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Annals of Oncology Advance Access published online on November 22, 2005
Annals of Oncology, doi:10.1093/annonc/mdj063
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© 2005 European Society for Medical Oncology
Received September 1, 2005
Revised September 27, 2005
Accepted September 30, 2005

original article

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

A. Jatoi 1 *, B. R. Murphy 2, N. R. Foster 1, D. A. Nikcevich 3, S. R. Alberts 1, J. A. Knost 4, T. R. Fitch 5, and K. M. Rowland Jr 6

1 Mayo Clinic and Mayo Foundation, Rochester, MN, USA
2 Toledo Community Hospital Oncology Program CCOP, Toledo, OH, USA
3 Duluth CCOP, Duluth, MN, USA
4 Illinois Oncology Research Assn. CCOP, Peoria, IL, USA
5 Scottsdale CCOP, Scottsdale, AZ, USA
6 Carle Cancer Center CCOP, Urbana, IL, USA

* To whom correspondence should be addressed.
A. Jatoi, E-mail: Jatoi.aminah{at}mayo.edu


  Abstract

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.

Keywords: chemotherapy; esophageal cancer; metastatic; oral therapy; response rate.
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