Search results for "randomized controlled trial"
showing 10 items of 2199 documents
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…
Preliminary Results of Two Eortc Randomized Trials in Previously Untreated Patients with Advanced T3 — T4 Prostatic Cancer
1983
At the end of 1976 and the beginning of 1977 respectively, the EORTC Genito-Urinary Tract Cancer Cooperative Group started two randomized phase III protocols in previously untreated patients with advanced T3–4 prostatic cancer (1–3). The first trial, 30762, compared Stilboestrol and Estracyt, while the second, 30761, was a randomized comparison of Stilboestrol, Cyproterone Acetate and Medroxyprogesterone Acetate. Both trials have now been closed to patient entry and the principal endpoints of the studies analyzed. This paper will present the interim results which have emerged from these two studies.
Efficacy of Rituximab Combined in Salvage- and High Dose-Therapy (HDT) for Patients with Relapsed NHL; Interim Analysis of a Multicenter Phase II Stu…
2004
Abstract The introduction of Rituximab (R) in the treatment of B-NHL resulted in improvement in first line therapies for indolent (ind.) and aggressive (agg.) B-NHL. However, the value of R in intensive chemotherapy relapse strategies has not definitely been demonstrated. In a phase I/II clinical trial we have demonstrated safety of R as an in vivo purging agens in salvage and high dose therapy for relapsed/refractory B-NHL. This led, with promising response rates, to the initiation of a multicenter phase II trial to further prove therapeutic efficacy. Inclusion criteria were: Pt < 65 years, ECOG < 3, relapse or progression for patients with ind. NHL and induction failure or relapse f…
Intraperitoneal chemotherapy (IP CT) after cytoreductive surgery benefits survival in epithelial ovarian cancer (EOC): Results of a pooled meta-analy…
2018
Related versus unrelated donor transplantation for high risk (HiRi) acute myeloid leukemia (AML) in first complete remission (CR1)
2007
Abstract Allogeneic hematopoietic stem cell transplantation (allo-SCT) from an HLA-identical sibling donor (SIB) is considered the preferred postremission therapy for younger patients with HiRi AML in CR1. The role of allo-SCT from volunteer unrelated donors (VUDs) is less clear and randomized controlled trials addressing this issue do not exist. We performed an observational landmark analysis on parallel cohorts of patients aged &lt;60 years with AML in CR1 and HiRi cytogenetics who had been enrolled into the AML Cooperative Group (AMLCG) 1999 trial. 2347 patients were evaluable for the present update. 243/2347 patients were &lt;60 years of age and had unfavorable cytogenetics [com…