Second-line chemotherapy for advanced non-small cell lung cancer (NSCLC) with weekly versus three-weekly docetaxel: Results of a randomized phase III study.

7036 Background: Single agent docetaxel, 75 mg/m2 every 3 weeks given second line improves survival compared with other chemotherapeutic regimens or best supportive care in advanced NSCLC. This multicentre phase III study was initiated to compare standard 3-weekly docetaxel with weekly docetaxel as second-line therapy for advanced NSCLC. METHODS Patients (pts) with stage IIB-IV NSCLC were randomized to 3-weekly docetaxel 75mg/m2 (Arm A) or weekly docetaxel 35 mg/m2 for 3 weeks followed by 1 week without therapy (Arm B; 1 cycle=28 days). The primary endpoint is survival and secondary endpoints are toxicity and response. RESULTS Between April 2000 and September 2003, 216 pts (median age 63.0 yrs; range 41-80 yrs) were enrolled (208 pts planned) and 162 pts (82 pts in Arm A; 80 pts in Arm B) are currently evaluable for toxicity and response. A maximum of 6 treatment cycles (Arm A: median 4 [range: 1-6]; Arm B: median 2 [range: 1-6]) were administered on an outpatient basis and 16% of patients received all 6 cycles. In total, 38 pts (23.5%) had previously received paclitaxel therapy. Reasons for treatment discontinuation (% of 162 pts) included: tumor progression (54%), toxicity (11%) and the patient's request (4%). In Arm A (82 pts), toxicities (WHO grade 3-4) included (% pts): neutropenia (19.4%), infection (3.9%), alopecia (22.7%), fluid retention (5.5%) and pain (13.2%). In Arm B (80 pts), toxicities were infrequent and included: pain (6.6%), nausea (6.6%) neutropenia (4.1%) and neurotoxicity (6.8%). There were no reports of grade 3-4 thrombocytopenia or mucositis and febrile neutropenia occurred in 2.6% pts (Arm A) and 1.3% pts (Arm B). Neutropenia was less frequent in Arm B than in Arm A (p<0.0001). The overall response rates in Arm A and B, respectively were 9.7% and 7.6%. CONCLUSIONS Both regimens are suitable for administration on an outpatient basis and are well tolerated as second-line therapy for advanced NSCLC. Severe toxicity seems less frequent with weekly docetaxel. Unblinded results will be available for ASCO 2004. No significant financial relationships to disclose.