Objective: To investigate the prognosis and related factors impacting renal response in newly diagnosed multiple myeloma (NDMM) patients with renal impairment. Methods: A total of 375 NDMM patients diagnosed at the Department of Hematology, the First Affiliated Hospital of Nanjing Medical University from August 2012 to April 2022 were retrospectively recruited. Patients were categorized into non-renal impairment group(n=273) and renal impairment group (n=102) according to renal function at initial diagnosis. All patients received≥2 cycles of bortezomib-based induction chemotherapy after admission. The hematological response included stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) and stable disease (SD). The renal responses were defined as CR, PR, minor response (MR) and non-response (NR). General clinical data of the patients were collected, and patients were followed up by telephone. The follow-up deadline was December 3, 2022, and the median follow-up time [M (Q1, Q3)] was 42 (22, 61) months. Kaplan-Meier analysis was used to plot the survival curve. The log-rank test was utilized for inter-group comparisons. Multivariate logistic regression modeling facilitated the exploration of associated factors impacting renal response. Results: In the renal impairment group, there were 68 males and 34 females with a median age [M (Q1, Q3)] of 64 (58, 69) years. In the non-renal impairment group, there were 149 males and 124 females with a median age of 62 (54, 68) years. Compared with the renal impairment group, the age, lactate dehydrogenase and 24-hour urinary protein quantity were increased, the proportion of patients with light chain M protein and the proportion of patients at the DS-Ⅲ stage, ISS-Ⅲ stage and R-ISS-Ⅲ stage were higher, the hemoglobin level and the proportion of patients receiving autologous hematopoietic stem cell transplantation were lower in the renal impairment group (all P<0.05). In 102 patients with renal impairment, renal responses of CR, PR, MR and NR were obtained in 53 (52.0%), 8 (7.9%), 18 (17.6%), 23 (22.5%) patients, respectively, and the overall response rate was 77.5% (79/102). Kaplan-Meier survival curve revealed that the median progression-free survival (PFS) was 24.0 (95%CI: 18.3-29.7) months in the renal impairment group, which was shorter than 31.0 (95%CI: 24.7-37.3) months in the non-renal impairment group (P=0.003). The median overall survival (OS) was 46.0 (95%CI: 36.5-55.5) months in the renal impairment group, which was shorter than 79.0 (95%CI: 59.9-98.1) months in the non-renal impairment group (P=0.002). Among the renal impairment group, patients with renal response of less than PR exhibited a median PFS of 19.0 (95%CI: 9.7-28.3) months, which was shorter than 28.0 (95%CI: 21.4-34.5) months for those achieving PR or better (P=0.048). The median OS was 31.0 (95%CI: 23.5-38.5) months in renal response with less than PR group, which was also worse than 57.0 (95%CI: 42.8-71.2) months for those who achieved PR or better (P=0.003). The results of multivariate logistic regression showed that hematological response achieving VGPR or better was a factor associated with renal response achieving PR (OR=4.20, 95%CI: 1.20-14.68, P=0.025). Conclusions: The prognosis of NDMM patients with renal impairment is poor. The hematological response with VGPR or better is related to the renal response achieving PR.
目的： 探讨初诊多发性骨髓瘤（NDMM）伴肾损害患者预后和影响肾脏反应的相关因素。 方法： 回顾性纳入2012年8月至2022年4月南京医科大学第一附属医院血液科收治的375例NDMM患者。根据初诊时是否伴有肾功能损害将患者分为两组：不伴肾损害组（n=273）和伴肾损害组（n=102）。所有患者入院后接受≥2个周期的以硼替佐米为主的诱导化疗方案，血液学疗效评估包括严格意义上的完全缓解（sCR）、完全缓解（CR）、非常好的部分缓解（VGPR）、部分缓解（PR）、疾病稳定（SD）。肾脏反应包括CR、PR、轻微缓解（MR）、无反应（NR）。收集患者的一般临床资料，通过电话进行随访，随访截止日期为 2022年12月3日，中位随访时间［M（Q1，Q3）］为 42（22，61）个月。采用Kaplan-Meier法绘制生存曲线，组间生存率比较采用log-rank检验。采用多因素logistic回归模型分析影响肾脏反应的相关因素。 结果： 伴肾损害组男68例，女34例，年龄［M（Q1，Q3）］为64（58，69）岁；不伴肾损害组男149例，女124例，年龄［M（Q1，Q3）］为62（54，68）岁。与不伴肾损害组比较，肾损害组患者初诊时年龄、乳酸脱氢酶和24 h尿蛋白定量水平升高，M蛋白为轻链比例更高，DS分期、ISS分期和R-ISS分期中Ⅲ期比例更高，血红蛋白水平和接受自体造血干细胞移植比例降低（均P<0.05）。102例伴肾损害患者中，53例（52.0%）肾脏反应达CR，8例（7.9%）达PR，18例（17.6%）达MR，23例（22.5%）为NR，肾脏总缓解率为77.5%（79/102）。Kaplan-Meier生存曲线显示，伴肾损害组中位无进展生存期（PFS）为24.0（95%CI：18.3~29.7）个月，短于不伴肾损害组的31.0（95%CI：24.7~37.3）个月（P=0.003）；伴肾损害组中位总生存期（OS）为46.0（95%CI：36.5~55.5）个月，短于不伴肾损害组的79.0（95%CI：59.9~98.1）个月（P=0.002）。伴肾损害患者中，肾脏反应未达PR组中位PFS为19.0（95%CI：9.7~28.3）个月，短于肾脏反应达PR及以上组的28.0（95%CI：21.4~34.5）个月（P=0.048）；肾脏反应未达PR组中位OS为31.0（95%CI：23.5~38.5）个月，短于肾脏反应达PR及以上组的57.0（95%CI：42.8~71.2）个月（P=0.003）。多因素logistic回归模型结果显示：血液学疗效评估达VGPR及以上（OR=4.20，95%CI：1.20~14.68，P=0.025）为肾脏反应达PR的相关因素。 结论： NDMM伴肾损害患者预后差，血液学疗效评估达VGPR及以上为肾脏反应达PR的相关因素。.