Multimodality therapy for stage ida and nib non small cell lung cancer: A phase II study

Background: The prognosis of patients with locally advanced Stage IIIA and 1MB non small cell lung cancer (NSCLC) remains poor, but some recent randomised controlled trials have shown an advantage for adjuvant combination therapy. This study evaluated the use of a cisplatinum/gemcitabine chemotherapy combination as an induction programme in conjunction with definitive local treatment for State IIIA and 1MB NSCLC. Study Design: Eligibility criteria included proven NSCLC, measurable disease, ECOG performance status 0-2, weight loss <5%, no prior chemotherapy or RT, adequate renal and hepatic function and bone marrow reserve. All patients received two cycles of gemcitabine and cisplatinum combination therapy prior to restaging before local therapy, consisting of surgery for Stage IIIA disease and radiotherapy (RT) for Stage 1MB disease. Where there was no progression of disease at restaging, Stage IIIA patients underwent surgical excision followed by a further two cycles of gemcitabine/cisplatinum combination therapy, and Stage 1MB patients were given RT (63 Gy, 34F) in conjunction with concomitant therapy with two cycles of cisplatinum/5FU chemotherapy. Results: Stage IIIA patients entered: 1, partial responder, alive at 23 months with no local recurrence, cerebellar métastases diagnosed and treated at 14 months. Stage 1MB patients entered: 18, overall survival: 10 (range at time of reporting 5 - 22 months). Withdrawn: 5 (3 progressive disease, 1 deceased (PE), 1 patient choice, [all deceased]), partial response (>50% reduction of tumour size): 11, stable disease: 2. Toxicity: nausea and vomiting grades 0 = 3 pts, 1 = 3 pts, 2 = 8 pts, 3 = 1 pt; infection 2 patients. Overall response rate 61%.