Long-term follow-up and compilation of two trials utilizing concurrent paclitaxel/carboplatin/infusional 5-FU/radiation therapy (RT) in patients with localized esophageal cancer involved in the Minnie Pearl Cancer Research Network

Abstract

4028 Background: The role of preoperative chemoradiation in patients (pts) with localized esophageal cancer remains unclear. Most preoperative regimens produce 20–30% pathologic complete response (pCR) rates, which predicts improved survival. Our community-based multicenter group performed sequential trials evaluating a novel paclitaxel-containing preoperative chemoradiation regimen, now with median followup > 6 years. Methods: Eligibility: untreated adenocarcinoma or squamous carcinoma of esophagus or GE junction; clinical stage I-III; surgical candidate; ECOG PS 0–2, adequate organ function; informed consent. Pts received paclitaxel 200mg/m2 IV and carboplatin AUC 6.0 IV, days 1, 22; 5FU 225mg/m2, 24 hr continuous infusion, days 1–42; RT 45 Gy in 1.8 Gy/d single daily fractions. Surgical resection was performed 6–10 weeks after completion. Results: 226 pts with the following characterstics were treated: median age 58 years; adenocarcinoma 74%; distal/GE junction 79%; clinical stage II/III 84%. 220 pts (97%) completed preoperative therapy, and 199 pts (88%) had resection. Responses in resected pts: pCR 45% (39% of entire group), PR (microscopic residual) 29%, PR (macroscopic) 15%. After median followup of 75 months, median PFS and overall survival for the entire group were 19 and 26 months, respectively; 3- and 5-year survivals were 40% and 33%, respectively. Median survival was better in pts with pCR vs others (33 vs 21 mo; p=.026). 3-yr survival comparisons of other potential prognostic factors: adeno vs squamous, 43% vs 42%; clinical stage I vs II/III, 63% vs 36% (p=.001); distal location vs others, 38% vs 45% (p=.45). Toxicity data have been previously published; overall 13 pts (6%) had treatment-related death (preop 2, postop 11). Conclusions: This preoperative combined modality regimen was feasible and highly active in a community-based setting. This is one of the largest series of patients treated with an identical preoperative approach and with long-term followup is curative in one-third of pts with localized esophageal cancer. [Table: see text]