Burke Ellen, Rockey Michelle, Grauer Dennis, Henry Dave, Neupane Prakash
Department of Pharmacy, University of Kansas Hospital, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.
University of Kansas School of Pharmacy, 2010 Becker Drive, Lawrence, KS, 66047, USA.
Med Oncol. 2017 Apr;34(4):51. doi: 10.1007/s12032-017-0902-9. Epub 2017 Feb 22.
Cetuximab is approved for treatment of squamous cell carcinoma of the head and neck (SCCHN). Cetuximab is generally well tolerated, but does carry a black box warning for infusion reactions (IRs). Incidence of IR in clinical trials was 15-20% for all grades and 3-5% for grades III-IV. Retrospective studies reported a higher incidence of all grade IRs and grades III-IV IR in areas of the Southeastern United States. Information regarding rechallenge doses after an IR has not been well described. At our institution, we frequently rechallenge on the same day after an initial IR. The primary objective was to determine the incidence, timing, IR grade, and completion of a rechallenge dose in patients who experienced an initial IR. Secondary objectives included: (1) determining the incidence and grade of IR in patients who received a first dose of cetuximab and (2) identifying specific risk factors for cetuximab IR with the first dose. A single-center retrospective chart review was conducted in SCCHN patients treated with cetuximab between June 2008 and September 2015 at the University of Kansas Hospital Cancer Center and inpatient setting. The majority of patients (87.9%) were able to be quickly and successfully rechallenged after an initial IR. Minimal patients (27.6%) experienced a rechallenge IR, resulting in only 1 patient discontinuation. Rechallenge doses were most frequently (37.9%) administered between 30 and 59 min after initial dose discontinuation. This was a single-center retrospective study based on data collected from electronic medical records. Other limitations include interpretation of infusion reactions on a subjective basis by providers. These findings demonstrate the practice of same-day rechallenges in initial IR patients is feasible and safe.
西妥昔单抗被批准用于治疗头颈部鳞状细胞癌(SCCHN)。西妥昔单抗一般耐受性良好,但确实有关于输注反应(IRs)的黑框警告。在临床试验中,所有级别的IR发生率为15%-20%,III-IV级为3%-5%。回顾性研究报告称,在美国东南部地区,所有级别的IR和III-IV级IR的发生率更高。关于IR后再次给药剂量的信息尚未得到充分描述。在我们机构,我们经常在首次出现IR后的同一天进行再次给药。主要目的是确定经历首次IR的患者中再次给药的发生率、时间、IR级别和完成情况。次要目的包括:(1)确定接受第一剂西妥昔单抗的患者中IR的发生率和级别,以及(2)识别首次使用西妥昔单抗时发生IR的特定风险因素。在堪萨斯大学医院癌症中心对2008年6月至2015年9月期间接受西妥昔单抗治疗的SCCHN患者进行了单中心回顾性病历审查,审查在住院环境中进行。大多数患者(87.9%)在首次出现IR后能够迅速且成功地接受再次给药。极少患者(27.6%)经历了再次给药IR,仅导致1例患者停药。再次给药剂量最常(37.9%)在首次给药停止后30至59分钟之间给予。这是一项基于从电子病历中收集的数据的单中心回顾性研究。其他局限性包括提供者对输注反应的主观解读。这些发现表明,对首次出现IR的患者进行同一天再次给药的做法是可行且安全的。