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1.
Eur Neuropsychopharmacol ; 28(6): 710-718, 2018 06.
Article in English | MEDLINE | ID: mdl-29724638

ABSTRACT

The aim of the study was to investigate the efficacy and safety of inhaled loxapine compared with the intramuscular (IM) antipsychotic aripiprazole in acutely agitated patients with schizophrenia or bipolar I disorder. PLACID was an assessor-blind, parallel-group trial conducted in 23 centres in the Czech Republic, Germany, Spain, and Russia. Patients (aged 18-65 years) diagnosed with schizophrenia or bipolar I disorder experiencing acute agitation (Clinical Global Impression [CGI]-Severity score ≥ 4) while hospitalized or attending an emergency room were randomized to receive up to two doses of inhaled loxapine 9.1 mg or IM aripiprazole 9.75 mg (≥ 2 h between doses) during the 24-h study period. The primary efficacy endpoint was time to response (CGI-Improvement score 1 [very much improved] or 2 [much improved]). The primary analysis included randomized patients who provided informed consent (full analysis set [FAS]); the safety analysis included all patients who received study medication. The FAS comprised 357 patients (enrolled December 2, 2014 - October 31, 2016). The between-treatment difference in median time to CGI-Improvement response was 10 min (95% CI 0.0-30.0); p = 0.0005) in favour of inhaled loxapine (median [95% CI]: 50 min [30.0-50.0] vs 60 min [50.0-90.0] with IM aripiprazole); the difference was significant at 10 min (responders: 14% [loxapine] vs 4% [aripiprazole]; p = 0.001). There were no safety issues. Inhaled loxapine reduced agitation faster than IM aripiprazole, supporting its use as a first-line option for managing acute agitation in patients with schizophrenia or bipolar disorder.


Subject(s)
Antipsychotic Agents/administration & dosage , Aripiprazole/administration & dosage , Loxapine/administration & dosage , Psychomotor Agitation/drug therapy , Administration, Inhalation , Adolescent , Adult , Aged , Bipolar Disorder/complications , Female , Humans , Injections, Intramuscular , Male , Middle Aged , Psychiatric Status Rating Scales , Psychomotor Agitation/etiology , Schizophrenia/complications , Single-Blind Method , Treatment Outcome , Young Adult
2.
Clin Breast Cancer ; 18(1): e41-e47, 2018 02.
Article in English | MEDLINE | ID: mdl-28666812

ABSTRACT

PURPOSE: Single-agent oral chemotherapy is widely used in patients with bone metastases without visceral involvement, especially in hormone receptor-positive metastatic breast cancer (mBC). However, this option has been poorly evaluated in clinical trials. METHODS: Eligible patients had mBC with predominantly bone but not visceral metastases, were receiving bisphosphonate therapy, and had previously received endocrine therapy (any setting) but not chemotherapy for mBC. Patients received oral vinorelbine 60 mg/m2 on days 1, 8, 15, and 22 every 4 weeks (escalating to 80 mg/m2 from cycle 2 in the absence of grade 3/4 toxicity) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Secondary endpoints included clinical benefit rate (complete/partial response or ≥24 weeks' stable disease), overall survival, and safety. RESULTS: Seventy patients were treated for a median of 6 cycles (range 1-18). Most (73%) continued treatment until disease progression. After 43 months' median follow-up, median PFS was 8.2 months (95% confidence interval [CI], 5.5-9.8). The clinical benefit rate was 56% (95% CI, 43%-68%). Median overall survival was 35.2 months (95% CI, 26.8-47.1). The most common grade 3/4 adverse event was neutropenia (38% of patients); febrile neutropenia was absent. The most common grade 1/2 adverse events were bone pain, fatigue, and gastrointestinal toxicities. Alopecia was infrequent. CONCLUSIONS: In patients with hormone receptor-positive mBC, bone disease, and prior endocrine therapy, first-line oral vinorelbine chemotherapy demonstrated long PFS and good tolerability. In this setting, it could be considered as an active oral alternative to intravenous chemotherapy.


Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Antineoplastic Agents, Phytogenic/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bone Neoplasms/drug therapy , Breast Neoplasms/drug therapy , Vinorelbine/therapeutic use , Administration, Oral , Adult , Aged , Bone Neoplasms/secondary , Breast/pathology , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Chemotherapy-Induced Febrile Neutropenia/epidemiology , Chemotherapy-Induced Febrile Neutropenia/etiology , Disease Progression , Fatigue/chemically induced , Fatigue/epidemiology , Female , Humans , Middle Aged , Progression-Free Survival , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism , Treatment Outcome
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