Cabazitaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Interim results from the Australian early access program [NCT01254279] — ASN Events
  1. Schedule
  2. COSA Posters: Education and Supportive Care
  3. Cabazitaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Interim results from the Australian early access program [NCT01254279]

Cabazitaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Interim results from the Australian early access program [NCT01254279] (#866)

Phillip Parente 1 , Siobhan Ng 2 , Francis Parnis 3 , Alexander Guminski 4 , Mark Rosenthal 5 , Stanley Gauden 6 , George Kannourakis 7 , Howard Gurney 8
  1. Medical Oncology, Box Hill Hospital, Boxhill, VIC, Australia
  2. Medical Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia
  3. Adelaide Cancer Centre, Adelaide, SA, Australia
  4. Medical Oncologist, Royal North Shore Hospital, St Leonards, NSW, Australia
  5. Medical Oncology, Royal Melbourne Hospital , Parkville, VIC, Australia
  6. Medical Oncology, Launceston General Hospital, Launceston, TAS, Australia
  7. Director, Ballarat Cancer Research Centre, Ballarat, VIC, Australia
  8. Medical Oncology, Westmead Hospital, Sydney, NSW, Australia

Background: Despite the survival benefit with docetaxel in mCRPC,1,2 patients inevitably progress. Cabazitaxel, a novel taxane, improved survival in the TROPIC trial.3 A single-arm multicenter, open label trial has been established to provide early access to cabazitaxel.

Methods: Patients received intravenous cabazitaxel (25mg/m2) every 3 weeks and oral prednisone 10mg daily. Safety assessments were undertaken following each cabazitaxel cycle.

Results: Baseline characteristics - median age 70 years, 34% aged ≥ 75 years, 93% had ECOG PS of 0 or 1, 93% had bone metastases and 48% had disease progression during/within 3 months of their last docetaxel dose. Of the 86 patients enrolled: >50% have received at least 4 cycles of cabazitaxel, 50 are still undergoing treatment and 36 discontinued treatment predominantly due to disease progression (22 patients). G-CSF was administered at cycle one of cabazitaxel in 36 (41.9%) patients. Treatment-emergent adverse events (TEAE) considered related to the study drug were experienced by 77 (89.5%) patients. The table shows the frequency of TEAEs occurring in ≥5% of the safety population. There were 2 (2.3%) treatment-related deaths (acute renal failure, neutropenic colitis); 11 (12.8%) patients experienced a TEAE resulting in permanent, premature discontinuation of treatment.

Frequency of selected toxicities:
                                                                  TROPIC cabazitaxel arm (n=378)                 Australian EAP (n=86)
                                                                      All grades     Grade ≥3                                All grades     Grade ≥3
Neutropenia                                                  347 (94%)    303 (82%)                                20 (23%)      17 (20%)
Febrile neutropenia                                            -                28   (8%)                                   -                  9 (11%)
Anaemia                                                        361 (97%)     39 (11%)                                26 (30%)          7 (8%)
Diarrhoea                                                      173 (47%)     23   (6%)                                49 (57%)          7 (8%)
Fatigue                                                          136 (37%)     18   (5%)                                47 (52%)          4 (5%)

Conclusions: Rapid accrual is suggestive of a high unmet treatment need in this patient population. The toxicity profile of cabazitaxel appears to be similar to that observed in the TROPIC study. Funding: Sanofi Australia Pty Ltd.

  1. Tannock IF, et al. NEJM 2004;351(15):1502-12.
  2. Petrylak DP, et al. NEJM 2004;351(15):1513-20.
  3. de Bono JS, et al. Lancet 2010;376(9747):1147-54.