Objective: To investigate the clinical efficacy and safety of ixazomib-containing regimens in the treatment of patients with multiple myeloma (MM).
Methods: A retrospective analysis was performed on the clinical efficacy and adverse reactions of 32 MM patients treated with a combined regimen containing ixazomib in the Hematology Department of the First People's Hospital of Lianyungang from January 2020 to February 2022. Among the 32 patients, 15 patients were relapsed and refractory multiple myeloma (R/RMM) (R/RMM group), 17 patients who responded to bortezomib induction therapy but converted to ixazomib-containing regimen due to adverse events (AE) or other reasons (conversion treatment group). The treatment included IPD regimen (ixazomib+pomalidomide+dexamethasone), IRD regimen (ixazomib+lenalidomide+dexamethasone), ICD regimen (ixazomib+cyclophosphamide+dexamethasone), ID regimen (ixazomib+dexamethasone).
Results: Of 15 R/RMM patients, overall response rate (ORR) was 53.3%(8/15), among them, 1 achieved complete response (CR), 2 achieved very good partial response (VGPR) and 5 achieved partial response (PR). The ORR of the IPD, IRD, ICD and ID regimen group were 100%（3/3）, 42.9%（3/7）, 33.3%（1/3）, 50%（1/2）， respectively， there was no statistically significant difference in ORR between four groups (χ 2=3.375, P =0.452). The ORR of patients was 50% after first-line therapy, 42.9% after second line therapy, 60% after third line therapy or more, with no statistically significant difference among them (χ2=2.164, P =0.730). In conversion treatment group, ORR was 88.2%(15/17), among them, 6 patients achieved CR, 5 patients achieved VGPR and 4 patients achieved PR. There was no statistically significant difference in ORR between the IPD（100%， 3/3）, IRD（100%， 6/6）, ICD（100%， 3/3） and ID（60%， 3/5） regimen groups (χ2=3.737，P =0.184). The median progression-free survival (PFS) time of R/RMM patients was 9 months (95% CI : 6.6-11.4 months), the median overall survival (OS) time was 18 months (95% CI : 11.8-24.4 months). The median PFS time of conversion treatment group was 15 months (95% CI : 7.3-22.7 months), the median OS time not reached. A total of 10 patients suffered grade 3- 4 adverse event (AE). The common hematological toxicities were leukocytopenia, anemia, thrombocytopenia. The common non-hematological toxicities were gastrointestinal symptoms (diarrhea, nausea and vomit), peripheral neuropathy, fatigue and infections. Grade 1-2 peripheral neurotoxicity occurred in 7 patients.
Conclusion: The ixazomib-based chemotherapy regimens are safe and effective in R/RMM therapy, particularly for conversion patients who are effective for bortezomib therapy. The AE was manageable and safe.
题目: 含伊沙佐米的联合方案治疗多发性骨髓瘤患者的临床疗效及安全性分析.
目的: 观察含伊沙佐米的联合方案治疗多发性骨髓瘤 (MM) 的临床疗效及安全性。.
方法: 回顾性分析2020年1月至2022年2月连云港市第一人民医院血液科32例MM患者应用含伊沙佐米联合方案治疗的临床疗效及相关不良反应。32例患者包括复发难治多发性骨髓瘤患者15例 (R/RMM组) 和硼替佐米诱导有效但因不良反应 (AE) 或其他原因转换为含伊沙佐米方案治疗的MM患者17例 (转换治疗组)。治疗方案包括IPD (伊沙佐米+泊马度胺+地塞米松) 方案，IRD (伊沙佐米+来那度胺+地塞米松) 方案，ICD (伊沙佐米+环磷酰胺+地塞米松) 方案，ID (伊沙佐米+地塞米松) 方案。.
结果: R/RMM患者总有效率(ORR) 为53.3%（8/15），其中完全缓解 (CR) 1例，非常好的部分缓解 (VGPR) 2例，部分缓解 (PR) 5例。IPD方案组、IRD方案组、ICD方案组、ID方案组R/R MM患者的ORR分别为100%（3/3）、42.9%（3/7）、33.3%（1/3）、50%（1/2），4组间差异无统计学意义 (χ2=3.375，P =0.452)。既往接受1线治疗后的患者ORR为50%（2/4），2线治疗后的患者ORR为50%（3/6），3线及以上治疗后的患者ORR为60%（3/5），其不同线数间的有效率差异无统计学意义 (χ2=2.164，P =0.730)。17例转换治疗后获得CR 6例，VGPR 5例，PR 4例，ORR为88.2%（15/17）。IPD方案组、IRD方案组、ICD方案组、ID方案组的ORR分别为100%（3/3）、100%（6/6）、100%（3/3）、60%（3/5），4组间差异无统计学意义 (χ2=3.737，P =0.184)。R/RMM组患者中位无进展生存 (PFS) 时间为 9 (6.6-11.4)个月，中位总生存 (OS) 时间为 18(11.8-24.2)个月。转换治疗组患者中位PFS时间为15(7.3-22.7)个月，中位OS时间未达到。所有接受联合治疗患者中10例发生3-4级AE。主要血液学不良反应为白细胞减少、贫血、血小板减少。非血液学不良反应主要为消化道不良反应(腹泻、恶心、呕吐)，周围神经病变，乏力及感染等。接受伊沙佐米治疗后周围神经病变发生7例，均为1-2级。.
结论: 以伊沙佐米为基础的化疗方案对R/RMM治疗有效，特别是对于硼替佐米诱导有效的转换患者，AE整体可控，安全性高。.
Keywords: multiple myeloma； ixazomib； relapsed or refractory； efficacy； safety.