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Capecitabine, Fluorouracil, Oxaliplatin and Cisplatin All Showing Good Activity Against Gastric Cancer: Presented at CFS

By Rabiya S. Tuma
Special to DG News

New York, NY -- November 14, 2002 -- An interim analysis of the first 80 patients enrolled in a two-by-two randomized trial comparing capecitabine (X) with fluorouracil (F) and oxaliplatin (O) with cisplatin (C) shows that all of the regimens have good efficacy and are well tolerated in oesophageal-gastric cancer.

Dr. Niall Tebbutt, from the Royal Marsden Hospital in Sutton, England, presented the data here yesterday at the Chemotherapy Foundation Symposium (CFS).

Dr. Tebbutt cautions that clinicians should not view this as a practice-changing study until the study is complete. However, based on this scheduled interim analysis, Dr. Tebbutt told Doctor's Guide, "the regimens look as though they have significant activity. They look as though they are well tolerated. But, we'll have to wait until the completion of the phase III trial to decide whether we should change clinical practice."

The patients recruited thus far to the phase III trial have been diagnosed with oesophageal-gastric cancer and had an ECOG performance status of 0-2 and adequate liver, renal and hematological function at the time of enrollment.

All patients in the trial receive epirubicin at 50 mg/m² intravenously three times weekly. Half of the patients are then randomized to either cisplatin (60 mg/m² intravenously three times weekly) or to oxaliplatin (130 mg/m² intravenous three times weekly). In addition, they are randomly assigned to 5-fluoruracil (200 mg/m²/day IV) or to capecitabine (1000 mg/m² orally everyday). Thus, there were four arms in the trial: ECF, EOF, ECX, EOX. Such a trial design, says Dr. Tebbutt, allows the researchers to make two comparisons simultaneously, comparing fluorouracil to capecitabine and cisplatin to oxaliplatin.

The demographics of all four groups are well matched, with the percentage of patients having metastatic disease between 84 and 89 percent in the various trial arms. Thus far, the total response rates for the groups are as follows: 28 percent for ECF+EOF, 54 percent for ECX+EOX, 34 percent for ECF+ECX, and 47.5 percent for EOF+EOX.

At this point in the trial, with only 80 of the target 600 patients enrolled, the more important results are in regards to toxicity and tolerance, says Dr. Tebbutt. This current interim analysis was scheduled to evaluate the percentage of patients with grade 3/4 diarrhea, stomatitis and PPE in the capecitabine arm. Because the percentage of patients experiencing such toxicities was well below the predetermined level of 10 percent, the researchers have increased the capecitabine dose by 25 percent to 625 mg/m²/day. They have subsequently enrolled another 80 patients in the trial and will evaluate patient tolerance to the new regimen.

Other significant toxicities detected in the first 80 patients were grade 3/4 neutropenia at a rate ranging from 28.6 percent in patients in the ECF+EOF arms to 59 percent in patients enrolled in the EOF+EOX arms. In the EOF+EOX arms, 2.3 percent of patients experienced febrile neutropenia, while as many as 5.7 percent patients in the ECF+ECX arms experienced such complications.

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