In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 18_suppl ( 2007-06-20), p. 7588-7588
Abstract:
7588 Background: Predictors of response and survival in patients (pts) who benefit from Erlotinib (Elb) remain controversial. The primary objective is to prospectively identify downstream markers of EGFR linked signaling pathways that are predictive of response. The secondary objectives are to estimate response rate (RR), disease control rate (dcr), time to progression (ttp), survival, and if a grade (gr) 2 rash is predictive of survival. Methods: Pts with advanced NSCLC (Stage IIIB with pleural effusion and IV, no prior systemic treatment, performance status 0–2, no symptomatic CNS metastasis, and adequate renal, hepatic and hematologic function) were accrued to this single arm study. Elb was taken orally once a day until disease progression or unacceptable toxicity. Starting at 150 mg per day, the dose was escalated by 25 mg once every 2 weeks until a gr 2 rash developed, other toxicities precluded escalation, or 250 mg dose reached. Paraffin- fixed tumor tissue was collected on pts for correlative studies including quantitative immunohistochemistry (IHC) for pMAPK. Results: Of 137 pts recruited, 118 were eligible and 57 pts had adequate tissue to do IHC. Dose escalation occurred in 60/118 pts, with 15 getting up to 250 mg. The RR, by RECIST criteria, was 7% (8/112, 1 CR) with dcr of 46% (51/112). Most pts went off trial because of progression of disease (69%). Median survival was 7.9 months (mo), and median ttp was 3.5 mo. Of the 134 pts evaluated for toxicity, 43 (32%), 66 (49%), and 13 (10%) had a gr 1, 2 and 3 rash respectively. pMAPK was not a predictor for response. Using a median score of 20 as the cutoff for pMAPK as positive or negative, negative pMAPK tended to have a longer survival (7.6 mo vs. 5.3 mo, p=0.051). A gr ≥ 2 rash trended towards an association with prolonged survival (12.6 mo vs. 6.4 mo, p=0.099). Conclusions: Elb used as first-line treatment in an unselected population has a response rate and survival similar to first-line chemotherapy. Negative pMAPK may predict for prolonged survival but does not predict response. EGFR mutation and FISH analysis will be available at the meeting. No significant financial relationships to disclose.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2007.25.18_suppl.7588
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2007
detail.hit.zdb_id:
2005181-5
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