A PHASE-II TRIAL, FEASIBILITY OF COMBINATION OF DAILY CISPLATINUM ANDACCELERATED RADIOTHERAPY VIA CONCOMITANT BOOST IN STAGE-III NONSMALL CELL LUNG-CANCER

Purpose: A prospective phase II trial was conducted by the Institute o f Oncology, istanbul University in December 1994 on patients with loca lly-advanced non-small cell lung cancer to assess acute toxicity and t he feasibility of a combination of radiosensitizer and accelerated rad iotherapy with concomitant boost. Materials and methods: Patients were irradiated using 'large' fields (primary tumour and locoregional lymp h nodes) with 1.8 Gy per fraction, five fractions a week. Reduced 'boo st' fields (primary and involved nodes only) were also irradiated twic e-weekly 1.8 Gy per fraction in ten fractions concomitantly 6 h after the administration of large field. Total radiation dose was 63 Gy in 5 weeks (45 Gy 'large' fields and 18 Gy 'boost'). The maximum allowed d ose to the spinal cord was 3750 cGy. Cisplatinum, 6 mg/m(2) was given daily just before 'large' field irradiation, Results: As of January199 7, 15 patients were evaluated (median follow-up of 12.5 months with a range of 5.5-23 months). The overall acute toxicity rate was 38% and G rade 3 acute toxicity was 8%. Grade 4 or greater acute toxicities were not observed. The overall rate of cisplatinum-induced nausea and vomi ting was 80% (severe in 60%), but all were easily treated with antieme tics. Complete response rate (clinical and radiological) was 40% and a n overall response rate was 73%. Median survival was 16 months and pro gression-free survival was 5.5 months (range of 2.5-21 months). Conclu sions: Toxicity was well tolerated and no treatment-related death occu rred with this combined treatment regimen. Although it appears that be tter local control rates can be achieved, additional phase II/III stud ies are needed. (C) 1998 Elsevier Science Ireland Ltd. All rights rese rved.