Abstract 3666
Background
Non-small cell lung cancer (NSCLC) is one of the commonest disease worldwide and the leading cause of cancer-related death. Incidence increases with age and reaches a peak in senility, when patients’ (pts) comorbidities may limit the efficacy of treatments. At this time, no homogeneous indications are available for elderly NSCLC pts and the optimization of treatment, with the lowest side effects, is still an unmet need, also after the introduction of innovative drugs. The ribonucleotide reductase catalytic subunit M1(RRM1), the DNA-excision repair protein ERCC1 and the thymidylate synthetase (TS) are cancer molecular markers able to predict response to gemcitabine, platinum compounds and pemetrexd, respectively. Originally, aim of the EPIC study (active from July 2012) was to optimize survival of elderly NSCLC pts with the use of a genomic driven chemotherapy, comparing it to standard treatment. After the proven efficacy of first-line immunotherapy, on June 2018 the protocol was amended with the introduction of a new study arm, aiming to clarify the best strategy in this setting.
Trial design
EPIC is an Italian multicenter, randomized phase III trial, comparing Avelumab (A) vs genomic driven chemotherapy (B) and genomic driven chemotherapy vs standard chemotherapy according to investigator’s choice (C) in elderly untreated NSCLC pts, randomized in a 2:2:1 fashion manner. Age over 70 years, ECOG performance-status 0-1, stage IV non-oncogene addicted NSCLC and tissue availability for gene expression analysis, are key inclusion criteria. Before study entry, pharmacogenomic evaluations of RRM1, ERCC1 and TS is performed in the entire study population, but results are disclosed only to pts randomized in arm B to not influence subsequent treatments in the other arms. Primary endpoint of the EPIC study is overall survival (OS), while secondary endpoints include progression-free survival (PFS) and treatment response rate (by investigator’s assessment). Further objectives are the evaluation of feasibility of treatment selection based on pharmacogenomic parameters, and treatment-related toxicities in every study arm. End of enrollment is expected by the end of 2022.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Department of Oncology - University of Turin, Italy.
Funding
Italian Pharmacology Agency (AIFA).
Disclosure
E. Capelletto: Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim. F. Grossi: Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Roche; Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Pierre Fabre; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Novartis. P. Bidoli: Advisory / Consultancy: Eli Lilly; Advisory / Consultancy: Boheringher; Advisory / Consultancy: BMS. O. Caffo: Honoraria (self): Pfizer ; Honoraria (institution): AstraZeneca. S. Novello: Advisory / Consultancy: Boehringer Ingelheim; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lilly; Advisory / Consultancy: BMS; Advisory / Consultancy: MSD; Advisory / Consultancy: Roche ; Advisory / Consultancy: Takeda; Advisory / Consultancy: Pfizer; Advisory / Consultancy: AbbVie; Advisory / Consultancy: Celgene. G. Scagliotti: Advisory / Consultancy, Speaker Bureau / Expert testimony: Eli Lilly; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: MSD; Advisory / Consultancy: Pfizer. All other authors have declared no conflicts of interest.
Resources from the same session
4321 - Health-related quality of life of advanced melanoma survivors treated with CTLA-4 immune checkpoint inhibition: a matched cohort study
Presenter: Annelies Boekhout
Session: Poster Display session 1
Resources:
Abstract
779 - Capecitabine vs Cisplatin along with concurrent radiotherapy in the treatment of inoperable lower esophageal cancers focusing on TWISTT score and QOL
Presenter: Goutham Anugu
Session: Poster Display session 1
Resources:
Abstract
5914 - Cancer, Mental Health and End Life Simulation (CAMhELS): A novel effectiveness evaluation.
Presenter: Asanga Fernando
Session: Poster Display session 1
Resources:
Abstract
2597 - Cancer patients’ expectations and understanding about their disease
Presenter: Mónica Pinho
Session: Poster Display session 1
Resources:
Abstract
5187 - Impact of patients’ death on oncologists and coping strategies: An online survey
Presenter: Soumaya Labidi
Session: Poster Display session 1
Resources:
Abstract
4579 - Clinical benefit from late lines of therapy offered to patients treated in a tertiary referral centre
Presenter: Andrea Sbrana
Session: Poster Display session 1
Resources:
Abstract
5058 - Preparedness for caregiving in caregivers of cancer patients
Presenter: Hatice Yakar
Session: Poster Display session 1
Resources:
Abstract
5917 - Oncologic Emergency Medicine in the real world: A survey and proposal for improvement
Presenter: Carintia Dorta Pérez
Session: Poster Display session 1
Resources:
Abstract
4077 - The Reality of Critical Cancer Patients in a Polyvalent Intensive Care Unit
Presenter: Tiago Filipe Da Cruz Tomas
Session: Poster Display session 1
Resources:
Abstract
1728 - A phase III trial evaluating olanzapine 5 mg for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin: J-FORCE Study
Presenter: Hironobu Hashimoto
Session: Poster Display session 1
Resources:
Abstract