Virtual Library

Start Your Search

Merel Hennink

Author of

  • +

    PC01 - Reinventing Clinical Trials (ID 83)

    • Event: WCLC 2019
    • Type: Pro-Con Session
    • Track: Advocacy
    • Presentations: 1
    • Now Available
    • +

      PC01.02 - Real World Research Groups - ROS1ders (Now Available) (ID 3556)

      11:00 - 12:30  |  Presenting Author(s): Merel Hennink

      • Abstract
      • Presentation
      • Slides


      Presentation Title: Real World Research Groups - ROS1ders
      Session: Reinventing Clinical Trials

      Merel Hennink

      Lung cancer research has made great progress in the last decade. Discovery of more treatable mutations have paved the way to more treatment options. We are moving away from a “one-size-fits-all” chemotherapy towards personalized medicine. (1)

      However, these developments require accurate diagnostics to identify the right treatment options. Furthermore, as a common cancer like lung cancer is split into rare subgroups, it also poses additional challenges. Rare mutations in NSCLC (for instance ROS1) result in small patient populations for trials and less bio-materials for research. The main question here is how to navigate this changing landscape.

      The ROS1ders – a community

      The ROS1 rearrangement was first described in 2007 and occurs in about 1% of patients with NSCLC. Of the estimated 1.5 million new cases of NSCLC worldwide each year, approximately 15,000 may be driven by oncogenic ROS1 fusions.(2) In 2015, little was known about the ROS1 rearrangement and only a single drug was available to treat the disease. Also in 2015, a group of ROS1 positive lung cancer patients formed an international community on social media, The ROS1ders, allowing them to connect with each other. Through social media, patients are becoming increasingly engaged, and discussing the diagnostic and treatment options available in their countries or hospitals. In addition, these national and global online communities, where information is shared, can highlight (inter)national disparities in treatment access.

      Crizotinib is currently the only FDA- and EMA–approved agent for the treatment of ROS1-rearranged NSCLC. Unfortunately several healthcare systems across the world have difficulty with reimbursing the drug due to lack of data from randomized clinical trials (UK, South Africa, Canada, New Zealand). In Canada, Real World Data from the ROS1 Facebook group helped in the approval process. “The Committee expressed that they were impressed with the patient input of 259 ROS1 positive patients and caregivers from 32 countries who supported the use of crizotinib. Overall, from the perspectives of patients with ROS1-positive NSCLC, they value a chance to extend their life and spend more time with their families by having a treatment that is effective, and improves their symptoms and outcomes.”(3)

      Global ROS1 initiative – from advocacy to active research

      The ROS1ders transitioned from advocacy to active research in the past few years. Reaching out to academic cancer centers, they strove to increase the amount of cancer models available to stimulate ROS1 research. The Global ROS1 Initiative is a partnership connecting researchers, patients, caregivers, and physicians worldwide. Patients who have an upcoming biopsy contact the national study nurse, and can choose to donate extra material to generate a cell line, a patient-derived xenograft (PDX) mouse model, or both. The goal is to create models and data accessible to all researchers. All models and characterization data will be made available as an open access database to researchers and collaborators. The Global ROS1 initiative has already generated four cell lines at the University of Colorado, and three PDX mouse models are in development. Patients are in the driver seat!(4)



      Testing is essential to select the right treatment. Nevertheless, systematic diagnostic testing for ROS1 in metastatic NSCLC is not yet included in the European Society of Medical Oncology recommendation, but only suggested. (5) In Europe, access to molecular testing and new medicines differs between individual countries, even within the same country. In the Netherlands, a retrospective study in all patients that tested negative for EGFR and KRAS, showed an increase in ROS1 testing between 2013 (10%) and 2017 (61%) (6). Given the demonstrated added value of patient-driven organizations, both for patients and research, we need a more systematic testing for ROS1, in order to offer effective treatment to more ROS1 patients and strengthen our international community.

      ROS1 patients as research partners in Europe

      The Global ROS1 Initiative requires streamlined protocols to be successful. Currently, European ROS1ders cannot donate tissue for a variety of reasons. Therefore, a pan-European collaboration should be implemented, that centralizes expertise on the small number of potential tissue donations. In this network, tissue processing should be centralized in a single lab, and the resulting data and models could be distributed to collaborating partners. However, the setup of such network is very difficult, in part due to national differences in legislation.

      Furthermore, although we are a European Union, patients are not really united, and bringing together the European ROS1ders is not an easy task. We deal with language, boundary and policy issues. Due to European public health systems, all responsibility is given to doctors. Most patients see less benefit in getting informed and organized. Data protection laws and less use of social media make it more difficult to connect patients. Next, the number of non-governmental organizations supporting lung cancer patients is small - in particular in Europe. And finally, fundraising activities are rather uncommon in Europe. Overall these aspects make it harder for patient advocates to make a difference. As such, international networking and solidarity become even more important.

      In the Netherlands, was founded to raise awareness and accelerate research. As a result, research on drug resistance has been initiated in cell lines and PDX mouse models. In parallel, drug resistance is also studied in France and Germany. Combining these individual studies might result in a 1+1 equals 3 scenario.

      We strive to unite our national voices to influence European policies and use our European voices to connect national studies.

      Understanding the role of personalized medicine

      Jessica J. Lin MD & Alice T. Shaw (2017) “Recent Advances in Targeting ROS1 in Lung Cancer” in Journal of Thoratic Oncology .

      Xalkori for ROS1 positive advanced lungcancer. 2019 (4)

      D. Planchard et al. (2018) “Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.” Annals of Oncology 29 (Supplement 4): iv192–iv237, 2018 doi:10.1093/annonc/mdy275

      Kuijpers Chantal C.H.J. et al (2018). “National variation in molecular diagnostics in metastatic lung cancer. “ Nederlands Tijdschrift voor Geneeskunde 162:D1607

      Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.

      Only Active Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login or select "Add to Cart" and proceed to checkout.