Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer

Abstract The GIM2 phase III trial demonstrated the benefit of dose-dense chemotherapy in node-positive early breast cancer (eBC). To better define the dose-dense effect in the hormone receptor-positive subgroup, we evaluated its benefit through a composite measure of recurrence risk. We conducted an...

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Main Authors: Fabio Puglisi, Lorenzo Gerratana, Matteo Lambertini, Marcello Ceppi, Luca Boni, Filippo Montemurro, Stefania Russo, Claudia Bighin, Michelino De Laurentiis, Mario Giuliano, Giancarlo Bisagni, Antonio Durando, Anna Turletti, Ornella Garrone, Andrea Ardizzoni, Teresa Gamucci, Giuseppe Colantuoni, Adriano Gravina, Sabino De Placido, Francesco Cognetti, Lucia Del Mastro
Format: Article
Language:English
Published: Nature Portfolio 2021-06-01
Series:npj Breast Cancer
Online Access:https://doi.org/10.1038/s41523-021-00286-w
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author Fabio Puglisi
Lorenzo Gerratana
Matteo Lambertini
Marcello Ceppi
Luca Boni
Filippo Montemurro
Stefania Russo
Claudia Bighin
Michelino De Laurentiis
Mario Giuliano
Giancarlo Bisagni
Antonio Durando
Anna Turletti
Ornella Garrone
Andrea Ardizzoni
Teresa Gamucci
Giuseppe Colantuoni
Adriano Gravina
Sabino De Placido
Francesco Cognetti
Lucia Del Mastro
author_facet Fabio Puglisi
Lorenzo Gerratana
Matteo Lambertini
Marcello Ceppi
Luca Boni
Filippo Montemurro
Stefania Russo
Claudia Bighin
Michelino De Laurentiis
Mario Giuliano
Giancarlo Bisagni
Antonio Durando
Anna Turletti
Ornella Garrone
Andrea Ardizzoni
Teresa Gamucci
Giuseppe Colantuoni
Adriano Gravina
Sabino De Placido
Francesco Cognetti
Lucia Del Mastro
author_sort Fabio Puglisi
collection DOAJ
description Abstract The GIM2 phase III trial demonstrated the benefit of dose-dense chemotherapy in node-positive early breast cancer (eBC). To better define the dose-dense effect in the hormone receptor-positive subgroup, we evaluated its benefit through a composite measure of recurrence risk. We conducted an ancillary analysis of the GIM2 trial evaluating the absolute treatment effect through a composite measure of recurrence risk (CPRS) in patients with hormone receptor-positive HER2-negative eBC. CPRS was estimated through Cox proportional hazards models applied to the different clinicopathological features. The treatment effect was compared to the values of CPRS by using the Sub-population Treatment Effect Pattern Plot (STEPP) process. The Disease-Free Survival (DFS)-oriented STEPP analysis showed distinct patterns of relative treatment effect with respect to CPRS. Overall, 5-year DFS differed across CPRS quartiles ranging from 95.2 to 66.4%. Each CPRS quartile was characterized by a different patients’ composition, especially for age, lymph node involvement, tumor size, estrogen and progesterone receptor expression, and Ki-67. A number needed to treat of 154 and 6 was associated with the lowest and the highest CPRS quartile, respectively. Dose-dense adjuvant chemotherapy showed a consistent benefit in node-positive eBC patients with hormone receptor-positive HER2-negative disease, but its effect varied according to CPRS.
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spelling doaj.art-76849692dd90493e9b9efa13c03d952c2023-12-03T08:21:59ZengNature Portfolionpj Breast Cancer2374-46772021-06-01711910.1038/s41523-021-00286-wComposite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancerFabio Puglisi0Lorenzo Gerratana1Matteo Lambertini2Marcello Ceppi3Luca Boni4Filippo Montemurro5Stefania Russo6Claudia Bighin7Michelino De Laurentiis8Mario Giuliano9Giancarlo Bisagni10Antonio Durando11Anna Turletti12Ornella Garrone13Andrea Ardizzoni14Teresa Gamucci15Giuseppe Colantuoni16Adriano Gravina17Sabino De Placido18Francesco Cognetti19Lucia Del Mastro20Department of Medicine (DAME), University of UdineDepartment of Medicine (DAME), University of UdineDepartment of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of GenoaClinical Epidemiology Unit, IRCCS Ospedale Policlinico San MartinoClinical Epidemiology Unit, IRCCS Ospedale Policlinico San MartinoDay Hospital Oncologico Multidisciplinare, Istituto di Candiolo, FPO-IRCCSDepartment of Oncology, ASU FC University HospitalOncologia Medica 2, IRCCS Ospedale Policlinico San MartinoDepartment of Breast Oncology, Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”Department of Clinical Medicine and Surgery, University of Naples Federico IIAUSL-IRCCS Reggio EmiliaBreast Unit Ospedale S Anna, Citta’ della Salute e della Scienza di TorinoBreast Unit, ASL Citta’ di TorinoBreast Unit, Department of Medical Oncology AO S. Croce e Carle Ospedale di InsegnamentoMedical Oncology, S.Orsola University HospitalDepartment of Medical Oncology, Sandro Pertini Hospital and S. Eugenio Hospital, ASL Roma2Medical Oncology, Azienda Ospedaliera S Giuseppe MoscatiClinical Trial Unit, Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”Department of Clinical Medicine and Surgery, University of Naples Federico IIDepartment of Medical Oncology, Istituto Regina Elena per lo Studio e la Cura dei TumoriDepartment of Internal Medicine and Medical Specialties (DiMI), School of Medicine, University of GenoaAbstract The GIM2 phase III trial demonstrated the benefit of dose-dense chemotherapy in node-positive early breast cancer (eBC). To better define the dose-dense effect in the hormone receptor-positive subgroup, we evaluated its benefit through a composite measure of recurrence risk. We conducted an ancillary analysis of the GIM2 trial evaluating the absolute treatment effect through a composite measure of recurrence risk (CPRS) in patients with hormone receptor-positive HER2-negative eBC. CPRS was estimated through Cox proportional hazards models applied to the different clinicopathological features. The treatment effect was compared to the values of CPRS by using the Sub-population Treatment Effect Pattern Plot (STEPP) process. The Disease-Free Survival (DFS)-oriented STEPP analysis showed distinct patterns of relative treatment effect with respect to CPRS. Overall, 5-year DFS differed across CPRS quartiles ranging from 95.2 to 66.4%. Each CPRS quartile was characterized by a different patients’ composition, especially for age, lymph node involvement, tumor size, estrogen and progesterone receptor expression, and Ki-67. A number needed to treat of 154 and 6 was associated with the lowest and the highest CPRS quartile, respectively. Dose-dense adjuvant chemotherapy showed a consistent benefit in node-positive eBC patients with hormone receptor-positive HER2-negative disease, but its effect varied according to CPRS.https://doi.org/10.1038/s41523-021-00286-w
spellingShingle Fabio Puglisi
Lorenzo Gerratana
Matteo Lambertini
Marcello Ceppi
Luca Boni
Filippo Montemurro
Stefania Russo
Claudia Bighin
Michelino De Laurentiis
Mario Giuliano
Giancarlo Bisagni
Antonio Durando
Anna Turletti
Ornella Garrone
Andrea Ardizzoni
Teresa Gamucci
Giuseppe Colantuoni
Adriano Gravina
Sabino De Placido
Francesco Cognetti
Lucia Del Mastro
Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer
npj Breast Cancer
title Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer
title_full Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer
title_fullStr Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer
title_full_unstemmed Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer
title_short Composite risk and benefit from adjuvant dose-dense chemotherapy in hormone receptor-positive breast cancer
title_sort composite risk and benefit from adjuvant dose dense chemotherapy in hormone receptor positive breast cancer
url https://doi.org/10.1038/s41523-021-00286-w
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