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

被引：14

作者：

Arpino, Grazia ^{[1
]}

Michelotti, Andrea ^{[2
]}

Truini, Mauro ^{[3
]}

Montemurro, Filippo ^{[4
]}

Russo, Stefania ^{[5
]}

Palumbo, Raffaella ^{[6
]}

Zamagni, Claudio ^{[7
]}

Latorre, Agnese ^{[8
]}

Bruzzese, Dario ^{[9
]}

Riccardi, Ferdinando ^{[10
]}

De Laurentiis, Michelino ^{[11
]}

Beano, Alessandra ^{[12
]}

Biganzoli, Laura ^{[13
]}

Zaniboni, Alberto ^{[14
]}

Laudadio, Lucio ^{[15
]}

Malagoli, Maria ^{[16
]}

Bilancia, Domenico ^{[17
]}

Schettini, Francesco ^{[1
]}

Giuliano, Mario ^{[1
]}

Cazzaniga, Marina Elena ^{[18
]}

De Placido, Sabino ^{[1
]}

机构：

[1] Univ Naples Federico II, Dept Clin Med & Surg, Via S Pansini 5, I-80131 Naples, Italy

[2] Univ Pisa, Santa Chiara Hosp, Med Oncol, Pisa, Italy

[3] Natl Inst Canc Res, Dept Pathol, Genoa, Italy

[4] Candiolo Canc Inst, Invest Clin Oncol, Candiolo, Italy

[5] Univ Hosp, Med Oncol, Udine, Italy

[6] IRCCS Fdn Salvatore Maugeri, Serv Prevent Oncol, Pavia, Italy

[7] St Orsola Marcello Malpighi Hosp, Med Oncol Unit, Bologna, Italy

[8] Natl Canc Inst, Bari, Italy

[9] Univ Naples Federico II, Prevent Med Sci, I-80131 Naples, Italy

[10] A Cardarelli Hosp, Med Oncol, Naples, Italy

[11] Natl Canc Inst Fdn G Pascale, Naples, Italy

[12] Presidio Evangel Valdese ASL TO1, Area Med, Turin, Italy

[13] Hosp Prato, Ist Toscano Tumori, Dept Med Oncol, Prato, Italy

[14] Casa Cura Poliambulanza, Dept Med Oncol, Brescia, Italy

[15] Osped F Renzetti, Med Oncol, Lanciano, Italy

[16] Osped Riuniti Trieste, Oncol, Trieste, Italy

[17] San Carlo Hosp, Oncol, Potenza, Italy

[18] San Gerardo Hosp, Med Oncol, Monza, Italy

来源：

JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY | 2016年 / 142卷 / 03期

关键词：

Clinical practice; Early breast cancer; HER2; Adjuvant therapy; Trastuzumab; RANDOMIZED PHASE-III; MONOCLONAL-ANTIBODY; ADJUVANT TRASTUZUMAB; CHEMOTHERAPY; PLUS; PACLITAXEL; RECEPTOR; CHEMOSENSITIVITY; VINORELBINE; DOCETAXEL;

D O I：

10.1007/s00432-015-2033-z

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. 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. 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 a parts per thousand yen 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). 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.

引用

页码：669 / 678

页数：10

共 36 条

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