One hundred centers from Europe, the Middle East, Asia, and South America participated in a nonsmall-cell lung cancer (NSCLC) study with broad inclusion criteria (first and second line) to establish the toxicity and efficacy profile of docetaxel(Drug information on docetaxel) (Taxotere) at 100 mg/m² in worldwide clinical practice.
A total of 754 patients have been treated (585 male/169 female). A total of 3,023 cycles have been administered, with a median of three cycles per patient (range: 112 cycles). The median age was 59 years (range: 2583 years); the median World Health Organization (WHO) performance status was 1 (range: 03); the median number of organs involved was 2 (range: 16). Adenocarcinoma was seen in 313 patients, squamous cell carcinoma in 235 patients, large-cell carcinoma in 35 patients, and other forms of NSCLC in 171 patients.
To date, 536 patients are evaluable for reponse. The overall response rate in first-line treatment is 27.9% (95% CI: 17.5%29.8%). The safety profile is as follows: grade 3/4 neutropenia, 55% of patients; grade 3/4 nonhematologic toxicitiesinfection (5%), diarrhea (4%), pulmonary (3%), skin (2%), stomatitis (2%), neurosensory (3%).
CONCLUSION: The safety and efficacy reported in more limited studies is maintained in a broad population.