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Tytuł:
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Validation of the AJCC prognostic stage for HER2-positive breast cancer in the ShortHER trial.
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Autorzy:
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Dieci MV; Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.; Medical Oncology 2, Istituto Oncologico Veneto - IRCCS, Via Gattamelata 64, 35128, Padova, Italy.
Bisagni G; Department of Oncology and Advanced Technologies, Oncology Unit, Azienda USL-IRCCS, Reggio Emilia, Italy.
Brandes AA; Medical Oncology, Azienda Unità Sanitaria Locale di Bologna-IRCCS Istituto delle Scienze Neurologiche, Bologna, Italy.
Frassoldati A; Clinical Oncology, Department of Morphology, Surgery and Experimental Medicine, S Anna University Hospital, Ferrara, Italy.
Cavanna L; Department of Oncology-Hematology, G. da Saliceto Hospital, Piacenza, Italy.
Giotta F; IRCCS Istituto Tumori 'Giovanni Paolo II' di Bari, Bari, Italy.
Aieta M; Division of Medical Oncology, IRCCS-CROB, Referral Cancer Center of Basilicata, Rionero Vulture, Italy.
Gebbia V; Medical Oncology, Casa di Cura La Maddalena, University of Palermo, Palermo, Italy.
Musolino A; Medical Oncology Unit, University Hospital of Parma, Parma, Italy.
Garrone O; Medical Oncology, A.O. S. Croce and Carle Teaching Hospital, Cuneo, Italy.
Donadio M; Department of Medical Oncology 1, Città della Salute e della Scienza Hospital, Turin, Italy.
Rimanti A; Medical Oncology, Azienda Ospedaliera di Mantova, Mantova, Italy.
Beano A; Department of Medical Oncology 1, Città della Salute e della Scienza Hospital, Turin, Italy.
Zamagni C; Policlinico S.Orsola-Malpighi, SSD Oncologia Medica Addarii, Bologna, Italy.
Soto Parra H; Medical Oncology Unit, AOU Policlinico Vittorio Emanuele, Catania, Italy.
Piacentini F; Division of Medical Oncology Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy.
Danese S; Department of Gynecology and Obstetrics, Ospedale S. Anna, Turin, Italy.
Ferro A; Rete clinica senologica - Oncologia medica S. Chiara, Trento, Italy.
Cagossi K; Breast Unit Ausl Modena, Ramazzini Hospital, Carpi, Italy.
Sarti S; Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Gambaro AR; Oncology Unit, Luigi Sacco Hospital, Milan, Italy.
Romito S; Medical Oncology, A.O.U. 'Ospedali Riuniti', Foggia, Italy.
Bazan V; Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Palermo, Italy.
Amaducci L; Medical Oncology Unit, Ospedale degli Infermi Faenza, Faenza, Italy.
Moretti G; Department of Oncology and Advanced Technologies, Oncology Unit, Azienda USL-IRCCS, Reggio Emilia, Italy.
Foschini MP; Department of Biomedical and Neuromotor Sciences, University of Bologna, Unit of Anatomic Pathology at Bellaria Hospital, Bologna, Italy.
Balduzzi S; Department of Medical and Surgical Sciences for Children & Adults, University of Modena, Modena, Italy.
Vicini R; Azienda Ospedaliero-Universitaria di Modena, Modena, Italy.
D'Amico R; Department of Medical and Surgical Sciences for Children & Adults, University of Modena, Modena, Italy.; Azienda Ospedaliero-Universitaria di Modena, Modena, Italy.
Griguolo G; Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.; Medical Oncology 2, Istituto Oncologico Veneto - IRCCS, Via Gattamelata 64, 35128, Padova, Italy.
Guarneri V; Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.; Medical Oncology 2, Istituto Oncologico Veneto - IRCCS, Via Gattamelata 64, 35128, Padova, Italy.
Conte PF; Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy. .; Medical Oncology 2, Istituto Oncologico Veneto - IRCCS, Via Gattamelata 64, 35128, Padova, Italy. .
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Źródło:
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BMC medicine [BMC Med] 2019 Nov 21; Vol. 17 (1), pp. 207. Date of Electronic Publication: 2019 Nov 21.
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Typ publikacji:
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Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Validation Study
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Język:
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English
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Imprint Name(s):
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Original Publication: [London] : BioMed Central, 2003-
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MeSH Terms:
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Genes, erbB-2*
Neoplasm Staging*
Antineoplastic Agents, Immunological/*therapeutic use
Breast Neoplasms/*diagnosis
Trastuzumab/*therapeutic use
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; Breast Neoplasms/genetics ; Breast Neoplasms/pathology ; Disease-Free Survival ; Female ; Humans ; Middle Aged ; Neoplasm Recurrence, Local ; Prognosis
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References:
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Contributed Indexing:
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Keywords: 8th AJCC; Breast cancer; HER2-positive; Prognostic stage; Trastuzumab
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Molecular Sequence:
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ClinicalTrials.gov NCT00629278
EudraCT 2007-004326-25
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Substance Nomenclature:
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0 (Antineoplastic Agents, Immunological)
P188ANX8CK (Trastuzumab)
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Entry Date(s):
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Date Created: 20191122 Date Completed: 20200414 Latest Revision: 20200414
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Update Code:
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20240104
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PubMed Central ID:
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PMC6868696
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DOI:
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10.1186/s12916-019-1445-z
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PMID:
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31747948
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Background: The 8th edition of the American Joint Committee on Cancer (AJCC) staging has introduced prognostic stage based on anatomic stage combined with biologic factors. We aimed to validate the prognostic stage in HER2-positive breast cancer patients enrolled in the ShortHER trial.
Methods: The ShortHER trial randomized 1253 HER2-positive patients to 9 weeks or 1 year of adjuvant trastuzumab combined with chemotherapy. Patients were classified according to the anatomic and the prognostic stage. Distant disease-free survival (DDFS) was calculated from randomization to distant relapse or death.
Results: A total of 1244 patients were included. Compared to anatomic stage, the prognostic stage downstaged 41.6% (n = 517) of patients to a more favorable stage category. Five-year DDFS based on anatomic stage was as follows: IA 96.6%, IB 94.1%, IIA 92.4%, IIB 87.3%, IIIA 81.3%, IIIC 70.5% (P < 0.001). Five-year DDFS according to prognostic stage was as follows: IA 95.7%, IB 91.4%, IIA 86.9%, IIB 85.0%, IIIA 77.6%, IIIC 67.7% (P < 0.001). The C index was similar (0.69209 and 0.69249, P = 0.975). Within anatomic stage I, the outcome was similar for patients treated with 9 weeks or 1 year trastuzumab (5-year DDFS 96.2% and 96.6%, P = 0.856). Within prognostic stage I, the outcome was numerically worse for patients treated with 9 weeks trastuzumab (5-year DDFS 93.7% and 96.3%, P = 0.080).
Conclusions: The prognostic stage downstaged 41.6% of patients, while maintaining a similar prognostic performance as the anatomic stage. The prognostic stage is valuable in counseling patients and may serve as reference for a clinical trial design. Our data do not support prognostic stage as guidance to de-escalate treatment.
Trial Registration: EUDRACT number: 2007-004326-25; NCI ClinicalTrials.gov number: NCT00629278.
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