scholarly journals OCTANE (Ontario-wide Cancer Targeted Nucleic Acid Evaluation): a platform for intraprovincial, national, and international clinical data-sharing

2019 ◽  
Vol 26 (5) ◽  
Author(s):  
E. R. Malone ◽  
R. R. Saleh ◽  
C. Yu ◽  
L. Ahmed ◽  
T. Pugh ◽  
...  

Cancer is a genetic disease resulting from germline or somatic genetic aberrations. Rapid progress in the field of genomics in recent years is allowing for increased characterization and understanding of the various forms of the disease. The Ontario-wide Cancer Targeted Nucleic Acid Evaluation (octane) clinical trial, open at cancer centres across Ontario, aims to increase access to genomic sequencing of tumours and to facilitate the collection of clinical data related to enrolled patients and their clinical outcomes. The study is designed to assess the clinical utility of next-generation sequencing (ngs) in cancer patient care, including enhancement of treatment options available to patients. A core aim of the study is to encourage collaboration between cancer hospitals within Ontario while also increasing international collaboration in terms of sharing the newly generated data. The single-payer provincial health care system in Ontario provides a unique opportunity to develop a province-wide registry of ngs testing and a repository of genomically characterized, clinically annotated samples. It also provides an important opportunity to use province-wide real-world data to evaluate outcomes and the cost of ngs for patients with advanced cancer.    The octane study is attempting to translate knowledge to help deliver precision oncology in a Canadian environment. In this article, we discuss the background to the study and its implementation, current status, and future directions.

2021 ◽  
Author(s):  
Paola Karp ◽  
Matías Gatto ◽  
María Victoria Batto ◽  
Sol Ferrero ◽  
Gustavo Helguera

In the last decade, the expiration of patents protecting therapeutic monoclonal antibodies opened an opportunity for the development and approval of biosimilar versions of these drugs. The complexity of these biologic molecules required the imposition of strict regulations to establish robust comparability with the antibody of reference in physicochemical, analytical, biological and, when deemed necessary, clinical data. Accordingly, this period coincides with the updating of the requirements and guidelines for the manufacture and approval of biologics in Latin American countries by their respective regulatory agencies. Although the term “biosimilar” does not appear in the official regulatory provisions in most of the countries, it is of general use in Latin America, and several biosimilars of therapeutic monoclonal antibodies were approved based on comparative quality, nonclinical and clinical data that demonstrate similarity to a licensed biological reference registered before in a Regulatory Health Authority of reference. Here, we provide an overview of how the complexities of therapeutic monoclonal antibodies shaped the regulatory landscape of similar biologics, the current status of biosimilar monoclonal antibodies in Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, México, Paraguay, Perú and Uruguay and their potential to reduce the cost of antibody therapies in this region.


1991 ◽  
Vol 9 (6) ◽  
pp. 1071-1088 ◽  
Author(s):  
T D Moore ◽  
P H Phillips ◽  
S R Nerenstone ◽  
B D Cheson

Multiple systemic therapies have been used to treat patients with endometrial cancer. Although progestins have been the standard initial treatment for metastatic disease for the past 30 years, they are effective in only 20% of patients, and several large randomized trials have failed to demonstrate any benefit in the adjuvant setting. Alternative agents such as tamoxifen have shown modest activity. Few studies have investigated combinations of hormonally active drugs. Doxorubicin and cisplatin are the most active cytotoxic agents; a current randomized study is comparing the combination of these drugs with single-agent doxorubicin. Maximizing the effectiveness of established drugs, possibly with hematopoietic growth factors, and identifying alternative hormonal and cytotoxic agents with a sound scientific rationale will hopefully increase the effective treatment options for these patients.


2021 ◽  
Vol 22 (9) ◽  
pp. 4400
Author(s):  
Alberto A. Robles-Loaiza ◽  
Edgar A. Pinos-Tamayo ◽  
Bruno Mendes ◽  
Cátia Teixeira ◽  
Cláudia Alves ◽  
...  

Peptide-based drugs are an attractive class of therapeutic agents, recently recognized by the pharmaceutical industry. These molecules are currently being used in the development of innovative therapies for diverse health conditions, including tropical diseases such as leishmaniasis. Despite its socioeconomic influence on public health, leishmaniasis remains long-neglected and categorized as a poverty-related disease, with limited treatment options. Peptides with antileishmanial effects encountered to date are a structurally heterogeneous group, which can be found in different natural sources—amphibians, reptiles, insects, bacteria, marine organisms, mammals, plants, and others—or inspired by natural toxins or proteins. This review details the biochemical and structural characteristics of over one hundred peptides and their potential use as molecular frameworks for the design of antileishmanial drug leads. Additionally, we detail the main chemical modifications or substitutions of amino acid residues carried out in the peptide sequence, and their implications in the development of antileishmanial candidates for clinical trials. Our bibliographic research highlights that the action of leishmanicidal peptides has been evaluated mainly using in vitro assays, with a special emphasis on the promastigote stage. In light of these findings, and considering the advances in the successful application of peptides in leishmaniasis chemotherapy, possible approaches and future directions are discussed here.


2021 ◽  
pp. 827-842
Author(s):  
May Abdel-Wahab ◽  
Soehartati S. Gondhowiardjo ◽  
Arthur Accioly Rosa ◽  
Yolande Lievens ◽  
Noura El-Haj ◽  
...  

Recognizing the increase in cancer incidence globally and the need for effective cancer control interventions, several organizations, professional bodies, and international institutions have proposed strategies to improve treatment options and reduce mortality along with minimizing overall incidence. Despite these efforts, an estimated 9.6 million deaths in 2018 was attributed to this noncommunicable disease, making it the second leading cause of death worldwide. Left unchecked, this will further increase in scale, with an estimated 29.5 million new cases and 16.3 million deaths occurring worldwide in 2040. Although it is known and generally accepted that cancer services must include radiotherapy, such access is still very limited in many parts of the world, especially in low- and middle-income countries. After thorough review of the current status of radiotherapy including programs worldwide, as well as achievements and challenges at the global level, the International Atomic Energy Agency convened an international group of experts representing various radiation oncology societies to take a closer look into the current status of radiotherapy and provide a road map for future directions in this field. It was concluded that the plethora of global and regional initiatives would benefit further from the existence of a central framework, including an easily accessible repository through which better coordination can be done. Supporting this framework, a practical inventory of competencies needs to be made available on a global level emphasizing the knowledge, skills, and behavior required for a safe, sustainable, and professional practice for various settings. This white paper presents the current status of global radiotherapy and future directions for the community. It forms the basis for an action plan to be developed with professional societies worldwide.


2018 ◽  
Vol 7 (4) ◽  
pp. 39 ◽  
Author(s):  
Atif Ahmed ◽  
Divya Vundamati ◽  
Midhat Farooqi ◽  
Erin Guest

Precision oncologic medicine is an emerging approach for cancer treatment that has recently taken giant steps in solid clinical practice. Recent advances in molecular diagnostics that can analyze the individual tumor’s variability in genes have provided greater understanding and additional strategies to treat cancers. Although tumors can be tested by several molecular methods, the use of next-generation sequencing (NGS) has greatly facilitated our understanding of pediatric cancer and identified additional therapeutic opportunities. Pediatric tumors have a different genetic make-up, with a fewer number of actionable targets than adult tumors. Nevertheless, precision oncology in the pediatric population has greatly improved the survival of patients with leukemia and solid tumors. This review discusses the current status of pediatric precision oncology and the different clinical scenarios in which it can be effectively applied.


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