Revisión sistemática

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Cabazitaxel (jevtana): a novel agent for metastatic castration-resistant prostate cancer.

Año 2012
Autores Nightingale G , Ryu J
Revista P & T : a peer-reviewed journal for formulary management
Enlaces Pubmed , PMC

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OBJECTIVE:

This article presents current clinical evidence supporting the use of cabazitaxel (Jevtana) in men with metastatic castration-resistant prostate cancer (mCRPC).

DATA SOURCES:

We conducted a literature search using abstracts from MEDLINE and PubMed (from January 1966 to December 2011) and the American Society of Clinical Oncology (from January 2000 to December 2011). The search included clinical studies and abstracts in the English language that described the pharmacology, pharmacokinetics, clinical activity, and safety of cabazitaxel in mCRPC.

RESULTS:

Cabazitaxel, a semisynthetic microtubule inhibitor that induces cell death by microtubule stabilization, was approved in combination with prednisone for the treatment of mCRPC in patients who had been treated with a docetaxel-(Taxotere)-containing regimen. The approval of this taxane derivative was based primarily on the results of a randomized, open-label trial in patients with mCRPC who were treated with either cabazitaxel 25 mg/m(2) or mitoxantrone (Novantrone) 12 mg/m(2) intravenously every 3 weeks, both in combination with prednisone 10 mg/day. The median survival period was 15.1 months with cabazitaxel and 12.7 months with mitoxantrone. Neither group experienced complete responses. Cabazitaxel has also shown activity in breast cancer and other malignancies. In clinical trials, common grade 3 or grade 4 adverse reactions were myelosuppression, febrile neutropenia, diarrhea, fatigue, and asthenia. Other adverse effects included abdominal pain, back pain, arthralgia, and peripheral neuropathy.

CONCLUSION:

Cabazitaxel appeared to be an effective second-line agent in patients with mCRPC refractory to a docetaxel-containing regimen. Studies comparing cabazitaxel with existing first-line regimens for mCRPC are under way. Until the results of these head-to-head trials are published, it remains uncertain whether cabazitaxel is more effective or more tolerable than the currently available first-line regimens.

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Resumen estructurado de revisiones sistemáticas

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Cabazitaxel – Nutzenbewertung gemäß § 35a SGB V [Cabazitaxel - Benefit assessment according to § 35a Social Code Book V (dossier assessment)]

Año 2012
Autores IQWiG
Revista HTA Database
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RECORD STATUS:

This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.

CITATION:

IQWiG. Cabazitaxel – Nutzenbewertung gemäß § 35a SGB V. [Cabazitaxel - Benefit assessment according to § 35a Social Code Book V (dossier assessment)] Cologne: Institut fuer Qualitaet und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). IQWiG - Berichte 114. 2012

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Estudio primario

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Effectiveness and safety of cabazitaxel plus prednisolone chemotherapy for metastatic castration-resistant prostatic carcinoma: data on Korean patients obtained by the cabazitaxel compassionate-use program.

Año 2014
Autores Lee JL , Park SH , Koh SJ , Lee SH , Kim YJ , Choi YJ - Más
Revista Cancer chemotherapy and pharmacology
Enlaces Pubmed , DOI

Este artículo no está incluido en ninguna revisión sistemática

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PURPOSE:

To report the efficacy and safety of using cabazitaxel plus prednisolone chemotherapy to treat Korean patients with metastatic castration-resistant prostate cancer (mCRPC) following docetaxel therapy.

METHODS:

This cohort study enrolled 26 mCRPC patients. Treatment consisted of 25 mg/m(2) cabazitaxel that was intravenously administered every 3 weeks, in addition to twice-daily 5 mg prednisolone.

RESULTS:

The median patient age was 67 years (range = 53-82), median Eastern Cooperative Oncology Group performance status was 1 (range = 0-2), Gleason score was ≥ 8 in 25 patients (96 %), and median serum prostate-specific antigen (PSA) was 95.3 ng/mL (interquartile range = 9.1-297.7). A total of 180 treatment cycles were administered, and a median of five cycles were administered per patient (range = 1-23). A PSA response was observed in 32 % of evaluable patients. Tumor response was evaluated in eight patients, and three and four patients achieved partial response and stable disease, respectively. Over a median follow-up duration of 23.4 months (95 % CI 11.1-35.6), median time to treatment failure was 4.2 months (95 % CI 1.8-6.6) and median time to progression was 8.5 months (95 % CI 3.0-13.1). Median overall survival was 16.5 months (95 % CI 12.1-20.9). Grade 3 or worse febrile neutropenia developed in eight patients (31 %) and neutropenic infection in four patients (15 %).

CONCLUSION:

Cabazitaxel plus prednisolone chemotherapy can be used to treat Korean mCRPC patients. Prophylactic growth factor support should be considered for patients at high risk of neutropenic fever or infection.

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Resumen estructurado de revisiones sistemáticas

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Cabazitaxel for the second-line treatment of hormone refractory, metastatic prostate cancer

Año 2011
Autores [No se listan los autores]
Revista HTA Database
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RECORD STATUS:

None

CITATION:

Cabazitaxel for the second-line treatment of hormone refractory, metastatic prostate cancer.. NIHR Health Technology Assessment programme.

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Estudio primario

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Cabazitaxel for metastatic castration-resistant prostate cancer: safety data from the Spanish expanded access program.

Año 2014
Revista Expert opinion on drug safety
Enlaces Pubmed , DOI

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BACKGROUND:

Based on the TROPIC study results, cabazitaxel was approved for the management of metastatic castration-resistant prostate cancer (mCRPC) progressing on or after docetaxel.

METHODS:

This multi-centre program provided early access to cabazitaxel to patients with mCRPC before its commercialization. Safety data from 153 Spanish patients receiving cabazitaxel 25 mg/m(2) i.v. Q3W, plus oral prednisone/prednisolone 10 mg daily, are reported.

RESULTS:

Median age of patients was 70 years (26.8% ≥ 75 years), 94.1 and 26.8% had bone and visceral metastasis, respectively. Most had an Eastern Cooperative Oncology Group ≤ 1 (88.9%) and had received a median of 8.0 cycles of last docetaxel treatment. The median of cabazitaxel cycles and cumulative dose were 6.0 (Interquartile range [IQR]: 4.0; 8.0) and 148.9 (

IQR:

98.2; 201.4) mg/m(2), respectively. Adverse events (AEs) possibly related to cabazitaxel occurred in 143 (93.5%) patients. The most frequent grade ≥ 3 AEs were neutropenia (n = 25, 16.3%) and asthenia (n = 17, 11.1%). Febrile neutropenia and grade ≥ 3 diarrhea occurred in 5.2% of the patients each. There were five (3.3%) possibly treatment-related deaths, mainly infection-related. G-CSFs were used in 114 (74.5%) patients, generally as prophylaxis (n = 107; 69.9%). Grade ≥ 3 peripheral neuropathy and nail disorders were uncommon.

CONCLUSIONS:

Cabazitaxel administration, in a real-world setting, is tolerated by Spanish patients with mCRPC, and the AEs are manageable.

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Resumen estructurado de revisiones sistemáticas

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Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer - second line after docetaxel

Año 2010
Revista HTA Database
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RECORD STATUS:

None

CITATION:

National Horizon Scanning Centre. Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer - second line after docetaxel Birmingham: National Horizon Scanning Centre (NHSC). Horizon Scanning Technology Briefing. 2009

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Resumen estructurado de revisiones sistemáticas

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Cabazitaxel (Jevtana) for the second-line therapy of patients with hormone-refractory metastatic prostate cancer

Año 2011
Autores Nachtnebel A
Revista HTA Database
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RECORD STATUS:

None

CITATION:

Nachtnebel A. Cabazitaxel (Jevtana) for the second-line therapy of patients with hormone-refractory metastatic prostate cancer Vienna: Ludwig Boltzmann Institut fuer Health Technology Assessment (LBI-HTA). Decision Support Document: Horizon Scanning in Oncology No. 16. 2011

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Estudio primario

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Neoadjuvant Chemotherapy With Cabazitaxel

Año 2013
Autores RWTH Aachen University
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

Este artículo no está incluido en ninguna revisión sistemática

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This study is aimed at evaluating the efficacy regarding the response rate and metastasis-free survival time of cabazitaxel as a neoadjuvant treatment in patients with high risk prostate cancer.

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Estudio primario

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Cabazitaxel - An option? - 1St experiences

Año 2012
Revista European Urology, Supplements
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Introduction & Objectives: First-line docetaxel is the standard of care for castration-resistant prostate cancer (CRPC). Until recently, patients with CRPC had limited therapeutic options and poor prognosis once they became refractory to docetaxel chemotherapy. In 2010 the reported results from phase 3 trials for second line treatment with the novel taxane cabazitaxel were published. They showed improved survival rates for patients with CRPC. Therefore in 2011 we have started cabazitaxel chemotherapy for treatment of patients with CRPC who have previously been treated with docetaxel. Material & Methods: Our first patient had a systemic disease progression 5 years after radical surgical therapy in 8/2005. After resistance to further hormonal manipulation and radiation we started the chemotherapy with docetaxel. Due to a PSA-Progression (747 ng/ml) under chemotherapy we saw the indication for a second-line therapy with cabazitaxel. Our second patient had his surgical therapy already in 1997. After radiatio-, hormone depletion-therapy and two times 6 courses of docetaxel chemotherapy he showed up with a hydronephrosis and raising PSA (301 ng/ml). Results: The first patient tolerated the cabazitaxel chemotherapy very badly. Already during the first few courses this patient developed neutropenic fever. Therefore we decided to a dose-reduction. After an initial PSA decrease to 540ng/ml the PSA-increased up to 1910 ng/ml already after the 3rd course of chemotherapy. In addition the patient developed gastrointestinal bleedings, so we had to stop the cabazitaxel therapy and switch to abiraterone. The second patient showed initially a good treatment response with cabazitaxel, with a PSA decrease to 179ng/ml. But even this patient developed after the 3rd course neutropenic fever and a PSA-progression. Due to the distinctive side effects and toxicity we recommended a therapy-alteration to abiraterone. Conclusions: Cabazitaxel is a new option for patients with CRPC with disease progression during or after docetaxel treatment. The therapy side effects are particularly so severe that they limit the therapy effect of the already usually very morbid patients. The therapy effect has according to our experience only a limited duration. We assume abiraterone is a better second-line alternative.

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Estudio primario

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Cabazitaxel in Relapsed and Metastatic NSCLC

Año 2012
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

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The investigators propose to study the single agent activity of Cabazitaxel in a Phase II trial of subjects with relapsed or refractory non-small cell lung cancer pretreated with docetaxel, given the fact of its significant activity and its acceptable toxicity profile.

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