Non–Small-Cell Lung Cancer Single-Agent Therapy

One hundred centers from Europe, the Middle East, Asia, and South America participated in a non–small-cell lung cancer (NSCLC) study with broad inclusion criteria (first and second line) to establish the toxicity and efficacy profile of 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: 1–12 cycles). The median age was 59 years (range: 25–83 years); the median World Health Organization (WHO) performance status was 1 (range: 0–3); the median number of organs involved was 2 (range: 1–6). 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 toxicities—infection (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.

Click here for Dr. Vincent A. Miller’s commentary on this abstract.