Efficacy of erlotinib in patients with advanced non-small-cell lung cancer (NSCLC): analysis of the Australian subpopulation of the TRUST study.
OBJECTIVE
The efficacy of erlotinib (Tarceva, Roche Products, Dee Why, Australia) has been demonstrated in patients with advanced non-small-cell lung cancer (NSCLC). Tarceva lung cancer survival treatment (TRUST) is an open-label, single-arm, phase IV global trial which investigated erlotinib in advanced NSCLC patients who had failed prior therapy or were unsuitable for chemo/radiotherapy. The aim of this analysis was to report the safety and efficacy of erlotinib in the Australian patient subpopulation.


METHODS
Patients with stage IIIB/IV NSCLC progressing after standard systemic chemotherapy or unsuitable to receive chemo/radiotherapy were eligible for the study. The patients were treated with erlotinib at 150 mg/day orally, until disease progression or unacceptable toxicity.


RESULTS
In Australia, 460 patients were recruited. Erlotinib was given as first-line (16%), second-line (49%) or third-line (35%) treatment. In the intent-to-treat population (N = 460), the median progression-free survival was 2.7 months (95% CI 2.3-3.4), 1-year survival was 35% (95% CI 30-39%) and median overall survival was 6.9 months (95% CI 5.7-8.0). Tumor response rates were available for 363 patients, with a disease control rate of 58%. Of the 460 patients included in the safety analysis, 24% had one or more erlotinib-related adverse event (AE). Rash was reported in 77% of patients, most commonly grade 1/2 (63%). Treatment-related serious AE were reported in 7% of patients; most commonly diarrhea (2%). Dose modifications were required in 18% of patients.


CONCLUSIONS
Outcomes for Australian patients confirmed the efficacy and tolerability of erlotinib for the treatment of advanced NSCLC in routine clinical practice.
Sydney Cancer Centre, Royal Prince Alfred Hospital, Camperdown, NSW 2050, Australia. Michael.Boyer@sswahs.nsw.gov.au
Michael
M
Boyer
Keith
K
Horwood
Nick
N
Pavlakis
Paul
P
De Souza
Michael
M
Millward
Brian
B
Stein
Michael
M
Johnston
Fiona
F
Abell
Danny
D
Rischin
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001315:Australia; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride