Artikel
Irinotecan/Capecitabine versus Cisplatin/Capecitabine in Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction: Preliminary Results of a Randomized German AIO Phase II-Study
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Veröffentlicht: | 20. März 2006 |
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Gliederung
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Introduction: Irinotecan in combination with 5-FU is highly effective in advanced or metastatic gastric cancer. In addition, the oral administered fluoropyrimidine capecitabine seems to be at least as effective as 5-FU. Therefore, we designed this trail to prospectively compare efficacy and toxicity of the combination of irinotecan/capecitabine versus cisplatin/capecitabine.
Methods: Patients (pts) with previously untreated locally advanced or metastatic gastric or gastroesophageal adenocarcinoma were eligible with a Karnofsky Performance status (KPS) of at least 60%, measurable lesions and adequate major organ functions. Pts were randomized to receive 3-weekly cycles of either irinotecan 250 mg/m2, day 1 (arm A) or cisplatin 80 mg/m2, day 1 (arm B). Capecitabine was administered at 1000 mg/m2 twice daily for 14 days followed by a 7-day rest period in both treatment arms. Treatment was continued until progression of disease occurred.
Results: Preliminary results from an interim analysis will be present.