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
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.
Disclaimer
This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org
Abstract Disclosures
2020 ASCO Virtual Scientific Program
First Author: Cora N. Sternberg
2023 ASCO Annual Meeting
First Author: Antoine Thiery-Vuillemin
2024 ASCO Genitourinary Cancers Symposium
First Author: Maha H. A. Hussain
2024 ASCO Genitourinary Cancers Symposium
First Author: Sumit Kumar Subudhi