Hospital Universitario Austral, Facultad de Ciencias Biomédicas, Universidad Austral, Buenos Aires B1629HJ, Argentina.
Hospital Italiano de Buenos, Cuidad Autónoma de Buenos Aires, Buenos Aires C1424BYE, Argentina.
World J Gastroenterol. 2019 Jul 21;25(27):3607-3618. doi: 10.3748/wjg.v25.i27.3607.
Hepatocellular carcinoma (HCC) represents the sixteenth most frequent cancer in Argentina. The rise of new therapeutic modalities in intermediate-advanced HCC opens up a new paradigm for the treatment of HCC.
To describe real-life treatments performed in patients with intermediate-advanced HCC before the approval of new systemic options.
This longitudinal observational cohort study was conducted between 2009 and 2016 in 14 different regional hospitals from Argentina. Included subjects had intermediate-advanced Barcelona Clinic Liver Cancer (BCLC) HCC stages (BCLC B to D). Primary end point analyzed was survival, which was assessed for each BCLC stage from the date of treatment until last patient follow-up or death. Kaplan Meier survival curves and Cox regression analysis were performed, with hazard ratios (HR) calculations and 95% confidence intervals (95%CI).
From 327 HCC patients, 41% were BCLC stage B, 20% stage C and 39% stage D. Corresponding median survival were 15 mo (IQR 5-26 mo), 5 mo (IQR 2-13 mo) and 3 mo (IQR 1-13 mo) ( < 0.0001), respectively. Among BCLC-B patients ( = 135), 57% received TACE with a median number of 2 sessions (IQR 1-3 sessions). Survival was significantly better in BCLC-B patients treated with TACE HR = 0.29 (CI: 0.21-0.40) than those without TACE. After tumor reassessment by RECIST 1.1 criteria following the first TACE, patients with complete response achieved longer survival [HR = 0.15 (CI: 0.04-0.56, = 0.005)]. Eighty-two patients were treated with sorafenib, mostly BCLC-B and C (87.8%). However, 12.2% were BCLC-D. Median survival with sorafenib was 4.5 mo (IQR 2.3-11.7 mo); which was lower among BCLC-D patients 3.2 mo (IQR 2.0-14.1 mo). A total of 36 BCLC-B patients presented tumor progression after TACE. In these patients, treatment with sorafenib presented better survival when compared to those patients who received sorafenib without prior TACE [HR = 0.26 (CI: 0.09-0.71); = 0.013].
In this real setting, our results were lower than expected. This highlights unmet needs in Argentina, prior to the introduction of new treatments for HCC.
肝细胞癌(HCC)是阿根廷第十六大常见癌症。在中晚期 HCC 中出现的新治疗方法为 HCC 的治疗开辟了新的范例。
描述在新的全身治疗方案获得批准之前,中晚期 HCC 患者接受的真实治疗方法。
这是一项在阿根廷 14 家不同地区医院进行的纵向观察性队列研究。纳入的受试者患有中晚期巴塞罗那临床肝癌(BCLC)HCC 分期(BCLC B 至 D)。主要终点分析为生存,从治疗日期到最后一次患者随访或死亡,对每个 BCLC 分期进行评估。进行 Kaplan-Meier 生存曲线和 Cox 回归分析,计算风险比(HR)和 95%置信区间(95%CI)。
在 327 名 HCC 患者中,41%为 BCLC 分期 B,20%为分期 C,39%为分期 D。相应的中位生存期分别为 15 个月(IQR 5-26 个月)、5 个月(IQR 2-13 个月)和 3 个月(IQR 1-13 个月)(<0.0001)。在 BCLC-B 患者(n=135)中,57%接受 TACE 治疗,中位数为 2 次(IQR 1-3 次)。与未接受 TACE 治疗的患者相比,接受 TACE 治疗的 BCLC-B 患者的生存显著更好(HR=0.29(95%CI:0.21-0.40))。在首次 TACE 后根据 RECIST 1.1 标准进行肿瘤重新评估后,完全缓解的患者生存期更长[HR=0.15(95%CI:0.04-0.56,=0.005)]。82 名患者接受索拉非尼治疗,主要为 BCLC-B 和 C(87.8%)。然而,12.2%为 BCLC-D。索拉非尼的中位生存期为 4.5 个月(IQR 2.3-11.7 个月);BCLC-D 患者的中位生存期为 3.2 个月(IQR 2.0-14.1 个月)。共有 36 名 BCLC-B 患者在 TACE 后出现肿瘤进展。在这些患者中,与未接受 TACE 治疗的患者相比,接受索拉非尼治疗的患者的生存更好[HR=0.26(95%CI:0.09-0.71);=0.013]。
在这种真实环境下,我们的结果低于预期。这突显了阿根廷在引入 HCC 新治疗方法之前存在的未满足的需求。