MANAGEMENT OF ADENOCARCINOMA OF THE ESOPHAGUS WITH CHEMORADIATION ALONE OR CHEMORADIATION FOLLOWED BY ESOPHAGECTOMY - RESULTS OF SEQUENTIALNONRANDOMIZED PHASE-II STUDIES

Purpose: The incidence of adenocarcinoma of the esophagus is increasin g, but the optimal treatment for this disease is unknown. We evaluated the efficacy of chemoradiation and chemoradiation followed by esophag ectomy as treatment for adenocarcinoma of the esophagus in sequential prospective nonrandomized phase II studies. Methods and Materials: Bet ween May 1981 and June 1992, all previously untreated patients (N = 35 ) with potentially resectable adenocarcinoma of the esophagus (clinica l Stage I or II) were treated with curative intent in sequential prosp ective Phase II studies. From May 1981 to August 1987, 11 patients (me dian age 66) were treated with concurrent chemotherapy [mitomycin C, a nd 5-fluorouracil (5-FU)] and radiotherapy to a median dose of 60 Gy ( CRT group). From September 1987 to June 1992, 24 patients (median age 65) were treated with the same regimen of chemoradiation followed by p lanned esophagectomy (CRT + PE group. Of these, 12 patients (median ag e 62) actually underwent esophagectomy (CRT + E subgroup). Results: Th e median overall survival was 19 months for the CRT group and 15 month s for the CRT + PE group. For the CRT + E subgroup, the median overall survival was 33 months. The 3-year actuarial overall survival for the CRT and the CRT + PE groups were 36 and 28% (p = 0.949). The subset o f patients treated with chemoradiation followed by esophagectomy had a 3-year actuarial overall survival of 33% (p = 0.274). The 3-year actu arial freedom from local failure rates were similar: 62% in the CRT gr oup vs. 58% in the CRT + PE group. Of the 12 patients who underwent es ophagectomy (CRT + E group), 9 (75%) were free of local failure. Four of 12 (33%) patients had no pathologic evidence of malignancy in their surgical specimen. Six of 11 patients (55%) in the CRT group were fre e of local failure at the time of analysis. Two of five patients in th is group who had local recurrence at 2 and 10 months underwent surgica l salvage with subsequent survivals of 20 and 100 months, respectively . Treatment-related mortality was 0 out of 11 in the CRT group and 2 o ut of 24 in the CRT + PE group. Dysphagia relief was similar in the CR T group vs. the CRT + E subgroup; however, a greater percentage of pat ients treated with chemoradiation alone had normal long-term swallowin g function when compared to those patients also undergoing esophagecto my (100% vs. 73%). Conclusion: High-dose chemoradiation alone appears to provide similar survival and relief of dysphagia compared with high -dose chemoradiation followed by esophagectomy for patients with poten tially resectable esophageal adenocarcinoma. Local failure may be high er in patients undergoing chemoradiation compared to chemoradiation fo llowed by esophagectomy, but surgical salvage is possible, thus provid ing similar overall local control. However, because of the small numbe r of patients in each group, these treatment modalities need to be fur ther evaluated in a prospective randomized Phase III study.