Effects of low-dose cisplatin on 89Sr therapy for painful bone metastases from prostate cancer: a randomized clinical trial.
This study evaluated the effects of low-dose cisplatin plus 89Sr versus 89Sr alone in the treatment of painful bone metastases from prostate cancer, addressing both pain palliation and cytostatic effects.


METHODS
Seventy patients with metastatic hormone-refractory prostate cancer were randomized into 2 groups: One group (arm A) received 148 MBq 89Sr plus 50 mg/m(2) cisplatin, and the other group (arm B) received 148 MBq 89Sr plus placebo. After treatment, the patients were followed up until death to evaluate the outcome variables: grade and duration of pain palliation, onset of new painful sites, changes in bone disease, global survival, serum prostate-specific antigen and alkaline phosphatase changes, and hematologic toxicity.


RESULTS
Overall pain relief occurred in 91% of patients in arm A and 63% of patients in arm B (P < 0.01), with a median duration of 120 d in arm A and 60 d in arm B (P = 0.002). New painful sites on previously asymptomatic bone metastases appeared in 14% of patients in arm A and in 30% of patients in arm B (P = 0.18). The median survival without new painful sites was 4 mo in arm A and 2 mo in arm B (P = 0.04). Bone disease progression was observed in 27% of patients in arm A and in 64% of patients in arm B (P = 0.01). Median global survival after therapy was 9 mo in arm A and 6 mo in arm B (P = 0.30). Transient and moderate hematologic toxicity, as determined by World Health Organization criteria, was apparent in both arms without significant differences.


CONCLUSIONS
The addition of a low dose of cisplatin enhances the effect of a standard dose of 89Sr without significant side effects, producing a significant improvement in pain palliation and a cytostatic effect on bone disease.
Sciuto
Rosa
R
Nuclear Medicine Department, Regina Elena Cancer Institute, Rome, Italy. sciuto@ifo.it
Festa
Anna
A
Rea
Sandra
S
Pasqualoni
Rosella
R
Bergomi
Serenella
S
Petrilli
Germana
G
Maini
Carlo L
CL
D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary*; D002945:Cisplatin / Q000008:administration & dosage* / Q000627:therapeutic use; D003131:Combined Modality Therapy; D006801:Humans; D008297:Male; D010166:Palliative Care / Q000379:methods*; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000473:pathology*; D013326:Strontium Radioisotopes / Q000627:therapeutic use*; D015996:Survival Rate
D000970:Antineoplastic Agents; D013326:Strontium Radioisotopes; D002945:Cisplatin