962TiP - Cabazitaxel plus prednisone (CBZP) in metastatic castration-resistant prostate cancer (mCRPC) patients previously treated with docetaxel (D): effica...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Prostate Cancer
Presenter Pasquale Rescigno
Authors P. Rescigno1, C. D'Aniello1, P. Federico1, L. Puglia1, A. Petremolo1, C. Cavaliere1, C. Buonerba1, S. De Placido2, G. Di Lorenzo1
  • 1Genitourinary Cancer Section And Rare-cancer Center, University Federico II, 80131 - Napoli/IT
  • 2Medical Oncology Department, University Federico II, 80131 - Napoli/IT

Abstract

Background

In the phase 3 TROPIC trial, mCRPC pts previously treated with D had a significant survival and clinical benefit with CbzP, a new tubulin-binding taxane, compared with mitoxantrone plus prednisone. The clinical benefits observed supported a global EAP, allowing pts with mCRPC to have access to Cbz prior to its commercial availability and providing safety and efficacy data in the real life population. We report the safety and efficacy results of 32 consecutive pts treated with CbzP in a single Italian centre.

Methods

Pts recruited from a single centre between March and December 2011 received Cbz 25mg/m2 IV q21 and prednisone 10 mg daily until disease progression, unacceptable toxicity, physician/pt decision or death. Biochemical and Tumour response were assessed before cycle 6 and 12. Pain response was assessed in symptomatic Pts before each cycle.

Results

32 pts were analyzed; median age was 67 years (≥ 75 years, 18%); 68.8% of pts had one previous D regimen and 31.2% ≥ 2 regimens, 93.8% had ECOG PS 0-1; Median number of CbzP cycles was 8; 43.7% had pain at treatment initiation with a median PSA value of 85 ng/mL. All pts had bone mets, 68% had visceral disease (visceral and nodes). The most common Grade 3/4 adverse events (AEs) were neutropenia (64.5%, 20 Pts) leukopenia (45.2%, 14 Pts), and febrile neutropenia (9.7%, 3 Pts). G3/4 diarrhoea was reported 3.2%, 1 pt. Pain response was 64.3%.

PSA response 6 cycles (32 Pts)
decline ≥50% 53%
PSA response by Gleason (decline >50%)
GS 4-6 ( 9 Pts) 44%
GS 7 (10 Pts) 60%
GS 8-10 (13 Pts) 54%
PSA response by previous D regimen
1 (17 Pts) 12 (71%)
>1 (15 Pts) 5 (33%)
Tumor Response (RECIST) 22 Pts
PR + SD 19 (86.4%)
PD 3 (13.6%)

Conclusions

Our results indicate a high activity of cabazitaxel in terms of PSA, tumor and pain responses in all subgroups of pts analysed; cabazitaxel shows globally a clinically manageable safety profile in daily clinical practice.

Disclosure

All authors have declared no conflicts of interest.