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Sub-category:
Metastatic Lung Cancer
Category:
Lung Cancer--Metastatic Lung Cancer
Meeting:
2008 ASCO Annual Meeting
Abstract No:
8031
Citation:
J Clin Oncol 26: 2008 (May 20 suppl; abstr 8031)
Author(s):
J. S. Lee, J. Ignacio, C. Yu, C. Zhou, Y. Wu, Y. Chen, L. Zhang, K. Jin, M. Johnston, T. S. Mok
Abstract:
Background: Concurrent administration of EGFR TKIs and chemotherapy in 1st line failed to improve survival. Preclinical data suggested potential antagonism due to TKI-induced G1 arrest reducing cell cycle phase-dependent activity of chemotherapy, whereas sequential administration of EGFR-TKI following chemotherapy may improve efficacy [Gumerlock et al, ASCO 2003; Solit et al, Clin Can Res 2005]. Methods: All eligible pts with chemonaïve stage IIIB/IV NSCLC, performance status of 0/1 and adequate organ function were randomized to receive either erlotinib (E) 150mg/d or placebo (P) p.o. on d15-28 of 4-weekly chemotherapy cycles. Chemotherapy consisted of gemcitabine (G) 1250mg/m2 i.v. (d1, 8) plus either cisplatin (C) 75mg/m2 or carboplatin (C) 5xAUC (d1) for a maximum of 6 cycles. Responding pts continued to receive E or P until progression or unacceptable toxicity. The primary endpoint was non-progression rate (NPR: CR+PR+SD) at 8 wks using RECIST. Results: Between Aug 2006 and Apr 2007, 154 pts were enrolled from 7 countries. Median age was 57 years and 94% were Asian. Other baseline characteristics and efficacy results are shown in the table below. The median number of treatment cycles received was 6 vs 5 (GC-E vs GC-P). Rash-like events were noted in 66% of GC-E vs 35% of GC-P arm, and diarrhea was observed in 24% and 18% of pts, respectively. The most common grade 3-5 adverse events (GC-E vs GC-P) were neutropenia (20% vs 15%); anemia (8% vs 6%); thrombocytopenia (5% vs 5%); and vomiting (3% vs 8%). Overall safety profiles were similar between the two arms. A statistically significant improvement in PFS (p=0.005) was observed in the GC-E arm. Conclusions: 1st- line sequential administration of erlotinib with chemotherapy has demonstrated promising results. This treatment strategy warrants further investigation in advanced NSCLC. Baseline characteristics and efficacy results| Characteristics (%) | GC-E (n=76) | GC-P (n=78) | | Male/Female | 71/29 | 69/31 | | Never/Former/Current smoker | 32/25/43 | 36/18/46 | | Adenocarcinoma/Others | 67/33 | 67/33 | | Stage IIIB/IV | 17/83 | 21/79 | | Efficacy | | | | NPR at 8 wks | 80.3% | 76.9% | | ORR (CR+PR) | 36.8% | 24.4% | | Median PFS* | 7.2 mo | 5.5 mo | | Median OS | NR | NR | | *HR=0.57 (95% CI 0.38; 0.84), p=0.005; NR=not reached |
Abstract Disclosures
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by J. S. Lee :
Presentations by J. S. Lee :
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1. FAST-ACT: A phase II randomized double-blind trial of sequential erlotinib and chemotherapy as first-line treatment in patients (pts) with stage IIIB/IV non-small cell lung cancer (NSCLC).
Meeting:
2008 ASCO Annual Meeting
Presenter:
Jin S Lee, MD
Session:
Lung Cancer — Metastatic
(Poster Discussion)
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2. The progress of small cell lung cancer management using irinotecan plus cisplatin chemotherapy.
Meeting:
2007 ASCO Annual Meeting
Presenter:
Jin S Lee
Session:
Lung Cancer
(General Poster Session)
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3. Randomized phase II cross-over sequential chemotherapy trial of irinotecan/cisplatin (IP) vs. gemcitabine/vinorelbine (GV) in chemo-naïve patients with stage IIIb/IV non-small cell lung cancer (NSCLC).
Meeting:
2006 ASCO Annual Meeting
Presenter:
Jin Soo Lee
Session:
Lung Cancer
(General Poster Session)
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More...
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Educational Book Manuscripts by J. S. Lee :
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