Lapatinib plus letrozole for postmenopausal patients with advanced HER2⁺/HR⁺ breast cancer

References

• Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer Statistics, 2009. CA Cancer J. Clin.59(4), 225–249 (2009).
   PubMed Web of Science ®Google Scholar
• Ferlay J, Autier P, Boniol M et al. Estimates of the cancer incidence and mortality in Europe in 2006. Ann. Oncol.18, 581–592 (2007).
   PubMed Web of Science ®Google Scholar
• Berry DA, Cronin KA, Plevritis SK et al. Effect of screening and adjuvant therapy on mortality from breast cancer. N. Engl. J. Med.353, 1784–1792 (2005).
   PubMed Web of Science ®Google Scholar
• Rusnak DW, Lackey K, Affleck K et al. The effects of the novel, reversible epidermal growth factor receptor/ErbB-2 tyrosine kinase inhibitor, GW2016, on the growth of human normal and tumor-derived cell lines in vitro and in vivo. Mol. Cancer Ther.1, 85–94 (2001).
   PubMed Web of Science ®Google Scholar
• Xia W, Mullin RJ, Keith BR et al. Anti-tumor activity of GW572016: a dual tyrosine kinase inhibitor blocks EGF activation of EGFR/erbB2 and downstream Erk1/2 and AKT pathways. Oncogene21, 6255–6263 (2002).
   PubMed Web of Science ®Google Scholar
• Zhou H, Kim YS, Peletier A et al. Effects of the EGFR/HER2 kinase inhibitor GW572016 on EGFR- and HER2-overexpressing breast cancer cell line proliferation, radiosensitization, and resistance. Int. J. Radiat. Oncol. Biol. Phys.58, 344–352 (2004).
   PubMed Web of Science ®Google Scholar
• Konecny G, Pegram MD, Venkatesan N et al. Activity of the dual kinase inhibitor lapatinib against HER-2-overexpressing and trastuzumab-treated breast cancer cells. Cancer Res.66, 1630–1639 (2006).
   PubMed Web of Science ®Google Scholar
• Chu I, Blackwell K, Chen S et al. The dual ErbB1/ErbB2 inhibitor, lapatinib (GW572016), cooperates with tamoxifen to inhibit both cell proliferation- and estrogen-dependent gene expression in antiestrogen-resistant breast cancer. Cancer Res.65, 18–25 (2005).
   PubMed Web of Science ®Google Scholar
• Xia W, Liu LH, Ho P et al. Truncated ErbB2 receptor (p95ErbB2) is regulated by heregulin through heterodimer formation with ErbB3 yet remains sensitive to the dual EGFR/ErbB2 kinase inhibitor GW572016. Oncogene23, 646–653 (2004).
   PubMed Web of Science ®Google Scholar
• Bence AK, Anderson EB, Doukas MA et al. Phase I pharmacokinetic studies evaluating single and multiple doses of oral GW572016, a dual EGFR–ErbB2 inhibitor, in healthy subjects. Invest. New Drugs23, 39–49 (2005).
   PubMed Web of Science ®Google Scholar
• Pandite L, Burris H, Jones L et al. A safety, tolerability, and pharmacokinetic (PK) study of GW572016 in patients with solid tumors. J. Clin. Oncol.22(14 Suppl.), (2004) (Abstract 3179).
   Google Scholar
• Smith DA, Koch KM, Lee D et al. The effect of food on the pharmacokinetic of GW572016. Eur. J. Cancer169(Suppl. 1), (2003) (Abstract 558).
   Google Scholar
• Koch KM, Reddy NJ, Cohen RB et al. Effects of food on the relative bioavailability of lapatinib in cancer patients. J. Clin. Oncol.27, 1191–1196 (2009).
   PubMed Web of Science ®Google Scholar
• Versola M, Burris HA, Jones S et al. Clinical activity of GW572016 in EGF10003 in patients with solid tumors. Proc. Am. Soc. Clin. Oncol.23, (2004) (Abstract 3047).
   Google Scholar
• Burris HA 3rd, Hurwitz HI, Dees EC et al. Phase I safety, pharmacokinetics, and clinical activity study of lapatinib (GW572016), a reversible dual inhibitor of epidermal growth factor receptor tyrosine kinases, in heavily pretreated patients with metastatic carcinomas. J. Clin. Oncol.23, 5305–5313 (2005).
   PubMed Web of Science ®Google Scholar
• Nakagawa K, Minami H, Kanezaki M et al. Phase I dose-escalation and pharmacokinetic trial of lapatinib (GW572016), a selective oral dual inhibitor of ErbB-1 and -2 tyrosine kinases, in Japanese patients with solid tumors. Jpn. J. Clin. Oncol.39, 116–123 (2009).
   PubMed Web of Science ®Google Scholar
• Blackwell KL, Pegram MD, Tan-Chiu E et al. Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. Ann. Oncol.20, 1026–1031 (2009).
   PubMed Web of Science ®Google Scholar
• Burstein HJ, Storniolo AM, Franco S et al. A Phase II study of lapatinib monotherapy in chemotherapy-refractory HER2-positive and HER2-negative advanced or metastatic breast cancer. Ann. Oncol.19, 1068–1074 (2008).
   PubMed Web of Science ®Google Scholar
• Gomez HL, Doval DC, Chavez MA et al. Efficacy and safety of lapatinib as first-line therapy for ErbB2-amplified locally advanced or metastatic breast cancer. J. Clin. Oncol.26, 2999–3005 (2008).
   PubMed Web of Science ®Google Scholar
• Johnston S, Trudeau M, Kaufman B et al. Phase II study of predictive biomarker profiles for response targeting human epidermal growth factor receptor 2 (HER-2) in advanced inflammatory breast cancer with lapatinib monotherapy. J. Clin. Oncol.26, 1066–1072 (2008).
   PubMed Web of Science ®Google Scholar
• Kaufman B, Trudeau M, Awada A et al. Lapatinib monotherapy in patients with HER2-overexpressing relapsed or refractory inflammatory breast cancer: final results and survival of the expanded HER2+ cohort in EGF103009, a Phase II study. Lancet Oncol.10, 581–588 (2009).
   PubMed Web of Science ®Google Scholar
• Cristofanilli M, Boussen H, Baselga J et al. A Phase II combination study of lapatinib and paclitaxel as a neoadjuvant therapy in patients with newly diagnosed inflammatory breast cancer (IBC). Presented at: 29th Annual San Antonio Breast Cancer Symposium San Antonio, TX, USA 14–17 December 2006 (Abstract 1).
   Google Scholar
• Lin NU, Carey LA, Liu MC et al. Phase II trial of lapatinib for brain metastases in patients with human epidermal growth factor receptor 2-positive breast cancer. J. Clin. Oncol.26, 1993–1999 (2008).
   PubMed Web of Science ®Google Scholar
• Lin NU, Diéras V, Paul D et al. Multicenter Phase II study of lapatinib in patients with brain metastases from HER2-positive breast cancer. Clin. Cancer Res.15, 1452–1459 (2009).
   PubMed Web of Science ®Google Scholar
• Benz CC, Scott GK, Sarup JC et al. Estrogen-dependent, tamoxifen resistant tumorigenic growth of MCF-7 cells transfected with HER2/neu. Breast Cancer Res. Treat.24, 85–95 (1992)
   PubMed Web of Science ®Google Scholar
• Pietras R, Arboleda J, Reese DM et al. HER-2 tyrosine kinase pathway targets estrogen receptor and promotes hormone independent growth in human breast cancer cells. Oncogene10, 2435–2446 (1995)
   PubMed Web of Science ®Google Scholar
• Wright C, Nicholson S, Angus B et al. Relationship between c-erbB-2 protein product expression and response to endocrine therapy in advanced breast cancer. Br. J. Cancer65, 118–121. (1992)
   PubMed Web of Science ®Google Scholar
• Osborne CK, Schiff R. Estrogen-receptor biology: continuing progress and therapeutic implications. J. Clin. Oncol.23, 1616–1622 (2005).
   PubMed Web of Science ®Google Scholar
• Kushner PJ, Agard DA, Greene GL et al. Estrogen receptor pathways to AP-1. J. Steroid Biochem. Mol. Biol.74, 311–317 (2000).
   PubMed Web of Science ®Google Scholar
• Lee AV, Cui X, Oesterreich S. Cross-talk among estrogen receptor, epidermal growth factor, and insulin-like growth factor signaling in breast cancer. Clin. Cancer Res.7, 4429s–4435s (2001).
   PubMed Web of Science ®Google Scholar
• Aronica SM, Kraus WL, Katzenellenbogen BS. Estrogen action via the cAMP signaling pathway: stimulation of adenylate cyclise and cAMP-regulated gene transcription. Proc. Natl Acad. Sci. USA91, 8517–8521 (1994).
   PubMed Web of Science ®Google Scholar
• Chu QS, Cianfrocca ME, Goldstein LJ et al. A Phase I and pharmacokinetic study of lapatinib in combination with letrozole in patients with advanced cancer. Clin. Cancer Res.14, 4484–4490 (2008).
   PubMed Web of Science ®Google Scholar
• Johnston S, Pegram M, Press M et al. Lapatinib combined with letrozole vs letrozole alone for front line postmenopausal hormone receptor positive (HR+) metastatic breast cancer (MBC): first results from the EGF30008 Trial. Presented at: 31st Annual San Antonio Breast Cancer Symposium San Antonio, TX, USA 10–14 December 2008 (Abstract 46).
   Google Scholar
• Sherif BN, Sherrill B, Amonkar M et al. Lapatinib plus letrozole compared with letrozole alone as first-line therapy in hormone receptor positive HER2+ metastatic breast cancer (MBC): a quality-of-life (QOL) analysis. J. Clin. Oncol.27(15S), (2009) (Abstract 1039).
   Google Scholar
• Kaufman B, Mackey JR, Clemens MR et al. Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer: results from the randomized Phase III TAnDEM Study. J. Clin. Oncol. (2009) (Epub ahead of print).
   Google Scholar
• Frassoldati A, Guarneri V, Piacentini F et al. Letrozole versus letrozole plus Lapatinib (GW572016) in hormone-sensitive, HER2-negative operable breast cancer: a double-blind, randomized, Phase II study with biomarker evaluation (EGF109077-LAP107692/LETLOB). Clin. Breast Cancer8, 97–100 (2008).
   PubMed Web of Science ®Google Scholar
• Frassoldati A, Guarneri V, Bottini A et al. Preplanned first-step analysis of LET-LOB neoadjuvant study: a double-blind randomized Phase IIb trial of letrozole (L) plus lapatinib (Lp) or placebo (P) in postmenopausal HER2-ve, HR+ve operable breast cancer. J. Clin. Oncol.27(15), (2009) (Abstract 570).
   Google Scholar
• Crown JP, Burris HA 3rd, Boyle F et al. Pooled analysis of diarrhea events in patients with cancer treated with lapatinib. Breast Cancer Res. Treat.112, 317–325 (2008).
   PubMed Web of Science ®Google Scholar
• Lacouture ME, Laabs SM, Koehler M et al. Analysis of dermatologic events in patients with cancer treated with lapatinib. Breast Cancer Res. Treat.114, 485–493 (2009).
   PubMed Web of Science ®Google Scholar
• Moy B, Sorensen PG, Tange UB et al. Hepatobiliary abnormalities in patients with metastatic cancer treated with lapatinib. J. Clin. Oncol.27(15S), (2009) (Abstract 1043).
   PubMedGoogle Scholar
• Perez EA, Koehler M, Byrne J et al. Cardiac safety of lapatinib: pooled analysis of 3689 patients enrolled in clinical trials. Mayo Clin. Proc.83, 679–686 (2008).
   PubMed Web of Science ®Google Scholar
• Guarneri V, Lenihan DJ, Valero V et al. Long-term cardiac tolerability of trastuzumab in metastatic breast cancer: the MD Anderson Cancer Center experience. J. Clin. Oncol.24, 4107–4115 (2006).
   PubMed Web of Science ®Google Scholar
• Zembryki D, Byrne J, Gomez H et al. Cardiac safety of the lapatinib/letrozole combination as first-line therapy in patients (pts) with metastatic breast cancer (MBC). J. Clin. Oncol.27(15S), (2009) (Abstract 1095).
   Google Scholar
• Zhou X, Cella D, Cameron D et al. Lapatinib plus capecitabine versus capecitabine alone for HER2+ (ErbB2+) metastatic breast cancer: quality-of-life assessment. Breast Cancer Res. Treat.117(3), 577–589 (2009).
   PubMed Web of Science ®Google Scholar