Phase II neoadjuvant and adjuvant chemotherapy for localized esophageal carcinoma

Abstract

4147 Background: Patients (Pts) with localized esophageal carcinoma were evaluated for toxicity, operative mortality/morbidity, and overall survivorship in a regimen that did NOT contain radiation therapy. Methods: Pts with T3N1M0 esophageal carcinoma confirmed by endoscopic ultrasound and CAT scan were eligible for this study. Our therapy consisted of combined Cisplatin100 mg/m2, Paclitaxel (Taxol) 125mg/ m2, Fluorodeoxyuridine (FUdR) 150 mg /Kg or 80 mg/Kg, and Leucovorin 500mg /m2. Chemotherapy was given for 16 weeks prior to surgery. Adjuvant chemotherapy was administered for the patients whose pathology at the time of the surgery demonstrated microscopic disease. Results: 33 pts (29 males, 4 females) with adenocarcinoma (n=30) or squamous cell carcinoma (n=3) were enrolled. 26 pts (78%) were symptomatic with dysphagia at the time of enrollment on the study. 28 pts completed two cycles of neoadjuvant chemotherapy, 19 (68%) showed improvement of dysphagia. There were 9 instances of grade 3 or 4 hematological toxicity. There were 11 instances of non-hematological grades 3–4 toxicities: fatigue (4), nausea (1) diarrhea (2) and stomatitis (4). Of 33 R0 resections, 5(15%) had no gross disease, 2 (6%) had no microscopic residual disease. Major surgical complication occurred in 5(15%) of 33 pts. Operative mortality was 1 of 33 pts. Conclusions: Our regimen of preoperative and postoperative chemotherapy without radiation for esophageal carcinoma has produced a rapid relief of dysphagia, acceptable toxicity and durable response rates. No patient developed local recurrence, however, 14 pts developed distant metastasis, the sites included: 1 rectum and mediastinal lymph node, 2 brain, 2 liver and lung, 1 liver and spleen, 3 bone, 4 liver, lung, and brain, and 1 lung. Seventeen pts died after being followed for a median of 12 months (range 2 to 43 months), while 16 others remain alive with median follow up of 39 months (range 5 to 60 months). Median survival was estimated to be 42 months with a 95% lower confidence bound of 14 months. The Kaplan-Meier estimates of 1- and 3-year survival were 75% (95%CI: 60–90%) and 50% (95%CI: 32 to 68%). No significant financial relationships to disclose.