Affiliation:
1. From the Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie, Charité, Universitätsmedizin Berlin, Campus Virchow-Klinkum; HELIOS-Klinikum Berlin, Robert-Rössle-Klink, Charité Campus Buch; and Onkologische Schwerpunktpraxis Tiergarten, Berlin; Städtisches Klinikum St. Georg, Leipzig; and Vinzenz-Pallotti-Krankenhaus, Hämato-onkologische Ambulanz, Bergisch-Gladbach, Germany
Abstract
Purpose A combination of docetaxel and fluorouracil (DF) was evaluated in an outpatient setting and compared with epirubicin, cisplatin, and fluorouracil (ECF), which served as an internal control arm to avoid selection bias. Patients and Methods Patients with metastatic or locally advanced gastric adenocarcinoma without prior chemotherapy were randomly assigned to receive either ECF (epirubicin 50 mg/m2 day 1, cisplatin 60 mg/m2 day 1, and fluorouracil 200 mg/m2 days 1 through 21, every 3 weeks) or DF (docetaxel 75 mg/m2 day 1, and fluorouracil 200 mg/m2 days 1 through 21, every 3 weeks). Results Ninety patients were randomly assigned. Toxicity was rarely severe. Major toxic effects included diarrhea, stomatitis, and leukopenia in the DF arm and nausea, vomiting, and leukopenia in the ECF arm. Forty-three of 45 patients in each arm were assessable. In the DF arm, two patients (4.4%, intent to treat) experienced a confirmed complete tumor remission as best response, and 15 patients (33.3%) experienced a confirmed partial remission (overall response rate [ORR], 37.8%; 95% CI, 25.9% to 51.9%). Two patients (4.4%) in the ECF arm showed confirmed complete remission, and 14 (31.1%) showed confirmed partial remission (ORR, 35.6%; 95% CI, 24.8% to 48.7%). For the DF and ECF arms, the median survival was 9.5 and 9.7 months, and the median time to tumor progression 5.5 and 5.3 months, respectively. Conclusion DF can be safely given in an ambulant setting. Compared with ECF, the dual combination of DF shows promising efficacy and may be an alternative treatment option that avoids cisplatin.
Publisher
American Society of Clinical Oncology (ASCO)
Reference30 articles.
1. Wilke H, Korn M, Köhne C, et al: Phase II results of weekly infusional high-dose FU (HD-FU) plus folinic acid (FA) and biweekly cisplatin (C) for advanced gastric cancer. Ann Oncol 7:46,1996, (suppl 5)
2. Rougier P, Ducreux M, Mahjoubi M, et al: Efficacy of combined 5-fluorouracil and cisplatinum in advanced gastric carcinoma: A phase II trial with prognostic factor analysis. Eur J Cancer 30A:1263,1994-1269,
3. Randomized trial comparing epirubicin, cisplatin, and fluorouracil versus fluorouracil, doxorubicin, and methotrexate in advanced esophagogastric cancer.
4. Ross P, Cunningham D, Scarffe H, et al: Results of a randomised trial comparing ECF with MCF in advanced oesophago-gastric cancer. Proc Am Soc Clin Oncol 18:272a,1999, (abstr 1042)
5. CPT-11 plus cisplatin in patients with advanced, untreated gastric or gastroesophageal junction carcinoma