An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer

Annals of Oncology

Volumn 21, Issue 3, 2009, Pages 474-480

  Capri, G ^a   Chang, J ^b   Chen, S C ^c   Conte, P ^d   Cwiertka, K ^e   Jerusalem, G ^f   Jiang, Z ^g   Johnston, S ^h   Kaufman, B ⁱ   Link, J ^j   Ro, J ^k   Schutte J ^l   Oliva, C ^m   Parikh, R ^m   Preston, A ⁿ   Rosenlund, J ⁿ   Selzer, M ⁿ   Zembryki, D ⁿ   De Placido, S ^o  

^a NATIONAL CANCER INSTITUTE   (Italy)

^b RS McLaughlin Durham Regional Cancer Centre   (Canada)

^c CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^d UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^e UNIVERSITY HOSPITAL OLOMOUC   (Czech Republic)

^f UNIVERSITY OF LIÈGE   (Belgium)

^g Breast Cancer Department   (China)

^h INSTITUTE OF CANCER RESEARCH   (United Kingdom)

ⁱ SHEBA MEDICAL CENTER   (Israel)

^j Breast Link Medical Group Inc   (United States)

^k National Cancer Center   (South Korea)

^l MARIEN HOSPITAL DÜSSELDORF   (Germany)

^m GLAXOSMITHKLINE   (United Kingdom)

ⁿ GLAXOSMITHKLINE   (United States)

^o UNIVERSITY OF NAPLES FEDERICO II   (Italy)

more..

Author keywords

Capecitabine; EGFR; Expanded access; HER2; Lapatinib; Metastatic breast cancer

Indexed keywords

CAPECITABINE; LAPATINIB;

ADULT; ADVANCED CANCER; AGED; ARTICLE; ASTHENIA; BREAST CANCER; CANCER GROWTH; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG FEVER; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; EVENING DOSAGE; FEMALE; HAND FOOT SYNDROME; HEART ARREST; HEART DISEASE; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HEPATOBILIARY DISEASE; HEPATOMEGALY; HUMAN; HYPERBILIRUBINEMIA; INTERSTITIAL LUNG DISEASE; INTERSTITIAL PNEUMONIA; ISCHEMIA; LUNG EMBOLISM; LUNG INFILTRATE; MAJOR CLINICAL STUDY; MALE; METASTASIS POTENTIAL; MORNING DOSAGE; MUCOSA INFLAMMATION; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SIDE EFFECT; TREATMENT DURATION; VERTIGO; VOMITING;

EID: 77949540771     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdp373     Document Type: Article

References (20)

1. American Cancer Society. Global Cancer Facts and Figures 2007 [on-line]; http://www.cancer.org/docroot/STT/content/STT_1x_Global_Cancer_Facts_and_Figures_2007.asp (10 March, 2009, date last accessed).
2. 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. Abstract presented at 31st Annual San Antonio Breast Cancer Symposium; December 10-14, 2008; San Antonio, TX.
3. Zahnow CA. ErbB receptors and their ligands in the breast. Expert Rev Mol Med 2006; 8: 1-21.
4. Zhang H, Berezov A, Wang Q et al. ErbB receptors: from oncogenes to targeted cancer therapies. J Clin Invest 2007; 117: 2051-2058.
5. Badache A, Goncalves A. The ErbB2 signaling network as a target for breast cancer therapy. J Mammary Gland Biol Neoplasia 2006; 11: 13-25.
6. Slamon DJ, Godolphin W, Jones LA et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989; 244: 707-712.
7. 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 2001; 1: 85-94.
8. Geyer CE, Forster J, Lindquist D et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006; 355: 2733-2743.
9. Cameron D, Casey M, Press M et al. A phase III randomized comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat 2008; 112: 533-543.
10. Di Leo A, Gomez HL, Aziz Z et al. Phase III, double-blind, randomized study comparing lapatinib plus paclitaxel with placebo plus paclitaxel as first-line treatment for metastatic breast cancer. J Clin Oncol 2008; 26: 5544-5552.
11. Gomez HL, Doval DC, Chavez MA et al. Efficacy and safety of lapatinib as firstline therapy for ErbB2-amplified locally advanced or metastatic breast cancer. J Clin Oncol 2008; 26: 2999-3005.
12. Boccardo F, Kaufman B, Baselga J et al. Evaluation of lapatinib plus capecitabine in patients with brain metastases from HER2+ breast cancer enrolled in the Lapatinib Expanded Access Program (LEAP) and French Authorisation Temporaire d'Utilisation (ATU) Poster presented at 44th Annual Meeting of the American Society of Clinical Oncology; May 30-June 3, 2008; Chicago, IL.
13. Campone M, El-Kouri C, Cottu P et al. French Lapatinib Authorization for Temporary Use (ATU): design, operation and initial safety data. Poster presented at 6th European Breast Cancer Conference; April 15-19, 2008; Berlin, Germany.
14. De Placido S, Capri G, Ro J et al. Lapatinib Expanded Access Program (LEAP): updated safety data Poster presented at European Society for Medical Oncology 33rd Annual Meeting; September 12-16, 2008; Stockholm, Sweden.
15. Capdeville R, Krahnke T, Hatfield A et al. Report of an international expanded access program of imatinib in adults with Philadelphia chromosome positive leukemias. Ann Oncol 2008; 19: 1320-1326.
16. Venturini M, Paridaens R, Rossner D et al. An open-label, multicenter study of outpatient capecitabine monotherapy in 631 patients with pretreated advanced breast cancer. Oncology 2007; 72: 51-57.
17. 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 2009; 15: 1452-1459.
18. Suter TM, Cook-Bruns N, Barton C. Cardiotoxicity associated with trastuzumab (Herceptin) therapy in the treatment of metastatic breast cancer. Breast 2004; 13: 173-183.
19. Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001; 344: 783-792.
20. Perez EA, Koehler M, Byrne J et al. Cardiac safety of lapatinib: pooled analysis of 3689 patients enrolled in clinical trials. Mayo Clin Proc 2008; 83: 679-686.