Ten-year clinical outcome, toxicity and compliance of dose-dense sequential adjuvant administration of cyclophosphamide & epirubicin followed by docetaxel in patients with early breast cancer: A hellenic cooperative oncology group observational study (HE 10/10) with concurrent investigation of significance of tumor infiltrating lymphocytes.

CD8 Dose-dense chemotherapy Early breast cancer Prognosis TILs

Journal

Breast (Edinburgh, Scotland)
ISSN: 1532-3080
Titre abrégé: Breast
Pays: Netherlands
ID NLM: 9213011

Informations de publication

Date de publication:
25 Dec 2023
Historique:
received: 26 10 2023
revised: 18 12 2023
accepted: 21 12 2023
medline: 5 1 2024
pubmed: 5 1 2024
entrez: 4 1 2024
Statut: aheadofprint

Résumé

Dose-dense sequential (dds) chemotherapy has changed the clinical outcome of patients with early breast cancer (BC). To investigate the impact of dose intensity (DI) in the adjuvant setting of BC, this observational trial (HE 10/10) was conducted assessing the long-term survival outcome, safety and toxicity of a currently widely used chemotherapeutic regimen. In addition, the prognostic significance of tumor infiltrating lymphocytes (TILs) and infiltrating CD8 Totally, 1054 patients were prospectively enrolled in the current study with 1024 patients being eligible, while adequate tissue was available for 596 of them. TILs, CD8 Within a median follow-up of 125.18 months, a total of 200 disease-free survival (DFS) events (19.5%) were reported. Importantly, the 10-year DFS and OS rates were 78.4% (95% CI 75.0-81.5) and 81.7% (95% CI 79.0-84.1), respectively. Interestingly, higher CD8 In conclusion, this study confirms the significance of dds adjuvant chemotherapeutic regimen in terms of long-term survival outcome, safety and toxicity as well as the prognostic significance of TILs and infiltrating CD8

Sections du résumé

BACKGROUND BACKGROUND
Dose-dense sequential (dds) chemotherapy has changed the clinical outcome of patients with early breast cancer (BC). To investigate the impact of dose intensity (DI) in the adjuvant setting of BC, this observational trial (HE 10/10) was conducted assessing the long-term survival outcome, safety and toxicity of a currently widely used chemotherapeutic regimen. In addition, the prognostic significance of tumor infiltrating lymphocytes (TILs) and infiltrating CD8
PATIENTS AND METHODS METHODS
Totally, 1054 patients were prospectively enrolled in the current study with 1024 patients being eligible, while adequate tissue was available for 596 of them. TILs, CD8
RESULTS RESULTS
Within a median follow-up of 125.18 months, a total of 200 disease-free survival (DFS) events (19.5%) were reported. Importantly, the 10-year DFS and OS rates were 78.4% (95% CI 75.0-81.5) and 81.7% (95% CI 79.0-84.1), respectively. Interestingly, higher CD8
CONCLUSIONS CONCLUSIONS
In conclusion, this study confirms the significance of dds adjuvant chemotherapeutic regimen in terms of long-term survival outcome, safety and toxicity as well as the prognostic significance of TILs and infiltrating CD8

Identifiants

DOI: 10.1016/j.breast.2023.103668 PMID: 38176305
pubmed: 38176305
pii: S0960-9776(23)00794-4
doi: 10.1016/j.breast.2023.103668
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

103668

Informations de copyright

Copyright © 2023. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

Declaration of competing interest GA: Advisory Boards: Novartis, BMS, Roche Hellas, Astra Zeneca, Sanofi, Amgen, Genesis Pharma, Merck, Pfizer. DP: Advisory Role: Roche, MSD, Astellas. Honoraria: Roche, MSD, Astellas. AK: Speaker fees: Roche, MSD, Pfizer. Educational grant: Pfizer. Advisory Boards: ENETS. Adverse Events Monitoring: EOF. GR: Research funding: Tesaro, IQvia, ICON Clinical Research, MSD, PPD Global. Consulting fees: Roche, Pfizer, IQvia. Honoraria: Ipsen, MSD, Myriad. Travel: Pfizer, Merck, Sanofi, Astellas Pharma, MSD Oncology, Servier, AstraZeneca, ICON Clinical Research. FZ: Honoraria for lectures and have served in an advisory role for AstraZeneca, Daiichi, Eli- Lilly, Merck, Novartis, MSD, Pfizer, Genesis- Pharma, Roche and Gilead. GF: Advisory Board: Pfizer, Novartis. Honoraria: AstraZeneca, Novartis. Stock ownership: Genprex, Daiichi Sankyo, RFL Holdings, Formycon.

Auteurs

Foteinos-Ioannis Dimitrakopoulos (FI)

Division of Oncology, University Hospital of Patras "Panagia the Help", University of Patras, Patras, Greece; Molecular Oncology Laboratory, Department of Medicine, University of Patras, Patras, Greece. Electronic address: fodimitrakopoulos@upatras.gr.

Anna Goussia (A)

Department of Pathology, Ioannina University Hospital, Ioannina, Greece; Department of Pathology, German Oncology Center, Limassol, Cyprus.

Georgia-Angeliki Koliou (GA)

Section of Biostatistics, Hellenic Cooperative Oncology Group, Data Office, Athens, Greece.

Katerina Dadouli (K)

Laboratory of Hygiene and Epidemiology, Faculty of Medicine, University of Thessaly, Larissa, Greece.

Anna Batistatou (A)

Department of Pathology, Ioannina University Hospital, Ioannina, Greece.

Helen P Kourea (HP)

Department of Pathology, University Hospital of Patras, Rion, Greece.

Mattheos Bobos (M)

Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloniki, Greece; Department of Biomedical Sciences, School of Health Sciences, International Hellenic University, Thessaloniki, Greece.

Petroula Arapantoni-Dadioti (P)

Department of Pathology, Henry Dunant Hospital, Athens, Greece.

Olympia Tzaida (O)

Department of Pathology, Metaxas Cancer Hospital, Piraeus, Greece.

Triantafyllia Koletsa (T)

Department of Pathology, Aristotle University of Thessaloniki, School of Health Sciences, Faculty of Medicine, Thessaloniki, Greece.

Sofia Chrisafi (S)

Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloniki, Greece.

Maria Sotiropoulou (M)

Department of Pathology, Alexandra Hospital, Athens, Greece.

Alexandra Papoudou-Bai (A)

Department of Pathology, Ioannina University Hospital, Ioannina, Greece.

Irene Nicolaou (I)

Department of Histopathology, Agii Anargiri Hospital, Athens, Greece.

Antonia Charchanti (A)

Department of Anatomy-Histology-Embryology, Faculty of Medicine, School of Health Sciences, University of Ioannina, Ioannina, Greece.

Davide Mauri (D)

Department of Medical Oncology, Medical School, University of Ioannina, Ioannina, Greece.

Gerasimos Aravantinos (G)

Second Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.

Ioannis Binas (I)

Second Department of Medical Oncology, Metropolitan Hospital, Piraeus, Greece.

Eleni Res (E)

Third Department of Medical Oncology, Agii Anargiri Cancer Hospital, Athens, Greece.

Amanda Psyrri (A)

Section of Medical Oncology, Department of Internal Medicine, Attikon University Hospital, Faculty of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.

Dimitrios Pectasides (D)

Oncology Section, Second Department of Internal Medicine, Hippokratio Hospital, Athens, Greece.

Dimitrios Bafaloukos (D)

First Department of Medical Oncology, Metropolitan Hospital, Piraeus, Greece.

Anna Koumarianou (A)

Hematology-Oncology Unit, Fourth Department of Internal Medicine, Attikon University Hospital, Medical School, National and Kapodistrian University of Athens, Greece.

Iliada Bompolaki (I)

Oncology Department, General Hospital of Chania, Crete, Greece.

Georgios Rigakos (G)

Third Department of Medical Oncology, Hygeia Hospital, Athens, Greece.

Charisios Karanikiotis (C)

Department of Medical Oncology, 424 Army General Hospital, Thessaloniki, Greece.

Angelos Koutras (A)

Division of Oncology, University Hospital of Patras "Panagia the Help", University of Patras, Patras, Greece.

Flora Zagouri (F)

Department of Clinical Therapeutics, Alexandra Hospital, National Andistrian U Kapodniversity of Athens School of Medicine, Athens, Greece.

Helen Gogas (H)

First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens School of Medicine, Athens, Greece.

George Fountzilas (G)

Laboratory of Molecular Oncology, Hellenic Foundation for Cancer Research/Aristotle University of Thessaloniki, Thessaloniki, Greece; Aristotle University of Thessaloniki, Thessaloniki, Greece; Department of Medical Oncology, German Oncology Center, Limassol, Cyprus.

Classifications MeSH