Yazarlar : de Souza JA, Davis DW, Zhang Y, et al

Yayın : Clin Cancer Res.

Yayın Yılı : 2012

Pubmed Linki : http://www.ncbi.nlm.nih.gov/pubmed/22371453

Konu : Tıbbi Onkoloji

Literatür İçeriği :  

Abstract

PurposeThis study sought to determine the efficacy and safety profile of lapatinib in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).Experimental DesignThis phase II multi-institutional study enrolled patients with recurrent/metastatic SCCHN into 2 cohorts: those without (arm A) and those with (arm B) prior exposure to an epidermal growth factor receptor (EGFR) inhibitor. All subjects were treated with lapatinib 1500 mg daily. Primary endpoints were response rate (arm A) and progression-free survival (arm B). The biologic effects of lapatinib on tumor growth and survival pathways were assessed in paired tumor biopsies obtained before and after therapy.ResultsForty-five patients were enrolled, 27 in arm A and 18 in arm B. Diarrhea was the most frequent toxicity occurring in 49% of patients. Seven patients experienced related grade 3 toxicity (3 fatigue, 2 hyponatremia, 1 vomiting, 1 diarrhea). In an intent-to-treat analysis, no complete or partial responses were observed and stable disease was the best response observed in 41% of arm A (median duration 50 days, range 34 - 159) and 17% of arm B subjects (median 163 days, range 135 - 195). Median PFS was 52 days in both arms. Median OS was 288 (95% CI, 62-374) and 155 (95% CI, 75-242) days for arms A and B, respectively. Correlative analyses revealed an absence of EGFR inhibition in tumor tissue.ConclusionLapatinib as a single agent in recurrent/metastatic SCCHN, although well tolerated, appears to be inactive in either EGFR inhibitor naive or refractory subjects.

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