KMID : 1137020210320010009
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Journal of Gynecologic Oncology 2021 Volume.32 No. 1 p.9 ~ p.9
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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
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Motohashi Takashi
Yabuno Akira Michimae Hiroshi Ohishi Tetsuro Nonaka Miwa Takano Masashi Nishio Shin Fujiwara Hiroyuki Fujiwara Keiichi Kondo Eiji Sugiyama Toru Tabata Tsutomu
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Abstract
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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 ¡Â2 prior lines. Stratification was by performance status and PFS of prior chemotherapy (<3 months versus ¡Ã3 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 (¡Ãgrade 2) were more frequent in the standard arm than in the experimental arm, but no difference was seen in ¡Ãgrade 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.
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KEYWORD
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Chemotherapy, Ovarian Neoplasms, Doxorubicin, Recurrence
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