Juniper Publishers-Cancer Therapy Oncology International Journal

  Cancer Therapy & Oncology International Journal Abstract The medical devices that are designated to be marketed need to go through a clearance process set forth by FDA. The Premarket notification (PMN) or 510(k) is the most common regulatory pathway in US but poses many challenges to medical device manufacturers. FDA has cleared more than 1, 40,000 medical devices since 1976. This is a clearance process, and not an approval, for medical devices. 510(K) submission has a purpose, a process and should be well understood in order to avoid unnecessary delays and failures. Keywords: Medical device; Regulation; FDA; 510(K); Substantially Equivalent Abbreviations: FDA: Food and Drug Administration, PMA: Premarket Approval; SE: Substantially Equivalent; Introduction Getting a clearance letter from FDA on 510(K) for a medical device is a milestone and the ultimate goal for any medical device manufacturer, be it a small or a

  Cancer Therapy & Oncology International Journal Abstract Neurofibromatosis was first described in 1882 by Friedrich Daniel von Reckling hausen, a German pathologist. Neurofibroma is a benign peripheral nerve sheath tumor that consists of Schwann cells, associated or unassociated with axons, perineural cells, and fibroblasts. Whenever possible, the treatment of choice should be surgical, but the management depends on the location and growth pattern. We present the case of a patient with left axillary neurofibroma without neurofibromatosis (NF) in whom surgery was delayed due to involvement of the brachial plexus, so was sent to radiotherapy, planned and treated with volumetrically modulated arc therapy (VMAT). Keywords: Neurofibroma; VMAT; Radiotherapy; Axillary Tumor; INCART Abbreviations: NF: Neurofibromatosis; VMAT: Volumetrically Modulated Arc Therapy; CRO: Radiation Oncology Center; INCART: Institute Rosa Emilia Sánchez Pérez de Tavares; CW:

  Cancer Therapy & Oncology International Journal Abstract Multiple myeloma (MM) is a malignant disorder of antibody-producing clonal plasma cells. It is the second most common hematologic neoplasia worldwide [1]. Despite recent advances in myeloma treatment (high-dose chemotherapy followed by autologous stem cell transplantation, novel immunomodulatory drugs, and proteasome inhibitors); MM remains largely incurable with chemotherapy [2]. This is mostly due to the persistence of minimal residual disease (MRD), which leads to high relapse rates [2]. Furthermore, the prognosis of MM patients who become refractory to recently developed novel agents is very poor [1]. Abbreviations: MM: Multiple Myeloma; MRD: Minimal Residual Disease; PD-L1: Programmed Cell Death Ligand; MDSCs: Myeloid-Derived Suppressor Cells; ACT: Adoptive Cellular Therapy; SLAMF7: Signaling Lymphocyte Activating-Molecule Family Member 7; ADCC: Antibody-Dependent Cellular Cytotoxicity; RRM

  Cancer Therapy & Oncology International Journal Abstract Management of patients with glioblastoma multiform requires the concerted efforts of multiple healthcare professionals, including pharmacists. Pharmacists across different practice settings may encounter patients being treated for glioblastoma multiforme. The oral chemotherapy temozolomide is a standard of care forglioblastoma multiforme, with dosing regimens and cycles that require dispensing considerations by the pharmacist as well as careful patient monitoring. Pharmacists should be able to direct the patient with glioblastoma multiforme to payment assistance for this drug as well. Bevacizumab is used to increase progression-free survival in recurrent glioblastoma multiforme, and pharmacists can also aid in the dosing and monitoring of this agent. Sequelae of glioblastoma multiforme include brain edema, seizures, venous thromboembolism, depression, and fatigue. Management of sequelae may include th