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Background
There are limited to no data regarding the use of immune checkpoint inhibitors (ICIs) in patients who have preexisting organ dysfunction because these patients are frequently excluded from clinical trials. The authors’ objective was to evaluate the effects of ICIs in patients with chronic kidney disease (CKD), cirrhosis, chronic obstructive pulmonary disease (COPD), and congestive heart...
Background
SH‐1028 is a new third‐generation EGFR tyrosine kinase inhibitors (TKI) to benefit patients with EGFR T790M‐mutated NSCLC. Here, the authors report its clinical safety, preliminary efficacy, and pharmacokinetic (PK) profile for the first time.
Methods
Patients with EGFR T790M mutation, locally advanced non–small cell lung cancer (NSCLC), or metastatic NSCLC who had progressed after previous...
Background
This study compares the safety and efficacy of first‐line treatments for anaplastic lymphoma kinase (ALK)‐mutated non–small cell lung cancer (NSCLC).
Methods
A comprehensive literature search was conducted in PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases. Abstracts related to lung cancer presented at important international conferences...
Background
The optimal treatment strategy for refractory or relapse (R/R) indolent non‐Hodgkin lymphoma (iNHL) has not been fully identified. This study aims to investigate the efficacy and tolerance of bendamustine hydrochloride developed in native Chinese corporation in the treatment of patients with R/R iNHL.
Methods
A total of 101 patients from 19 centers were enrolled in this study from July...
Two Janus‐associated kinase inhibitors (JAKi) (initially ruxolitinib and, more recently, fedratinib) have been approved as treatment options for patients who have intermediate‐risk and high‐risk myelofibrosis (MF), with pivotal trials demonstrating improvements in spleen volume, disease symptoms, and quality of life. At the same time, however, clinical trial experiences with JAKi agents in MF have...
Background
Acupuncture is frequently used to treat the side effects of cancer treatment, but the safety of this intervention remains uncertain. The current meta‐analysis was conducted to assess the safety of acupuncture in oncological patients.
Methods
The PubMed, Cochrane Central Register of Controlled Trials, and Scopus databases were searched from their inception to August 7, 2020. Randomized...
Background
This multicenter clinical trial was designed to evaluate the efficacy and safety of thalidomide (THD) in preventing oral mucositis (OM) in patients with nasopharyngeal carcinoma (NPC) undergoing concurrent chemoradiotherapy (CCRT).
Methods
Patients with locally advanced NPC were randomly assigned to either a THD group or a control group. All 160 patients received radical intensity‐modulated...
Background
Cyclin‐dependent kinase 4/6 (CDK4/6) inhibitors, including palbociclib, are approved to treat hormone receptor (HR)‐positive/human epidermal growth factor receptor 2 (HER2)‐negative advanced breast cancer (ABC) and are associated with hematologic toxicity. African American women, who are underrepresented in CDK4/6 inhibitor clinical trials, may experience worse neutropenia because of benign...
Background
The objective of this study was to report on the long‐term effects of pexidartinib on tenosynovial giant cell tumor (TGCT).
Methods
This was a pooled analysis encompassing 3 pexidartinib‐treated TGCT cohorts: 1) a phase 1 extension study (NCT01004861; 1000 mg/d; n = 39), 2) ENLIVEN patients randomized to pexidartinib (1000 mg/d for 2 weeks and then 800 mg/d; n = 61), and 3) ENLIVEN crossover...
Background
Immune checkpoint inhibitors are being considered for locally advanced cervical cancer (LACC) together with standard‐of‐care pelvic chemoradiation (CRT). However, the safety of the combination and its optimal schedule are unknown. Defining the safety of the combination is a primary objective of a study examining concurrent and sequential schedules. This article presents a safety analysis...
Background
Nilotinib is a potent, second‐generation inhibitor of BCR‐ABL1 tyrosine kinase and has been approved as frontline and salvage therapy for patients with chronic‐phase chronic myeloid leukemia (CP‐CML).
Methods
In this single‐institution, phase 2 study, 122 patients with newly diagnosed CP‐CML received nilotinib 400 mg twice daily. The median follow‐up on study was 78.3 months (interquartile...
Background
The objective of this study was to determine whether fertility preservation (FP) with oocyte/embryo cryopreservation is associated with differences in disease‐free survival (DFS).
Methods
This retrospective study included patients aged 18 to 45 who were diagnosed with invasive breast cancer between 2007 and 2017 and were seen for FP consultation at a university fertility center before...
Background
The large registry, PROVENGE Registry for the Observation, Collection, and Evaluation of Experience Data (PROCEED)(NCT01306890), evaluated sipuleucel‐T immunotherapy for asymptomatic/minimally symptomatic metastatic castration‐resistant prostate cancer (mCRPC).
Methods
PROCEED enrolled patients with mCRPC receiving 3 biweekly sipuleucel‐T infusions. Assessments included overall survival...
Background
The adjuvanted recombinant zoster vaccine (RZV) has demonstrated >90% efficacy against herpes zoster in adults ≥50 years of age and 68% efficacy in autologous hematopoietic stem cell transplant recipients ≥18 years of age. We report the immunogenicity and safety of RZV administered to patients with solid tumors (STs) before or at the start of a chemotherapy cycle.
Method
In this phase...
Background
This randomized phase 2 trial compared the efficacy and safety of second‐line nanoparticle albumin‐bound paclitaxel (nab‐paclitaxel) with or without the addition of CC‐486 (an oral formulation of 5‐azacytidine) in patients with advanced‐stage, nonsquamous non‐small cell lung cancer.
Methods
Patients were randomized to receive either nab‐paclitaxel 100 mg/m2 on days 8 and 15 plus CC‐486...
Background
Phase I cancer trials increasingly incorporate dose‐expansion cohorts (DECs), reflecting a growing demand to acquire more information about investigational drugs. Protocols commonly fail to provide a sample‐size justification or analysis plan for the DEC. In this study, we develop a statistical framework for the design of DECs.
Methods
We assume the maximum tolerated dose (MTD) for the...
BACKGROUND
This is the first report of long‐term (>10 years) safety, tolerability, and survival data on patients with non–small cell lung cancer (NSCLC) who received treatment with gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor.
METHODS
Patients with advanced NSCLC (N = 191) who entered the IRESSA Clinical Access Program (ICAP) (June 2011 to January 2013) and...
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