In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 18_suppl ( 2006-06-20), p. 7162-7162
Abstract:
7162 Background: Markers of response and survival in patients (pts) who benefit from erlotinib (Elb) remain controversial. In another study, pts who developed a rash on Elb survived longer. The primary objective of this study 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, time to progression, survival, and if a grade (gr) 2 rash is a predictor of response and 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 a maximum dose of 250 mg reached. Response was evaluated by RECIST criteria. Paraffin-fixed tumor tissue was collected on all patients for correlative studies. Results: Over 8 months, 137 pts (58 M, 79 F) were recruited with a median age of 70 (41–92). Most pts were Caucasian (92%) and had adenocarcinoma (54%). Dose escalation occurred in 53/117 of pts, with 11 getting a dose of 250mg. Only 58 pts have been evaluated for response so far. The preliminary RR is 1% (1/58) with stable disease rate of 18% (32/58). Pts have received a median of 4 cycles of treatment (range 0–10). Most pts went off trial because of progression of disease (38%, 52/137) with only 8% (11/137) stopping because of toxicities (42% unknown). Of the 123 pts evaluated for toxicity, 44 (36%) and 10 (8%) had a grade 1 / 2 and 3 rash respectively. Grade 1 / 2 diarrhea occurred in 16% (20/123) and Grade 3 diarrhea in 10% (13/123). One pt died of pneumonitis of unclear cause. Conclusions: Mature toxicity, response, and survival data as well as laboratory studies which include IHC, EGFR mutation and FISH analysis, and genotype and allele frequency will be available at the meeting. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2006.24.18_suppl.7162
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2006
detail.hit.zdb_id:
2005181-5
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