{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T22:32:48Z","timestamp":1761863568188,"version":"build-2065373602"},"reference-count":16,"publisher":"Wiley","issue":"15","license":[{"start":{"date-parts":[[2016,5,19]],"date-time":"2016-05-19T00:00:00Z","timestamp":1463616000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2016,8]]},"abstract":"<jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>The combination of cisplatin, 5\u2010fluorouracil, and cetuximab is a standard treatment for patients with recurrent\/metastatic head and neck cancer, with a high rate of toxicity. Identifying less toxic, equally effective regimens is imperative. Therefore, in the current study, the authors investigated first\u2010line treatment with an all\u2010oral regimen of capecitabine and lapatinib.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>Patients were required to have incurable head and neck cancer of any primary site other than the nasopharynx, an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2, and no prior exposure to capecitabine or lapatinib. Subjects were treated with capecitabine at a dose of 1000 mg\/m<jats:sup>2<\/jats:sup> twice daily and lapatinib at a dose of 1250 mg daily. Capecitabine was administered for 14 days of each 21\u2010day cycle for 4 cycles. Lapatinib was administered daily until disease progression. The primary outcome was overall survival.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>A total of 44 subjects were accrued between November 13, 2009 and April 29, 2014. Approximately 38.6% of the sample had an ECOG PS of 0, 52.3% had an ECOG PS of 1, and 9.1% had an ECOG PS of 2. Approximately 81.8% were male and the median age of the patients was 62 years. Prior attempts at curative treatment with chemotherapy had been used in 68.2% of patients (platinum was used in 55.8%). There was no grade 5 toxicity noted (toxicity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]). The most common adverse events were diarrhea (18.2% of patients with grade 3) and rash (13.6% of patients with grade 3). The primary objective was met; the median overall survival was 10.7 months (90% confidence interval [90% CI], 8.7\u201012.9 months). The overall response rate was 25% (90% CI, 15%\u201038%). The median progression\u2010free survival was 4.2 months (90% CI, 3.6\u20105.1 months). The results were not substantially different when subdivided by p16 status. Only 2 patients were positive for human epidermal growth factor receptor 2 by immunohistochemistry.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>The current study met its primary objective of survival comparable to the combination of cisplatin, 5\u2010FU and cetuximab regimen, and the toxicity of this all\u2010oral regimen was tolerable. <jats:bold><jats:italic>Cancer<\/jats:italic> 2016;122:2350\u20132355<\/jats:bold>. \u00a9 <jats:italic>2016 American Cancer Society<\/jats:italic>.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.30067","type":"journal-article","created":{"date-parts":[[2016,5,19]],"date-time":"2016-05-19T19:20:47Z","timestamp":1463685647000},"page":"2350-2355","source":"Crossref","is-referenced-by-count":20,"title":["Capecitabine and lapatinib for the first\u2010line treatment of metastatic\/recurrent head and neck squamous cell carcinoma"],"prefix":"10.1002","volume":"122","author":[{"given":"Jared M.","family":"Weiss","sequence":"first","affiliation":[{"name":"Division of Hematology and Oncology University of North Carolina, Lineberger Comprehensive Cancer Center Chapel Hill North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Bagley","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology University of Pennsylvania, Abramson Comprehensive Cancer Center Philadelphia Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei\u2010Ting","family":"Hwang","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Epidemiology University of Pennsylvania Perelman School of Medicine Philadelphia Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joshua","family":"Bauml","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology University of Pennsylvania, Abramson Comprehensive Cancer Center Philadelphia Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juneko Grilley","family":"Olson","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology University of North Carolina, Lineberger Comprehensive Cancer Center Chapel Hill North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roger B.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology University of Pennsylvania, Abramson Comprehensive Cancer Center Philadelphia Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David Neil","family":"Hayes","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology University of North Carolina, Lineberger Comprehensive Cancer Center Chapel Hill North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corey","family":"Langer","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology University of Pennsylvania, Abramson Comprehensive Cancer Center Philadelphia 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