[Effectiveness and tolerability of zoledronic acid in the treatment of metastatic prostate cancer].
OBJECTIVE
To assess the effectiveness and tolerability of zoledronic acid in prostate cancer patients with bone metastases at the hormone-sensitive (HS) and hormone-independent (HI) stages.


METHODS
A nationwide, observational, prospective, open and multi-centre trial was devised, with a total of 218 male patients diagnosed with prostate cancer at the HS stage (36%) or HI stage (64%) who were administered zoledronic acid (4 mg/IV/month for 6 months) in addition to their specific oncological treatment. Effectiveness was assessed by the following means: 1) Assessment of the improvement in pain and mobility; 2) Incidence and time to onset of skeletal-related events (SREs) and 3) Analysis of bone markers. Tolerability was assessed by means of registering the number and type of adverse effects. A satisfaction survey was carried out amongst the patients after the end of the trial.


RESULTS
Out of the 218 patients, 170 (78%) were evaluable for effectiveness. A decrease in pain ratings at rest and during movement was observed in all patients, whether in the HS or HI groups (p < 0.0001). Improved mobility was observed likewise (p = 0.005), as was quality of life. The global incidence of skeletal events was 11.2%, with a time to onset of SREs of 10.7 months. There were no significant differences observed between HS vs. HI patients. Osteolysis markers (N-telopeptide) decreased significantly with the treatment across both the HS and HI groups. For safety reasons. 212 patients were evaluable (97.2%). The incidence of adverse drug reactions was 16% (34/212) and was found to be significantly higher in HS patients (22.4%) compared with HI patients (11.9%). Overall, the tolerability of zoledronic acid was good, with no significant morbidity in either group (HS and HI). 66% of the patients reported feeling satisfied or very satisfied.


CONCLUSIONS
Zoledronic acid proved effective in the relief of pain, improving mobility and quality of life as well as reducing or delaying the occurrence of skeletal-related events in prostate cancer patients presenting metastatic bone disease, regardless of the phase, whether HS or HI, they found themselves in. Tolerability and patient satisfaction were rates as good.
Cózar Olmo
J M
JM
Servicio de Urología H. Universitario Virgen de las Nieves, Granada. cozarjm@yahoo.es
Carballido Rodriguez
J
J
Luque Galvez
P
P
Tabernero Gómez
A G
AG
Barreiro Mouro
A
A
Sánchez Sánchez
E
E
González Enguita
C
C
Alcover García
J
J
Garcia-Galisteo
E
E
Abascal García
J M
JM
Sanchez Chapado
M
M
GómezVeiga
F
F
Minguez Martínez
R J
RJ
Rodriguez Antolin
A
A
Medina López
R A
RA
Rico Morales
M
M
Regadera Sejas
F J
FJ
Búcar Terrades
S
S
Jamardo Gonzalez
D
D
Gálvez
R
R
D000368:Aged; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000150:complications* / Q000556:secondary*; D004164:Diphosphonates / Q000627:therapeutic use*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology*; D000077211:Zoledronic Acid
D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid