Treatment with nanosomal paclitaxel lipid suspension conventional paclitaxel in metastatic breast cancer patients - a multicenter, randomized, comparative, phase II/III clinical study.

Background: A novel nanosomal paclitaxel lipid suspension (NPLS), free from Cremophor EL (CrEL) and ethanol, was developed to address the solvent-related toxicities associated with conventional paclitaxel formulation.

Objective: To evaluate the efficacy and safety of NPLS CrEL-based paclitaxel (conventional paclitaxel) in patients with metastatic breast cancer (MBC).

Design: A prospective, open-label, randomized, multiple-dose, parallel, phase II/III study.

The Impact of CFTR Modulator Triple Therapy on Type 2 Inflammatory Response in Patients with Cystic Fibrosis.

Background Treatment of cystic fibrosis (CF) has been revolutionized by the use of cystic fibrosis transmembrane conductance regulator (CFTR) protein modulators such as elexacaftor/tezacaftor/ivacaftor (ETI) triple therapy. Prior studies support a role for type 2 (T2) inflammation in many people with CF (PwCF) and CF-asthma overlap syndrome (CFAOS) is considered a separate clinical entity. It is unknown whether initiation of ETI therapy impacts T2 inflammation in PwCF.

Somatic mutations show no clear association with red blood cell or human leukocyte antigen alloimmunization in de novo or therapy-related myelodysplastic syndrome.

Background: Myelodysplastic syndrome (MDS) is a marrow failure disease. As patients often require chronic transfusion, many develop red blood cell (RBC) alloimmunization or immune-mediated platelet refractoriness. MDS represents a spectrum of diseases with specific categorizations and genetic abnormalities, and we set out to determine if these characteristics predispose patients to antibody formation.

Bioequivalence of a hybrid pegylated liposomal doxorubicin hydrochloride injection and Caelyx®: A single-dose, randomized, multicenter, open-label, two-period crossover study in patients with advanced ovarian cancer.

Objective: To evaluate the bioequivalence of a hybrid pegylated liposomal doxorubicin (PLD) hydrochloride injection with reference product Caelyx®.

Methods: This multicenter, open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study was conducted in female patients aged ≥18 years and ≤75 years with ovarian cancer, whose disease progressed or recurred after platinum-based chemotherapy, and who were scheduled to start PLD therapy. Patients were intravenously infused drugs over 1 h at 50 mg/m dose two hours after breakfast on the first day of the chemotherapy cycle in period-I and crossed over to the other arm in period-II (day 29).

Afatinib alone and in combination with vinorelbine or paclitaxel, in patients with HER2-positive breast cancer who failed or progressed on prior trastuzumab and/or lapatinib (LUX-Breast 2): an open-label, multicenter, phase II trial.

Purpose: Resistance to HER2 (ErbB2)-targeted therapy may be mediated by other members of the ErbB family. We investigated the efficacy and safety of the irreversible ErbB family blocker, afatinib, alone as first-line therapy in the advanced setting and in combination with vinorelbine or paclitaxel for those who progressed on afatinib monotherapy, in female patients with metastatic breast cancer who had failed or progressed on prior HER2-targeted therapy in the early disease setting.

Methods: In this phase II, single-arm, two-part study (ClinicalTrials.

Effect of Mindfulness-Based Art Therapy (MBAT) on Psychological Distress and Spiritual Wellbeing in Breast Cancer Patients Undergoing Chemotherapy.

Objectives: Psychological distress and spiritual well-being (SWB) are directly related to the quality of life in cancer patients. Mindfulness-Based Art Therapy (MBAT) integrates mindfulness practices with art therapy and has shown to decrease distress levels and improve SWB in women with breast cancer. The objective of the study was to identify the effects of a 1-week MBAT intervention on psychological distress and SWB in breast cancer patients undergoing chemotherapy.

Diagnostic Challenge Involving Diffuse Mandibular Swelling in Mixed Dentition: Use of Cone-beam Radiography.

Aim And Objective: This case report aims to discuss a case of chronic osteomyelitis with proliferative periostitis (COPP) in which cone-beam computed tomography (CBCT) played a key role in the diagnosis and identification of the disease.

Background: Osteomyelitis is frequently seen in the maxillofacial region, with the mandible being more affected as compared to the maxilla. Chronic osteomyelitis with proliferative periostitis is often seen in children and young adults, which occurs due to the spread of infection from a bacterial focus.

Solitary Pancreatic Head Metastasis from Ductal Carcinoma of Breast: A Case Report.

Liver, bones, and brain are common sites for breast cancer metastasis. We report here a rare scenario of metastasis to pancreatic head from breast cancer after a disease free interval of 7 years. A 60-year old breast cancer survivor noticed upper abdominal pain for 2 weeks, and her investigations revealed a pancreatic head mass lesion.

Updated results from the international phase III ALTTO trial (BIG 2-06/Alliance N063D).

Aim: To present the pre-specified analyses of >5-years follow-up of the Phase III ALTTO trial.

Patients And Methods: 8381 patients with stage I-III HER2 positive breast cancer randomised to chemotherapy plus 1-year of trastuzumab (T), oral lapatinib (L; no longer evaluated), trastuzumab followed by lapatinib (T→L), and lapatinib + trastuzumab (L+T). The primary endpoint was disease-free survival (DFS).

Nutritional status and symptom burden in advanced non-small cell lung cancer: results of the dietetic assessment and intervention in lung cancer (DAIL) trial.

Introduction: European Society for Clinical Nutrition and Metabolism guidelines recommend that patients with cancer should be screened for malnutrition at diagnosis. The dietetic assessment and intervention in lung cancer study investigated the nutritional status of patients with non-small cell lung cancer (NSCLC) and the need for dietetic intervention.

Methods: In this observational cohort pilot study, patients with stage 3b and 4 NSCLC were assessed prior to starting first line systemic anticancer therapy (SACT) with a range of measurements and questionnaires.

A Randomized Phase 2 Study of ADXS11-001 Listeria monocytogenes-Listeriolysin O Immunotherapy With or Without Cisplatin in Treatment of Advanced Cervical Cancer.

Objectives: A global unmet medical need exists for effective treatments for persistent, recurrent, or metastatic cervical cancer, as patients have a short life expectancy. Recently, immunotherapies have shown promising survival benefits for patients with advanced forms of cancer. Axalimogene filolisbac (ADXS11-001), a Listeria monocytogenes immunotherapy with a broad effect on the immune system, is under investigation for treatment of human papillomavirus-associated cancers including cervical cancer.

Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial.

Importance: Efficacious ERBB2 (formerly HER2 or HER2/neu)-directed treatments, in addition to trastuzumab and lapatinib, are needed.

Objective: To determine whether neratinib, an irreversible pan-ERBB tyrosine kinase inhibitor, plus paclitaxel improves progression-free survival compared with trastuzumab plus paclitaxel in the first-line treatment of recurrent and/or metastatic ERBB2-positive breast cancer.

Design, Setting, And Participants: In the randomized, controlled, open-label NEfERT-T trial conducted from August 2009 to December 2014 at 188 centers in 34 countries in Europe, Asia, Africa, and North America, 479 women with previously untreated recurrent and/or metastatic ERBB2-positive breast cancer were randomized to 1 of 2 treatment arms (neratinib-paclitaxel [n = 242] or trastuzumab-paclitaxel [n = 237]).

Comparative accuracy of supine-only and combined supine-prone myocardial perfusion imaging in men.

Background: Combined supine-prone myocardial perfusion imaging (CSP MPI) has been shown to reduce attenuation artifact in comparison to supine-only (SU) MPI in mixed-gender populations with varying risk for coronary artery disease (CAD), often where patients served as their own controls. However, there is limited direct comparison of these imaging strategies in men.

Methods: 934 male patients underwent CSP or SU MPI.

Acute vitamin d toxicity in an infant.

We report vitamin D toxicity in an infant following consecutive administration use of a large dose of vitamin D, causing symptomatic hypercalcemia, which was successfully managed with injectable calcitonin. However, the child developed bilateral medullary nephrocalcinosis which persisted 42 mon after the initial episode.

Opening plugged tympanostomy tubes: effect of biofilm formation.

Objective: To determine if the presence of a bacterial biofilm impacts the rate of clearing of mucoid plugs from tympanostomy tubes (TTs).

Study Design And Setting: Ex vivo model. Stainless steel Reuter Bobbin TTs (n = 18) were placed in growth medium with Pseudomonas aeruginosa and Streptococcus pneumoniae for 12 days to promote biofilm formation.

Opening plugged tympanostomy tubes: effect of inner diameter and shaft length.

Objective: To determine whether tympanostomy tube (TT) inner diameter or shaft length impacts the rate of mucoid plug clearance.

Study Design And Setting: Ex vivo model. Silicone TTs with different inner-diameters (ID) and shaft-length (SL) pairings (1.

Delayed bowel perforation following suprapubic catheter insertion.

Background: Complications of suprapubic catheter insertion are rare but can be significant. We describe an unusual complication of a delayed bowel perforation following suprapubic catheter insertion.

Case Presentation: A gentleman presented with features of peritonitis and feculent discharge along a suprapubic catheter two months after insertion of the catheter.