Safety analysis, association with response and previous treatments of everolimus and exemestane in 181 metastatic breast cancer patients: A multicenter Italian experience

被引：15

作者：

Moscetti, L. ^{[1
,14
]}

Vici, P. ^{[2
]}

Gamucci, T. ^{[3
]}

Natoli, C. ^{[4
]}

Cortesi, E. ^{[5
]}

Marchetti, P. ^{[6
,7
]}

Santini, D. ^{[8
]}

Giuliani, R. ^{[9
]}

Sperduti, I. ^{[10
]}

Mauri, M. ^{[12
]}

Pizzuti, L.

Mancini, M. L.

Fabbri, M. A. ^{[1
]}

Magri, V. ^{[5
]}

Iezzi, L. ^{[13
]}

Sini, V. ^{[6
,7
]}

D'Onofrio, L. ^{[8
]}

Mentuccia, L. ^{[3
]}

Vaccaro, A. ^{[3
]}

Ramponi, S. ^{[11
]}

Roma, C. L. ^{[12
]}

Ruggeri, E. M. ^{[1
]}

机构：

[1] AUSL Viterbo, Div Oncol, Complesso Osped Belcolle, Viterbo, Italy

[2] Regina Elena Inst Canc Res, Div Med Oncol B, Rome, Italy

[3] ASL Frosinone, Med Oncol Unit, Frosinone, Italy

[4] Univ G DAnnunzio, Dept Med Oral & Biotechnol Sci, Chieti, Italy

[5] Univ Rome, Dept Radiol Oncol & Pathol Sci, Med Oncol Unit, Rome, Italy

[6] Sapienza Univ Rome, St Andrea Hosp, Oncol Unit, Rome, Italy

[7] IDI IRCCS, Oncol Unit, Rome, Italy

[8] Policlin Univ Campus Biomed, Med Oncol, Rome, Italy

[9] San Camillo & Forlanini Hosp, Dept Med Oncol, Rome, Italy

[10] Regina Elena Inst Canc Res, Biostat, Rome, Italy

[11] Sandro Pertini Hosp, Div Oncol, Rome, Italy

[12] San Giovanni Hosp, Div Oncol, Rome, Italy

[13] SS Annunziata Hosp, Med Oncol Unit, Chieti, Italy

[14] Azienda Osped Policlin, Dept Haematol & Oncol, Via Pozzo 71, I-41124 Modena, Italy

来源：

BREAST | 2016年 / 29卷

关键词：

Everolimus; Metastatic breast cancer; Exemestane; ADVANCED SOLID TUMORS; PHASE-I; MAMMALIAN TARGET; CLINICAL-TRIALS; BOLERO-2; EFFICACY; SCHEDULES; LETROZOLE;

D O I：

10.1016/j.breast.2016.07.005

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose: The everolimus and exemestane combination represents a treatment option for the endocrine sensitive metastatic breast cancer (MBC) patients. The toxicity profile reported in the Bolero 2 trial showed the feasibility in the selected patients. Few data are available for the unselected population. Methods: In order to evaluate the safety in the unselected population of the clinical practice and to evaluate a possible association of toxicities with previous treatments, clinical data from 181 consecutive patients were retrospectively collected. Results: Due to toxic events, everolimus dosage was reduced to 5 mg in 27% of patients. No association was found in the analysis between toxicity and number of prior therapies, neither between toxicity and response. In the multivariate analysis the previous exposure to anthracyclines for advanced disease represents the only predictive factor of developing grade >= 2 toxicity (OR = 2.85 CI 95% 1.07-7.59, p = 0.036). Conclusions: The association of everolimus and exemestane has confirmed to be a safe and effective treatment for endocrine sensitive MBC patients even in routine clinical practice. The rate of treatment discontinuation due to toxicity is low and none association between previous number of treatments and response or between toxicity and response was found. (C) 2016 Elsevier Ltd. All rights reserved.

引用

页码：96 / 101

页数：6

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