PUB009 New Chemotherapy Regimen; Does It Really Work for Esophageal Cancer Adenocarcinoma?

Abstract

Neoadjuvant chemotherapy for esophageal cancer changed over last years with the current most used regimen being EOX(Epirubicin,Oxaloplatin &Xeloda)for adenocarcinoma but this treatment still carries many adverse events(AE)as identified by NCI-CTCAEv.4.Among R0(complete resection)group, we sought to investigate a modification for current ones seeking a better response rate, lower AE rate and better quality of life(QoL). This is a pilot study(Sep.2008-Dec.2014)involving Taxol/Carboplatin/ Xeloda(TCX(paclitaxel 80mg/m2days 1 and 8, carboplatin 5AUC day 1, capecitabine 750mg/m2 BID for 14 days)){Ruoff, C.A., Hong, B., Kaplan, et al, Single-center experience with paclitaxel(T), carboplatin(C), and capecitabine(X) in treatment of advanced esophagogastric cancer. In ASCO-Gastrointestinal Cancer Symposium, 2013;116}. Patients were followed through chemotherapy course to capture grade 1,2,3,4 and 5 AE(Mild, Moderate, Severe, Life-threatening and Death respectively). Kaplan-Meier survival curves were used to identify disease free survival(DFS). QoL was assessed using Functional Assessment of Cancer Therapy-Esophagus(FACT-E) questionnaire 12 months or more post-operatively. Among our database, 8 patients received neoadjuvant-TCX for adenocarcinoma with median age 61(51-75) years, BMI28.8(20.1-33.6).Most patients were male, performance status of 0(7 patients). They had lower or GEJ-adenocarcinoma predominantly(7 patients).Clinical stage IIand III were present in 2 and 6 patients respectively. Pathological stage I, II and III were present in 3, 3 and 2 patients respectively. Median pre-induction PET-standardized uptake value (PET-SUV) was 10.1 vs 3.6 post-induction (p=0.014) with median PET-SUV decrease percent of 75.3%. 87.5% were clinical responder (>50% reduction) and 75% were radiological responder (>50% decrease in PET-SUV) .25% of our cohort received adjuvant treatment. Grade 2-3 toxicity occurred in 44.4% of the patients (37.5% grade 2, 12.5% grade 3 and none had grade 4 or 5). Hematologic AE were the most frequent (anemia 87.5%, neutropenia 50% (grade 1, 2, and 3 in 2, 1 and 1 patients respectively), leukopenia 25% and thrombocytopenia 37.5%) followed by diarrhea (25%). No patient had neutropenic sepsis. Mean DFS was 66 months. 3- and 5-years DFS was 87.5 and 72.9% respectively (Figure1A). QoL was improved compared to published data (Figure1B, Table 1). TCX is a novel, safe regimen and carries a low AE rate(mostly low grade AE). It is associated with reasonable DFS and better QoL. However, large scale RCT is necessary and warranted.