweekly XELOX as first line monotherapy in elderly patients (pts) with metastatic colorectal cancer (MCRC), based in results of W. Scheithauer (J Clin Oncol 2003; 21: 1307).Methods: From March/06 to November/08, 28 chemonaïve elderly pts (>75 years old) with MCRC, PS: 0-2, and adequate renal, hepatic and bone marrow functions, were included in a phase II study of: oxaliplatin 85 mg/ m2/ day 1 plus capecitabine 2000/ m2/ in 2 divided doses/ days 1-7 every 2 weeks. Treatment was continued until 12 cycles, tumour progression or innaceptable toxicity. Response evaluation every 6 cycles and toxicity every cycle was performed. At present 28 pts for toxicity and 24 pts for response are evaluable.Results: Median age: 78.2 years (range: 73.5-79.5). Male/Female: 14/14. Rectal/Colon: 9/19. Metastatic sites 1/2/>2: 15/6/6. Liver 78.6%, Lung 32.1%, Local tumour 7.1%, Retroperitoneum 14.2%, Peritoneum 10.7%. and Bones 7.1 %. Previous adjuvant with 5-FU regimens to 4 pts. Comorbidity grade by Charlson index 0-1/2/>2: 60.8%/ 28.6% / 10.7%, respectively. Median number of cycles for oxaliplatin and capecitabine were 8 (5.25-12) and 8 (5.25-11.75). Response rate: 2 pts complete response (8.3%), 8 pts partial response (33.3%),10 pts stable disease (41.7 %) and 4 pts progression (16.7%). The main CTC toxicity was Asthenia G2+3 in 6 (21.5%), Nausea and emesis G2 in 7 (25%), Diarrhea G2+3 in 7 (25%) and Hand-foot syndrome G1+2 in 5 pts (17.8%). No G4 toxicity or toxic deaths were observed. Median time to progression was 8.6 months.Median overall survival will be given updated at the congress.Conclusions: Preliminary results suggest that bi-weekly XELOX is an effective first line treatment for MCRC in elderly pts with an acceptable toxicity profile (especial surveillance of diarrhea is necessary) and protocol cumpliment. Combination with bevacizumab should be considered. No significant financial relationships to disclose.