Multicenter Phase II Study of Erlotinib, an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck
Denis Soulieres, Neil N. Senzer, Everett E. Vokes, Manuel Hidalgo, Sanjiv S. Agarwala, Lillian L. Siu
[parking, for future reference]
From the CHUM, Hospital Notre Dame, Montreal, Quebec; Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada; US Oncology, Dallas; Cancer Therapy and Research Center, San Antonio, TX; the University of Chicago, Chicago, IL; and the Pittsburgh Clinical Research Network, Pittsburgh, PA.
Address reprint requests to Lillian L. Siu, MD, FRCPC, Princess Margaret Hospital, University Health Network, 610 University Ave, Suite 5-210, Toronto, Ontario, M5G 2M9 Canada; e-mail: lillian.siu@uhn.on.ca
PURPOSE: To determine the efficacy and safety profiles of erlotinib in patients with advanced recurrent and/or metastatic squamous cell cancer of the head and neck (HNSCC).
PATIENTS AND METHODS: Patients with locally recurrent and/or metastatic HNSCC, regardless of their HER1/EGFR status, were treated with erlotinib at an initial dose of 150 mg daily. Dose reductions or escalations were allowed based on tolerability of erlotinib.
RESULTS: One-hundred fifteen patients were enrolled onto this study. Forty-seven percent of patients received erlotinib at 150 mg daily throughout the entire study, 6% had dose escalations, and 46% required dose reductions and/or interruptions. Five patients achieved partial responses on study, for an overall objective response rate of 4.3% (95% CI, 1.4% to 9.9%). Disease stabilization was maintained in 44 patients (38.3%) for a median duration of 16.1 weeks. The median progression-free survival was 9.6 weeks (95% CI, 8.1 to 12.1 weeks), and the median overall survival was 6.0 months (95% CI, 4.8 to 7.0 months). Subgroup analyses revealed a significant difference in overall survival favoring patients who developed at least grade 2 skin rashes versus those who did not (P = .045), whereas no difference was detected based on HER1/EGFR expression. Rash and diarrhea were the most common drug-related toxicities, encountered in 79% and 37% of patients, respectively, though the severity was mild to moderate in most cases.
CONCLUSION: Erlotinib was well tolerated in this heavily pretreated HNSCC population and produced prolonged disease stabilization; hence, further evaluation of its role in this tumor type is warranted.
Supported by OSI Pharmaceuticals Inc; Hoffman-La Roche Inc; and Genentech Inc.
Presented in part at the 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001. |
