Ohguchi Hiroto, Sugawara Tomohiro, Ishikawa Izumi, Okuda Mitsutaka, Tomiya Yasuo, Yamamoto Joji, Onishi Yasushi, Fujiwara Yamada Minami, Ishizawa Kenichi, Kameoka Junichi, Harigae Hideo
Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan.
Department of Internal Medicine, Osaki Citizen Hospital, 2-3-10 Senjuji-machi, Furukawa, Osaki, 989-6183, Japan.
Int J Hematol. 2009 Apr;89(3):342-347. doi: 10.1007/s12185-009-0279-4. Epub 2009 Mar 19.
Bortezomib is approved for the treatment of patients with relapsed or refractory multiple myeloma (MM), but only a few clinical studies for Japanese patients who were treated with bortezomib have been reported. We retrospectively analyzed 40 patients with relapsed or refractory MM who have received bortezomib at three collaborating centers in Miyagi prefecture in Japan. All the patients have been received bortezomib in combination with dexamethasone. Responses were determined using International Myeloma Working Group uniform response criteria. The overall response was observed in 30 patients (75%), including very good partial response in 8 patients (20%), and partial response in 22 patients (55%). The median time to disease progression was 8.7 months, and the median overall survival has not been reached. The factors affecting time to disease progression were International Staging System stage, serum beta2-microglobulin level, and number of treatment cycles. The most common grade 3 and 4 adverse events were thrombocytopenia (50%), peripheral neuropathy (25%), leukopenia (25%), and herpes zoster infection (25%). Thus, bortezomib is well tolerated and effective for Japanese patients with relapsed or refractory MM. Our results suggest that serum beta2-microglobulin level may be a marker of prognosis on bortezomib therapy for patients with relapsed or refractory MM although further studies are needed.
硼替佐米已被批准用于治疗复发或难治性多发性骨髓瘤（MM）患者，但仅有少数关于日本患者接受硼替佐米治疗的临床研究被报道。我们回顾性分析了日本宫城县三个合作中心接受硼替佐米治疗的40例复发或难治性MM患者。所有患者均接受硼替佐米联合地塞米松治疗。使用国际骨髓瘤工作组统一反应标准确定反应情况。30例患者（75%）观察到总体反应，包括8例（20%）非常好的部分反应和22例（55%）部分反应。疾病进展的中位时间为8.7个月，总生存期中位值尚未达到。影响疾病进展时间的因素有国际分期系统分期、血清β2-微球蛋白水平和治疗周期数。最常见的3级和4级不良事件为血小板减少（50%）、周围神经病变（25%）、白细胞减少（25%）和带状疱疹感染（25%）。因此，硼替佐米对日本复发或难治性MM患者耐受性良好且有效。我们的结果表明，血清β2-微球蛋白水平可能是复发或难治性MM患者硼替佐米治疗预后的一个标志物，尽管还需要进一步研究。
