Yes to lung cancer screening with a specific framework, coordinated policy,

national guidelines and pilot implementation

 

In the course of FairLife’s conference, “Lung Cancer in the Age of Innovation: The importance of early screening, new therapeutic approaches – a modern approach to molecular testing and clinical studies”, 36 speakers and commentators discussed lung cancer treatment from various perspectives. Representatives from the State, the research community and patients addressed lung cancer as a strategic priority and a public health issue, a field of innovation as well as a constant race against time, supported by modern therapeutic approaches and with the contribution of the scientific community and the pharmaceutical industry.

The conference was opened by Mrs. Korina Pateli-Bell, President of FairLife Lung Cancer Care, who noted that “the unprecedented health crisis, caused by the pandemic, has changed many aspects of our daily lives, but for people living with lung cancer, the need for effective treatment remains imperative. No patient can or should wait any longer…”.

On behalf of the State, Mr. Thanos Plevris, Minister of Health, pointed out that lung cancer prevention is considered as a priority. In this perspective, the Ministry focuses on providing innovative treatments to patients, as well as on reinforcing clinical studies in Greece, by creating a framework for treating various forms of cancer, including lung cancer. Deputy Minister of Health, Mrs. Mina Gaga, highlighted the importance of screening for the society as well as for the National Health System.

Representing the academic and research community, Mr. Athanasios-Meletios Dimopoulos, Rector of the National and Kapodistrian University of Athens, Professor of Hematology-Oncology, Director of the Therapeutic Clinic of the Faculty of Medicine, National and Kapodistrian University of Athens, stated : “In our country we expect more than 5,000 cases of lung cancer every year; therefore, early diagnosis, through the development and implementation of screening and intervention methods, is very important, both to patients and to the National Health System. LDCT scanning is an effective tool, which has contributed to reduce mortality to 26% in men and to 59% in women.

 Professor Sanjay Popat (PhD FRCP), Consultant Medical Oncologist, Royal Marsden Hospital, Professor of Thoracic Oncology, Institute of Cancer Research, described lung cancer as a “silent killer”. He underlined that the disease remains a major public health problem globally, which has not been addressed, due to a failure of public policy. “An understanding of national epidemiological data is required with mapping of diagnoses, stage, type, treatments and outcomes to each hospital.” He also highlighted the need for a national and funded strategy for genetic testing, as well as patients’ access to clinical trials.

 “In modern medicine – precision medicine with targeted therapeutic approaches –  patients are at the core of decisions, attention and evolution. They must have a voice in both the research and the use of innovative drugs”, stated Mr. Konstantinos Syrigos (MD, PhD, FCCP), Professor & Director, School of Medicine, National and Kapodistrian University of Athens.

A message of optimism was conveyed by Mrs. Karen Kelly (MD), CEO of the IASLC, Professor Emeritus University of California, who noted that “we will conquer cancer in this century, perhaps even in the next few decades, by matching scientific innovation with educational innovation. Only by educating physicians, patients, policymakers and the public about the amazing progress and then by applying that knowledge, we can make a monumental impact.”

Concluding her opening remarks at the FairLife conference, Mrs. Ewelina Szmytke, Vice President, Lung Cancer Europe , stressed that the implementation of lung cancer screening programs – always proven to be effective – , the training of health professionals as well as the ongoing information provided to patients about available options, are necessary points of intervention.

A targeted screening program saves many years of life.

 

 “The question that needs an immediate answer is how we will effectively implement screening (as it is already being implemented through pilot programs) and not whether we are ready…” noted Mrs. Helena Linardou (MD, PhD), Medical Oncologist, Director of the 4th Oncology Clinic – Metropolitan Hospital, President of the Scientific Committee of HeCOG and Member of the Board, FairLife L.C.C.  “Screening is an entire process. It is not only about  prescribing low-dose CT scans. The process includes risk assessment, low-dose CT scanning – already available in several areas in Greece – , the connection to a smoking cessation clinic, a multidisciplinary board with all specialties involved in lung cancer, oncologists, pulmonologists and radiologists, along with any other relevant specialty. And it should definitely be concluded by connecting the community and primary care physicians and by recalling  high-risk patients.”

 Mr. Kyriakos Souliotis, Professor of Health Policy, Dean of the Faculty of Social and Political Sciences, University of Peloponnese, noted:

«Evidence indicates that a targeted screening program saves years of life. It needs to be well organized with a specific standardized process, each step of the way. It is not enough to undergo screening, one needs to be tested   through a mechanism that guarantees a follow-up after screening and specific recommendation for the next steps. We have both the personnel and the infrastructure to support such a program. But this requires a plan, which respects budgetary limits and the financial capacity of the health system, and thoroughly determines all necessary conditions”.

Commenting on the implementation of screening, Mrs. Eirini Agapidaki, Secretary General of Public Health, Ministry of Health, stressed that the political will is given. However, it is necessary to proceed carefully and with specific qualitative criteria, as screening programs are new to Greece. “We need to build the program on solid foundations to make it sustainable. The inclusion of lung cancer screening in the guidelines is now being considered in the EU. This development gives us the opportunity to follow a common European framework.”

On closing the introductory part of the conference, Mr. Stelios Loukidis, (MD, FCCP, FERS), President of the Hellenic Thoracic Society(HTS), Professor of Respiratory Medicine, National and Kapodistrian University of Athens, emphasized that the integration of screening should be done in coordinated  framework, with specific guidelines and interdisciplinary cooperation, pilot programs, and of course, as a prerequisite, smoking cessation. He promised that the Hellenic Thoracic Society would soon present a full plan, based on a multidisciplinary approach and with clear implementation criteria.

 

A modern approach to molecular testing, the role of precision medicine in lung cancer and the value to patients.

 

During Section A of the conference, speakers referred to the importance of molecular testing in terms of its diagnostic function. They also stressed the need for accessible DNA analysis tests to lung cancer patients through the Public Health System.

 Mr. Petros Christopoulos (MD, PhD), Pathologist Oncologist – Hematologist, Professor of Pathological Oncology, University of Heidelberg, highlighted:

“Genomic testing has a key role in modern oncology, as a prerequisite for the administration of targeted drugs with better efficacy and tolerance than chemotherapy. Every patient with advanced non-small cell lung cancer needs combined DNA+RNA tumor sequencing (NGS) for comprehensive screening of “curable” mutations. Repeat biopsy during disease progression to perform NGS with a broader panel and assessment by a molecular oncology board can further improve survival. ”

 Mrs. Evi Lianidou (PhD), Professor of Analytical Chemistry, Clinical Chemistry, Department of Chemistry, National and Kapodistrian University of Athens, spoke about the clinical applications of liquid biopsy today and in the future, as well as the role of rebiopsy: “Liquid biopsy is not new and it involves the analysis of cancer DNA in plasma and circulating cancer cells. Compared to conventional biopsy, it allows us to follow patients at different time intervals, even when the primary tumor has been surgically removed, and to obtain information about the tumor in cases, where biopsies are not feasible. From this simple blood analysis we can get a lot of information at the DNA and RNA level.”

On behalf of the State, Mr. Theofanis Rigatos, Head of the Independent Directorate of Contracts and Vendor Auditing, National Organization for Health Care Services Provision (EOPYY) stressed that “our country must examine and research all challenges and perspectives related to health issues. Our goal is to provide better and higher quality services to beneficiaries of the Organization”. He made reference to Article 6 of the EOPYY’s Unified Health Benefits Regulation (EOPYY) (Official Government Gazette 4898/B/2018): The beneficiaries of the Organization are provided with diagnostic tests and procedures, which are provided for by the legislation in force; “moreover”, he noted, “Article 62 of the EOPYY provides that: By decision of the Board of Directors of the EOPYY, following a recommendation of the competent Directorate and a positive opinion of the Supreme Health Council, the Agency may reimburse benefits not provided for in this Regulation.”

 Mrs. Zenia Saridaki (MD, PhD), Pathological Oncologist, President of the Hellenic Society of Medical Oncology (HeSMO),
Director at the First Oncology Clinic Metropolitan Hospital, Athens Scientific Head of Oncology Department “Asklipios DIAGNOSIS”, Heraklion Crete stated “as a scientific society we are striving for the integration of all biomarkers in the national prescription system and integration of NGS for the right therapeutic approach to patients. There is a gap in biomarker reimbursement, which is an absolute priority.”

“Although there are some positive efforts in Greece, they seem to be isolated and fragmented, in the sense that not all biomarkers are reimbursed, despite the fact that certain targeted therapy drugs have been approved. Also, there are no organized molecular pathological anatomy centres that start from histology to get to the molecular profile of the tumor, in order to provide the oncologist with the right information. It is an important issue that requires organization, financial support, expertise and certified laboratories” noted Mrs. Aphrodite Nonni (MD), Professor of Pathological Anatomy, School of Medicine, National and Kapodistrian University of Athens, President of the Hellenic Society of Pathology (HSP)

 The topic of biomarkers was raised by Mrs. Kathi Apostolidis, President of the Hellenic Cancer Federation ELLOK, Past President and Chair Scientific Committee, ECPC, Cancer Federation. Mrs. Apostolidis referred to a European study that recorded the need for simultaneous approval of drugs and corresponding biomarkers and the approval of NGS especially for lung cancer.

 

Personalised therapies in the modern treatment of lung cancer and the latest developments

 

Issues, raised by representatives of the scientific community and patient representatives in the Section B of the conference, included the importance of specific biomarkers for lung cancer treatment and their inclusion in the national prescription system. Biomarkers can identify people at risk of developing cancer and contribute to the implementation of targeted treatment based on the patient’s profile.

“The ALK biomarker can predict whether a patient will respond to a specific treatment and can also be used to monitor disease remission. The ALK (Anaplastic Lymphoma Kinase) biomarker in lung cancer is a mutation in DNA with a predictive role and indicates which individuals with non-small cell lung cancer are likely to benefit therapeutically from specific targeted therapies. Studies have shown that 2% to 5% of patients with specific features carry mutations in the ALK gene” reported Mrs. Athina Christopoulou (MD, PhD) Medical Oncologist, Director of Oncology Unit, General Hospital of Patras.

 “The emergence of mutations in the EGFR (Epidermal Growth Factor Receptor) gene involves specific populations with a histological type of adenocarcinoma and 12% of these mutations involve insertions in exon 20, resulting in resistance to standard EGFR inhibitors and a poor prognosis, with a median survival of only 16 months. The use of modern NGS (Next Generation Sequencing) technology is of great importance in diagnosis. Platinum – based combinations are indicated as first-line therapy, while targeting agents such as the monoclonal antibody amivantamab have proven strong efficacy in the second-line setting,” pointed out Mr. George Lainakis (MD), Medical Oncologist, Deputy Head of the 4th Oncology Department, Metropolitan Hospital.

KRAS mutations represent mutations with the highest prevalence, affecting 1 in 7 patients with non-small cell lung cancer. “Historically, targeting this mutation has been very difficult for many reasons, mainly because of the high affinity of KRAS with its substrate, which means that it is difficult to use inhibitors, but also because of the complexity of the protein,” explained Mr. Ferdinandis Skoulidis (MD, PhD, MRCP), Associate Professor Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center.

“Non-small cell lung cancer is a particular example of personalized medicine in oncology. A multitude of genetic alterations that promote carcinogenesis have been identified and can be targeted therapeutically. Mutations in the BRAF, HER2 and MET genes are found in a small percentage of patients. However, the survival benefit of existing targeted therapies is important and the presence of these genetic alterations should be actively screened for in all patients,” stressed Mr. Michalis Liontos (MD, PhD), Medical Oncologist, Assistant Professor at the Department of Clinical Therapeutics, Oncology Unit, National and Kapodistrian University of Athens.

“The landscape in molecular classification of non-small cell lung cancer is impressive. So many mutations have been discovered, molecular changes that are of great importance. Although each one corresponds to a small percentage of patients, lung cancer is such a common disease that each small sub-group has clinical significance, because the right targeted therapy can benefit thousands of patients. 50% of patients with advanced non-small cell lung cancer have a driver mutation and can receive an approved targeted therapy. The ROS 1, RET and NTRK transmutations are rare and are detected in 1%-2% of patients,” reported Mrs. Maria Skondra (MD), Pathologist Oncologist,Curator 2, 3rd Oncology Department, Henry Dunant Hospital.

Tumor-infiltrating lymphocyte (TIL) therapy was introduced by Mrs. Evi Hatziandreou (MD, DrPH), Sr. Director, Health Policy and Market Access, Theracell Advanced Biotechnology, Vice President of FairLife LCC: “It is an adopted cell therapy technique that is being studied for various types of cancer, particularly melanoma. The immunogenic tumor microenvironment of lung cancer makes it a potential candidate for immunotherapy therapies such as TIL therapy. Available results are not conclusive on the efficacy and safety of TIL therapy for lung cancer and several clinical trials are in the process of further evaluating this method. TIL therapy could be enhanced using modifications such as gene editing or incorporation of TWS119, although further studies are needed to establish their efficacy.”

“It is highly important to stop smoking”, noted Mrs. Paraskevi Katsaounou (MD), Associate Professor of Pulmonology, Medical School, National and Kapodistrian University of Athens, Pulmonology and Respiratory Deficiency Unit, 1st Hospital, Evangelismos, Hellenic Pulmonology Society, Board Member,President of the Health Promotion, Medical Education and Smoking Cessation Group of the Hellenic and European Pulmonology Society. Commenting on the topics of the Section, Ms Katsaounou pointed out that smoking cessation is extremely important for patients who are diagnosed and still smoke, as studies show that quitting after diagnosis significantly increases survival rates.

The importance of biomarkers was mentioned by Mrs. Anna Batistatou (MD, PhD), Professor of Pathology, Director of the Department of Pathology UOI and of the Pathology/Cytology Laboratory UHI, University of Ioannina, Greece.  Mrs. Batistatou noted that “studies highlight the importance of molecular classification and tissue reaction around the neoplasm. These studies are based on biomarker testing, so we must insist on reliable biomarker testing to be performed in all patients so as to proceed with targeted therapy.”

Mr. Ioannis Boukovinas (MD, PhD, PharmaD), Medical Oncologist, Scientific Manager of Medical Oncology Unit at Bioclinic Thessaloniki, focused on the example of the USA, where changes in legislation have led to the immediate entry of drugs and treatments into the market. “This example”, he said, “should be followed by the EU and by our country, as any delay could mean the loss of human lives. We should all work together to reduce the time of entry of innovative medicines in the Greek market.”

“50% of lung cancer patients have a mutation for which we have a targeted therapy. This means that all our patients with metastatic cancer should have access to modern techniques, such as NGS, which will allow us to identify the most common and rare mutations,” said Mr. Epaminondas Samantas (MD, PhD), Medical Oncologist
Director of the 2nd Oncology Department, Metropolitan Hospital.

 

New therapeutic approaches

 

The role of immunotherapy in the early stage of NSCLC was focused on by Mr. Ioannis Mountzios (MD, MSc, PhD), Medical Oncologist, Director 4th Oncology Department and Clinical Trials Unit, Henry Dunant Hospital Center. “Immunotherapy, after very positive results in advanced lung cancer, is entering the therapeutic field of early disease. Studies show that, when administered preoperatively along with chemotherapy, it reduces recurrence rates, and when administered after surgery and chemotherapy, it increases the disease’s recurrence-free interval. A number of studies examine the role of perioperative immunotherapy in elective lung cancer.”

“Immunotherapy has invaded to radically change the therapeutic field of Oncology and the way we approach cancer,” noted Mr. Ilias Athanasiadis (MD), Medical Oncologist, Director of the Oncology Clinic, Mitera Hospital, on the contribution of immunotherapy in metastatic NSCLC. “Metastatic NSCLC presents a complete change in its natural history and immunotherapy is part of the first-line treatment for all patients, where targeted therapy is not a priority. Resistance is the subject of intense clinical research and new approaches are necessary.”

On behalf of the State, Mrs. Panagiota Mitrou (MD PhD), Diabetologist, Head of Independent Department of Therapeutic Protocols and Patient Registries,Ministry of Health noted: “Nationwide digital applications for patients with neoplasms can help ensure optimal treatment, more effective monitoring, access to innovative treatments and the most efficient management of health resources. Their design and use should focus on achieving the ultimate goal, which is to facilitate the patient’s journey through the health system and improve both the prediction of the disease and the quality of patients’ lives.”

Mr. Christos Apostolakos, a patient engaged in his personal battle with the disease, shared his experience in an optimistic tone, regarding lung cancer treatment. He urged patients not to lose time, to visit their doctor and follow instructions, to adopt a healthy lifestyle, to exercise and never give up. “What does not kill me makes me stronger”, he added.

“Immunotherapy, when administered at an early stage to properly selected patients, can prove more effective”, commented Mrs. Dimitra Kanaloupiti (MD), Medical Oncologist, Director of the 4th Oncology Clinic, Iaso Hospital

“The State, Scientific Societies and health professionals should work together to improve services provided to patients, focusing on the patient and his family”, stressed  Mr. Anastasios Boutis (MD), Medical Oncologist, Theagenio Cancer Hospital, Thessaloniki, General Secretary of HeSMO.

Mr. Paris Kosmidis (MD), Medical Oncologist, Director of the 2nd Internal Medicine-Oncology Clinic, Ygeia Hospital, focused on the need to improve deficit structures with the cooperation of all parties involved and the support of the State, so that patients can enjoy practical benefits.

Mrs. Zoi Grammatoglou, President of the KEFI Association (Association of Cancer Patients, Volunteers, Friends and Doctors of Athens) highlighted the urgent need to equip hospitals, as well as the implementation of home care, following hospital care.

 

Clinical Research

 

Clinical Research was the topic of Section D of the conference, attended by representatives of the scientific community and pharmaceutical companies.

Clinical studies are the only scientifically proven strategy for the development of new medicines. The number of new clinical trials in oncology has increased significantly worldwide over the last decade, with almost 50% of them being conducted in the US. However, it appears that only 5% of patients with malignancies participate in clinical trials; the reason is that they do not know what clinical trials are, they have never discussed the issue with their doctor, they have not been given the option to participate in a clinical trial.

“Our country lags behind in the number of clinical trials when compared to countries in Europe of a similar size.  Over €36 billion is invested annually in Europe, while Greece unfortunately absorbs around €100 million! Compared to Greece, Hungary attracts 5 times more, Denmark 30 times more and Belgium attracts 70 times more investment in pharmaceutical R&D. Clinical Research can give a new impetus to Public Health and Greece’s development. “noted Mrs. Helena Linardou (MD, PhD), Medical Oncologist, Director of the 4th Oncology Clinic – Metropolitan Hospital, President of the Scientific Committee of HeCOG. “The establishment of our country as a major centre for clinical research with international impact should be a top priority for health policy, as this research offers new expertise, high quality health services, new jobs in specialized fields,” she added.

The academic survey data was analyzed by Mrs. Amanda Psyrri (MD, PhD, FACP), Professor of internal medicine and medical oncology, Chairman, 2nd Department of internal medicine, ATTIKON university hospital. “Clinical trials provide patients with immediate access to innovative treatments that can be life-saving, while at the same time they are a source of economic growth for the health sector. Of great importance is proper study design and especially patient safety. For this reason, the regulatory framework has a set of international strict rules and principles that must be consistently applied in every clinical trial”, noted Mr. Dimitrios Philippou, General Surgeon, Assistant Professor of Anatomy, National & Kapodistrian University of Athens,President of the National Organization for Medicines (EOF).

Mr. George Siaravas, Patient advocate, ICAN Ambassador, shared his experience as a caregiver, describing a patient’s journey through lung cancer, which in 4 years is reflected in 4.500 drugs and injections, 181 treatments, 55 imaging tests, 121 daily hospitalizations, 42 days of hospitalization. “All this might have been avoided, if CHECK-UP was done preventively at regular intervals with Low Dose Rate Computed Tomography”, he added.

Mrs. Janet Freeman Daily, Co-Founder, President, Board Chair – TheROS1ders, Inc, Mrs. Terri Conneran, Founder of KRAS Kickers and Mrs. Lindi Campbell, President Breath of Hope KY, Inc., shared their own lung cancer story, highlighting the need to inform patients and their environment about the importance of biomarkers, clinical trials, innovative treatments, in order to cope with the disease, as knowledge is power and must be communicated.

“Speaking of the age of innovation, as the title of the conference, innovation is only valuable, if and when patients have access to clinical trials and we should all work together in collaboration to move in that direction. At Roche, we continue to invest in Clinical Research and we are proud to have been able to initiate over 65 clinical studies in the last five years, giving access to 700 new patients.  Today, in our country, in all therapeutic areas, we are conducting 60 therapeutic studies with 250 research centres”, underlined Mr. Konstantinos Poulimenos, Head of the Clinical Trial Operations Department, Roche Hellas.

“To win the battle against lung cancer, we need to work together at all levels. All  pillars involved in accurate diagnosis, in the development of  new treatments, in the quality of life for people experiencing cancer, should collaborate. The pharmaceutical industry has been, is and will always be on the side of patients to ensure easy access to innovation”, emphasized Mr. Christos Antonopoulos (MD, PhD, EMB), Director of the Oncology-Hematology Business Unit, AstraZeneca Greece.

 “Clinical Research for targeted therapeutic solutions for lung cancer patients is accelerating and making progress. Early detection of mutations, through biomarkers, is a prerequisite for as many patients as possible to rapidly receive personalized treatment”, underlined Mr. Periklis Giovas (MD, PhD), Medical Director Amgen.

Mrs. Zefi Vlachopioti, Market Access Lead, BMS Greece and Cyprus, referred to the conditions, regarding the promotion of our country as a pole of attracting R&D investments.  Particular importance should be given to additional incentives to companies for attracting R&D investments, to the simplification of procedures and the operation of a special office at the Ministry of Health and in hospitals, to the facilitation of patient participation and to the training of hospital staff.

The need to simplify the regulatory framework, the training of administrative staff, the staffing of clinical trials offices, as well as the application of digital technology and the creation of a National Clinical Trials Office for the ongoing information of patients, as well as the prioritization of needs, were some of the points raised by Mr. Dimitrios Stathopoulos (MD, MSc, PhD), Therapeutic Area Lead Oncology/Hematology/PAH, Janssen.

“Patients are institutionally involved from the identification of research priorities to the design of clinical protocols. Participation is very important in ethics committees,” stressed Mr. Nikos Dedes, President of the Greek Patient Association.

Commenting on the discussion on Clinical Research, Mr. Kyriakos Souliotis, Professor of Health Policy, Dean of the Faculty of Social and Political Sciences, University of Peloponnese pointed out: “This is a huge opportunity for our country, as the human resources, infrastructure and financial opportunities exist to foster Clinical Research. We should see it as an investment priority and as a health policy priority.”

“Apart from the existence of clinical trials, we need to ensure open access to patients, and we can only achieve this by keeping them informed with the cooperation of all parties involved,” underlined Mr. Caius Kim, Global Director, AstraZeneca, Lung Ambition Alliance, Mr. Andrew Ciupek (PhD), Associate Director, Clinical Research GO2 Foundation and Mrs. Amy Moore (PhD), VP, Global Engagement and Patient Partnerships LUNGevity Foundation.

The event was coordinated and presented by journalist Mrs. Elena Papadimitriou.

 

 

The event was held under the auspices of the scientific companies: Hellenic Society of Medical Oncology (HeSMO), Hellenic Thoracic Society (HTS), Hellenic Association of Lung Cancer (HeALC), Hellenic Society of Thoracic and Cardiovascular Surgeons (HCTSS), Hellenic Society of Radiation Oncology (HESRO), ) Hellenic Radiological Society (HELRAD.), Hellenic Society of Pathological Anatomy (H.E.P.A.), Hellenic Foundation for Cancer Research (H.F.C.R.) And of the European and international bodies,  Global Lung Cancer Coalition (GLCC), International Association for the Study of Lung Cancer (IASLC), Lung Cancer Europe (LuCE), Lung Ambition Alliance (LAA), Lung Cancer Awareness Month Coalition (LCAM) and the Hellenic Association of Pharmaceutical Companies (S.F.Ε.Ε) and PhRMA Innovation Forum (PIF).

The conference was supported by: Roche Hellas (Distinguished Sponsor), MSD (Grand Sponsor), AstraZeneca Greece, Amgen Hellas, BMS Greece ,Janssen-Cilag (Sponsors), Pfizer Hellas, Pharmaserve-Lilly S.A.C.I., Sanofi, Ipsen,  Takeda (Supporters).

 

 

Αθήνα,28.11.2022