Abstract 607P
Background
Despite a higher risk of toxicity in elderly pts treated with chemotherapy, the impact of chemotherapy on quality of life in this pt subgroup has not been extensively studied. We aimed to evaluate the impact of docetaxel on QoL in elderly vs non-elderly mCRPC pts.
Methods
We performed a retrospective analysis of docetaxel-treated pts in the control arms of the MAINSAIL (NCT00988208), ENTHUSE (NCT00617669) and VENICE (NCT00519285) phase III trials. Mean changes in FACTP total score (FACTP-Total) as well as the physical (PWB), emotional (EWB), social (SWB) and functional (FWB) subscales after 12 weeks of treatment in elderly (≥75 yrs) and non-elderly (< 75 yrs) pts were estimated. For FACTP-Total, a threshold of 10 points (p) was used to define a clinically significant improvement (increase) or worsening (decrease); a threshold of 3p was used for the PWB, EWB, SWB and FWB subscales. Linear and logistic regression models were used to compare outcomes across groups. Data was accessed through the Project DataSphere platform.
Results
1536 pts were analyzed; 305 (19.9%) ≥ 75 yrs. Cycle 4 scores were available in 1229 pts. Mean FACTP-Total after 12 wks increased by 4.3 p in all pts; 4.86 p in pts <75 and 2.08 p in ≥75 yr pts (p=0.013). Clinically significant improvements in FACTP-Total were seen in 31.7% overall (32.9 vs 26.4% in <75 vs ≥75 yrs; p=0.052). Elderly pts experienced higher rates of clinically significant worsening (19.4 vs 14.2%; p=0.043) of FACTP-Total (Table). Clinically significant improvements in FACTP-Total were associated with a slight overall survival benefit (23.2 vs 19.7m; HR 1.19; p=0.045). Table: 607P
FACT-P Change After 12 Weeks
| Age (yrs) | Mean change | p-val | Improvement: N (%) | p-val | Worsening: N (%) | p-val | |
| Total Score | <75 | 4.86 | 0.013 | 325 (32.9%) | 0.052 | 140 (14.2%) | 0.043 |
| ≥75 | 2.08 | 64 (26.4%) | 47 (19.4%) | ||||
| PWB | <75 | 0.36 | 0.003 | 262 (26%) | 0.384 | 207 (20.5%) | <0.001 |
| ≥75 | -0.62 | 57 (23.3%) | 77 (31.4%) | ||||
| FWB | <75 | 0.33 | 0.032 | 268 (26.5%) | 0.082 | 232 (23%) | 0.039 |
| ≥75 | -0.41 | 52 (21.1%) | 72 (29.3%) | ||||
| EWB | <75 | 1.36 | 0.027 | 322 (31.9%) | 0.028 | 102 (10.1%) | 0.139 |
| ≥75 | 0.63 | 61 (24.7%) | 33 (13.4%) | ||||
| SWB | <75 | 0.05 | 0.918 | 204 (20.3%) | 0.094 | 194 (19.3%) | 0.982 |
| ≥75 | 0.02 | 38 (15.6%) | 47 (19.3%) |
Conclusions
Despite the lower benefit in QoL outcomes compared to younger mCRPC pts treated with docetaxel, a relevant proportion of elderly pts experience clinically relevant improvements. Functional assessment for the identification of fit elderly pts who may benefit from chemotherapy is critical.
Clinical trial identification
NCT00988208; NCT00617669; NCT00519285.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
I. Paredero Perez: Financial Interests, Personal, Invited Speaker: Roche. R. Lozano Mejorada: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Other, Travel/Accomodation: Roche; Financial Interests, Personal, Other, Travel/Accomodation: Astellas; Financial Interests, Personal, Other, Travel/Accomodation: Sanofi; Financial Interests, Personal, Other, Travel/Accomodation: Janssen; Financial Interests, Personal, Other, Travel/Accomodation: MSD. N. Romero Laorden: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Ipsen; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Institutional, Research Grant: Janssen; Financial Interests, Institutional, Research Grant: Pfizer. E. Castro: Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Institutional, Research Grant: Janssen; Financial Interests, Institutional, Research Grant: Synlab; Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Invited Speaker: Clovis; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: MSD; Financial Interests, Personal, Advisory Board: Astellas. A. Sanchez Hernandez: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Advisory Board: Roche. D. Olmos: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Clovis; Financial Interests, Personal, Invited Speaker: Daiichi-Sankyo; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Clovis; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: MSD. D. Lorente Estelles: Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Astellas; Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Sanofi; Financial Interests, Personal, Advisory Board: Astellas; Financial Interests, Personal, Advisory Board: AstraZeneca. All other authors have declared no conflicts of interest.