Hypersensitivity reaction to pegylated liposomal doxorubicin administration for Mullerian carcinoma in Japanese women

2021 ◽  
Author(s):  
Shinichiro Yamaguchi ◽  
Hideaki Yahata ◽  
Kaoru Okugawa ◽  
Keisuke Kodama ◽  
Hiroshi Yagi ◽  
...  
Keyword(s):  
Hypersensitivity Reaction ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Japanese Women ◽  
Müllerian Carcinoma ◽  
Doxorubicin Administration

Randomized phase III trial comparing pegylated liposomal doxorubicin (PLD) 50 mg/m2 and 40 mg/m2 in patients with platinum-resistant Müllerian carcinoma (JGOG3018).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5550-5550
Author(s):  
Akira Yabuno ◽  
Tsutomu Tabata ◽  
Hirofumi Michimae ◽  
Tetsuro Oishi ◽  
Miwa Nonaka ◽  
...  
Keyword(s):  
Liposomal Doxorubicin ◽  
Standard Dose ◽  
Performance Status ◽  
Single Agent ◽  
Pegylated Liposomal Doxorubicin ◽  
Phase Iii ◽  
Skin Reactions ◽  
Platinum Resistant ◽  
Number Of Patients ◽  
Müllerian Carcinoma

5550 Background: The standard dose of single-agent pegylated liposomal doxorubicin (PLD) is 50 mg/m2 every 4 weeks, but 40 mg/m2 has recently been used in clinical practice, though there is no evidence available to support its use. Methods: A Phase III, randomized, multicenter, non-inferiority study comparing progression-free survival (PFS) of patients with platinum-resistant Mullerian carcinoma (epithelial ovarian, fallopian tube, or primary peritoneal carcinoma) treated with an experimental arm (40 mg/m2 PLD) versus a standard arm (50 mg/m2 PLD) until 10 courses, disease progression, or unacceptable toxicity was conducted. Eligible patients had ≤ 2 prior lines. Stratification was by performance status (PS) and PFS of prior chemotherapy (<3 months versus ≥3 months). The primary endpoint was PFS, and secondary endpoints were overall survival (OS), toxicity profile, clinical response, and tolerability. The target total number of patients was 412. Results: The trial was closed due to accrual futility as patient recruitment was slow , with 272 patients randomized to the experimental arm (n=137) and the standard arm (n=135). The final analysis was performed with 234 deaths and 269 events for PFS. Median patient age was 62 years; 58% of patients had a treatment-free interval less than 3 months, and 81% of patients had PS 0. In the experimental versus standard arm, median PFS was 4.0 months versus 4.0 months (HR 1.065, 95.8%CI: 0.830-1.366), and median OS was 14.0 months versus 14.0 months (HR 1.078, 95%CI: 0.831-1.397). Adverse events ≥Grade 2 including oral cavity mucositis were more frequent in the standard arm than in the experimental arm (26.7% vs. 13.5%, respectively; p=0.0089), but there was no difference in ≥Grade 2 hand-foot-skin reactions (19.8% vs. 15.0%, respectively; p=0.333). Conclusions: The non-inferiority of PFS with the reduced dosing schedule was not confirmed because the trial was closed prematurely, but PFS and OS were similar. These results suggest a reduction of the standard dose of PLD because of the low rate of oral mucositis in patients with platinum-resistant ovarian cancer treated with the lower dose regimen. Clinical trial information: UMIN000003130.

Immediate hypersensitivity reaction to pegylated liposomal doxorubicin: management and outcome in four patients

2017 ◽  
Vol 27 (3) ◽  
pp. 271-274 ◽  
Author(s):  
Saskia Ingen-Housz-Oro ◽  
Anne Pham-Ledard ◽  
Pauline Brice ◽  
Bénédicte Lebrun-Vignes ◽  
Ouidad Zehou ◽  
...  
Keyword(s):  
Hypersensitivity Reaction ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Immediate Hypersensitivity

scholarly journals Bradycardia associated with pegylated liposomal doxorubicin administration: a case report

2016 ◽  
Vol 24 (2) ◽  
pp. 128-130 ◽  
Author(s):  
Zhaolu Xie ◽  
Wei Wu ◽  
Haiyan Xing ◽  
Yongqing Cai ◽  
Xianfeng Wang ◽  
...  
Keyword(s):  
Case Report ◽  
Liposomal Doxorubicin ◽  
Pegylated Liposomal Doxorubicin ◽  
Doxorubicin Administration
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