TABATA Tsutomu
Department School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine Position Professor and Division head |
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Article types | Original article |
Language | English |
Peer review | Peer reviewed |
Title | 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. |
Journal | Formal name:Journal of gynecologic oncology Abbreviation:J Gynecol Oncol ISSN code:20050399/20050380 |
Domestic / Foregin | Foregin |
Volume, Issue, Page | 32(1),pp.e9 |
Author and coauthor | Motohashi Takashi, Yabuno Akira, Michimae Hiroshi, Ohishi Tetsuro, Nonaka Miwa, Takano Masashi, Nishio Shin, Fujiwara Hiroyuki, Fujiwara Keiichi, Kondo Eiji, Sugiyama Toru, Tabata Tsutomu |
Authorship | Last author |
Publication date | 2021/01 |
Summary | 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 |