タバタ　ツトム   TABATA Tsutomu   田畑　務    所属   医学部 医学科（東京女子医科大学病院）    職種   教授・基幹分野長
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Randomized phase III trial comparing pegylated liposomal doxorubicin (PLD) at 50 mg/m² versus 40 mg/m² in patients with platinum-refractory and -resistant ovarian carcinoma: the JGOG 3018 Trial.
掲載誌名	正式名：Journal of gynecologic oncology 略　 称：J Gynecol Oncol ISSNコード：20050399/20050380
掲載区分	国外
巻・号・頁	32(1),pp.e9
著者・共著者	Motohashi Takashi, Yabuno Akira, Michimae Hiroshi, Ohishi Tetsuro, Nonaka Miwa, Takano Masashi, Nishio Shin, Fujiwara Hiroyuki, Fujiwara Keiichi, Kondo Eiji, Sugiyama Toru, Tabata Tsutomu
担当区分	最終著者
発行年月	2021/01
概要	OBJECTIVE:The standard dose for pegylated liposomal doxorubicin (PLD) is 50 mg/m² every 4 weeks. While 40 mg/m² has recently been used in clinical practice, evidence supporting this use remains lacking.METHODS:This phase III randomized, non-inferiority study compared progression-free survival (PFS) for patients with platinum-resistant ovarian carcinoma between an experimental arm (40 mg/m² PLD) and a standard arm (50 mg/m² PLD) until 10 courses, disease progression or unacceptable toxicity. Eligible patients had received ≤2 prior lines. Stratification was by performance status 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 total number of patients was 470.RESULTS:The trial was prematurely closed due to slow recruitment, with 272 patients randomized to the experimental arm (n=137) and standard arm (n=135). Final analysis was performed with 234 deaths and 269 events for PFS. In the experimental arm vs. standard arm, median PFS was 4.0 months vs. 4.0 months (hazard ratio [HR]=1.065; 95% confidence interval [CI]=0.830-1.366) and median OS was 14.0 months vs. 14.0 months (HR=1.078; 95% CI=0.831-1.397). Hematologic toxicity and oral cavity mucositis (≥grade 2) were more frequent in the standard arm than in the experimental arm, but no difference was seen in ≥grade 2 hand-foot skin reaction.CONCLUSION:Non-inferiority of 2 PLD dosing schedule was not confirmed because the trial was closed prematurely. However, recommendation of dose reduction of PLD should be based both on efficacy and safety.TRIAL REGISTRATION:UMIN Clinical Trials Registry Identifier: UMIN000003130.
DOI	10.3802/jgo.2021.32.e9
PMID	33185050