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 results of neoadjuvant chemotherapy followed by concurrent chemotherapy plus high-dose radiation therapy in patients with local/regional squamous cell carcinoma of the esophagus, Materials and Methods: Forty-five patients with clinical stage T1-4NO-1MO squamous cell carcinoma were entered onto the trial. Eight patients were declared ineligible after registration. 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 duration was 9 months, and the overall median survival was 20 months. Conclusion: The preliminary analysis of this trial demonstrated that the incidence of grade 3 + toxicity was similar to that reported in the combined modality arm of the prior Radiation Therapy Oncology Group (RTOG) intergroup esophageal trial RTOG 85-01. However, because of the increased 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.