Literature DB >> 24295376

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

Sergio Bracarda1, Angela Gernone, Donatello Gasparro, Paolo Marchetti, Monica Ronzoni, Roberto Bortolus, Lucia Fratino, Umberto Basso, Roberto Mazzanti, Caterina Messina, Marcello Tucci, Francesco Boccardo, Giacomo Cartenì, Carmine Pinto, Giuseppe Fornarini, Rodolfo Mattioli, Giuseppe Procopio, Vincenzo Chiuri, Tiziana Scotto, Davide Dondi, Giuseppe Di Lorenzo.   

Abstract

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.

Entities:  

Keywords:  cabazitaxel; castrate resistant; docetaxel; prostate cancer; safety; taxane

Mesh:

Substances:

Year:  2013        PMID: 24295376     DOI: 10.2217/fon.13.256

Source DB:  PubMed          Journal:  Future Oncol        ISSN: 1479-6694            Impact factor:   3.404


  16 in total

Review 1.  Diagnostic tools for hypersensitivity to platinum drugs and taxanes: skin testing, specific IgE, and mast cell/basophil mediators.

Authors:  Joana Caiado; Matthieu Picard
Journal:  Curr Allergy Asthma Rep       Date:  2014-08       Impact factor: 4.806

2.  Generating Evidence from Expanded Access Use of Rare Disease Medicines: Challenges and Recommendations.

Authors:  Tobias B Polak; David G J Cucchi; Joost van Rosmalen; Carin A Uyl-de Groot; Jonathan J Darrow
Journal:  Front Pharmacol       Date:  2022-05-23       Impact factor: 5.988

Review 3.  Re-visiting Hypersensitivity Reactions to Taxanes: A Comprehensive Review.

Authors:  Matthieu Picard; Mariana C Castells
Journal:  Clin Rev Allergy Immunol       Date:  2015-10       Impact factor: 8.667

Review 4.  Treatment of Advanced Prostate Cancer-A Review of Current Therapies and Future Promise.

Authors:  Semini Sumanasuriya; Johann De Bono
Journal:  Cold Spring Harb Perspect Med       Date:  2018-06-01       Impact factor: 6.915

5.  Efficacy, quality of life, and safety of cabazitaxel in Canadian metastatic castration-resistant prostate cancer patients treated or not with prior abiraterone.

Authors:  Fred Saad; Eric Winquist; Stacey Hubay; Scott Berry; Hazem Assi; Eric Levesque; Nathalie Aucoin; Piotr Czaykowski; Jean-Baptiste Lattouf; Karine Alloul; John Stewart; Srikala S Sridhar
Journal:  Can Urol Assoc J       Date:  2016 Mar-Apr       Impact factor: 1.862

6.  Continuing cabazitaxel beyond 10 cycles for metastatic castrate-resistant prostate cancer: is there a benefit?

Authors:  Loma Al-Mansouri; Malmaruha Arasaratnam; Howard Gurney
Journal:  Eur J Hosp Pharm       Date:  2019-06-14

Review 7.  Metastatic castration-resistant prostate cancer in very elderly patients: challenges and solutions.

Authors:  Orazio Caffo; Francesca Maines; Mimma Rizzo; Stefania Kinspergher; Antonello Veccia
Journal:  Clin Interv Aging       Date:  2016-12-22       Impact factor: 4.458

8.  The Influence of Prednisone on the Efficacy of Cabazitaxel in Men with Metastatic Castration-Resistant Prostate Cancer.

Authors:  Carlo Buonerba; Guru Sonpavde; Francesca Vitrone; Davide Bosso; Livio Puglia; Michela Izzo; Simona Iaccarino; Luca Scafuri; Margherita Muratore; Francesca Foschini; Brigitta Mucci; Vincenzo Tortora; Martina Pagliuca; Dario Ribera; Vittorio Riccio; Rocco Morra; Mirta Mosca; Nicola Cesarano; Ileana Di Costanzo; Sabino De Placido; Giuseppe Di Lorenzo
Journal:  J Cancer       Date:  2017-08-22       Impact factor: 4.207

9.  Towards better dose individualisation: metabolic phenotyping to predict cabazitaxel pharmacokinetics in men with prostate cancer.

Authors:  A Janssen; C P M Verkleij; A van der Vlist; R H J Mathijssen; H J Bloemendal; R Ter Heine
Journal:  Br J Cancer       Date:  2017-04-11       Impact factor: 7.640

10.  Lack of Cumulative Toxicity Associated With Cabazitaxel Use in Prostate Cancer.

Authors:  Giuseppe Di Lorenzo; Sergio Bracarda; Donatello Gasparro; Angela Gernone; Caterina Messina; Vittorina Zagonel; Livio Puglia; Davide Bosso; Davide Dondi; Guru Sonpavde; Giuseppe Lucarelli; Sabino De Placido; Carlo Buonerba
Journal:  Medicine (Baltimore)       Date:  2016-01       Impact factor: 1.817

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