Metastatic Esophageal Squamous Cell Research Articles

A retrospective analysis of 5-fluorouracil plus cisplatin as first-line chemotherapy in patients with metastatic or recurrent esophageal squamous cell carcinoma.

204 Background: Patients with metastatic or recurrent esophageal squamous cell carcinoma (ESCC) have a poor prognosis. For decades, 5-fluorouracil /Cisplatin (FP) have been mostly used for these patients as first line chemotherapy. But there were few reports which reveal the reality containing the efficacy of FP regimen for ESCC. We conduct this retrospective study to reveal the efficacy and prognostic factors of the patients treated with FP as first line chemotherapy for ESCC. Methods: Patients with metastatic or recurrent ESCC after esophagectomy were enrolled. FP comprised of CDDP at a dose of 80mg/m2 on day1, and 5-FU at a dose of 800mg/m2given by continuous on days 1-5 every 4 weeks. Cox-proportional hazard model was used for multivariate analysis to evaluate prognostic factors. Results: Between April 2001 and March 2012 in the National Cancer Center Hospital, data of 187 patients were collected by medical records. Characteristics of 187 patients were as follows; the median age (range) 62 (34-84); (male/female) 163/24; (performance status: 0/1/2) 69/110/8; (metastatic/recurrent) 116/71; median number of metastasis 1(range1-4); median cycles of FP 2(range1-10). Overall response rate was 31.6% (95%CI: 25.0-38.7%). Median progression free and overall survival time was 4.9 month and 10.5 month, respectively. In multivariate analysis, serum CRP (≥2 vs <2 mg/dl) (HR=2.61, p<0.001), serum albumin (<3.5 vs >3.5 mg/dl) (HR=1.85, p=0.001) at the time of diagnosis and number of metastatic site (≥2 vs <2) (HR=1.563, p=0.01) were remaining independent prognostic factor for survival. Survival time of the patients who had no these poor prognostic factors was 17.9 month, while survival time who had all poor prognostic factors was only 4.0 month. Conclusions: Number of metastatic site, CRP, and serum albumin are independent prognostic factor on metastatic or recurrent ESCC patients treated with FP. Information from this analysis can be used to aid clinical decision-making and help individual patient risk stratification.

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

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.