Predictors of disease control in patients treated with platinum-based chemotherapies for metastatic squamous-cell esophageal cancer: First results of the e-DIS trial.

Abstract

95 Background: There is little evidence that chemotherapy (CT) impacts on outcome of patients with MSEC. We designed an ongoing randomized phase 2 trial to detect a progression-free survival benefit of CT continuation over CT discontinuation in disease-controlled and ECOG≤2 patients at 6 weeks after an initial CT treatment. The aim of the present study was to identify predictors of disease control at 6 weeks (DC6wkx) in MSEC patients receiving platinum-based CTs as first-line treatment for metastatic disease. Methods: Among 68/70 evaluable patients included between 1/2011 and 7/2013 who received at least 1 CT cycle, 58 were evaluable for disease assessment at 6 weeks. Ten patients were not evaluable (early death: 4, patient’s decision: 2, concomitant disease 1, early progressive disease 1, other reasons: 2). Baseline demographic, clinical, biological, and tumor characteristics were tested for prediction of DC6wkx. Significant variables for DC6wkx were identified with the chi-squared test and logistic regression. Results: Baseline patients characteristics were as follows: median age: 61.5yo; male: 57/68; ECOG 0/1/2: 13/42/13; metachronous/synchronous MSEC: 38/30; number of metastatic sites 1/2/>2: 35/20/13; metastatic location: lung 36, liver 23, bone 11, nodes 37, other 11; prior exposure to CT: 37/68; time from previous CT exposure: ≤ 6m 6/37, 6-12m 14/37, > 12m 17/37; gr>2 dysphagia (Atkinson) 19/67; BMI<18.5kg/m²: 13/68. Current CTs were FU-CDDPq3w 2/68, LV5FU2-CDDPq2w 15/68, FOLFOX 51/68, and patients received the following number of cycles 1/2/>2: 5/7/54. DC6wkx rate was 65.7%, with 16/68 PR (23.5%) and 28/68 SD (42.2%). Albumin (p<0.01), BMI (p<0.02), bone metastases (p<0.005), gender (p<0.047) and ECOG status (p<0.05) were predictive of DC6wkx. Normal or overweight BMI, grade 0 albumin, and no bone metastases, were predictive of DC6wkx in multivariate analysis. Conclusions: DC at 6 wks was 65.7% in MSEC receiving platinum-based CTs as first line treatment for metastatic disease. Normal or overweight BMI, normal albumin, and the absence of bone metastasis were significant predictors of DC6wkx in this prospective phase 2 trial. Clinical trial information: NCT01248299.