Abstract:
PURPOSE:Capecitabine has shown similar efficacy to 5-fluorouracil (5-FU); a regimen containing 2 weeks of capecitabine/oxaliplatin (CapOx) has demonstrated noninferiority to infusional 5-FU/oxaliplatin/leucovorin (FOLFOX) for the treatment of metastatic colorectal cancer (mCRC). This phase II study explores the efficacy and safety of a 2-day course of oxaliplatin/capecitabine (2DOC), with oxaliplatin given on day 1 and capecitabine given orally every 8 hours in high doses over 6 doses, mimicking FOLFOX6. PATIENTS AND METHODS:This phase II study was conducted by the University of Wisconsin Carbone Cancer Center. Eligible patients with mCRC received oxaliplatin 100 mg/m2 intravenously (I.V.) over 2 hours followed by leucovorin 20 mg/m2 I.V. bolus and 5-FU 400 mg/m2 I.V. bolus on day 1 and day 15. Capecitabine was administered at 1500 mg/m2 orally every 8 hours over 6 doses starting on day 1 and day 15. RESULTS:A total of 45 patients were enrolled; 44 were evaluated for response. Seventeen patients (39%) had objective responses. Median time to progression was 6.8 months, and median overall survival (OS) was 17.5 months. The most common side effects were grade 1/2 neuropathy, fatigue, and nausea. Severe hand-foot syndrome (HFS) was rare. CONCLUSION:The overall response rate with the 2DOC regimen is similar to published CapOx regimens, and time to progression and OS are similar. The incidence of HFS, diarrhea, and mucositis were lower compared with published results of 2-week schedules of capecitabine. The 2DOC regimen merits further study as a more convenient regimen than infusional 5-FU with less HFS when compared with a 2-week administration of capecitabine.
journal_name
Clin Colorectal Cancerjournal_title
Clinical colorectal cancerauthors
Lubner SJ,Loconte NK,Holen KD,Schelman W,Thomas JP,Jumonville A,Eickhoff JC,Seo S,Mulkerin DLdoi
10.3816/CCC.2010.n.021subject
Has Abstractpub_date
2010-07-01 00:00:00pages
157-61issue
3eissn
1533-0028issn
1938-0674pii
S1533-0028(11)70051-2journal_volume
9pub_type
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pub_type: 杂志文章,meta分析
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pub_type: 杂志文章,评审
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pub_type: 杂志文章,随机对照试验
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pub_type: 杂志文章
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journal_title:Clinical colorectal cancer
pub_type: 杂志文章,评审
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pub_type: 临床试验,杂志文章
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pub_type: 杂志文章,评审
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