Safety, Pharmacokinetics and Preliminary Efficacy of IL4-Rα Monoclonal Antibody AK120 in Both Healthy and Atopic Dermatitis Subjects: A Phase I, Randomized, Two-Part, Double-Blind, Placebo-Controlled, Dose-Escalation, First-In-Human Clinical Study.

Introduction: Interleukin-4 (IL-4) and interleukin-13 (IL-13) are two essential cytokines involved in the T helper 2 (Th2)-mediated inflammatory response to diseases, such as atopic dermatitis (AD). AK120 is a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody (mAb) directed against the IL-4 receptor alpha (IL-4Rα) subunit shared by the IL-4 and IL-13 receptor complexes. This mAb inhibits the signaling of the IL-4 and IL-13 cytokines.

A randomized, single-blind, Phase I trial (INVICTAN-1) assessing the bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects.

Objectives: This Phase I trial (INVICTAN®-1) evaluated three-way bioequivalence and safety of BI 695502 a bevacizumab biosimilar candidate, and reference product bevacizumab from two sources (US-approved Avastin®, Genentech; EU-approved Avastin, Roche).

Methods: Healthy male subjects (N = 91) were randomized 1:1:1 to receive a single intravenous infusion of 1 mg/kg of BI 695502 or US- or EU-approved Avastin. An interim analysis was planned when ~50% of subjects were evaluable for the primary end point to determine if the prespecified criteria for bioequivalence were achieved; if demonstrated, the study could be stopped early.

The cathepsin K inhibitor odanacatib suppresses bone resorption in women with breast cancer and established bone metastases: results of a 4-week, double-blind, randomized, controlled trial.

Background: Metastatic bone disease (MBD) is a frequent complication in patients with breast cancer and is associated with significant morbidity. This study assessed the pharmacokinetics, efficacy, and safety of odanacatib, a selective Cat K inhibitor, in reducing markers of bone resorption in women with breast cancer and MBD.

Patients And Methods: Women with breast cancer and MBD were randomized 2:1 (double-blind) to oral odanacatib 5 mg daily for 4 weeks or intravenous (I.

Efficacy of an integrated continuing medical education (CME) and quality improvement (QI) program on radiation oncologist (RO) clinical practice.

Purpose: There has been little radiation oncologist (RO)-specific research in continuing medical education (CME) or quality improvement (QI) program efficacy. Our aim was to evaluate a CME/QI program for changes in RO behavior, performance, and adherence to department protocols/studies over the first 12 months of the program.

Methods And Materials: The CME/QI program combined chart audit with feedback (C-AWF), simulation review AWF (SR-AWF), reminder checklists, and targeted CME tutorials.

A study of complications arising from different methods of anesthesia used in high-dose-rate brachytherapy for cervical cancer.

The purpose of this report is to review the complications related to different methods of anesthesia for high-dose-rate (HDR) brachytherapy for cervical carcinoma. All patients diagnosed with cervical cancer between 1999 and 2002 treated with 3-channel HDR brachytherapy were entered. Complications due to anesthesia for each fraction of brachytherapy were graded using the Common Toxicity Criteria.

Evaluation of a radiotherapy protocol based on INT0116 for completely resected gastric adenocarcinoma.

Purpose: With the results of the INT0116 study, adjuvant radiochemotherapy has become the standard treatment after complete resection of gastric adenocarcinoma. However, the implementation of radiotherapy (RT) remains a concern. In response, consensus guidelines on RT technique have been published.

Design of an internationally accredited radiation oncology resident training program incorporating novel educational models.

Purpose: Our primary aim was to design a new, internationally accredited, comprehensive radiation oncology (RO) training program for Singaporean residents that satisfied the needs of stake holders and incorporated published evidence.

Methods And Materials: The evidence-based method included Medline literature review and broad-based training needs assessment.

Results: Literature review revealed few studies describing or evaluating RO resident training programs.

A comparison of RANZCR and Singapore-designed radiation oncology practice audit instruments: how does reproducibility affect future approaches to revalidation?

Physician competency assessment requires the use of validated methods and instruments. The Royal Australian and New Zealand College of Radiologists (RANZCR) developed a draft audit form to be evaluated as a competency assessment instrument for radiation oncologists (ROs) in Australasia. We evaluated the reliability of the RANZCR instrument as well as a separate The Cancer Institute (TCI) Singapore-designed instrument by having two ROs perform an independent chart review of 80 randomly selected patients seen at The Cancer Institute (TCI), Singapore.

Adjuvant high-dose rate brachytherapy after chemoradiation for treatment of early T-stage nasopharyngeal carcinoma.

The local control of nasopharyngeal carcinoma after conventional radiotherapy has historically been suboptimal. Recently, investigators have reported improved outcomes for this patient population with the use of combined chemoradiotherapy. The purpose of this analysis of our prospective treatment protocol was to evaluate the additional value of high-dose rate intracavitary brachytherapy (HDRIB) on the disease response, local control, and survival.

Patient preference for radiotherapy fractionation schedule in the palliation of painful bone metastases.

Purpose: The radiotherapeutic management of painful bone metastases is controversial, with several institutional and national guidelines advocating use of single-fraction radiotherapy. We aimed to determine patient choice of fractionation schedule after involvement in the decision-making process by use of a decision board.

Patients And Methods: Advantages and disadvantages of two fractionation schedules (24 Gy in six fractions v 8 Gy in one fraction) used in the randomized Dutch Bone Metastasis Study were discussed with patients using a decision board.

Cultural attitudes to cancer management in traditional South-East Asian patients.

Cultural differences might influence patients' attitudes to decision-making for cancer management. In a Western medical system promoting shared decision-making and patient autonomy, the effects of traditional South-East Asian cultural and religious attitudes might provoke confusion for both the patient and health-care provider. Especially in oncology, these beliefs might influence patients' perceptions of diagnosis, symptoms, interventions and approaches to death.