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J Cancer Res Clin Oncol. 2016 Mar;142(3):669-78. doi: 10.1007/s00432-015-2033-z. Epub 2015 Aug 25.

Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study.

Author information

1
Department of Clinical Medicine and Surgery, University of Naples Federico II, Via S. Pansini 5, 80131, Naples, Italy. grazia.arpino@unina.it.
2
Medical Oncology, "Santa Chiara" Hospital, University of Pisa, Pisa, Italy.
3
Department of Pathology, National Institute for Cancer Research, Genoa, Italy.
4
Investigative Clinical Oncology, Candiolo Cancer Institute, Candiolo, Italy.
5
Medical Oncology, University Hospital, Udine, Italy.
6
Service of Preventive Oncology, IRCCS Fondazione "Salvatore Maugeri", Pavia, Italy.
7
Medical Oncology Unit, "S.Orsola-Malpighi" Hospital, Bologna, Italy.
8
National Cancer Institute, Bari, Italy.
9
Preventive Medical Sciences, University of Naples "Federico II", Naples, Italy.
10
Medical Oncology, "A. Cardarelli" Hospital, Naples, Italy.
11
National Cancer Institute Fondazione "G.Pascale", Naples, Italy.
12
Presidio Evangelico Valdese-ASL TO1, Area Medica, Turin, Italy.
13
Department of Medical Oncology, Hospital of Prato, Istituto Toscano Tumori, Prato, Italy.
14
Department of Medical Oncology, Casa di Cura Poliambulanza, Brescia, Italy.
15
Medical Oncology, Ospedale F. Renzetti, Lanciano, Italy.
16
Oncology, Ospedali Riuniti di Trieste, Trieste, Italy.
17
Oncology, "San Carlo" Hospital, Potenza, Italy.
18
Department of Clinical Medicine and Surgery, University of Naples Federico II, Via S. Pansini 5, 80131, Naples, Italy.
19
Medical Oncology, "San Gerardo" Hospital, Monza, Italy.

Abstract

BACKGROUND:

Several randomized clinical trials (RCTs) have demonstrated the efficacy of trastuzumab-based adjuvant therapy in HER2-positive breast cancer (BC). However, RCT patients may not invariably be representative of patients routinely seen in clinical practice (CP). To address this issue, we compared the clinical and tumor features of RCT and CP patients with HER2-positive BC.

PATIENTS AND METHODS:

From January to December 2012, 650 consecutive patients with HER2-positive early BC, treated in 36 different types of Italian healthcare facilities, were enrolled in this study. Age, treatment, tumor size (T), nodes (N), grade (G), estrogen receptor (ER) and progesterone receptor (PgR) status were prospectively collected in these CP patients. The same data were extracted from the main adjuvant trastuzumab RCTs and pooled using the random-effects model of DerSimonian and Laird. RCT and CP patients were compared by using the Cochran Q statistics.

RESULTS:

Versus RCT patients, CP patients were more likely to be older than 50 years (65 vs. 49 %; p < 0.0001) and to have HR (ER and/or PgR)-positive (72 vs. 54 %; p < 0.0001) BC and less likely to have tumor >2 cm (T ≥ 2 cm 39 vs. 59 %; p < 0.0001), positive N (47 vs. 89 %; p < 0.0001) and a high G (61 vs. 67 %; p = 0.0241). CP patients more frequently received adjuvant endocrine therapy (70 vs. 57 %; p < 0.0003) and less frequently adjuvant chemotherapy (97 vs. 99.7 %; p < 0.0001).

CONCLUSIONS:

Most tumor and clinical features differed significantly between CP and RCT patients. These data raise concerns about the applicability of RCT results to CP patients.

KEYWORDS:

Adjuvant therapy; Clinical practice; Early breast cancer; HER2; Trastuzumab

PMID:
26531187
DOI:
10.1007/s00432-015-2033-z
[Indexed for MEDLINE]

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