Oral clodronate in breast cancer patients with bone metastases: a randomized study
Oral clodronate in breast cancer patients with bone metastases: a randomized study
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DOI：
10.1046/j.1365-2796.1999.00507.x
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发表时间：
1999-07-01
影响因子：
11.1
通讯作者：
Mouridsen, HT
中科院分区：
文献类型：
--
作者：
Kristensen, B;Ejlertsen, B;Mouridsen, HT
目标.研究双膦酸盐氯膦酸盐对乳腺癌骨转移患者骨骼事件（高钙血症、骨折和放疗）发生的影响。前瞻性、随机、对照、临床试验。一所大学医院的肿瘤科，受试者，100名接受一线全身化疗治疗转移性乳腺癌伴骨受累的患者随机接受氯膦酸盐，每天两次，每次400 mg胶囊，持续2年，或不接受额外治疗，结果，在氯膦酸盐组中，48名可评价患者的骨骼事件数量减少至14起，而51名可评价对照患者的骨骼事件数量为21起。氯膦酸二钠组的首次骨骼事件发生时间显著长于对照组（P = 0.015），最明显的差异是氯膦酸二钠组骨折发生率较低（P = 0.023）。15个月后，与对照组相比，氯膦酸盐组的效果趋于下降，因为对放射治疗的需求增加（P = 0.069）。在前6个月，两组在生活质量的几个方面都有显著改善，但两组之间没有显著差异。未观察到对放射学评价的骨疾病进展时间或生存率的影响。最常见的副作用，导致在停止氯膦酸二钠恶心和diarrhoea.Conclusion，口服氯膦酸二钠与乳腺癌患者骨转移相关的发病率暂时降低。
Objectives. To investigate the effect of the bisphosphonate clodronate on the occurrence of skeletal events (hypercalcaemia, fractures and radiotherapy) in breast cancer patients with bone metastases.Design. Prospective, randomized, controlled, clinical trial.Setting. A department of oncology in a university hospital,Subjects, One hundred patients who received first-line systemic antineoplastic treatment for metastatic breast cancer with bone involvement were randomized to receive clodronate as two 400 mg capsules twice a day for 2 years or no additional therapy,Results, In the clodronate group the number of skeletal events was reduced to 14 events in 48 evaluable patients as compared with 21 events in 51 evaluable control patients. The time to the first skeletal event was significantly longer in the clodronate group than in the control group (P = 0.015) and the most distinct difference was a lower occurrence of fractures in the clodronate group (P = 0.023). After 15 months the effect of clodronate tended to decline as the need for radiotherapy increased in the clodronate group compared with the control group (P = 0.069). Significant improvements in several quality-of-life aspects were seen in both groups during the first 6 months, but there was no significant difference between the groups. No effect was observed on time to radiologically evaluated disease progression in bone or on survival. The most frequent side-effects resulting in discontinuation of clodronate were nausea and diarrhoea.Conclusion, Oral clodronate is associated with a temporary reduction of morbidity related to bone metastases in breast cancer patients.