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- 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.
- Authors
Takashi Motohashi; Akira Yabuno; Hiroshi Michimae; Tetsuro Ohishi; Miwa Nonaka; Masashi Takano; Shin Nishio; Hiroyuki Fujiwara; Keiichi Fujiwara; Eiji Kondo; Toru Sugiyama; Tsutomu Tabata
- Abstract
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 progressionfree 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.
- Subjects
DOXORUBICIN; MOUTH; CARCINOMA; DISEASE progression; CONFIDENCE intervals
- Publication
Journal of Gynecologic Oncology, 2021, Vol 32, Issue 1, p1
- ISSN
2005-0380
- Publication type
Article
- DOI
10.3802/jgo.2021.32.e9