Randomized study of lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer

Journal of Clinical Oncology

Volumn 28, Issue 7, 2010, Pages 1124-1130

  Blackwell, Kimberly L ^a   Burstein, Harold J ^a   Storniolo, Anna Maria ^a   Rugo, Hope ^a   Sledge, George ^a   Koehler, Maria ^a   Ellis, Catherine ^a   Casey, Michelle ^a   Vukelja, Svetislava ^a   Bischoff, Joachim ^a   Baselga, Jose ^a   O'Shaughnessy, Joyce ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

EPIDERMAL GROWTH FACTOR RECEPTOR 2; LAPATINIB; TRASTUZUMAB; ANTINEOPLASTIC AGENT; ERBB2 PROTEIN, HUMAN; MONOCLONAL ANTIBODY; QUINAZOLINE DERIVATIVE;

ACNE; ANOREXIA; ARTICLE; BREAST CANCER; CANCER GROWTH; CANCER SURVIVAL; CONTROLLED STUDY; COUGHING; DERMATITIS; DIARRHEA; DISEASE COURSE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSPNEA; FATIGUE; FEMALE; HEART FAILURE; HEART INFARCTION; HEART LEFT VENTRICLE EJECTION FRACTION; HUMAN; LUNG EMBOLISM; MAJOR CLINICAL STUDY; METASTATIC BREAST CANCER; MONOTHERAPY; MULTICENTER STUDY; NAUSEA; OPEN STUDY; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PLEURA EFFUSION; POPULATION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; SIDE EFFECT; TREATMENT RESPONSE; VOMITING; ADULT; AGED; BREAST TUMOR; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DISEASE FREE SURVIVAL; DRUG EFFECT; HEART LEFT VENTRICLE FUNCTION; HEART STROKE VOLUME; METASTASIS; MIDDLE AGED; MORTALITY; PATHOLOGY;

ADULT; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM METASTASIS; QUALITY OF LIFE; QUINAZOLINES; RECEPTOR, ERBB-2; STROKE VOLUME; VENTRICULAR FUNCTION, LEFT;

EID: 77949884661     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2008.21.4437     Document Type: Article

References (27)

1. Révillion F, Bonneterre J, Peyrat JP: ERBB2 oncogene in human breast cancer and its clinical significance. Eur J Cancer 34:791-808, 1998 (Pubitemid 28248487)
2. Press M, Bernstein L, Thomas P, et al: HER-2/neu gene amplification characterized by fluorescence in situ hybridization: Poor prognosis in node-negative breast carcinomas. J Clin Oncol 15:2894-2904, 1997 (Pubitemid 27330017)
3. Moy B, Goss P: Lapatinib: Current status and future directions in breast cancer. Oncologist 11: 1047-1057, 2006 (Pubitemid 44788395)
4. Cobleigh MA, Vogel CL, Tripathy D, et al: Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 17:2639-2648, 1999 (Pubitemid 29415219)
5. Vogel CL, Cobleigh MA, Tripathy D, et al: Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 20:719-726, 2002 (Pubitemid 34111379)
6. Hudis C: Trastuzumab-mechanism of action and use in clinical practice. N Engl J Med 357:39-51, 2007
7. Montemurro F, Donadio M, Clavarezza M, et al: Outcome of patients with HER2-positive advanced breast cancer progressing during trastuzumab-based therapy. Oncologist 11:318-324, 2006
8. von Minckwitz G, du Bois A, Schmidt M, et al: Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: A German Breast Group/Breast International Group 03-05 study. J Clin Oncol 27:1999-2006, 2009
9. Bartsch R, Wenzel C, Zielinski CC, et al: HER-2-positive breast cancer: Beyond trastuzumab. BioDrugs 21:69-77, 2007 (Pubitemid 46624551)
10. Nahta R, Esteva F: Molecular mechanisms of trastuzumab resistance. Breast Cancer Res 8:215, 2006
11. Nahta R, Yuan LX, Du Y, et al: Lapatinib induces apoptosis in trastuzumab-resistant breast cancer cells: Effects on insulin-like growth factor 1 signaling. Mol Cancer Ther 6:667-674, 2007 (Pubitemid 46332467)
12. Mukherjee A, Dhadda AS, Shehata M, et al: Lapatinib: A tyrosine kinase inhibitor with a clinical role in breast cancer. Expert Opin Pharmacother 8:2189-2204, 2007 (Pubitemid 47505592)
13. Konecny GE, Pegram MD, Venkatesan N, et al: Activity of the dual kinase inhibitor lapatinib (GW572016) against HER-2-overexpressing and trastuzumab-treated BC cells. Cancer Res 66:1630-1639, 2006 (Pubitemid 43259947)
14. 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 112:533-543, 2008
15. Gomez H, Doval D, Chavez M, 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
16. 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
17. Di Leo A, Gomez H, 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 26:5544-5552, 2008
18. Scaltriti M, Verma C, Guzman M, et al: Lapatinib, a HER2 tyrosine kinase inhibitor, induces stabilization and accumulation of HER2 and potentiates trastuzumab-dependent cell cytotoxicity. Oncogene 28:803-814, 2009
19. Storniolo AM, Pegram MD, Overmoyer B, et al: A phase I dose escalation and pharmacokinetic study of lapatinib in combination with trastuzumab in patients with advanced ErbB2-positive breast cancer. J Clin Oncol 26:3317-3323, 2008
20. Baselga J, Tripathy D, Mendelsohn J, et al: Phase II study of weekly intravenous trastuzumab (Herceptin) in patients with HER2/neu-overexpressing metastatic breast cancer. Semin Oncol 4:78-83, 1999 (suppl 12) (Pubitemid 29411436)
21. Tripathy D, Slamon D, Cobleigh M, et al: Safety of treatment of metastatic breast cancer with trastuzumab beyond disease progression. J Clin Oncol 22:1063-1070, 2004 (Pubitemid 41095039)
22. Blackwell K, Pegram M, Tan-Chiu E, et al: Single-agent lapatinib for the treatment of HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab containing regimens. Ann Oncol 20:1026-1031, 2009
23. 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 (Pubitemid 351796331)
24. Crown JP, Burris HA, Boyle F, et al: Pooled analysis of diarrhea events in patients with cancer treated with lapatinib. Breast Cancer Res Treat 112:317-325, 2008
25. Genentech: Herceptin (trastuzumab) product information. http://www.gene.com/gene/products/information/oncology/herceptin/
26. 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 (Pubitemid 351810568)
27. Smith KL, Dang C, Seidman A: Cardiac dysfunction associated with trastuzumab. Expert Opin Drug Saf 5:619-629, 2006