Cabazitaxel in patients with metastatic castration-resistant prostate cancer: safety and quality of life data from the Australian early access program

Phillip Parente, Siobhan Ng, Francis Parnis, Alex Guminski, Howard Gurney

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Aim: Cabazitaxel is a next generation taxane that has been shown to improve overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed during or after docetaxel-based therapy. A worldwide early access program (EAP) study was established to provide access to cabazitaxel ahead of commercial availability and to evaluate its safety and tolerability. The Australian EAP included patient-reported outcomes to evaluate the impact of cabazitaxel on quality of life (QoL). The final safety and QoL results from the Australian EAP for cabazitaxel are reported. Methods: Australian patients with mCRPC previously treated with a docetaxel-containing regimen received cabazitaxel (25 mg/m2) every 3 weeks plus prednisone/prednisolone (10 mg daily) until disease progression, death, unacceptable toxicity, physician's decision or patient's refusal of further treatment. QoL data was collected using the AQoL-8D questionnaire. Results: 104 patients from 18 Australian sites (median age at baseline, 70) enrolled in the EAP and completed at least one AQoL-8D questionnaire. Patients received a median of 6 cycles of cabazitaxel. 67 patients (64.4%) experienced grade ≥3 treatment-emergent adverse events (TEAEs); the most frequent TEAEs were neutropenia, febrile neutropenia, diarrhoea, and vomiting. QoL scores remained stable with increasing treatment cycles. Conclusion: The results suggest that the safety profile cabazitaxel is manageable in the Australian clinical practice setting and that QoL is maintained with little or no detrimental effect of cabazitaxel in patients continuing on treatment without disease progression.

LanguageEnglish
Pages391-399
Number of pages9
JournalAsia-Pacific Journal of Clinical Oncology
Volume13
Issue number6
DOIs
Publication statusPublished - Dec 2017
Externally publishedYes

Fingerprint

Castration
Prostatic Neoplasms
Quality of Life
Safety
docetaxel
Disease Progression
Treatment Refusal
Therapeutics
Febrile Neutropenia
cabazitaxel
Prednisone
Prednisolone
Neutropenia
Vomiting
Diarrhea
Physicians
Survival

Keywords

  • Cabazitaxel
  • Early access program
  • Metastatic castration-resistant prostate cancer
  • Quality of life
  • Safety

Cite this

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title = "Cabazitaxel in patients with metastatic castration-resistant prostate cancer: safety and quality of life data from the Australian early access program",
abstract = "Aim: Cabazitaxel is a next generation taxane that has been shown to improve overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed during or after docetaxel-based therapy. A worldwide early access program (EAP) study was established to provide access to cabazitaxel ahead of commercial availability and to evaluate its safety and tolerability. The Australian EAP included patient-reported outcomes to evaluate the impact of cabazitaxel on quality of life (QoL). The final safety and QoL results from the Australian EAP for cabazitaxel are reported. Methods: Australian patients with mCRPC previously treated with a docetaxel-containing regimen received cabazitaxel (25 mg/m2) every 3 weeks plus prednisone/prednisolone (10 mg daily) until disease progression, death, unacceptable toxicity, physician's decision or patient's refusal of further treatment. QoL data was collected using the AQoL-8D questionnaire. Results: 104 patients from 18 Australian sites (median age at baseline, 70) enrolled in the EAP and completed at least one AQoL-8D questionnaire. Patients received a median of 6 cycles of cabazitaxel. 67 patients (64.4{\%}) experienced grade ≥3 treatment-emergent adverse events (TEAEs); the most frequent TEAEs were neutropenia, febrile neutropenia, diarrhoea, and vomiting. QoL scores remained stable with increasing treatment cycles. Conclusion: The results suggest that the safety profile cabazitaxel is manageable in the Australian clinical practice setting and that QoL is maintained with little or no detrimental effect of cabazitaxel in patients continuing on treatment without disease progression.",
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Cabazitaxel in patients with metastatic castration-resistant prostate cancer : safety and quality of life data from the Australian early access program. / Parente, Phillip; Ng, Siobhan; Parnis, Francis; Guminski, Alex; Gurney, Howard.

In: Asia-Pacific Journal of Clinical Oncology, Vol. 13, No. 6, 12.2017, p. 391-399.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - Cabazitaxel in patients with metastatic castration-resistant prostate cancer

T2 - Asia-Pacific Journal of Clinical Oncology

AU - Parente, Phillip

AU - Ng, Siobhan

AU - Parnis, Francis

AU - Guminski, Alex

AU - Gurney, Howard

PY - 2017/12

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N2 - Aim: Cabazitaxel is a next generation taxane that has been shown to improve overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed during or after docetaxel-based therapy. A worldwide early access program (EAP) study was established to provide access to cabazitaxel ahead of commercial availability and to evaluate its safety and tolerability. The Australian EAP included patient-reported outcomes to evaluate the impact of cabazitaxel on quality of life (QoL). The final safety and QoL results from the Australian EAP for cabazitaxel are reported. Methods: Australian patients with mCRPC previously treated with a docetaxel-containing regimen received cabazitaxel (25 mg/m2) every 3 weeks plus prednisone/prednisolone (10 mg daily) until disease progression, death, unacceptable toxicity, physician's decision or patient's refusal of further treatment. QoL data was collected using the AQoL-8D questionnaire. Results: 104 patients from 18 Australian sites (median age at baseline, 70) enrolled in the EAP and completed at least one AQoL-8D questionnaire. Patients received a median of 6 cycles of cabazitaxel. 67 patients (64.4%) experienced grade ≥3 treatment-emergent adverse events (TEAEs); the most frequent TEAEs were neutropenia, febrile neutropenia, diarrhoea, and vomiting. QoL scores remained stable with increasing treatment cycles. Conclusion: The results suggest that the safety profile cabazitaxel is manageable in the Australian clinical practice setting and that QoL is maintained with little or no detrimental effect of cabazitaxel in patients continuing on treatment without disease progression.

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