Abstract 640P
Background
Although advanced age is associated with a higher risk of toxicity, no significant impact on the efficacy of chemotherapy in mCRPC pts has been established to date. Data on the impact of age in quality of life are lacking. We aimed to evaluate quality of life and survival in elderly vs non-elderly docetaxel-treated mCRPC pts treated in the control arm of three randomized clinical trials.
Methods
We performed a retrospective analysis of pts treated with docetaxel in the control arms of the MAINSAIL (NCT00988208), ENTHUSE (NCT00617669) and VENICE (NCT00519285) phase III clinical trials. Overall survival (OS) and time to FACTP progression (FACT-PFS: time to first decrease in total FACTP score by ≥10 points) in elderly (≥75 yrs) and non-elderly (< 75 yrs) pts were compared. Kaplan Meier and Cox-regression models were used to determine median survival times and compare outcomes across groups. Data was accessed through the Project Data Sphere platform.
Results
1539 pts were analyzed. Of these, 307 (19.9%) were ≥ 75 yrs in age; 95 pts (20.1%) in the ENTHUSE, 90 pts (19.8%) in the MAINSAIL and 122 pts (19.9%) in the VENICE trials. Mean baseline FACTP total score was higher in elderly (107.3) than non-elderly (105.3) pts (p<0.001). However, both median FACT-PFS (11 vs 7.5 months; HR: 1.4; p<0.001) and OS (19.5 vs 16.6 months; HR: 1.2; p=0.02) were significantly lower in elderly pts. Table: 640P
OS and FACTP-PFS by clinical trial
| Trial | Age Group | OS | FACTP-PFS | ||
| Median | HR (95%CI); p-value | Median | HR (95%CI); p-value | ||
| ENTHUSE (N=473) | < 75 yrs | 20.5 m | 1.4 (1.03-1.9); p=0.035 | 9.3 m | 1.1 (0.8-1.5); p=0.517 |
| ≥ 75 yrs | 18.6 m | 9.2 m | |||
| MAINSAIL (N=454) | < 75 yrs | Not reached | 1.4 (0.8-2.3); p=0.258 | 11.3 m | 1.5 (1.05-2.2); p=0.027 |
| ≥ 75 yrs | Not reached | 7.4 m | |||
| VENICE (N=612) | < 75 yrs | 22.4 m | 1.2 (0.9-1.5); p=0.228 | 13.1 m | 1.6 (1.2-2.2); p<0.001 |
| ≥ 75 yrs | 19.6 m | 5.8 m |
Conclusions
Despite showing higher baseline FACTP scores, outcome (FACTP-PFS and OS) was inferior in elderly pts. Despite the inferior outcome, results suggest docetaxel still confers relevant benefit in elderly patients. Adequate patient selection to identify fit elderly patients who may have a higher likelihood of benefit from chemotherapy in mCRPC is critical.
Clinical trial identification
MAINSAIL trial: NCT00988208. Release date March 2015. ENTHUSE trial: NCT00617669. Release date May 2013. VENICE trial: NCT00519285. Release date June 2013.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.