Efficacy and quality of life (QoL) of cabazitaxel/prednisone (Cbz) in Canadian metastatic castration resistant prostate cancer (mCRPC) patients (pts) with or without prior abiraterone acetate (Abi).

Authors

Fred Saad

Fred Saad

University of Montréal Hospital Center, CRCHUM, Montréal, QC, Canada

Fred Saad , Eric Winquist , Stacey Hubay , Scott R. Berry , Hazem Assi , Eric Levesque , Nathalie Aucoin , Piotr Czaykowski , Jean-Baptiste Lattouf , Karine Alloul , John Stewart , Srikala S. Sridhar

Organizations

University of Montréal Hospital Center, CRCHUM, Montréal, QC, Canada, London Health Sciences Centre, London, ON, Canada, Grand River Regional Cancer Centre, Kitchener, ON, Canada, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada, Moncton Hospital, NB, Canada, Moncton, NB, Canada, Centre de recherche - CHUQ - L'Hôtel-Dieu de Québec, Quebec City, QC, Canada, Cite De La Santé De Laval, Laval, QC, Canada, CancerCare Manitoba, Winnipeg, MB, Canada, CRCHUM, Université de Montréal, Montreal, QC, Canada, Sanofi, Laval, QC, Canada, University Health Network, Princess Margaret Hospital, Toronto, ON, Canada

Research Funding

Pharmaceutical/Biotech Company

Background: In the TROPIC study, Cbz was shown to improve overall survival in mCRPC pts post-docetaxel, however none of these pts had prior exposure to Abi. To better understand the impact of prior Abi treatment on Cbz efficacy and QoL, we evaluated Canadian pts enrolled in the International Phase IIIb/IV single arm Cbz study. Methods: In total 61 pts were enrolled from 9 centers (May 2011 to February 2012). Cbz efficacy (PSA Response Rate (RR, decline ≥50%)) and impact on QoL were analyzed as a function of prior Abi use. Results: Baseline and disease characteristics were similar between NoPriorAbi (n=35, 57%) and PriorAbi (n=26, 43%) groups, except for age and time between last docetaxel dose and progression (Table). Pts received a median of 9 cycles of prior docetaxel. 92% of pts were ECOG 0/1, with 88% having bone metastases and 25% visceral metastases. 31% of pts received prophylactic G-CSF. Median number of Cbz cycles received was similar between groups (NoPriorAbi= 6, PriorAbi= 7) as were PSA RR (NoPriorAbi= 42.4%, PriorAbi= 47.6%, p=0.78). QoL and pain were improved in Cbz pts with no significant difference observed based on prior Abi use (Table). Overall, treatment discontinuation was mainly due to progression (45.9%) and adverse events (32.8%). Most frequent grade 3/4 toxicities were anemia and fatigue (9.8%), with diarrhea, neutropenia and febrile neutropenia each observed in 8.2% of pts. Conclusions: Cbz efficacy and impact on QoL were not affected by prior Abi use. In routine clinical practice, toxicity rates observed were similar to the TROPIC study. Clinical trial information: NCT01254279.

Variable Unit Total No Prior Abi Prior Abi P
Median age Yrs 65 64 69 0.02
Time between last docetaxel dose and progression <0 mos 11.7 17.1 4.0 0.05
0-3 23.3 28.6 16.0
3-6 18.3 14.3 24.0
≥6 46.7 40.0 56.0
Pts with ≥10 cycles of Cbz % 26.7 28.6 24.0 0.70
FACT-P ≥16 points ǂ % 14.8 12.1 19.1 0.70
FACT-P ≥6 points ǂ % 44.4 39.4 52.4 0.41
PCS subscale ≥2 points ǂ % 53.7 51.52 57.14 0.78
PCS pain subscale ≥2 points ǂ % 27.8 24.24 33.33 0.54
Pain response Rate * ǂ % 20.7 15.00 33.33 0.34

* as defined in TROPIC (de Bono 2010). ǂ Minimal clinically important difference observed on 2 consecutive cycles.

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Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary (Prostate) Cancer

Track

Genitourinary Cancer

Sub Track

Prostate Cancer

Clinical Trial Registration Number

NCT01254279

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 5062^)

DOI

10.1200/jco.2014.32.15_suppl.5062

Abstract #

5062^

Poster Bd #

191

Abstract Disclosures