Article
Single institution experience in advanced non-small cell lung cancer (NSCLC) patients (pts) with erlotinib (Tarceva®) within a large extended access programme* (EAP)
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Published: | March 20, 2006 |
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Background: Erlotinib (Tarceva®) is an orally administered selective EGF-R tyrosinekinase inhibitor. This drug has demonstrated survival improvement in previously treated NSCLC pts in the BR21 trial, a multicenter double-blind randomized phase-III study investigating erlotinib versus placebo + BSC in advanced NSCLC in second- or third-line therapy [Ref. 1].
Methods: Chemotherapy(CTx)-treated (one or two CTx-lines), stage IIIB/IV, PS 0-3 NSCLC pts have been enrolled to receive erlotinib 150 mg/day until disease progression. The primary aim of this study was to investigate the efficacy/toxicity profile of erlotinib within a single center experience of pts with advanced disease following first- and second-line chemotherapy.
Results: 75 pts were enrolled from January 2005 till October 2005 in our Cancer Treatment Center (WGCC). All pts received erlotinib and were assessable for toxicity, efficacy as well as survival analysis. All patients have at least been on study follow-up for four weeks time. Demographics: M/F 40/35; median age 59 years (range; 41 – 81); PS 0/1/2/3 19/43/13/0; histopathology adeno ca 42, squamous cell ca 18, bronchioalveolar cell ca (BAC) 8, large cell ca 4, others 3; smoking status current/former/never/not eligible 25/35/11/4. The rate of non-progression under treatment with erlotinib was 61 %. Best response was 0 CR, 6 PR, 40 SD, 22 PD, 7 NE (ORR 8 %). To date, 11.11.2005, 27 patients have not progressed and 7 have been treated for 6 months or longer. Responses have been observed in males/females 1/5, mostly in adenocarcinomas (6) and in non- (4) or former smokers (2). For the whole patient cohort (ITT population) the median progression-free survival and median overall survival results were 3 months and not yet reached, respectively. Overall survival rate at 7 months wass currently 52 % (+/-7 %). The median time on Tarceva treatment was 3 months. The most common adverse events observed were rash (35) and diarrhea (12), primarily of grades 1 or 2. 8 Patients experienced a grade 3 event: 6 rash, 1 nausea, 1 vomiting. No grade 4 events could be observed in the whole treated patient population. No other unexpected toxicity was seen in this single center experience.
Conclusion: Erlotinib is active and well-tolerated as single agent therapy following one or two CTx-lines in advanced NSCLC. The given ORR is exactly comparable to the data of the pivotal phase-III trial. Objective responses were typically seen in women, adenocarcinomas and non-smokers.
* this trial was sponsored by a full trials grant from Hoffmann-La Roche