Weekly Versus 3-Weekly Docetaxel Plus Cisplatin for Advanced NSCLC

Randomized Phase II Trial of Two Different Schedules of Docetaxel Plus Cisplatin as First-Line Therapy in Advanced Non-Small Cell Lung Cancer

To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced NSCLC.

The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks is one of the most commonly used chemotherapy regimen in Korea for the first-line treatment of advanced NSCLC. Although the 3-weekly regimen is active and tolerated, it is associated with a significant incidence of severe neutropenia, often complicated by fever. Therefore, there has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. We designed this randomized phase II trial to evaluate the safety profile and antitumor activity of two different schedules of docetaxel plus cisplatin given as first-line therapy in patients with advanced NSCLC.

Inclusion Criteria:

• histologically or cytologically proven non-small cell lung cancer
• no prior chemotherapy or only adjuvant chemotherapy which had been completed >6 months before registration
• ECOG performance status 0 to 2
• measurable lesion(s)
• normal marrow, hepatic and renal functions
• provision of written informed consent

Exclusion Criteria:

• active infection or severe comorbidities
• history of anaphylaxis of any origin