白蛋白结合型紫杉醇治疗卵巢癌的疗效、安全性及SPARC相关性分析
Efficacy and Safety of Nab-Paclitaxel and Its Correlation With SPARC Expression in Ovarian Cancer
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摘要:目的 比较白蛋白结合型紫杉醇与其他剂型紫杉醇治疗卵巢癌的疗效与安全性，并探讨白蛋白结合型紫杉醇疗效与SPARC蛋白表达的相关性。方法 选取2018年1月—2024年12月收治的48例卵巢癌患者，分为白蛋白结合型紫杉醇组（32例）与其他剂型紫杉醇组（16例）。评估两组患者的疗效指标、不良反应发生情况，并对白蛋白结合型紫杉醇组患者肿瘤组织中SPARC蛋白表达进行检测分析。结果 两组患者基线资料均衡，差异无统计学意义（均P>0.05）。白蛋白结合型紫杉醇组客观缓解率（objective response rate，ORR）为87.5%（28/32），显著高于其他剂型紫杉醇组的56.3%（9/16）（P＝0.039）；疾病控制率（disease control rate，DCR）分别为96.9%和87.5%，组间差异无统计学意义（P＝0.527）。生存分析显示，白蛋白结合型紫杉醇组中位无进展生存期（progression-free survival，PFS）为25.0个月95%置信区间（confidence interval，CI） 12.4~37.6，中位总生存期（overall survival，OS）为54.0个月（95% CI 31.9~76.2）；其他紫杉醇组分别为19.0个月（95%CI 13.2~24.6）和44.0个月（95%CI 23.7~64.3），组间PFS与OS差异均无统计学意义（P＝0.12，P＝0.46）。两组在血液学毒性、胃肠道反应、神经毒性及肝肾功能异常等不良反应发生率方面差异均无统计学意义（均P>0.05）。进一步对25例白蛋白结合型紫杉醇治疗患者进行SPARC检测，阳性表达率为60.0%（15/25）。SPARC阳性组ORR为100%（15/15），显著高于阴性组的60.0%（6/10）（P＝0.017）；DCR分别为100%和90%，中位PFS分别为25.0个月和20.0个月，组间差异均无统计学意义（均P>0.05）。相关性分析显示，SPARC表达与ORR呈正相关（r＝0.535，P＝0.006），与DCR呈弱正相关但无统计学意义（r＝0.250，P＝0.228）。结论 在卵巢癌治疗中，白蛋白结合型紫杉醇的ORR显著优于其他紫杉醇剂型，生存结局与安全性相当，且其疗效与SPARC蛋白表达呈正相关，提示SPARC可能作为白蛋白结合型紫杉醇疗效的潜在预测标志物。Abstract:Objective To compare the efficacy and safety of nab-paclitaxel versus other paclitaxel formulations in the treatment of ovarian cancer, and to explore the correlation between the efficacy of nab-paclitaxel and SPARC protein expression.Methods A total of 48 patients with ovarian cancer treated between January 2018 and December 2024 were enrolled and assigned to a nab-paclitaxel group (n=32) or a non-nab-paclitaxel group (n=16).Treatment efficacy and adverse reactions were assessed. SPARC protein expression in tumor tissues was detected and analyzed in the nab-paclitaxel group.Results Baseline characteristics were balanced between the two groups (all P > 0.05). The objective response rate (ORR) was significantly higher in the nab-paclitaxel group (87.5%, 28/32) compared to the other-paclitaxel group (56.3%, 9/16) (P=0.039). The disease control rate (DCR) was 96.9% versus 87.5%, respectively, with no significant difference (P=0.527). Survival analysis showed median progression-free survival (PFS) of 25.0 months 95% confidence interval(CI) 12.4–37.6 and median overall survival (OS) of 54.0 months (95%CI 31.9–76.2) for the nab-paclitaxel group, compared to 19.0 months (95%CI 13.2–24.6) and 44.0 months (95%CI 23.7–64.3) for the other-paclitaxel group, with no statistically significant differences in PFS or OS (P=0.12 and P=0.46, respectively). No significant differences were observed in the incidence of hematologic toxicity, gastrointestinal reactions, neurotoxicity, or hepatic/renal dysfunction between the groups (all P > 0.05). Among 25 patients in the nab-paclitaxel group evaluated for SPARC expression, the positive rate was 60.0% (15/25). The ORR was significantly higher in the SPARC-positive subgroup (100%, 15/15) compared to the SPARC-negative subgroup (60.0%, 6/10) (P=0.017). DCR was 100% versus 90%, and median PFS was 25.0 versus 20.0 months, respectively, with no significant differences (all P > 0.05). Correlation analysis indicated a positive association between SPARC expression and ORR (r=0.535, P=0.006), and a weak, non-significant positive correlation with DCR (r=0.250, P=0.228).Conclusions Nab-paclitaxel demonstrates a significantly higher ORR compared to other paclitaxel formulations in treating ovarian cancer, with comparable survival outcomes and safety profile. The positive correlation between treatment efficacy and SPARC protein expression suggests SPARC as a potential predictive biomarker for nab-paclitaxel response.
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