In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. e19079-e19079
Abstract:
e19079 Background: The introduction of EGFR inhibitors to standard chemotherapy is an attractive approach to improved outcome. However, the tumor cells which were driven to G0/G1 phase by gefitinib may not sensitive to cytotoxic chemotherapy which is active to G2M arrested tumor cells. This randomized phase II study compared the efficacy of PC intercalated with gefitinib versus PC, as first-line treatment in a clinically selected population of advanced NSCLC patients. Methods: Eligible patients were chemotherapy-naïve advanced NSCLC patients with good ECOG PS of 0 or 1. Non-smoking patients with adenocarcinoma or patients with activating EGFR mutation were excluded because they could benefit from gefitinib alone. They were randomized to either one of the treatments; standard chemotherapy alone (control arm, 46 pts) of paclitaxel (175 mg/m 2 ) and carboplatin (AUC 5) on day 1; or the same chemotherapy plus gefitinib 250 mg/day on day 2 through 15 (study arm, 44 pts). The treatment was repeated every 3 weeks for maximum 4 cycles without maintenance. The primary endpoint included the response rate (RR), and the secondary endpoints were progression-free survival (PFS) and overall survival (OS). Results: A total of 90 patients (male 85.6%, median age 59, adenocarcinoma 63.3%, smoker 90.0%, wild-type EGFR 24.4%, unknown EGFR status 75.6%) were included. There was no difference in terms of RR (the study arm, 40.9% [95% CI 27.3-56.8%] vs. the control arm, 37.0% [95% CI 23.8-51.2%] , p=0.701). There was also not difference in terms of PFS (the median PFS; 4.13 vs. 4.13, HR=0.941 [95% CI 0.61-1.45], p=0.781) and OS (the median OS; 9.33 vs. 10.53, HR=0.95 [95% CI 0.58-1.54] , p=0.827). Safety analyses showed a similar incidence of drug-related grade 3/4 toxicity in study group (20.9%) compared with control group (23.3%), while mild rash (58% vs. 9%) and diarrhea (14% vs. 7%) were more common in the study arm. Conclusions: PC chemotherapy intercalated with gefitinib did not improved RR, PFS, and OS compared to PC chemotherapy alone in clinically selected population of advanced NSCLC patients who were smoker or wild-type EGFR. Clinical trial information: NCT01196234.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2013.31.15_suppl.e19079
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2013
detail.hit.zdb_id:
2005181-5
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