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.

No abstract available.
Hemodynamics* ; Humans ; Infant*

No abstract available.

No abstract available.

We had previously reported the purification of bovine lung natural surfactant-phospholoipd (PNSL)and the assessment of it's surface physical properties in vitro. To observe the clinical effectiveness of PNS-L in vivo, the degree of improvement of thoracic pressure-volume, compliance and histological changes following PNS-L instilation in premature rabbits with respiratory distress syndrome(RDS)were investigated. Rabbits, delivered prematurely by cesarean section at 27 days, treated with PNS-L via tracheostomy, were enrolled the study group. Two control groups were premature RDS rabbits (no treatment with PNS-L)and mature rabbits. We compared the results of thoracic pressure-volume changes during deflation phase and lung compliance changes among PNS-L treated study group and two control groups, and compared the results of aefated lung area ratio (%) on histologic samples among PNS-L treated study group and two control groups by the methods of IBSA-2000. There were significant improvements of thoracic pressure-volume during duflation phase(p<0.001), lung compliance (p<0.01, p<0.005, p<0.001) and increased acrated area histologically (p<0.005)in PNS-L treated study group compared with premature control group. It was suspected that PNS-L had contained the effective survace physical properties as a function of pulmonary surfactant. And improvement of pulmonary ventilatory functions and histological characteristics, were observed in PNS-L treated RDS model in vivo study.
Cesarean Section ; Compliance ; Female ; Humans ; Infant, Newborn* ; Lung ; Lung Compliance ; Pregnancy ; Pulmonary Surfactants ; Rabbits ; Tracheostomy