STUDIO PROSPETTICO RANDOMIZZATO DI CHEMIOTERAPIA NEOADIUVANTE VERSUS SOLA CHIRURGIA NEL CANCRO OPERABILE (T2-3, OGNI N, M0) DELL'ESOFAGO

The preliminary, short and mid-term results obtained in a prospective randomized trial comparing surgery alone (arm A, 43 cases) with Cisplatin-Fluorouracil based preoperative chemotherapy (arm B, 35 cases already evaluable) in operable squamous cell carcinoma of the esophagus are evaluated herein. A WHO grade 0, 1 or 2 toxicity was recorded in 88% of arm B cases, and no toxic death was recorded. A major pathological response was documented in 45% of the cases concerning the T parameter, and in 43% concerning the N parameter. However, 2 of 5 patients with complete histological response of the T parameter presented lymph node metastases. The resectability rate aiming at cure, based on the intention to treat, was 74% in arm A, and 69% in arm B. Postoperative mortality after esophagectomy was 5.4% in arm A, and 7.4% in arm B; the overall postoperative morbidity rate was 48% and 37%, respectively. In conclusion, the preoperative chemotherapeutic regimen used in the present trial is feasible and well tolerated. According to the intention to treat, 3 of 35 (8.6%) patients randomized into arm B had a complete histological response. The real clinical role of this regimen of preoperative chemotherapy will be evaluated according to the impact on the long-term survival.