Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands.

Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. Research Abstract Details 

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Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. Abstract Text:

Mark Agulnik,Ezra W E Cohen,Roger B Cohen,Eric X Chen,Everett E Vokes,Sebastien J Hotte,Eric Winquist,Scott Laurie,D Neil Hayes,Janet E Dancey,Shirley Brown,Gregory R Pond,Ian Lorimer,Manijeh Daneshmand,James Ho,Ming-Sound Tsao,Lillian L Siu,

PURPOSE: Expression of erbB2 and/or epidermal growth factor receptor (EGFR) is associated with biologic aggressiveness and poor prognosis in malignant salivary gland tumors (MSGTs). This phase II study was conducted to determine the antitumor activity of lapatinib, a dual inhibitor of EGFR and erbB2 tyrosine kinase activity, in MSGTs. PATIENTS AND METHODS: Patients with progressive, recurrent, or metastatic adenoid cystic carcinoma (ACC) immunohistochemically expressing at least 1+ EGFR and/or 2+ erbB2 were treated with lapatinib 1,500 mg daily, in a two-stage cohort. Patients with non-ACC MSGTs were treated as a separate single-stage cohort. RESULTS: Of 62 patients screened, 29 of 33 (88%) ACC and 28 of 29 (97%) non-ACC patients expressed EGFR and/or erbB2. Forty patients with progressive disease were enrolled onto the study. Among 19 assessable ACC patients, there were no objective responses, 15 patients (79%) had stable disease (SD), nine patients (47%) had SD > or = 6 months, and four patients (21%) had progressive disease (PD). For 17 assessable non-ACC patients, there were no objective responses, eight patients (47%) had SD, four patients (24%) had SD > or = 6 months, and nine patients (53%) had PD. The most frequent adverse events were grade 1 to 2 diarrhea, fatigue, and rash. Eight paired tumor biopsies for correlative studies were procured; results did not correlate with clinical outcome. CONCLUSION: Although no responses were observed, lapatinib was well tolerated, with prolonged tumor stabilization of > or = 6 months in 36% (95% CI, 21% to 54%) of assessable patients. The antitumor effects of lapatinib in MGSTs appear mainly cytostatic, hence evaluation of other molecular targeted agents, or combinations with lapatinib, may be considered. Continued efforts should be made to gain better understanding into the biology of this heterogeneous group of malignancies.

Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. Publishing Authors By Initials

M Agulnik,EW Cohen,RB Cohen,EX Chen,EE Vokes,SJ Hotte,E Winquist,S Laurie,DN Hayes,JE Dancey,S Brown,GR Pond,I Lorimer,M Daneshmand,J Ho,MS Tsao,LL Siu,

For similar biological factors: biological markers: tumor markers, biological research abstracts see: biological factors: biological markers: tumor markers, biological research

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Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. Journal Published:

PUBLICATION TYPE: Research Support, N.I.H., Extr

Journal: Journal of clinical oncology : official journal of

VOLUME: 25

Page Numbers: 3978-84

Journal Abbreviation: J. Clin. Oncol.

ISSN: 1527-7755

DAY: 1

MONTH: Sep

YEAR: 2007

Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. Information

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LANGUAGE: eng

NlmUniqueID: 8309333

Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. Keywords Mesh Terms:

KEYWORDS: Tumor Markers, Biological

MESH TERMS: metabolism

Chemical & Substance for Abstract: Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. Information

Substance Name: Protein-Tyrosine Kinases

Registry Number: EC 2.7.1.112

Grant and Affiliation Information for Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands.

AFFILIATION: Princess Margaret Hospital Phase II Consortium, Toronto, Ontario, Canada.

Country: United States

AGENCY: United States NCI

GRANT: N01-CM-62203

ACRONYM: CM

MEDLINETA: J Clin Oncol

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