Faculty Collaboration Database

A phase II study of lapatinib in recurrent/metastatic squamous cell carcinoma of the head and neck. Clin Cancer Res 2012 Apr 15;18(8):2336-43

Date

03/01/2012

Pubmed ID

22371453

Pubmed Central ID

PMC4467891

DOI

10.1158/1078-0432.CCR-11-2825

Scopus ID

2-s2.0-84859873106 (requires institutional sign-in at Scopus site)   101 Citations

Abstract

PURPOSE: This 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 DESIGN: This phase II multiinstitutional study enrolled patients with recurrent/metastatic SCCHN into two cohorts: those without (arm A) and those with (arm B) before exposure to an epidermal growth factor receptor (EGFR) inhibitor. All subjects were treated with lapatinib 1,500 mg daily. Primary endpoints were response rate (arm A) and progression-free survival (PFS; arm B). The biologic effects of lapatinib on tumor growth and survival pathways were assessed in paired tumor biopsies obtained before and after therapy.

RESULTS: Forty-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, and 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.

CONCLUSION: Lapatinib as a single agent in recurrent/metastatic SCCHN, although well tolerated, appears to be inactive in either EGFR inhibitor naive or refractory subjects.

Author List

de Souza JA, Davis DW, Zhang Y, Khattri A, Seiwert TY, Aktolga S, Wong SJ, Kozloff MF, Nattam S, Lingen MW, Kunnavakkam R, Stenson KM, Blair EA, Bozeman J, Dancey JE, Vokes EE, Cohen EE

Author

Stuart J. Wong MD Center Director, Professor in the Medicine department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Antineoplastic Agents
Carcinoma, Squamous Cell
Disease-Free Survival
ErbB Receptors
Female
Head and Neck Neoplasms
Humans
Male
Neoplasm Recurrence, Local
Quinazolines