Oxaliplatin With Lower-Dose Capecitabine Active in Metastatic GI and Esophageal Cancers

ROCHESTER, MINNESOTA- A phase II study from the North Central Cancer Treatment Group (NCCTG) showed that oxaliplatin(Drug information on oxaliplatin) (Eloxatin) combined with lower-dose capecitabine(Drug information on capecitabine) (Xeloda) is active as firstline treatment of a variety of metastatic gastrointestinal and esophageal cancers and should be studied further in this setting, according to Aminah Jatoi, MD, of the Mayo Clinic in Rochester, Minnesota (abstract 4059). Dr. Jatoi said that this study appears to be the first trial of oxaliplatin/ capecitabine in the first-line setting in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and gastric cardia. The study included 44 patients who were virtually chemotherapy-naive (4 had undergone prior radiosensitizing chemotherapy). Patients were initially treated with oxaliplatin (130 mg/m² IV on day 1) and capecitabine (1,000 mg/m² orally twice daily) on days 1-14 of a 21-day cycle. The capecitabine dose was reduced to 850 mg/m² orally twice daily on days 1-14 after three treatmentrelated deaths occurred in the first 24 patients treated at the higher dose. New Ideas From Work in Colon Cancer "We got ideas for new approaches to metastatic gastric and esophageal cancers from some of the work done in colon cancer, where studies advance faster because so many more patients are available for clinical trials. Some of these regimens, ironically, are relying on oral therapies. Patients can often swallow oral treatments, although this approach might seem odd at first in esophageal cancer, but if patients can swallow, these regimens are much less cumbersome than others," Dr. Jatoi said. Encouraging Response Rate Oxaliplatin/capecitabine produced partial responses in 34% of patients. The median time to tumor progres- sion was 3.8 months, and the median survival was 6.4 months. Dr. Jatoi said that there have been 30 deaths. Three were treatment-related (one due to an infection, two from myocardial infarction) and occurred prior to the capecitabine dose reduction. Grade 4 adverse events included diarrhea (two patients), vomiting (3), dyspnea (1), thrombosis (2), and anorexia (2). Grade 3 events included nausea (12 patients), diarrhea (12), fatigue (10), abdominal pain (7), vomiting (6), dyspnea (6), dehydration (5), hypokalemia (5), and infection (3). "Esophageal cancer often has a very low response rate, and we are very encouraged by the 34% response rate in this study. We think this combination should go forward in larger trials," Dr. Jatoi concluded.