Intense dose-dense epirubicin, paclitaxel, cyclophosphamide versus weekly paclitaxel, liposomal doxorubicin (plus carboplatin in triple-negative breast cancer) for neoadjuvant treatment of high-risk early breast cancer (GeparOcto-GBG 84): A randomised phase III trial.
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Carboplatin
/ administration & dosage
Chemotherapy, Adjuvant
Cyclophosphamide
/ administration & dosage
Doxorubicin
/ administration & dosage
Epirubicin
/ administration & dosage
Female
Germany
Humans
Middle Aged
Neoadjuvant Therapy
/ adverse effects
Paclitaxel
/ administration & dosage
Polyethylene Glycols
/ administration & dosage
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
Triple Negative Breast Neoplasms
/ drug therapy
Carboplatin
Dose-dense
High-risk early breast cancer
Neoadjuvant
Journal
European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373
Informations de publication
Date de publication:
01 2019
01 2019
Historique:
received:
11
07
2018
revised:
08
10
2018
accepted:
29
10
2018
pubmed:
12
12
2018
medline:
6
5
2020
entrez:
12
12
2018
Statut:
ppublish
Résumé
GeparOcto compared efficacy and safety of two chemotherapy regimens in high-risk early breast cancer (BC): sequential treatment with intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) and weekly treatment with paclitaxel plus non-pegylated liposomal doxorubicin (M, Myocet®) with additional carboplatin (PM(Cb)) in triple-negative BC (TNBC). Patients with cT1c-cT4a-d and centrally assessed human epidermal growth factor receptor (HER)2-positive BC or TNBC were eligible, irrespective of nodal status, luminal B-like tumours only if pN+. Patients were randomised (stratified by BC subtype, Ki67, lymphocyte-predominant BC) to receive 18 weeks of E (150 mg/m 945/961 randomised patients started treatment. The median age was 48 years; 7.6% had cT3-4, 46% cN+, 66% G3, 40% HER2-positive, 43% TNBC. pCR rate with iddEPC was 48.3%, with PM(Cb) 48.0%, respectively (PM(Cb) versus iddEPC odds ratio 0.99; 95% confidence interval 0.77-1.28, P = 0.979) with no significant differences observed in TNBC, HER2-positive, luminal B-like subtypes. 16.4% with iddEPC and 34.1% with PM(Cb) discontinued treatment (P < 0.001), mainly due to adverse events; two patients on PM(Cb) died. In high-risk early BC there is no difference in pCR rates following neoadjuvant treatment with iddEPC or weekly PM(Cb), respectively. iddEPC is one of the effective dose-dense regimens feasible in daily practice.
Sections du résumé
BACKGROUND
GeparOcto compared efficacy and safety of two chemotherapy regimens in high-risk early breast cancer (BC): sequential treatment with intense dose-dense epirubicin, paclitaxel, and cyclophosphamide (iddEPC) and weekly treatment with paclitaxel plus non-pegylated liposomal doxorubicin (M, Myocet®) with additional carboplatin (PM(Cb)) in triple-negative BC (TNBC).
PATIENTS AND METHODS
Patients with cT1c-cT4a-d and centrally assessed human epidermal growth factor receptor (HER)2-positive BC or TNBC were eligible, irrespective of nodal status, luminal B-like tumours only if pN+. Patients were randomised (stratified by BC subtype, Ki67, lymphocyte-predominant BC) to receive 18 weeks of E (150 mg/m
RESULTS
945/961 randomised patients started treatment. The median age was 48 years; 7.6% had cT3-4, 46% cN+, 66% G3, 40% HER2-positive, 43% TNBC. pCR rate with iddEPC was 48.3%, with PM(Cb) 48.0%, respectively (PM(Cb) versus iddEPC odds ratio 0.99; 95% confidence interval 0.77-1.28, P = 0.979) with no significant differences observed in TNBC, HER2-positive, luminal B-like subtypes. 16.4% with iddEPC and 34.1% with PM(Cb) discontinued treatment (P < 0.001), mainly due to adverse events; two patients on PM(Cb) died.
CONCLUSIONS
In high-risk early BC there is no difference in pCR rates following neoadjuvant treatment with iddEPC or weekly PM(Cb), respectively. iddEPC is one of the effective dose-dense regimens feasible in daily practice.
Identifiants
pubmed: 30528802
pii: S0959-8049(18)31456-4
doi: 10.1016/j.ejca.2018.10.015
pii:
doi:
Substances chimiques
liposomal doxorubicin
0
Polyethylene Glycols
3WJQ0SDW1A
Epirubicin
3Z8479ZZ5X
Doxorubicin
80168379AG
Cyclophosphamide
8N3DW7272P
Carboplatin
BG3F62OND5
Paclitaxel
P88XT4IS4D
Banques de données
ClinicalTrials.gov
['NCT02125344']
Types de publication
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
181-192Informations de copyright
Copyright © 2018 Elsevier Ltd. All rights reserved.