Study on the correlation between immediate hypersensitivity induced by pegylated liposomal doxorubicin and the anti-polyethylene glycol antibody in patients with advanced breast cancer
10.3760/cma.j.cn114015-20210322-00345
- VernacularTitle:聚乙二醇化脂质体多柔比星致晚期乳腺癌患者速发型超敏反应与抗聚乙二醇抗体的相关性研究
- Author:
Wei ZHUANG
1
;
Xiuping LAI
1
;
Suiwen YE
1
;
Junyi CHEN
1
;
Qingxiu MAI
1
;
Siming LI
1
;
Junyan WU
1
;
Herui YAO
1
Author Information
1. 中山大学孙逸仙纪念医院Ⅰ期临床研究中心，广州 510120
- Publication Type:Journal Article
- Keywords:
Breast neoplasms;
Doxorubicin;
Liposomes;
Hypersensitivity, immediate;
Pegylation
- From:
Adverse Drug Reactions Journal
2021;23(9):456-460
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the correlation between immediate hypersensitivity induced by pegylated liposomal doxorubicin (PLD) and the plasma anti-polyethylene glycol (anti-PEG) antibody in advanced breast cancer patients.Methods:The study was designed as a prospective and noninterventional study. The subjects were selected from advanced breast cancer patients in Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, who received monotherapy with PLD (an IV infusion of PLD 50 mg/m 2 in 5% glucose solution 250 ml for 90 minutes without pretreatment with dexamethasone or other drugs). Anti-PEG antibody before administration were detected for all the patients and antibody level >2 ng/L was defined as positive. Blood in patients who had hypersensitivity within 30 minutes after the start of infusion was collected (finding the opportunity as soon as possible) and IgE, C3, and C4 levels in serum were detected. According to whether there was an immediate hypersensitivity reaction, the patients were divided into hypersensitivity group and non-hypersensitivity group and the clinical characteristics and plasma anti-PEG antibody carrying status in patients between the 2 groups were compared; according to anti-PEG antibody carrying status, the patients were divided into anti-PEG antibody positive group and negative group and the clinical characteristics and the incidence of hypersensitivity in patients between the 2 groups were compared. Results:A total of 12 patients were included in the study, aged from 37 to 68 years with a median age of 50 (37-68) years. Ten patients had previously used non-pegylated anthracyclines and the median cumulative dose was 329 (185, 418) mg/m 2 after a doxorubicin equivalent dose conversion. Seven patients developed hypersensitivity within 2-18 minutes after the start of infusion. Between the hypersensitivity group and the non-hypersensitivity group, differences in clinical characteristics such as age, height, weight, body surface area, previous application of anthracyclines, and the cumulative doses in patients were not significant (all P>0.05); the difference in positive rate of anti-PEG antibodies in patients was also not statistically significant (4/7 vs. 2/5, P=1.000). Among the 12 patients, 6 were positive for anti-PEG antibody and 6 were negative and the differences in the above-mentioned clinical characteristics or the incidence of hypersensitivity (3/6 vs. 4/6) in patients between the 2 groups (all P>0.05) were not significant. In the hypersensitivity group, IgE, C3, and C4 levels in serum were detected in 4 patients. Two patients with positive anti-PEG antibody had increased IgE levels (404 and 545 μg/L, respectively), 1 of which had also increased C4 level (486 mg/L); the other 2 patients with negative anti-PEG antibody had normal IgE, C3, and C4 levels. Conclusions:It has not been found that PLD-induced immediate hypersensitivity is related to the anti-PEG antibody, which may be due to the small sample size of the study. It cannot be ruled out that anti-PEG antibody may be involved in the induction of the IgE-mediated immediate hypersensitivity, which may also be mediated by complement in some patients.
