This study was conducted to determine whether docetaxel (Taxotere)
prior to definitive local treatment improves overall survival when
compared to local treatment without prior chemotherapy in patients
with radically treatable stage IIIA N2 (T03), T3 (N0-1) or IIIB
nonsmall-cell lung cancer. Local treatment was defined at baseline.
A total of 274 patients were randomly assigned to arm Adocetaxel
100 mg/m² (1 h IV) every 3 weeks for three consecutive cycles
followed by local treatmentor arm Bimmediate local
treatment. Stratification was by extent of disease and World Health
Organization (WHO) performance status. Patient characteristics were
well balanced in both arms: median age, 62 years (range: 3281
years); male/female ratio, 80%/20%; WHO performance status 01/2,
88%/12%; histologyadenocarcinoma, 20%; squamous cell, 63%;
In total, 347 cycles were given. The major toxicity in arm A was
grade 4 neutropenia (34% of all cycles). 3.9% of patients experienced
febrile neutropenia (1.4% of cycles), and 3.2% experienced grade 3/4
infections. There were two deaths due to infections.
CONCLUSION: Preliminary results show a strong trend in favor of
improved survival in the docetaxel-treated patients.