Safety and Clinical Outcomes of Abiraterone Acetate after Docetaxel in Octogenarians with Metastatic Castration-Resistant Prostate Cancer: Results of the Italian Compassionate Use Named Patient Programme

Francesca Maines, Orazio Caffo, Ugo De Giorgi, Lucia Fratino, Giovanni Lo Re, Vittorina Zagonel, Alessandro D'Angelo, Maddalena Donini, Francesco Verderame, Raffaele Ratta, Giuseppe Procopio, Enrico Campadelli, Francesco Massari, D. Gasparro, Paola Ermacora, Caterina Messina, M. Giordano, Daniele Alesini, Umberto Basso, Anna Paola FracconG. Vicario, Vincenza Conteduca, E. Galligioni

Research output: Contribution to journalArticle

Abstract

Background Prostate cancer mainly affects elderly men, who are often frail and whose reduced physiological reserves and multiple comorbidities increase the risk of side effects. The availability of new drugs has improved the overall survival (OS) of patients with castration-resistant prostate cancer (CRPC) but has increased the number of very elderly CRPC patients receiving anticancer drugs, raising questions about their efficacy and safety in this population. Patients and Methods We assessed the tolerability of abiraterone (AA) in a cohort of very elderly adults with metastatic CRPC (mCRPC) enrolled in the Italian AA named patient program and analyzed their clinical outcomes. We retrospectively reviewed the clinical records of 47 mCRPC patients aged > 80 years who had received AA after docetaxel. The Kaplan-Meier method was used to calculate OS and progression-free survival (PFS). Safety and clinical outcomes were also analyzed by age group (<80 and > 80 years). Cox regression analysis was used to calculate the differences in PFS and OS between the groups according to the stratification variables. Results In very elderly men, the prostate-specific antigen response rate was 48.9%, and the median PFS and OS were 8 and 18 months, respectively. The differences in toxicities between the older and younger age groups were not major. The limitation of the present study was mainly its retrospective nature. Conclusion Our data show that AA is active and safe in very elderly patients and leads to outcomes similar to those observed in younger patients, thus confirming that AA is a manageable therapeutic option for this patient population.

Original languageEnglish
Pages (from-to)48-55
Number of pages8
JournalClinical Genitourinary Cancer
Volume14
Issue number1
DOIs
Publication statusPublished - Feb 1 2016

Fingerprint

docetaxel
Compassionate Use Trials
Castration
Prostatic Neoplasms
Safety
Disease-Free Survival
Survival
Age Groups
Abiraterone Acetate
Prostate-Specific Antigen
Pharmaceutical Preparations
Population
Comorbidity

Keywords

  • Abiraterone
  • Castration-resistant prostate cancer
  • Elderly
  • Outcomes
  • Safety

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

Safety and Clinical Outcomes of Abiraterone Acetate after Docetaxel in Octogenarians with Metastatic Castration-Resistant Prostate Cancer : Results of the Italian Compassionate Use Named Patient Programme. / Maines, Francesca; Caffo, Orazio; De Giorgi, Ugo; Fratino, Lucia; Lo Re, Giovanni; Zagonel, Vittorina; D'Angelo, Alessandro; Donini, Maddalena; Verderame, Francesco; Ratta, Raffaele; Procopio, Giuseppe; Campadelli, Enrico; Massari, Francesco; Gasparro, D.; Ermacora, Paola; Messina, Caterina; Giordano, M.; Alesini, Daniele; Basso, Umberto; Fraccon, Anna Paola; Vicario, G.; Conteduca, Vincenza; Galligioni, E.

In: Clinical Genitourinary Cancer, Vol. 14, No. 1, 01.02.2016, p. 48-55.

Research output: Contribution to journalArticle

Maines, F, Caffo, O, De Giorgi, U, Fratino, L, Lo Re, G, Zagonel, V, D'Angelo, A, Donini, M, Verderame, F, Ratta, R, Procopio, G, Campadelli, E, Massari, F, Gasparro, D, Ermacora, P, Messina, C, Giordano, M, Alesini, D, Basso, U, Fraccon, AP, Vicario, G, Conteduca, V & Galligioni, E 2016, 'Safety and Clinical Outcomes of Abiraterone Acetate after Docetaxel in Octogenarians with Metastatic Castration-Resistant Prostate Cancer: Results of the Italian Compassionate Use Named Patient Programme', Clinical Genitourinary Cancer, vol. 14, no. 1, pp. 48-55. https://doi.org/10.1016/j.clgc.2015.07.019
Maines, Francesca ; Caffo, Orazio ; De Giorgi, Ugo ; Fratino, Lucia ; Lo Re, Giovanni ; Zagonel, Vittorina ; D'Angelo, Alessandro ; Donini, Maddalena ; Verderame, Francesco ; Ratta, Raffaele ; Procopio, Giuseppe ; Campadelli, Enrico ; Massari, Francesco ; Gasparro, D. ; Ermacora, Paola ; Messina, Caterina ; Giordano, M. ; Alesini, Daniele ; Basso, Umberto ; Fraccon, Anna Paola ; Vicario, G. ; Conteduca, Vincenza ; Galligioni, E. / Safety and Clinical Outcomes of Abiraterone Acetate after Docetaxel in Octogenarians with Metastatic Castration-Resistant Prostate Cancer : Results of the Italian Compassionate Use Named Patient Programme. In: Clinical Genitourinary Cancer. 2016 ; Vol. 14, No. 1. pp. 48-55.
@article{33b4d3e281734db8ac0ca5f46e99ddaa,
title = "Safety and Clinical Outcomes of Abiraterone Acetate after Docetaxel in Octogenarians with Metastatic Castration-Resistant Prostate Cancer: Results of the Italian Compassionate Use Named Patient Programme",
abstract = "Background Prostate cancer mainly affects elderly men, who are often frail and whose reduced physiological reserves and multiple comorbidities increase the risk of side effects. The availability of new drugs has improved the overall survival (OS) of patients with castration-resistant prostate cancer (CRPC) but has increased the number of very elderly CRPC patients receiving anticancer drugs, raising questions about their efficacy and safety in this population. Patients and Methods We assessed the tolerability of abiraterone (AA) in a cohort of very elderly adults with metastatic CRPC (mCRPC) enrolled in the Italian AA named patient program and analyzed their clinical outcomes. We retrospectively reviewed the clinical records of 47 mCRPC patients aged > 80 years who had received AA after docetaxel. The Kaplan-Meier method was used to calculate OS and progression-free survival (PFS). Safety and clinical outcomes were also analyzed by age group (<80 and > 80 years). Cox regression analysis was used to calculate the differences in PFS and OS between the groups according to the stratification variables. Results In very elderly men, the prostate-specific antigen response rate was 48.9{\%}, and the median PFS and OS were 8 and 18 months, respectively. The differences in toxicities between the older and younger age groups were not major. The limitation of the present study was mainly its retrospective nature. Conclusion Our data show that AA is active and safe in very elderly patients and leads to outcomes similar to those observed in younger patients, thus confirming that AA is a manageable therapeutic option for this patient population.",
keywords = "Abiraterone, Castration-resistant prostate cancer, Elderly, Outcomes, Safety",
author = "Francesca Maines and Orazio Caffo and {De Giorgi}, Ugo and Lucia Fratino and {Lo Re}, Giovanni and Vittorina Zagonel and Alessandro D'Angelo and Maddalena Donini and Francesco Verderame and Raffaele Ratta and Giuseppe Procopio and Enrico Campadelli and Francesco Massari and D. Gasparro and Paola Ermacora and Caterina Messina and M. Giordano and Daniele Alesini and Umberto Basso and Fraccon, {Anna Paola} and G. Vicario and Vincenza Conteduca and E. Galligioni",
year = "2016",
month = "2",
day = "1",
doi = "10.1016/j.clgc.2015.07.019",
language = "English",
volume = "14",
pages = "48--55",
journal = "Clinical Genitourinary Cancer",
issn = "1558-7673",
publisher = "Elsevier Inc.",
number = "1",

}

TY - JOUR

T1 - Safety and Clinical Outcomes of Abiraterone Acetate after Docetaxel in Octogenarians with Metastatic Castration-Resistant Prostate Cancer

T2 - Results of the Italian Compassionate Use Named Patient Programme

AU - Maines, Francesca

AU - Caffo, Orazio

AU - De Giorgi, Ugo

AU - Fratino, Lucia

AU - Lo Re, Giovanni

AU - Zagonel, Vittorina

AU - D'Angelo, Alessandro

AU - Donini, Maddalena

AU - Verderame, Francesco

AU - Ratta, Raffaele

AU - Procopio, Giuseppe

AU - Campadelli, Enrico

AU - Massari, Francesco

AU - Gasparro, D.

AU - Ermacora, Paola

AU - Messina, Caterina

AU - Giordano, M.

AU - Alesini, Daniele

AU - Basso, Umberto

AU - Fraccon, Anna Paola

AU - Vicario, G.

AU - Conteduca, Vincenza

AU - Galligioni, E.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Background Prostate cancer mainly affects elderly men, who are often frail and whose reduced physiological reserves and multiple comorbidities increase the risk of side effects. The availability of new drugs has improved the overall survival (OS) of patients with castration-resistant prostate cancer (CRPC) but has increased the number of very elderly CRPC patients receiving anticancer drugs, raising questions about their efficacy and safety in this population. Patients and Methods We assessed the tolerability of abiraterone (AA) in a cohort of very elderly adults with metastatic CRPC (mCRPC) enrolled in the Italian AA named patient program and analyzed their clinical outcomes. We retrospectively reviewed the clinical records of 47 mCRPC patients aged > 80 years who had received AA after docetaxel. The Kaplan-Meier method was used to calculate OS and progression-free survival (PFS). Safety and clinical outcomes were also analyzed by age group (<80 and > 80 years). Cox regression analysis was used to calculate the differences in PFS and OS between the groups according to the stratification variables. Results In very elderly men, the prostate-specific antigen response rate was 48.9%, and the median PFS and OS were 8 and 18 months, respectively. The differences in toxicities between the older and younger age groups were not major. The limitation of the present study was mainly its retrospective nature. Conclusion Our data show that AA is active and safe in very elderly patients and leads to outcomes similar to those observed in younger patients, thus confirming that AA is a manageable therapeutic option for this patient population.

AB - Background Prostate cancer mainly affects elderly men, who are often frail and whose reduced physiological reserves and multiple comorbidities increase the risk of side effects. The availability of new drugs has improved the overall survival (OS) of patients with castration-resistant prostate cancer (CRPC) but has increased the number of very elderly CRPC patients receiving anticancer drugs, raising questions about their efficacy and safety in this population. Patients and Methods We assessed the tolerability of abiraterone (AA) in a cohort of very elderly adults with metastatic CRPC (mCRPC) enrolled in the Italian AA named patient program and analyzed their clinical outcomes. We retrospectively reviewed the clinical records of 47 mCRPC patients aged > 80 years who had received AA after docetaxel. The Kaplan-Meier method was used to calculate OS and progression-free survival (PFS). Safety and clinical outcomes were also analyzed by age group (<80 and > 80 years). Cox regression analysis was used to calculate the differences in PFS and OS between the groups according to the stratification variables. Results In very elderly men, the prostate-specific antigen response rate was 48.9%, and the median PFS and OS were 8 and 18 months, respectively. The differences in toxicities between the older and younger age groups were not major. The limitation of the present study was mainly its retrospective nature. Conclusion Our data show that AA is active and safe in very elderly patients and leads to outcomes similar to those observed in younger patients, thus confirming that AA is a manageable therapeutic option for this patient population.

KW - Abiraterone

KW - Castration-resistant prostate cancer

KW - Elderly

KW - Outcomes

KW - Safety

UR - http://www.scopus.com/inward/record.url?scp=84952871891&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84952871891&partnerID=8YFLogxK

U2 - 10.1016/j.clgc.2015.07.019

DO - 10.1016/j.clgc.2015.07.019

M3 - Article

VL - 14

SP - 48

EP - 55

JO - Clinical Genitourinary Cancer

JF - Clinical Genitourinary Cancer

SN - 1558-7673

IS - 1

ER -