Irinotecan/capecitabine versus cisplatin/capecitabine in advanced adenocarcinoma of the stomach or gastroesophageal junction: Interim analysis of a randomized German AIO phase II study

Abstract

4032 Background: Irinotecan with 5-FU is highly effective in advanced gastric cancer. In addition, capecitabine seems to be as effective as 5-FU, with its advantage of oral administration. Thus, we compared efficacy and toxicity of irinotecan/capecitabine versus cisplatin/capecitabine in this prospective multicentric, open trail. Methods: Patients (pts) with previously untreated locally advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction and Karnofsky Performance status (KPS) of ≥ 60%, at least one measurable lesion and adequate organ functions were eligible. Pts were randomized to 3-weekly cycles of irinotecan 250 mg/m2, day 1 (arm A) or to cisplatin 80 mg/m2, day 1 (arm B). Capecitabine was administered at a 1000 mg/m2 twice daily for 14 days followed by a 7-day rest in both arms. Primary endpoint was remission rate, treatment was continued until disease progression. Results: At time of abstract submission, 91 of 120 pts (planned sample size) were randomized to arm A (45 pts) or B (46 pts). Interim data were available on 76 patients included into intent to treat analysis (34 pts arm A, 42 pts arm B). Baseline characteristics (arm A vs. B) were median age: 60 vs. 64 years, gender (female/male) 23%/77% vs. 30%/70%, KPS (≥80%) 97% vs. 93%, tumor distribution of gastric origin and gastroesophageal junction 85%/15% vs. 63%/37%. Grade 3 toxicities in A/B (% of pts) were anemia 3/9, neutropenia 17/19, diarrhoea 17/5, nausea 14/21, vomiting 3/14, hand-foot syndrome 6/2, respectively. Grade 4 toxicity occured only for neutropenia with 3% vs.5% in A/B, respectively. In 59 evaluable pts (28/31 in A/B), overall remission rate (CR + PR) and tumor control rate (CR + PR + SD) were 39% vs. 42% and 64% vs. 74%, respectively. Despite being only very descriptive, median progression-free and overall survival (arm A vs B) were 5.2 vs. 5.0 and 8.9 vs. 9.4 months, respectively. Conclusions: In patients with locally advanced or metastatic gastric and gastroesophageal cancer, both regimen irinotecan/capecitabine or cisplatin/capecitabine are effective, well tolerated and can be administered safely on an out-patient basis. Currently, both treatment arms are comparable. Accrual continues. No significant financial relationships to disclose.