Usami Eiseki, Kimura Michio, Takenaka Shoya, Iwai Mina, Teramachi Hitomi, Yoshimura Tomoaki
Department of Pharmacy, Ogaki Municipal Hospital, Ogaki, Gifu 503-8502, Japan.
Department of Clinical Pharmacy, Gifu Pharmaceutical University, Gifu, Gifu 501-1196, Japan.
Mol Clin Oncol. 2019 Feb;10(2):293-298. doi: 10.3892/mco.2018.1775. Epub 2018 Nov 27.
Pomalidomide (POM) is a second-generation immunomodulatory agent with proven efficacy in patients with relapsed/refractory multiple myeloma (RRMM) proven to be refractory to previous treatment with lenalidomide (LEN) and bortezomib. We herein conducted a retrospective analysis of 14 RRMM patients receiving POM to determine its tolerability and safety in the clinical setting. The median age of the patients was 72 years (range, 58-84 years), and 85.7% of the patients were aged >70 years. The most frequent treatment dose was 3 mg/day. POM dose reductions were required in 54.5% (6/11) of the patients. The patient data were compared among three age groups (<70, 70-75 and >75 years) and there was only significant difference in daily POM treatment dose. The tolerability of POM must be confirmed, particularly in elderly patients. Dose reduction from 4 to 3 mg occurred during the second cycle in 83.3% (5/6) of the patients. It is important to determine the tolerability of POM in the early phases of treatment. The most frequently reported grade 3/4 hematological adverse events were neutropenia (64.3%), anemia (64.3%) and thrombocytopenia (57.1%). Although the median number of treatment cycles was 4 (range, 1-13), 21.4% (3/14) of the patients with a performance status (PS) of 3 were administered only 1 treatment cycle. The tolerability of POM was low among patients with poor PS and an aggressive treatment introduction should be avoided. However, 21.4% (3/14) of the patients were able to continue treatment for >1 year and some patients received long-term therapy. POM does not require dose modification for renal function, and multiple capsule doses are available, which is an advantage of POM compared with LEN. POM may be administered to late-stage RRMM patients in a real-world clinical setting, but elderly patients or those with poor PS must be treated with caution. In this manner, the treatment options for RRMM patients may be expanded by assessing the tolerability and safety of POM.
泊马度胺（POM）是一种第二代免疫调节剂，在复发/难治性多发性骨髓瘤（RRMM）患者中已证实具有疗效，这些患者被证明对先前使用来那度胺（LEN）和硼替佐米的治疗无效。我们在此对14例接受POM治疗的RRMM患者进行了回顾性分析，以确定其在临床环境中的耐受性和安全性。患者的中位年龄为72岁（范围58 - 84岁），85.7%的患者年龄大于70岁。最常用的治疗剂量为3毫克/天。54.5%（6/11）的患者需要减少POM剂量。在三个年龄组（<70岁、70 - 75岁和>75岁）之间比较患者数据，仅在每日POM治疗剂量上存在显著差异。必须确认POM的耐受性，尤其是在老年患者中。83.3%（5/6）的患者在第二个周期期间从4毫克减至3毫克。在治疗早期确定POM的耐受性很重要。最常报告的3/4级血液学不良事件是中性粒细胞减少（64.3%）、贫血（64.3%）和血小板减少（57.1%）。尽管治疗周期的中位数为4（范围1 - 13），但21.4%（3/14）的体力状况（PS）为3的患者仅接受了1个治疗周期。在PS较差的患者中，POM的耐受性较低，应避免积极引入治疗。然而，21.4%（3/14）的患者能够继续治疗超过1年，一些患者接受了长期治疗。POM不需要根据肾功能调整剂量，并且有多种胶囊剂型，与LEN相比，这是POM的一个优势。在实际临床环境中，POM可用于晚期RRMM患者，但老年患者或PS较差的患者必须谨慎治疗。通过这种方式，通过评估POM的耐受性和安全性，RRMM患者的治疗选择可能会得到扩展。
