Search results for "Randomized"

Evaluation of Treatment Integrity: The Treatment Specificity Index

2015

Objective To differentiate between treatments in a randomized controlled trial (RCT), therapies need to display not only high purity but also high specificity. The aim of this study was to demonstrate the benefits of calculating a treatment specificity index for the evaluation of treatment differentiation. Method Based on an RCT of relapse prevention in depression, comparing a cognitive with a psychoeducational treatment, the specificity and the purity index were calculated. Results As indicated by the specificity index, both conditions differed in their levels of implemented specific and common interventions. A significant relationship was found between symptom change before a therapy sess…

What can platinum offer yet in the treatment of PS2 NSCLC patients? A systematic review and meta-analysis

2015

Abstract: Background: Randomized phase III trials showed interesting, but conflicting results, regarding the treatment of NSCLC, PS2 population. This meta-analysis aims to review all randomized trials comparing platinum-based doublets and single-agents in NSCLC PS2 patients. Materials and methods: Data from all published randomized trials, comparing efficacy and safety of platinum-based doublets to single agents in untreated NSCLC, PS2 patients, were collected. Pooled ORs were calculated for the 1-year Survival-Rate (ly-SR), Overall Response Rate (ORR), and grade 3-4 (G3-4) hematologic toxicities. Results: Six eligible trials (741 patients) were selected. Pooled analysis showed a significan…

Large Between-Patient Variability in eGFR Decline before Clinical Trial Enrollment and Impact on Atrasentan’s Efficacy:

2021

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Evaluation of Prognostic Factors and Role of Participation in a Randomized Trial or a Prospective Registry in Pediatric and Adolescent Nonmetastatic …

2020

Purpose: We aimed to compare treatment results in and outside of a randomized trial and to confirm factors influencing outcome in a large retrospective cohort of nonmetastatic medulloblastoma treated in Austria, Switzerland and Germany. Methods and Materials: Patients with nonmetastatic medulloblastoma (n = 382) aged 4 to 21 years and primary neurosurgical resection between 2001 and 2011 were assessed. Between 2001 and 2006, 176 of these patients (46.1%) were included in the randomized HIT SIOP PNET 4 trial. From 2001 to 2011 an additional 206 patients were registered to the HIT 2000 study center and underwent the identical central review program. Three different radiation therapy protocols…

1281P The prognostic impact of tissue tumour mutational burden (TMB) in the first-line treatment of advanced non-oncogene addicted non-small cell lun…

2020

Palliative treatment for advanced gastrointestinal cancer: is response a suitable end-point?

1996

Treatment results of standard chemotherapy in advanced gastrointestinal tract cancer are disappointing. 5-Fluorouracil (FU) is the therapeutic mainstay since its discovery more than 35 years ago. Response rates of single agent FU treatment range between 5 and 20% dependent on dose and schedule. The efforts of the last two decades have been focused on the improvement of objective response rates using several combinations of chemotherapy regimens including doxorubicin, cisplatin, mitomycin and etoposide. Most of the phase l/II studies have reported encouraging treatment results initially with respect to response rates. Subsequent randomized trials, however, revealed a high rate of World Healt…

Definition and estimation of osteonecrosis of jaw (ONJ), and optimal duration of antiresorptive treatment in bone metastatic cancer patients: supplem…

2017

To the Editor, In their recent article, Stopeck et al. [1] concluded that denosumab confirms its known safety profile even after longterm exposure, or after switching to it from zoledronic acid, and that osteonecrosis of jaws (ONJ) rates increased with increasing exposure to antiresorptives, consistent with previous reports. This is based on the open label extension phase of two phase 3 studies in patients with breast and prostate cancer with bone metastases who were randomized to receive denosumab or zoledronic acid (ZA) [2, 3]. The patients were offered open-label denosumab for up to an additional 2 years after the results of the primary analysis, favorable for denosumab on several aspect…

Adding chemotherapy to TKI: Can we improve first-line treatment for EGFR-mutated NSCLC patients?

2016

In The Journal of Clinical Oncology , Ying Cheng and colleagues (1) have recently reported the results of a phase II randomized trial comparing pemetrexed plus gefitinib vs. gefitinib in treatment-naive, East Asian patients, with advanced non-squamous non-small cell lung cancer (NSCLC) and activating epidermal growth factor receptor (EGFR) mutations. The study met its primary end-point in the intent-to-treat population, showing a significantly longer median progression free survival (PFS) in favors of the combination arm (15.8 months) compared to single agent arm (10.9 months) [hazard ratio (HR): 0.68; 95% CI, 0.48 to 0.96; one-sided P=0.014; two-sided P=0.029].

Weekly docetaxel in the treatment of metastatic breast cancer

2008

Breast cancer is the most frequent tumor among women worldwide and is the second cause of cancer-related mortality in the US. Metastatic breast cancer (MBC) accounts for less than 10% of newly diagnosed breast cancer patients and about 30% of early breast cancer patients will develop recurrent, advanced, or metastatic disease. It remains an incurable illness and the primary goal of its management is palliative. Several agents are active for the fi rst-line treatment of MBC. The taxanes, paclitaxel and docetaxel, represent the standard of care for the treatment of these patients. Among the various schedules, docetaxel can be administered weekly, achieving similar effi cacy results with lower…

Long-Term Efficacy of Maintenance Therapy for Multiple Myeloma: A Quantitative Synthesis of 22 Randomized Controlled Trials

2018

We aimed to quantitatively synthesize data from randomized controlled trials (RCTs) concerning maintenance for multiple myeloma (MM). We searched electronic literature databases and conference proceedings to identify relevant RCTs. We selected eligible RCTs using predefined selection criteria. We conducted meta-analysis comparing maintenance containing new agents and conventional maintenance, and subgroup analysis by transplantation status and mainstay agent as well. We performed trial sequential analysis (TSA) to determine adequacy of sample size for overall and subgroup meta-analyses. We performed network meta-analysis (NMA) to compare and rank included regimens. A total of 22 RCTs involv…