The Promher Study: An Observational Italian Study on Adjuvant Therapy for HER2-Positive, pT1a-b pN0 Breast Cancer.
BACKGROUND
The management of pT1a-b pN0 HER2-positive breast cancer is controversial and no data about the efficacy of trastuzumab in this setting are available from randomized clinical trials. The aims of this retrospective study were to assess how patients are managed in clinical practice in Italy, which clinical or biological characteristics influenced the choice of adjuvant systemic therapy and the outcome of patients.


METHODS
Data of consecutive patients who underwent surgery from January 2007 to December 2012 for HER2-positive, pT1a-b pN0 M0 breast cancer were retrospectively collected from 28 Italian centres. Analysis of contingency tables and multivariate generalized logit models were used to investigate the association between the baseline clinical and biological features and the treatment strategy adopted.


RESULTS
Among 303 enrolled patients, 204 received adjuvant systemic therapy with trastuzumab, 65 adjuvant systemic therapy without trastuzumab and 34 did not receive adjuvant systemic therapy. At the multivariate analysis age, tumor size, proliferation index and hormone receptor status were significantly associated with the treatment choice. Five-year disease-free survival (DFS) probability was 95%, 94.3% and 69.6% for patients treated with adjuvant systemic therapy and trastuzumab, with adjuvant systemic therapy without trastuzumab and for patients who did not receive adjuvant systemic therapy, respectively (p<0.001).


CONCLUSIONS
The majority of patients (66%) with pT1a-b pN0 HER2-positive breast cancer enrolled in this retrospective study received adjuvant systemic therapy with trastuzumab, whereas only 11% patients did not receive any adjuvant systemic therapy. It should be emphasized, however, that in the adjuvant systemic therapy without trastuzumab group 94% of tumors were hormone receptor positive and 89% of patients were treated with endocrine therapy only [corrected]. The 5-year DFS probability was significantly higher for patients receiving adjuvant systemic therapy with trastuzumab compared with patients not receiving adjuvant systemic therapy or receiving adjuvant systemic therapy without trastuzumab.
Department of Oncology, Ospedale Sacro Cuore don Calabria, Negrar-Verona, Italy.
Stefania
S
Gori
Department of Oncology, Ospedale Sacro Cuore don Calabria, Negrar-Verona, Italy.
Alessandro
A
Inno
Unit of Oncology, Ospedale Civile Maggiore, Verona, Italy.
Elena
E
Fiorio
Medical Oncology, Azienda Ospedaliera di Perugia, Perugia, Italy.
Jennifer
J
Foglietta
Medical Oncology, Ospedale Santa Chiara, Trento, Italy.
Antonella
A
Ferro
Medical Oncology, Ospedale S. Bortolo, Vicenza, Italy.
Marcella
M
Gulisano
Department of Oncology, Ospedale di Circolo and University of Insubria, Varese, Italy.
Graziella
G
Pinotti
Medical Oncology, Ospedale Civile di Macerata, Macerata, Italy.
Marta
M
Gubiotti
Unit of Hematology and Oncology, AO Carlo Poma, Mantova, Italy.
Maria Giovanna
MG
Cavazzini
Department of Oncology, Ospedale Sacro Cuore don Calabria, Negrar-Verona, Italy.
Monica
M
Turazza
Department of Oncology, Ospedale Sacro Cuore don Calabria, Negrar-Verona, Italy.
Simona
S
Duranti
Medical Oncology, Ospedale San Donato, Arezzo, Italy.
Valeria
V
De Simone
Medical Oncology, Ospedale SS Annunziata, Chieti, Italy.
Laura
L
Iezzi
Medical Oncology, Breast Unit, Arcispedale S. Maria Nuova, Reggio Emilia, Italy.
Giancarlo
G
Bisagni
Medical Oncology, C.R.O.-I.R.C.C.S., Aviano-Pordenone, Italy.
Simon
S
Spazzapan
Department of Oncology and Hematology, Ospedale Guglielmo da Saliceto, Piacenza, Italy.
Luigi
L
Cavanna
Medical Oncology, Ospedale Maggiore della Carità, Novara, Italy.
Chiara
C
Saggia
Department of Medicine, Medical Oncology, University of Verona, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.
Emilio
E
Bria
Medical Oncology, Azienda Sanitaria dell'Alto Adige, Bolzano, Italy.
Elisabetta
E
Cretella
Division of Medical Oncology B, Regina Elena National Cancer Institute, Roma, Italy.
Patrizia
P
Vici
Department of Medical Oncology, Campus Bio-Medico University, Roma, Italy.
Daniele
D
Santini
Division of Medical Oncology A, Regina Elena National Cancer Institute, Roma, Italy.
Alessandra
A
Fabi
Division of Medical Oncology, Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy.
Ornella
O
Garrone
Medical Oncology, University Hospital, Ferrara, Italy.
Antonio
A
Frassoldati
Medical Oncology, Ospedale per gli Infermi, Faenza-Ravenna, Italy.
Laura
L
Amaducci
Medical Oncology, Ospedale Santa Maria degli Angeli, Pordenone, Italy.
Silvana
S
Saracchini
Medical Oncology, ASL CN1, Saluzzo-Cuneo, Italy.
Lucia
L
Evangelisti
Medical Oncology, Azienda Ospedaliera Treviglio, Treviglio-Bergamo, Italy.
Sandro
S
Barni
Medical Oncology Unit, ASL Frosinone, Frosinone, Italy.
Teresa
T
Gamucci
Medical Oncology Unit, ASL Frosinone, Frosinone, Italy.
Lucia
L
Mentuccia
Department of Oncology, Ospedale Floraspe Renzetti, Lanciano-Chieti, Italy.
Lucio
L
Laudadio
Medical Oncology, Ospedale San Sebastiano, Correggio-Reggio Emilia, Italy.
Alessandra
A
Zoboli
Department of Oncology, Ospedale Sacro Cuore don Calabria, Negrar-Verona, Italy.
Fabiana
F
Marchetti
Pathology, Ospedale Sacro Cuore don Calabria, Negrar-Verona, Italy.
Giuseppe
G
Bogina
Department of Oncology, Ospedale Sacro Cuore don Calabria, Negrar-Verona, Italy.
Gianluigi
G
Lunardi
Azienda Ospedaliero-Universitaria Careggi, Firenze, Italy.
Luca
L
Boni
D000277:Adjuvants, Pharmaceutic / Q000627:therapeutic use; D000328:Adult; D000367:Age Factors; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D018270:Carcinoma, Ductal, Breast / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D019468:Disease Management; D005260:Female; D015870:Gene Expression; D006801:Humans; D008875:Middle Aged; D015999:Multivariate Analysis; D009363:Neoplasm Proteins / Q000235:genetics / Q000378:metabolism; D011379:Prognosis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics* / Q000378:metabolism; D012189:Retrospective Studies; D016019:Survival Analysis; D000068878:Trastuzumab / Q000627:therapeutic use*; D047368:Tumor Burden
D000277:Adjuvants, Pharmaceutic; D000970:Antineoplastic Agents; D009363:Neoplasm Proteins; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human