Konference: 2014 39th Congress ESMO - účast ČR
Kategorie: Genitourinární nádory
Téma: Postery
Číslo abstraktu: 770P
Autoři: John P. Logue; Dr. Steffen Wedel; MUDr. Aleš Chodacki; MD A. Oliver Sartor; Sten Nilsson ; M.D. Robert Edward Coleman; Prof. Dr. Nicholas James; Anne-Kirsti Aksnes; Mona Wahba; Chris Parker
Aim
Adherence to prescribed tx is an important factor in determining outcome in advanced CRPC pts, and is often driven by drug tolerability. In ALSYMPCA, the first-in-class α-emitter Ra-223 had a highly favorable safety profile and was well tolerated (Parker et al. NEJM 2013). Here we report results from a post hoc analysis identifying factors associated with ALSYMPCA study tx discontinuation to inform pt management and allow the full course of Ra-223 therapy.
Methods
ALSYMPCA pts had progressive, symptomatic CRPC with ≥ 2 bone mets, had no known visceral mets, and had received docetaxel or were unfit for or declined docetaxel. Pts were randomized 2:1 to 6 injections (inj) of Ra-223 (50 kBq/kg IV) q 4 wk or matching placebo (pbo). Pts who did not receive all 6 study inj were considered to have discontinued tx and withdrawn early from the study. A post hoc analysis of these pts was performed.
Results
Of the 921 pts enrolled, 901 were treated (Ra-223, n = 600; pbo, n = 301); 209 (35%) Ra-223 and 157 (52%) pbo pts discontinued tx after inj 1-5. Prior vs no prior docetaxel was associated with a greater percentage of pts discontinuing tx in both groups. Adverse events (AEs) were the primary reason for discontinuing tx across all categories (Table on following page). The most common AE was disease progression (Ra-223, 17%; pbo, 16%). Anemia was a more common reason for discontinuing Ra-223 (15% vs 3%), as was general physical health deterioration (9% vs 2%); bone pain was more common with pbo (11% vs 2%), as was fatigue (8% vs 4%).
| Pts (n) Discontinuing Treatment After Injections 1-5 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pt Group Total Discontinued Reason for Discontinuing Treatment | Total, n (%) RA N = 600 | Total, n (%) Pbo N = 301 | Ra Inj 1 | Pbo Inj 1 | Ra Inj 2 | Pbo Inj 2 | Ra Inj 3 | Pbo Inj 3 | Ra Inj 4 | Pbo Inj 4 | Ra Inj 5 | Pbo Inj 5 |
| All pts | 209 (35) | 157 (52) | 18 | 21 | 37 | 36 | 48 | 37 | 60 | 34 | 46 | 29 |
| AE | 92 (44) | 59 (38) | 7 | 11 | 14 | 12 | 23 | 10 | 27 | 16 | 21 | 10 |
| Death | 27 (13) | 28 (18) | 6 | 4 | 5 | 3 | 7 | 8 | 4 | 5 | 4 | 8 |
| Inv Request | 25 (12) | 27 (17) | 1 | 0 | 7 | 6 | 3 | 9 | 9 | 7 | 5 | 5 |
| Pt Request | 40 (19) | 22 (14) | 4 | 4 | 7 | 6 | 9 | 4 | 8 | 3 | 12 | 5 |
| Other | 26 (12) | 21 (13) | 0 | 2 | 4 | 9 | 6 | 6 | 12 | 3 | 4 | 1 |
| Prior Doce | 132 (22) | 92 (30) | 11 | 12 | 17 | 21 | 31 | 20 | 40 | 20 | 33 | 19 |
| AE | 60 (45) | 37 (40) | 3 | 8 | 6 | 6 | 13 | 5 | 22 | 11 | 16 | 7 |
| Death | 12 (9) | 12 (13) | 5 | 2 | 1 | 2 | 4 | 4 | 1 | 1 | 1 | 3 |
| Inv Request | 17 (13) | 18 (20) | 1 | 0 | 5 | 5 | 2 | 4 | 5 | 5 | 4 | 4 |
| Pt Request | 29 (22) | 15 (16) | 2 | 1 | 3 | 3 | 7 | 3 | 7 | 3 | 10 | 5 |
| Other | 14 (11) | 10 (12) | 0 | 1 | 2 | 5 | 5 | 4 | 5 | 0 | 2 | 0 |
| No Prior Doce | 77 (13) | 65 (21) | 7 | 9 | 20 | 15 | 17 | 17 | 20 | 14 | 13 | 10 |
| AE | 32 (42) | 22 (35) | 4 | 3 | 8 | 6 | 10 | 5 | 5 | 5 | 5 | 3 |
| Death | 15 (19) | 16 (25) | 1 | 2 | 4 | 1 | 3 | 4 | 3 | 4 | 3 | 5 |
| Inv Request | 8 (10) | 9 (14) | 0 | 0 | 2 | 1 | 1 | 5 | 4 | 2 | 1 | 1 |
| Pt Request | 11 (14) | 7 (11) | 2 | 3 | 4 | 3 | 2 | 1 | 1 | 0 | 2 | 0 |
| Other | 12 (16) | 11 (17) | 0 | 1 | 2 | 4 | 1 | 2 | 7 | 3 | 2 | 1 |
Conclusions
The percentage of pts discontinuing tx before the full course of therapy was smaller with Ra-223 than with pbo, which indicates a positive tx effect and safety profile. Supportive measures to improve the pts' general health and tx of anemia could help achieve the full course of Ra-223 therapy.
Disclosure
O. Sartor: has had a consultant or advisory relationship with and has received research funding from Algeta and Bayer; S. Nilsson: has had a consultant or advisory relationship with Algeta and has received remuneration from Bayer for travel costs and accommodations for study and writing meetings;
R.E. Coleman: has had a consultant or advisory relationship with Bayer, has received honoraria from Bayer and Amgen, and has provided expert testimony for Novartis; N. James: has had a consultant or advisory relationship with Algeta and Bayer; A. Aksnes: is employed by Algeta ASA (Bayer); M. Wahba: is employed by Bayer HealthCare; C. Parker: has had a consultant or advisory relationship with Algeta, Bayer, and BNIT, and has received honoraria from Amgen, Astellas, Bayer, Janssen, Sanofi-Aventis, and Takeda. All other authors have declared no conflicts of interest.
Plný text abstraktu v časopise Ann Oncol (2014) 25 (suppl 4)
Datum přednesení příspěvku: 21. 9. 2014
