Phase II study of thoracic radiation therapy with concurrent cisplatin and etoposide in unresectable non-small cell lung cancer

ABSTRACT

The primary objectives were to determine the overall response rate [ORR], progression-free survival [PFS], and overall survival [OS]. Secondary objectives were evaluation of possible prognostic factors, and toxicity profile. Induction chemotherapy consisted of Cisplatin 30mg/m2 and etoposide 130 mg/m2 on days 1 through 3 every 28 days for 3 cycles, then concurrent hyper fractionated-split course radiation with 1.5 GY per fraction bid up to 60 GY together with 2 cycles of Cisplatin and etoposide in the 1st week and last week, followed by 1-2 cycles of Cisplatin and etoposide given to patients with locally advanced stage III non small cell lung cancer. Thirty five patients were enrolled, five were excluded, ORR was 76.7%, the mean time to tumor progression was 14.57 months, the estimated one year PFS was 73.9% with CI=95%, the two year OS was 21.7% with CI=95%, grade 3 hematological toxicity developed in 6.7% of patients [n=2], no more than grade 2 non hematological toxicity was developed. Our protocol was feasible and tolerable, but it did not add any advantage over the standard concurrent chemo radiation