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 2 cm (T ≥ 2 cm 39 vs. 59 %; p
| Original language | English |
|---|---|
| Pages (from-to) | 669-678 |
| Number of pages | 10 |
| Journal | Journal of Cancer Research and Clinical Oncology |
| Volume | 142 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Mar 1 2016 |
Fingerprint
Keywords
- Adjuvant therapy
- Clinical practice
- Early breast cancer
- HER2
- Trastuzumab
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer : results of a prospective study. / Arpino, G.; Michelotti, A.; Truini, Mauro; Montemurro, Filippo; Russo, Stefania; Palumbo, Raffaella; Zamagni, Claudio; Latorre, Agnese Carmela; Bruzzese, Dario; Riccardi, Fernando; De Laurentiis, Michelino; Beano, Alessandra; Biganzoli, Laura; Zaniboni, Alberto; Laudadio, Lucio; Malagoli, Maria; Bilancia, D.; Schettini, Francesco; Giuliano, M.; Cazzaniga, Marina; De Placido, S.
In: Journal of Cancer Research and Clinical Oncology, Vol. 142, No. 3, 01.03.2016, p. 669-678.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer
T2 - results of a prospective study
AU - Arpino, G.
AU - Michelotti, A.
AU - Truini, Mauro
AU - Montemurro, Filippo
AU - Russo, Stefania
AU - Palumbo, Raffaella
AU - Zamagni, Claudio
AU - Latorre, Agnese Carmela
AU - Bruzzese, Dario
AU - Riccardi, Fernando
AU - De Laurentiis, Michelino
AU - Beano, Alessandra
AU - Biganzoli, Laura
AU - Zaniboni, Alberto
AU - Laudadio, Lucio
AU - Malagoli, Maria
AU - Bilancia, D.
AU - Schettini, Francesco
AU - Giuliano, M.
AU - Cazzaniga, Marina
AU - De Placido, S.
PY - 2016/3/1
Y1 - 2016/3/1
N2 - 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 2 cm (T ≥ 2 cm 39 vs. 59 %; p
AB - 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 2 cm (T ≥ 2 cm 39 vs. 59 %; p
KW - Adjuvant therapy
KW - Clinical practice
KW - Early breast cancer
KW - HER2
KW - Trastuzumab
UR - http://www.scopus.com/inward/record.url?scp=84957944737&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84957944737&partnerID=8YFLogxK
U2 - 10.1007/s00432-015-2033-z
DO - 10.1007/s00432-015-2033-z
M3 - Article
VL - 142
SP - 669
EP - 678
JO - Journal of Cancer Research and Clinical Oncology
JF - Journal of Cancer Research and Clinical Oncology
SN - 0171-5216
IS - 3
ER -