Phase II study of capecitabine and cisplatin as first-line therapy in patients with recurrent or metastatic esophageal carcinoma

Abstract

4221 Background: 5-Fluorouracil and cisplatin remains as the standard treatment for metastatic esophageal carcinoma, producing response rates of 20 - 35% in phase II trials. Preclinical studies suggest synergistic anti-tumor activity of capecitabine (X) and cisplatin (P). XP has demonstrated activity in advanced gastrointestinal cancer (Kim et al, Ann Oncol 2002;13:1893). Methods: This non-randomised open label phase II study evaluated the efficacy and safety of capecitabine 1250 mg/m2 on days 1 to 14 twice daily and cisplatin 60 mg/m2 on day 1 every 21 days as first-line chemotherapy in metastatic or recurrent esophageal cell carcinoma patients. Patients with; histologically proven, bidimensionally measurable, metastatic esophageal squamous cell or adenocarcinoma, age 18 - 75 years, with a performance status 0 - 2, no prior chemotherapy, life expectancy > 3 months, signed written informed consent were eligible. Results: From May 2003 to Nov 2004, 20 patients were prospectively enrolled. The median age was 60 years (47 - 71) and male:female ratio was 19:1. In total, 76 cycles were administered with a median of 4 cycles per patient (range, 1 - 9 cycles), and 17/20 patients were evaluable for response (3 inevaluable pts included; 1 patient with broncho-esophageal fistula after 1st cycle; 1 patient’s refusal for further chemotherapy; too early for assessment in 1 patient). The objective RR was 47.1% (95% CI, 23.4 - 70.8) with no CR and 8 PRs. Six patients (35.3%) had SD and only 3 patients (17.6%) had PD. Median OS of all patients was 11.1 months (95% CI, 9.3 - 13.0 months). Median TTP was 5.8 months (95% CI, 4.0 - 7.6 months). In total of 76 cycles administered, grade 3/4 hematological toxicities were observed as follows: neutropenia (13.2% of all cycles), anemia (1.3%). Grade 3/4 non-hematological toxicities included anorexia (13.2%), constipation (5.3%), and diarrhea (4.0%). Grade II/III hand-foot syndrome occurred in 15% and 10% of patients, respectively. Conclusions: XP chemotherapy showed a very promising preliminary anti-tumor activity and was well tolerated with convenient administration as a first-line treatment for patients with metastatic esophageal carcinoma. Supported by Roche Korea. No significant financial relationships to disclose.