Longitudinal Analysis of Lung Cancer Austria

Steering Committee:
Georg-Christian FUNK
Prim. Priv.-Doz. Dr.
Klinik Ottakring – 2. Medizinische Abteilung mit Pneumologie

Arschang VALIPOUR
Prim. Priv.-Doz. Dr., FERS
Klinik Floridsdorf – Abteilung für Innere Medizin und Pneumologie

Marie-Kathrin BREYER
Prim.a Priv.-Doz.in Dr.in, PhD
Klinik Penzing – Abteilung für Atemwegs- und Lungenkrankheiten

Robab BREYER-KOHANSAL
Prim.a Priv.-Doz.in Dr.in
Klinik Hietzing – 6. Medizinische Abteilung – Innere Medizin mit Pneumologie

Vertretung: Frau Mag. Vania Mikaela Rodriguez
Start: 2019
Projektmitglieder an der Klinik Ottakring: OA. Dr. Klaus Kirchbacher, OÄ. Dr. Elena Egger, Dr. Nino Müser, Dr.Alexander Pertl, Almas Merchant, M.P.H,

Projektinformation/Beschreibung/Zielsetzung:

Study Type

Open, non-interventional, prospective, retrospective, multicenter clinical registry

Background

Lung cancer is one of the most common cancers in Austria. Diagnosis and staging is complex and requires collaboration by various disciplines. Depending on the stage and the performance status of the patient surgery, radiotherapy and/or systemic anti-cancer treatment including genome-driven therapy, immunotherapy and chemotherapy, as well as their combinations, are used to treat lung cancer.

The identification of driver-mutations, whose gene product can be specifically inhibited by targeted therapies, has markedly changed the diagnostic and therapeutic landscape for this tumor entity, leading to improved outcomes for patients with metastatic NSCLC. The use of next generation sequencing (NGS) allows for detection of a multitude of different drugable mutations. In absence of a curative treatment approach and a drugable mutation the prognosis of lung cancer remains poor.

Although lung cancer is a common and serious disease, few data are available regarding lung cancer diagnosis and management in routine clinical practice.

Purpose and rationale

Thorough knowledge of the treatment reality, e.g. characteristics, diagnostic, treatment and outcome of unselected patients in real-Iife practice, is crucial to evaluate and improve the quality of care for patients with lung cancer.

The purpose of this project is to set up a clinical platfom to document representative data on molecular testing, sequence of systemic treatment and other treatment modalities, and course of disease in patients with lung cancer. A particular focus is on molecular biomarker testing and NGS of patients before the start of first-line treatment. The data shall be used to assess the current state of care and to develop recommendations concerning topics that can be improved.

Specific objectives

To assess molecular biomarker testing and indicators of the quality of care in patients with lung cancer, in particular:

  • To collect data on the frequency of tumor mutations including rare mutations
  • To describe feasibility, frequency and clinical consequences of reflex NGS testing on therapeutic concepts in real-life practice
  • To assess the independent prognostic value of driver mutations in a real-life setting
  • To record the sequence of systemic treatments in real-Iife practice
  • To assess the effectiveness of systemic treatments in regards to initial response rate, progression free survival and overall survival
  • To describe physician-reported factors affecting treatment decision making besides biomarker profiling
  • To collect key data on specific supportive therapies
  • To investigate changes in general diagnostic and therapeutic approach during the course of time
  • To collect indicators of the quality of care for lung cancer patients e.g.:
    • Time from symptom onset to diagnosis
    • Time from diagnosis to first treatment application
    • Frequency and modality of imaging (CT scan etc)
    • Biopsy route
    • Pathological confirmation in stage I/II with ECOG 0-1
    • Frequency and modality of surgery and post-surgical follow-up in NSCLC
    • Frequency, modality, and sequences of systemic anti-cancer treatment in stage IIIb and IV with ECOG 0-1
    • Frequency and modality of chemotherapy and radiotherapy (including TBI and stereotactic radiation) in SCLC
    • Proportion of curative treatments
    • Characteristics of multimodality treatments
    • Timing of ambulatory palliative care
    • Overall survival
    • Time of death

    Population, number of patients and sites

    All unselected patients diagnosed with lung cancer at the research sites. The study is intended to commence at four sites in Vienna, with subsequent invitation of participation of other sites.

    Recruitment

    Patients will be recruited consecutively from clinical facilities at four high volume lung cancer sites. Approximately 600 to 700 newly diagnosed lung cancer patients per annum are estimated for the four sites based on retrospective data recruitment.