Effectiveness of radiation synovectomy with samarium-153 particulate hydroxyapatite in rheumatoid arthritis patients with knee synovitis: a controlled randomized double-blind trial

OBJECTIVES: The aim of the present study was to investigate the effectiveness of Samarium153-particulate hydroxyapatite radiation synovectomy in rheumatoid arthritis patients with chronic knee synovitis. METHODS: Fifty-eight rheumatoid arthritis patients (60 knees) with chronic knee synovitis participated in a controlled double-blinded trial. Patients were randomized to receive either an intra-articular injection with 40 mg triamcinolone hexacetonide alone (TH group) or 40 mg triamcinolone hexacetonide combined with 15 mCi Samarium153-particulate hydroxyapatite (Sm/TH group). Blinded examination at baseline (T0) and at 1 (T1), 4 (T4), 12 (T12), 32 (T32), and 48 (T48) weeks post-intervention were performed on all patients and included a visual analog scale for joint pain and swelling as well as data on morning stiffness, flexion, extension, knee circumference, Likert scale of improvement, percentage of improvement, SF-36 generic quality of life questionnaire, Stanford Health Assessment Questionnaire (HAQ), Lequesne index, use of non-steroidal anti-inflammatory drugs or oral corticosteroids, events and adverse effects, calls to the physician, and hospital visits. RESULTS: The sample was homogeneous at baseline, and there were no withdrawals. Improvement was observed in both groups in relation to T0, but no statistically significant differences between groups were observed regarding all variables at the time points studied. The Sm/TH group exhibited more adverse effects at T1 (p<0.05), but these were mild and transitory. No severe adverse effects were reported during follow-up. CONCLUSION: Intra-articular injection of Samarium153-particulate hydroxyapatite (15 mCi) with 40 mg of triamcinolone hexacetonide is not superior to triamcinolone hexacetonide alone for the treatment of knee synovitis in patients with rheumatoid arthritis at 1 y of follow-up.

Systemic Radionuclide Therapy of Painful Prostate Cancer Bone Metastases With Samarium-153-edtmp

Most patients with prostate cancer (PC) will develop painful bone metastases, which alters their quality of life. Objective: This study aimed to evaluate the efficacy and toxic hematological profile of samarium for the treatment of PC metastases’ bone pain. Methods: Twenty-nine PC patients (median age: 69 years, range: 46-84; Gleason score equal to or higher than 7 in 66.7% and under 7 in 33.3% of patients presenting multiple painful bone metastases were treated with intravenous injection of 153Sm-EDTMP. Response to treatment was defined as either a reduction of at least 25% in patient’s pain score, using a 0 to 10 scale (score 0: no pain, score 10: maximum pain), or in daily analgesic dosage. Complete blood counts were performed before 153Sm–EDTMP administration and 4 and 8 weeks after treatment with the purpose of evaluating hematological side effects of the agent. Results: Twenty-five patients (86.2%) responded to treatment (median time: 1.5 month, range: 1.0 to 2.0 months). A reduction equal to or higher than 25% in post-treatment values compared to baseline values was seen in hemoglobin (Hb) of 3 (12.0%) patients, in leukocytes (Lo) of 16 (64.0%) patients, and in platelets (Pl) of 19 (76.0%) patients. Hb under 10g/dl, Lo under 2.0x103/ul, and Pl under than 50.0x103/ul were seen in 7 (28.0%), 3 (12.0%) and 2 (8.0%) out of 25 patients analyzed after 153Sm–EDTMP, respectively. No infectious or bleeding episodes were seen in any patient during the study. Conclusion: 153Sm-EDTMP is effective for acute control of PC patients’ bone pain. However, additional studies with bone marrow assessment before and after 153Sm–EDTMP are necessary to clarify the origin of cytopenias found in our cases.

Uso de radioisótopos en metástasis óseas dolorosas: samario 153 EDTMP / Use of radioisotopes in painful bone metastasis: samarium 153 EDTMP

Los pacientes con dolor debido a metástasis óseas deben ser tratados por un equipo multidisciplinario. Los mecanismos de producción del dolor son poco conocidos y su fisiopatología es compleja, su evolución es progresiva y su manejo difícil. Entre las alternativas terapéuticas del dolor está el uso de isótopos radioactivos, que irradian al órgano blanco mediante emisión de partículas beta. Entre estos isótopos se encuentra el Samario153-EDTMP que está diponible en nuestro país y que tiene una bio distribución favorable y características fisioquímicas y de toxicidad aceptables para ser utilizado en metástasis principalmente osteoblásticas con alivio progresivo del dolor desde las primeras 48 horas y con una duración entre 4 a 35 semanas

Emprego do samário 153-EDTMP no tratamento do adenocarcinoma de próstata avançado. Resultados preliminares / The use of samarium 153-EDTMP for treatment of advanced prostatic adenocarcinoma

Introduçäo: Os autores analisam os efeitos do emprego endovenoso do Samário 153-EDTMP no tratamento de 35 pacientes portadores de adenocarcinoma de próstata refratário à hormonioterapia com metástases ósseas dolorosas. Material e métodos: Entre novembro de 1995 e março de 1998, 35 pacientes com metástase óssea de adenocarcinoma de próstata näo responsivo ao tratamento hormonal foram submetidos à aplicaçäo endovenosa do Samário 153-EDTMP (1,0 a 1,5 mCi/Kg de peso), com finalidade antiálgica. Sessenta porcento dos pacientes tinham pelo menos 20 metástases ósseas, 30 porcento usaram morfina e 68,5 porcento já haviam sido irradiados. Foram avaliadas a resposta à dor, a mielotoxicidade e os níveis de PSA após a aplicaçäo. Resultados: Verificou-se resposta completa à dor em 8 (24,2 porcento) e resposta parcial em 14 pacientes (42,4 porcento) dentre 33 pacientes avaliáveis, totalizando-se 66,6 porcento de resposta global à dor. O tempo de duraçäo de resposta variou de 30 a 60 dias nos casos de resposta completa e entre 20 a 90 dias nos casos de resposta parcial. A ocorrência de toxicidade medular ocorreu em 17 de 23 casos avaliáveis sendo predominantemente através de leucopenia e plaquetopenia sempre de regressäo espontânea, sendo que em nenhum caso a toxicidade foi letal. A queda parcial de PSA após a aplicaçäo ocorreu em 3 e a progressäo em 19 de 22 casos avaliáveis. O seguimento dos pacientes variou entre 7 e 903 dias (média 190 dias), com sobrevida global de 51,1 porcento aos 6 meses e de 20,9 porcento ao final de um ano. A sobrevida mediana foi de 6,2 meses. Conclusöes: Os resultados sugerem que o Samário é uma alternativa segura no tratamento paliativo do câncer de próstata hormônio refratário

Tratamiento paliativo del dolor óseo con samario 153-EDTMP en cáncer prostático metastásico: estudio controlado / Palliative pain treatment by means of samarium 143-EDTMP in metastatic prostate cancer: a controled study

Se realizó un ensayo clínico controlado, prospectivo, longitudinal, comparativo y experimental que abarcó el periodo comprendido entre el 26 de septiembre de 1995 y el 27 de marzo de 1996, con 18 pacientes de cáncer prostático metastásico que cursaban con dolor óseo refractario por actividad tumoral. De los 18 pacientes, a nueve se les aplicó el fármaco radiactivo samario 153 como terapia analgésica, y los otros nueve continuaron con el tratamiento analgésico ordinario (grupo testigo). Los resultados muestran una disminución significativa de la intensidad del dolor en los pacientes tratados con samario 153 en comparación con lo observado en los pacientes del grupo testigo. Se concluye que el samario puede ser un agente terapéutico útil para la paliación del dolor óseo que generalmente es refractario a la terapéutica analgésica convencional, lo que se traduce en una mejoría en la calidad de vida de los pacientes con cáncer prostatico en etapa avanzada.