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Clinical Trial
. 2011 Dec;22(12):2610-2615.
doi: 10.1093/annonc/mdr021. Epub 2011 Mar 17.

Southwest Oncology Group study S0413: a phase II trial of lapatinib (GW572016) as first-line therapy in patients with advanced or metastatic gastric cancer

S Iqbal  1 , B Goldman  2 , C M Fenoglio-Preiser  3 , H J Lenz  4 , W Zhang  4 , K D Danenberg  5 , S I Shibata  6 , C D Blanke  7
Affiliations
Clinical Trial

Southwest Oncology Group study S0413: a phase II trial of lapatinib (GW572016) as first-line therapy in patients with advanced or metastatic gastric cancer

S Iqbal et al. Ann Oncol. 2011 Dec.

Abstract

Background: Lapatinib (GW572016) is a dual tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2/ErbB2), which are reported as overexpressed in 15%-45% of gastric cancers, making them potential targets.

Patients and methods: The primary objective of this study was to assess response rate. Secondary objectives included overall survival (OS), toxicity, and the relationship of EGFR, ErbB2, and markers of angiogenesis with clinical outcome. Lapatinib was administered to chemonaive metastatic gastric cancer patients at a dose of 1500 mg orally daily for 28 days.

Results: The study enrolled 47 patients from February 2005 until May 2006. Four patients (9%) had a confirmed partial response (PR), 1 (2%) had an unconfirmed PR, and 10 (23%) had stable disease. Median (95% confidence interval) time to treatment failure was 1.9 (1.6-3.1) months and OS was 4.8 (3.2-7.4) months. Significant adverse events: one grade 4 cardiac ischemia/infarction, one grade 4 fatigue, and one grade 4 emesis. One treatment-related death was due to central nervous system ischemia. An exploratory analysis of markers revealed gene expression of HER2, interleukin (IL)-8 and genomic polymorphisms IL-8, and vascular endothelial growth factor correlated with OS.

Conclusions: Lapatinib is well tolerated, with modest single-agent activity in advanced/metastatic gastric cancer patients. Potential molecular correlatives were identified which warrant further validation.

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Figures

Figure 1.
Figure 1.
Overall survival Kaplan–Meier curve in patients with advanced or metastatic gastric cancer treated with lapatinib as first-line therapy.
See this image and copyright information in PMC

References

    1. American Cancer Society. Cancer Facts & Figures 2010. Atlanta, GA: American Cancer Society;; 2010.
    1. Wagner AD, Unverzagt S, Grothe W, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2010 CD004064. - PubMed
    1. Yoshida K, Tsujino T, Yasui W, et al. Induction of growth factor-receptor and metalloproteinase genes by epidermal growth factor and/or transforming growth factor-alpha in human gastric carcinoma cell line MKN-28. Jpn J Cancer Res. 1990;81:793–798. - PMC - PubMed
    1. Piontek M, Hengels KJ. The EGF receptor and stomach cancer. Z Gastroenterol. 1993;31(Suppl 5):18–20. - PubMed
    1. Teramoto T, Onda M, Tokunaga A, Asano G. Inhibitory effect of anti-epidermal growth factor receptor antibody on a human gastric cancer. Cancer. 1996;77:1639–1645. - PubMed

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