Rosenthal Eben L, Chung Thomas K, Carroll William R, Clemons Lisa, Desmond Renee, Nabell Lisle
Division of Otolaryngology, Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA,
Ann Surg Oncol. 2014 Dec;21(13):4263-9. doi: 10.1245/s10434-014-3878-0. Epub 2014 Jul 8.
To determine the tolerability and efficacy of long-term treatment with erlotinib for head and neck squamous cell carcinoma after salvage surgery.
An open-label study was conducted of 150 mg of daily erlotinib for 12 months in patients who completed definitive surgical therapy for recurrent head and neck squamous cell carcinoma. The primary outcome measures were tolerability of prolonged erlotinib therapy and disease-free survival and overall survival at 1 and 2 years.
Thirty-one patients were enrolled onto this study. Mean duration of erlotinib therapy was 5 months (range 2-374 days), with 8 patients completing the full 12-month course of erlotinib. Of the remaining patients, 8 discontinued therapy as a result of recurrence, 10 for medical or surgical complications deemed unrelated to the study medication, and 3 for drug-related toxicities. There were 25 grade 3 adverse events; 4 were classified as possibly related to study medication. The most common adverse events included acneiform rash (n = 26 patients), fatigue (n = 22), and diarrhea (n = 22). Overall survival was 61 % at 1 year and 56 % at 2 years. Disease-free survival was 54 % at 1 year and 45 % at 2 years. Mean time to recurrence (n = 16) was 8.7 months.
Long-term erlotinib is safe and demonstrates some potential survival benefit compared to historical controls. However, despite the absence of grade 3/4 adverse events attributable to the drug, tolerance of long-term erlotinib was a significant barrier to completion of a 12-month course of therapy.
确定厄洛替尼对挽救性手术后的头颈部鳞状细胞癌进行长期治疗的耐受性和疗效。
对完成复发性头颈部鳞状细胞癌确定性手术治疗的患者开展一项开放标签研究，给予每日150毫克厄洛替尼，持续12个月。主要结局指标为厄洛替尼延长治疗的耐受性以及1年和2年时的无病生存期和总生存期。
31名患者纳入本研究。厄洛替尼治疗的平均持续时间为5个月（范围2 - 374天），8名患者完成了12个月的完整厄洛替尼疗程。其余患者中，8名因复发停药，10名因被认为与研究药物无关的医疗或手术并发症停药，3名因药物相关毒性停药。有25例3级不良事件；4例被归类为可能与研究药物有关。最常见的不良事件包括痤疮样皮疹（26例患者）、疲劳（22例）和腹泻（22例）。1年时总生存率为61%，2年时为56%。1年时无病生存率为54%，2年时为45%。复发的平均时间（n = 16）为8.7个月。
与历史对照相比，长期使用厄洛替尼是安全的，并显示出一定的潜在生存获益。然而，尽管没有归因于该药物的3/4级不良事件，但长期使用厄洛替尼的耐受性是完成12个月疗程治疗的一个重大障碍。
