Annals of Oncology Advance Access originally published online on November 22, 2005
Annals of Oncology 2006 17(1):29-34; doi:10.1093/annonc/mdj063
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© 2005 European Society for Medical Oncology
Oxaliplatin and capecitabine in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia: a phase II study from the North Central Cancer Treatment Group
1 Mayo Clinic and Mayo Foundation, Rochester, MN; 2 Toledo Community Hospital Oncology Program CCOP, Toledo, OH; 3 Duluth CCOP, Duluth, MN; 4 Illinois Oncology Research Assn. CCOP, Peoria, IL; 5 Scottsdale CCOP, Scottsdale, AZ; 6 Carle Cancer Center CCOP, Urbana, IL, USA,
* Correspondence to: Dr A. Jatoi, Mayo Clinic, 200 First Street, SW, Rochester, MN 55905, USA. Tel: +1-507-5380548; Fax: +1-507-2841803; E-mail: Jatoi.aminah{at}mayo.edu
Purpose: The synergic combination of oxaliplatin and capecitabine has demonstrated activity against various gastrointestinal cancers, including colon cancer. We therefore undertook this phase II study to test this first-line combination in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia.
Patients and methods: Forty-three patients with histologic or cytologic confirmation of the above malignancy were recruited. The cohort had Eastern Cooperative Oncology Group performance statuses of 0, 1 and 2 in 47%, 51%, and 2%, respectively. Median age was 61 years (range 32–80). All had adequate organ function. Initially, patients were prescribed 130 mg/m2 intravenously on day 1 and capecitabine 1000 mg/m2 orally twice a day, on days 1–14 of a 21-day cycle. Four treatment-related deaths in the first 24 patients led to a reduction in capecitabine to 850 mg/m2 orally twice a day, days 1–14, for the remainder of the cohort.
Results: The tumor response rate was 35% [95% confidence intervals (CI) 23% to 50%]. All responses were partial; seven of 24 occurred before the capecitabine dose reduction, and eight of 19 after. Median time to tumor progression was 4 months (95% CI 3.1–4.6), and median survival 6.4 months (95% CI 4.6–10). To date, there have been 36 deaths. Four were treatment-related (one infection, two myocardial infarctions, one respiratory failure), and all occurred before the capecitabine dose reduction. Notable grade 4 events from the entire cohort included diarrhea (two patients), vomiting (three), dyspnea (one), thrombosis (two) and anorexia (two). Grade 3 events included nausea (12 patients), diarrhea (12), fatigue (10), abdominal pain (seven), vomiting (six), dyspnea (six), hypokalemia (six), dehydration (five), hypokalemia (five) and infection (four).
Conclusions: Oxaliplatin and capecitabine in combination demonstrates activity in metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia. The lower dose (capecitabine 850 mg/m2 orally twice a day, days 1–14, and oxaliplatin 130 mg/m2 intravenously on day 1) yielded an acceptable toxicity profile and merits further study.
Key words: chemotherapy, esophageal cancer, metastatic, oral therapy, response rate
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