Real-world cabazitaxel safety: the Italian early-access program in metastatic castration-resistant prostate cancer

被引：41

作者：

Bracarda, Sergio ^{[1
]}

Gernone, Angela ^{[2
]}

Gasparro, Donatello ^{[3
]}

Marchetti, Paolo ^{[4
,5
]}

Ronzoni, Monica ^{[6
]}

Bortolus, Roberto ^{[7
]}

Fratino, Lucia ^{[7
]}

Basso, Umberto ^{[8
]}

Mazzanti, Roberto ^{[9
]}

Messina, Caterina ^{[10
]}

Tucci, Marcello ^{[11
]}

Boccardo, Francesco ^{[12
,13
]}

Carteni, Giacomo ^{[14
]}

Pinto, Carmine ^{[15
]}

Fornarini, Giuseppe ^{[16
]}

Mattioli, Rodolfo ^{[17
]}

Procopio, Giuseppe ^{[18
]}

Chiuri, Vincenzo ^{[19
]}

Scotto, Tiziana ^{[20
]}

Dondi, Davide ^{[21
]}

Di Lorenzo, Giuseppe ^{[22
]}

机构：

[1] San Donato Hosp, Med Oncol Unit, Dept Oncol, I-52100 Arezzo, Italy

[2] Policlin Hosp, Med Oncol Unit, Bari, Italy

[3] Univ Hosp Parma, Dept Oncohematol, Parma, Italy

[4] Univ Roma La Sapienza, Med Oncol Unit, St Andrea Hosp, I-00185 Rome, Italy

[5] IDI IRCCS, Rome, Italy

[6] Med Oncol San Raffaele Hosp, Milan, Italy

[7] Natl Canc Inst, Aviano, Italy

[8] IRCSS Ist Oncol Veneto, Dept Oncol, Padua, Italy

[9] Univ Hosp Careggi, Tuscany Canc Inst, Med Oncol Unit 2, Florence, Italy

[10] Pope John Paul XXIII Hosp, Med Oncol Unit, Bergamo, Italy

[11] Univ Hosp S Luigi, Med Oncol Unit, Orbassano, Italy

[12] Univ Genoa, Dept Internal Med, Sch Med & Pharmaceut Sci, I-16126 Genoa, Italy

[13] IRCCS AOU San Martino IST, Unit Med Oncol Med Oncol B, Genoa, Italy

[14] Cardarelli Hosp, Dept Oncohematol, Naples, Italy

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

[16] IRCCS AOU San Martino IST, Genoa, Italy

[17] Osped Riuniti Marche Nord Hosp, Dept Med Oncol, Pesaro, Italy

[18] IRCCS Natl Canc Inst, Milan, Italy

[19] Lecce Hosp, Med Oncol Unit, Lecce, Italy

[20] Sassari Hosp, Med Oncol Unit, Sassari, Italy

[21] Sanofi Aventis, Med Affairs, Div Oncol, Milan, Italy

[22] Univ Naples Federico II, Dept Med Oncol, Naples, Italy

来源：

FUTURE ONCOLOGY | 2014年 / 10卷 / 06期

关键词：

cabazitaxel; castrate resistant; docetaxel; prostate cancer; safety; taxane; PLUS PREDNISONE; MITOXANTRONE;

D O I：

10.2217/fon.13.256

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Aim: Cabazitaxel is a novel taxane that is approved for use in metastatic castration-resistant prostate cancer based on the Phase III TROPIC study, which showed improved overall survival with cabazitaxel/prednisone versus mitoxantrone/prednisone. A global early-access program was initiated in order to provide early access to cabazitaxel in docetaxel-pretreated patients and to obtain real-world data. Patients & methods: We report interim safety results from an Italian prospective, single-arm, multicenter, open-label trial of 218 patients receiving cabazitaxel 25 mg/m2 every 3 weeks plus prednisolone 10 mg/day, until disease progression, unacceptable toxicity, investigator's decision or death. Results: Patients completing treatment received a median of six cabazitaxel cycles. The most common grade 3/4 adverse events were neutropenia (33.9%), leukopenia (15.6%), anemia (6%) and asthenia (6%). No peripheral neuropathy or nail disorders were observed. Conclusion: These results confirm that cabazitaxel has a manageable safety profile in daily clinical practice and support its use in patients with prostate cancer who progress during or after a docetaxel-based therapy.

引用

页码：975 / 983

页数：9

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