Saturday 18 August 2018

Basket study

Source: [4].

«Basket trials (or studies) test the effect of one drug on a single mutation in a variety of tumor types [baskets], at the same time. These studies also have the potential to greatly increase the number of patients who are eligible to receive certain drugs relative to other trials designs [1], «allowing researchers to analyze each cancer type individually, as well as assess the impact of the drug or drug combinations as a whole. Using this approach, it is possible to combine what would have been multiple phase 2 trials into a single study [4]». «In the evaluation of targeted therapies, basket trials have emerged as an approach to test the hypothesis that targeted therapies may be effective independent of tumor histology, as long as the molecular target is present [2].» «Most basket trials typically aim to answer multiple questions simultaneously [3].»

Bibliographic references:
[1] Clinical Trial Design and Methodology. ASCO. https://www.asco.org/research-progress/clinical-trials/clinical-trial-resources/clinical-trial-design-and-methodology. Accessed August 18, 2018.
[2] Redig AJ, Jänne PA. Basket trials and the evolution of clinical trial design in an era of genomic medicine. J Clin Oncol. 2015 Mar 20;33(9):975-7. Available at: https://doi.org/10.1200/JCO.2014.59.8433.
[3] Cunanan KM, Gonen M, Shen R, et al. Basket Trials in Oncology: A Trade-Off Between Complexity and Efficiency. J Clin Oncol. 2017 Jan 20;35(3):271-273. Available at: https://doi.org/10.1200/JCO.2016.69.9751.
[4] Illuminating ideas: Innovative clinical trial design. Roche.com. https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/innovative-clinical-trial-design.htm. Accessed August 18, 2018.

Heart radiation


Source: Kim M. Radiating The Heart Saves Patty Sweeney. ABC30 Fresno. https://abc30.com/health/radiating-the-heart-saves-patty-sweeney/3966266/. Published 2018. Accessed August 18, 2018.

Wednesday 15 August 2018

Febrile neutropaenia

«Febrile neutropaenia is defined as an oral temperature of >38.3°C or two consecutive readings of >38.0°C for 2 h and an absolute neutrophil count of <0.5 × 109/L, or expected to fall below 0.5 × 109/L.»
Bibliographic reference: Klastersky J, de Naurois J, Rolston K, Rapoport B, Maschmeyer G, Aapro M, Herrstedt J, on behalf of the ESMO Guidelines Committee; Management of febrile neutropaenia: ESMO Clinical Practice GuidelinesAnnals of Oncology, Volume 27, Issue suppl_5, 1 September 2016, Pages v111–v118, https://doi.org/10.1093/annonc/mdw325.

Monday 13 August 2018

Multi-arm multi-stage (MAMS) trial design

Advanced/metastatic NSCLC treatment algorithm

Advanced/metastatic NSCLC [non-small cell lung cancer] treatment algorithm:
ALK: anaplastic lymphoma kinase; EGFR: epidermal growth factor receptor; PD-L1: programmed cell death ligand 1; ROS1: proto-oncogene receptor tyrosine-protein kinase; TPS: tumor proportion score.
Source: Brahmer JR, Govindan R, Anders RA, et al. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of non-small cell lung cancer (NSCLC). J Immunother Cancer. 2018 Jul 17;6(1):75. Available at: https://doi.org/10.1186/s40425-018-0382-2. Creative Commons license: https://creativecommons.org/publicdomain/zero/1.0/.


[French]