NEOADJUVANT CHEMOTHERAPY PLUS CONCURRENT CHEMOTHERAPY AND HIGH-DOSE RADIATION FOR SQUAMOUS-CELL CARCINOMA OF THE ESOPHAGUS - A PRELIMINARY-ANALYSIS OF THE PHASE-II INTERGROUP TRIAL 0122

Purpose: To determine the preliminary acute toxicity and survival resu lts of neoadjuvant chemotherapy followed by concurrent chemotherapy pl us high-dose radiation therapy in patients with local/regional squamou s cell carcinoma of the esophagus, Materials and Methods: Forty-five p atients with clinical stage T1-4NO-1MO squamous cell carcinoma were en tered onto the trial. Eight patients were declared ineligible after re gistration. Patients received three monthly cycles of fluorouracil (5- FU; 1,000 mg/m(2)/24 hr for 5 days) and cisplatin (100 mg/m(2) on day 1) (neoadjuvant segment) followed by two additional monthly cycles of 5-FU (1,000 mg/m(2)/24 hr for 5 days) and cisplatin (75 mg/m(2) on day 1) plus concurrent 64.8 Gy (combined modality segment). Results: With a median follow-up of 15 months in surviving patients, the incidence of total grade 3+ toxicity during the neoadjuvant chemotherapy segment was 61%, and during the combined modality segment was 72%. Of the 33 patients who started radiation therapy, 91% were able to complete the full course. There were six deaths during treatment, five of which (11 %), because of nadir sepsis and/or dehydration, were treatment-related . For the 37 eligible patients, the median disease-free survival durat ion was 9 months, and the overall median survival was 20 months. Concl usion: The preliminary analysis of this trial demonstrated that the in cidence of grade 3 + toxicity was similar to that reported in the comb ined modality arm of the prior Radiation Therapy Oncology Group (RTOG) intergroup esophageal trial RTOG 85-01. However, because of the incre ased incidence of treatment-related mortality, this treatment program will not be used as an experimental arm of intergroup trial INT 0123 ( RTOG 94-05). (C) 1996 by American Society of Clinical Oncology.