Concurrent conventionally factionated radiotherapy and weekly docetaxel inthe treatment of stage IIIb non-small-cell lung carcinoma

Docetaxel has shown remarkable radiosensitizing in vitro properties. In a p revious phase [III dose escalation study in non-small-cell lung cancer (NSC LC) we observed a high response rate after concomitant boost radiotherapy a nd weekly docetaxel. The maximum tolerated dose was 30 mg m(-2) week(-1). i n the present phase Il study we evaluated whether weekly docetaxel and conv entionally fractionated radiotherapy could be better tolerated and equally effective in the treatment of locally advanced NSCLC, Thirty-five patients with T3, T4/N2, T3/M0-staged disease were recruited. Docetaxel (30 mg m(-2) ) was given as a 30 min infusion once a week. Asthenia and radiation-induce d oesophagitis were the main side-effects of the regimen enforcing 2-week t reatment delay in 6/35 (17%) patients and minor delay (3-7 days) in another 11/35 (31%) patients. Neutrophil, platelet and haemoglobin toxicity was mi nimal, but pronounced lymphocytopenia was observed. Complete response (CR) of the chest disease was observed in 12/35 (34%) patients and partial respo nse in 16/35 (46%), Although not statistically significant (P = 0.19). a hi gher CR rate (8/18; 44%) was observed in patients who accomplished their th erapy within the scheduled treatment time (44-47 days) as compared to patie nts that interrupted their treatment for several days due to treatment-rela ted toxicity [CR 4/17; 23%). The overall survival and the local progression -free survival at 1 year was 48% and 60% respectively, We conclude the doce taxel combination with radiotherapy is a promising approach for the managem ent of locally advanced NSCLC that results in high GR rate. Further trials with docetaxel-based radiochemotherapy should integrate accelerated radioth erapy together with cytoprotection.