METHODS: In this retrospective analysis, we screened all adult patients undergoing either DEB-BACE plus chemotherapy or chemotherapy alone for stage III or IV LCSS at authors\' center from January 2018 to August 2021. Each 21-day chemotherapy cycle consisted of intravenous injection of gemcitabine (1.0 g/m2) on days 1 and 8 and cisplatin 75 (mg/m2) on day 1. The planned cycles were 4. DEB-BACE consisted of microcatheter infusion of CalliSpheres beads carrying cisplatin (75 mg/m2) and gemcitabine (1.0 g/m2), at 3 weeks prior to chemotherapy. The primary outcome was overall survival (OS). The secondary outcomes included progression-free survival (PFS), pulmonary response, and adverse events (AEs).
RESULTS: The final analysis included 95 patients in the chemotherapy group and 41 patients in the combination treatment group. The median OS was 14 months (95 % CI 11.0-17.0) in the chemotherapy group and 19 months (95 % CI 18.0-24.0) in the combination group (P = 0.015). In multivariate Cox regression analysis, DEB-BACE plus chemotherapy was associated with lower risk of death versus chemotherapy only (HR 0.16, 95 % CI 0.05-0.52; log rank test P = 0.003). The median PFS was 6 months (95 % CI 4.0-7.0) in the chemotherapy group and 8 months (95 % CI 6.0-8.0) in the combination group (P = 0.015). The pulmonary objective response rate (ORR) and disease control rate (DCR) were 48.4 % and 62.1 % in chemotherapy group versus 82.9 % and 90.2 % in combination group (P < 0.001 and = 0.001, respectively). AEs occurred in 133 patients (97.8 %). The rate of bone marrow suppression was 48.4 % (46/95) in the chemotherapy group versus 7.3 % (3/41) in the combination group (P < 0.001).
CONCLUSIONS: Compared with chemotherapy alone, DEB-BACE plus chemotherapy was associated with longer survival outcomes and lower rate of bone marrow suppression.
方法:在本回顾性分析中,2018年1月至2021年8月,我们在作者中心对所有接受DEB-BACE联合化疗或单纯化疗的成年患者进行了III期或IV期LCSS筛查.每个21天的化疗周期包括在第1天和第8天静脉注射吉西他滨(1.0g/m2)和在第1天静脉注射顺铂75(mg/m2)。计划周期为4。DEB-BACE由携带顺铂(75mg/m2)和吉西他滨(1.0g/m2)的CalliSpheres珠的微导管输注组成,在化疗前3周。主要结果是总生存期(OS)。次要结局包括无进展生存期(PFS),肺反应,和不良事件(AE)。
结果:最终分析包括化疗组95例患者和联合治疗组41例患者。化疗组的中位OS为14个月(95%CI11.0~17.0),联合治疗组为19个月(95%CI18.0~24.0)(P=0.015)。在多元Cox回归分析中,与仅化疗相比,DEB-BACE加化疗与较低的死亡风险相关(HR0.16,95%CI0.05-0.52;对数秩检验P=0.003)。化疗组的中位PFS为6个月(95%CI4.0-7.0),联合治疗组为8个月(95%CI6.0-8.0)(P=0.015)。化疗组的肺客观反应率(ORR)和疾病控制率(DCR)分别为48.4%和62.1%,联合组分别为82.9%和90.2%(分别为P<0.001和0.001)。133例患者发生AE(97.8%)。化疗组骨髓抑制发生率为48.4%(46/95),联合治疗组为7.3%(3/41)(P<0.001)。
结论:与单纯化疗相比,DEB-BACE加化疗与较长的生存结果和较低的骨髓抑制发生率相关。