RESUMO
Objectives@#An Asian Gynecologic Oncology Group phase III randomized trial was conducted to determine whether maintenance chemotherapy could improve progression-free survival (PFS) in stages III/IV ovarian cancer. @*Methods@#Between 2007 and 2014, 45 newly-diagnosed ovarian cancer patients were enrolled after complete remission and randomized (1:1) to arm A (4-weekly carboplatin area under the curve 4 and pegylated liposomal doxorubicin [PLD] 30 mg/m2, n=24) for 6 cycles or arm B (observation, n=21). The primary end-point was PFS. A post hoc translational study was conducted to deep sequence BRCA/homologous recombination deficiency (HRD) genes, because BRCA/HRD mutations (BRCA/HRDm) are known to be associated with better prognosis. @*Results@#Enrollment was slow, accrual was closed when 7+ years had passed. With a medianfollow-up of 88.9 months, the median PFS was significantly better in arm A (55.5 months) than arm B (9.2 months) (hazard ratio [HR]=0.40; 95% confidence interval [CI]=0.19–0.87; p=0.020), yet the median overall survival was not significantly different in arm A (not reached) than arm B (95.1 months) (p=0.148). Overall grade 3/4 adverse events were more frequent in arm A than arm B (60.9% vs 0.0%) (p<0.001). Quality of life was generally not significantly different. Distribution of BRCA1/2m or BRCA/HRDm was not significantly biased between the two arms. Wild-type BRCAon-HRD subgroup seemed to fare better with maintenance therapy (HR=0.35; 95% CI=0.11–1.18; p=0.091). @*Conclusions@#Despite limitations in small sample size, it suggests that maintenance carboplatin-PLD chemotherapy could improve PFS in advanced ovarian cancer.
RESUMO
Assuntos
Humanos , Braço , Povo Asiático , Viés , Carboplatina , Intervalo Livre de Doença , Doxorrubicina , Tratamento Farmacológico , Seguimentos , Quimioterapia de Manutenção , Neoplasias Ovarianas , Prognóstico , Qualidade de Vida , Recombinação Genética , Tamanho da AmostraRESUMO
PURPOSE: Urinary catheterization is a common technique in clinical practice. There is, however, no consensus on management prior to removal of the indwelling catheter for short-term patients. This systematic review examined the necessity of clamping before removal of an indwelling urinary catheter in short-term patients. METHODS: A systematic literature review was conducted using eight databases and predetermined keywords-guided searches. Some 2,515 studies were evaluated. Ten studies that met the inclusion criteria were selected. RESULTS: The quality of the studies was assessed using the Jadad scoring system. Only 40.0% of studies were rated as high quality. This review found that catheter clamping prior to removal was not necessary for the short-term patient. When made a comparison with the unclamping group, there was no significant difference in recatheterization risk, risk of urine retention, patients' subjective perceptions and rate of urinary tract infection. CONCLUSIONS: This review indicated that bladder training by clamping prior to removal of urinary catheters is not necessary in short-term catheter patients. In addition, clamping carries the risk of complications such as prolonging urinary catheter retention and urinary tract injury. Further investigation requires higher quality methodologies and more diverse study designs.