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

August 1, 2005

ROCHESTER, MINNESOTA-A phase II study from the NorthCentral Cancer Treatment Group(NCCTG) showed that oxaliplatin(Eloxatin) combined with lower-dosecapecitabine (Xeloda) is active as first

ROCHESTER, MINNESOTA-A phase II study from the NorthCentral Cancer Treatment Group(NCCTG) showed that oxaliplatin(Eloxatin) combined with lower-dosecapecitabine (Xeloda) is active as firstlinetreatment of a variety of metastaticgastrointestinal and esophageal cancersand should be studied further inthis setting, according to Aminah Jatoi,MD, of the Mayo Clinic in Rochester,Minnesota (abstract 4059).Dr. Jatoi said that this study appearsto be the first trial of oxaliplatin/capecitabine in the first-line setting inpatients with metastatic adenocarcinomaof the esophagus, gastroesophagealjunction, and gastric cardia. Thestudy included 44 patients who werevirtually chemotherapy-naive (4 hadundergone prior radiosensitizing chemotherapy).Patients were initially treated withoxaliplatin (130 mg/m2 IV on day 1)and capecitabine (1,000 mg/m2 orallytwice daily) on days 1-14 of a 21-daycycle. The capecitabine dose was reducedto 850 mg/m2 orally twice dailyon days 1-14 after three treatmentrelateddeaths occurred in the first 24patients treated at the higher dose.New Ideas From Work inColon Cancer"We got ideas for new approachesto metastatic gastric and esophagealcancers from some of the work donein colon cancer, where studies advancefaster because so many more patientsare available for clinical trials. Some ofthese regimens, ironically, are relyingon oral therapies. Patients can oftenswallow oral treatments, although thisapproach might seem odd at first inesophageal cancer, but if patients canswallow, these regimens are much lesscumbersome than others," Dr. Jatoisaid.Encouraging Response RateOxaliplatin/capecitabine producedpartial responses in 34% of patients.The median time to tumor progres-sion was 3.8 months, and the mediansurvival was 6.4 months.Dr. Jatoi said that there have been30 deaths. Three were treatment-related(one due to an infection, twofrom myocardial infarction) and occurredprior to the capecitabine dosereduction.Grade 4 adverse events includeddiarrhea (two patients), vomiting (3),dyspnea (1), thrombosis (2), and anorexia(2). Grade 3 events includednausea (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 verylow response rate, and we are veryencouraged by the 34% response ratein this study. We think this combinationshould go forward in larger trials,"Dr. Jatoi concluded.