A study has concluded that erlotinib with concurrent cisplatin andgemcitabine shows no survival benefit compared with chemotherapy alonein patients with chemotherapy-naïve advanced nonsmall-cell lung cancer.
The phase III study, published in the Journal of Clinical Oncology,aimed to evaluate the safety and efficacy of erlotinib, an inhibitor ofepidermal growth factor receptor tyrosine kinase, in combinationcisplatin and gemcitabine as first-line treatment for advanced NSCLC.
Atotal of 1,172 patients with previously untreated advanced NSCLC(locally advanced, recurrent or metastatic) were randomised toerlotinib (150mg/day, n=580) or placebo (n=579), in combination with upto six 21-day cycles of chemotherapy (gemcitabine 1,250mg/m2 on days 1and 8 and cisplatin 80mg/m2 on day 1). The primary endpoint was overallsurvival (OS); secondary endpoints included time to disease progression(TTP), response rate (RR), duration of response, and quality of life(QoL).
The researchers found no difference between the two study groups in most endpoints studied:
• Median OS was 43 weeks for the erlotinib group and 44.1 weeks for the placebo group (HR 1.06; 95% CI, 0.90–1.23; p=NS)
• Median overall TTP was 23.7 and 24.6 weeks respectively (HR 0.98; 95% CI, 0.86–1.11; p=NS)
•Response rates were 31.5% and 29.9% respectively; the duration ofresponse was greater for erlotinib than for placebo (median 25.4 versus23.9 weeks, respectively; HR 0.77; 95% CI, 0.60–1.00; p=0.045),although this was a secondary endpoint.
• Median time to symptomatic progression (QoL) was similar between treatment groups (68 versus 76 days; n=1,054).
Theauthors conclude that “erlotinib with concurrent cisplatin andgemcitabine showed no survival benefit compared with chemotherapy alonein patients with chemotherapy-naïve advanced NSCLC”.
J Clin Oncol 2007;25(12):1545-52