Safety and clinical outcomes of patients treated with abiraterone acetate after docetaxel: results of the Italian Named Patient Programme

被引：17

作者：

Caffo, Orazio ^{[1
]}

De Giorgi, Ugo ^{[2
]}

Fratino, Lucia ^{[3
]}

Lo Re, Giovanni ^{[4
]}

Basso, Umberto ^{[5
]}

D'Angelo, Alessandro ^{[6
]}

Donini, Maddalena ^{[7
]}

Verderame, Francesco ^{[8
]}

Ratta, Raffaele ^{[9
]}

Procopio, Giuseppe ^{[11
]}

Campadelli, Enrico ^{[12
]}

Massari, Francesco ^{[13
]}

Gasparro, Donatello ^{[14
]}

Macrini, Sveva ^{[15
]}

Messina, Caterina ^{[16
]}

Giordano, Monica ^{[17
]}

Alesini, Daniele ^{[10
]}

Zustovich, Fable ^{[5
]}

Fraccon, Anna P. ^{[18
]}

Vicario, Giovanni ^{[19
]}

Conteduca, Vincenza ^{[2
]}

Maines, Francesca ^{[1
]}

Galligioni, Enzo ^{[1
]}

机构：

[1] Santa Chiara Hosp, Dept Med Oncol, I-38100 Trento, Italy

[2] IRCCS, Ist Sci Romagnolo Studio & Cura Tumori IRST, Dept Med Oncol, Meldola, Italy

[3] Natl Canc Inst, Dept Med Oncol, Aviano, Italy

[4] Santa Maria Angeli Hosp, Dept Med Oncol, Pordenone, Italy

[5] IRCCS, Ist Oncol Veneto, Med Oncol Unit 1, Padua, Italy

[6] San Vincenzo Hosp, Dept Med Oncol, Taormina, Italy

[7] Civil Hosp, Dept Med Oncol, Cremona, Italy

[8] Villa Sofia Cervello Hosp, Dept Med Oncol, Palermo, Italy

[9] Unicampus Univ, Dept Med Oncol, Rome, Italy

[10] Univ Rome, Dept Radiol Oncol & Anatomopathol Sci, Rome, Italy

[11] Natl Canc Inst, Dept Med Oncol, Milan, Italy

[12] Civil Hosp, Dept Med Oncol, Lugo Di Romagna, Spain

[13] Univ Verona, Azienda Osped Univ Integrata, Med Oncol, I-37100 Verona, Italy

[14] Civil Hosp, Dept Med Oncol, Parma, Italy

[15] Santa Maria Misericordia Hosp, Dept Med Oncol, Udine, Italy

[16] Papa Giovanni XXIII Hosp, Dept Med Oncol, Bergamo, Italy

[17] St Anna Hosp, Dept Med Oncol, Como, Italy

[18] Casa di Cura Pederzoli, Dept Med Oncol, Peschiera Del Garda, Italy

[19] San Giacomo Apostolo Hosp, Dept Med Oncol, Castelfranco Veneto, Italy

来源：

BJU INTERNATIONAL | 2015年 / 115卷 / 05期

关键词：

abiraterone acetate; castration-resistant prostate cancer; pre-treated patients; compassionate programme; safety; RESISTANT PROSTATE-CANCER; INCREASED SURVIVAL; PLUS PREDNISONE; MITOXANTRONE; INHIBITION; PLACEBO; CYP17;

D O I：

10.1111/bju.12857

中图分类号：

R5 [内科学]; R69 [泌尿科学（泌尿生殖系疾病）];

学科分类号：

1002 ; 100201 ;

摘要：

Objective To assess the safety and efficacy of abiraterone acetate (AA) in patients with metastatic castration-resistant prostate cancer (mCRPC) treated in a compassionate named patient programme (NPP). Patients and Methods We retrospectively reviewed the clinical records of patients with mCRPC treated with AA at the standard daily oral dose of 1000 mg plus prednisone 10 mg/day in 19 Italian hospitals. Results We assessed 265 patients with mCRPC treated with AA. The most frequent (>1%) grade 3-4 toxicities were anaemia (4.2%), fatigue (4.2%), and bone pain (1.5%). The median progression-free survival was 7 months; median overall survival was 17 months after starting AA, and 35 months after the first docetaxel administration. Our study reproduced the clinical outcomes reported in the AA pivotal trial, including those relating to special populations such as the elderly, patients with a poor performance status, symptomatic patients, and patients with visceral metastases. Conclusions Our data show the safety and activity of AA when administered outside clinical trials, and confirm the findings of the post-docetaxel pivotal trial in the patients as a whole population and in special populations of specific interest.

引用

页码：764 / 771

页数：8

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