Berger Michael J, Vargo Craig, Vincent Mary, Shaver Katy, Phillips Gary, Layman Rachel, Macrae Erin, Mrozek Ewa, Ramaswamy Bhuvaneswari, Wesolowski Robert, Shapiro Charles L, Lustberg Maryam B
Pharmacy Department, The Stefanie Spielman Comprehensive Breast Center, The James Cancer Hospital and Solove Research Institute at the Ohio State University, Columbus, USA,
Support Care Cancer. 2015 Jul;23(7):2019-24. doi: 10.1007/s00520-014-2556-x. Epub 2014 Dec 18.
Paclitaxel-based chemotherapy continues to be an integral component of breast cancer treatment. Prolonged use of paclitaxel may result in repeated doses of premedications that can have unwanted side effects. Infusion hypersensitivity reactions occurring beyond the second dose of paclitaxel are infrequent and not well characterized. We previously published the results of a small, prospective pilot trial demonstrating the safety and feasibility of discontinuing premedications in patients who received the first two doses of paclitaxel-based chemotherapy without experiencing an infusion hypersensitivity reaction. In this study, we aimed to retrospectively characterize the incidence of rescue medication using this abbreviated premedication regimen in our institution following the publication of the pilot study.
Patients with stages I-IV breast cancer who received paclitaxel from January 2011 through June 2013 were screened for eligibility. Patients who did not experience an infusion hypersensitivity reaction with their first or second dose of paclitaxel and discontinued paclitaxel premedication for subsequent doses were included in this analysis. The primary endpoint was to estimate the incidence of rescue medication use for the treatment of paclitaxel infusion hypersensitivity during doses three to six of paclitaxel in the study population.
In total, 449 patients received paclitaxel-based chemotherapy for the treatment of breast cancer during the interval time period. After receiving the first two doses of paclitaxel-based chemotherapy without experiencing an infusion hypersensitivity reaction, 234 breast cancer patients had their premedications discontinued for all remaining paclitaxel doses. These patients tolerated future paclitaxel doses without severe or life-threatening complications related to infusion hypersensitivity. The majority of patients did not have any symptoms of an infusion reaction, with only two of these patients requiring rescue medication to treat an infusion hypersensitivity reaction with subsequent paclitaxel doses (0.85; 95 % confidence interval (CI), 0.10-3.05 %).
Discontinuation of paclitaxel premedications in breast cancer patients who have not experienced an infusion hypersensitivity reaction with the first two doses of paclitaxel is not associated with increased rate of rescue medication use for infusion hypersensitivity.
基于紫杉醇的化疗仍是乳腺癌治疗的重要组成部分。长期使用紫杉醇可能导致重复使用预处理药物，而这些药物可能会产生不良副作用。在第二次使用紫杉醇后发生的输注过敏反应并不常见，且特征尚不明确。我们之前发表了一项小型前瞻性试验的结果，该试验证明了在接受前两剂基于紫杉醇的化疗且未发生输注过敏反应的患者中停用预处理药物的安全性和可行性。在本研究中，我们旨在回顾性地描述在试点研究发表后，我们机构采用这种简化预处理方案时救援药物的使用发生率。
筛选2011年1月至2013年6月期间接受紫杉醇治疗的I-IV期乳腺癌患者的资格。本分析纳入了在第一剂或第二剂紫杉醇时未发生输注过敏反应且后续剂量停用紫杉醇预处理的患者。主要终点是估计研究人群中在紫杉醇第三至六剂期间用于治疗紫杉醇输注过敏反应的救援药物使用发生率。
在该时间段内，共有449例患者接受了基于紫杉醇的化疗以治疗乳腺癌。在接受前两剂基于紫杉醇且未发生输注过敏反应的化疗后，234例乳腺癌患者在所有剩余的紫杉醇剂量中停用了预处理药物。这些患者耐受了后续紫杉醇剂量，未出现与输注过敏反应相关的严重或危及生命的并发症。大多数患者没有任何输注反应症状，其中只有两名患者需要救援药物来治疗后续紫杉醇剂量时的输注过敏反应（0.85；95%置信区间(CI)，0.10-3.05%）。
在接受前两剂紫杉醇未发生输注过敏反应的乳腺癌患者中停用紫杉醇预处理药物，与输注过敏反应救援药物使用增加率无关。
