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Oxaliplatin-Based Chemotherapy in Patients with Metastatic Colorectal Cancer Aged at Least 75 Years: A Post-Hoc Subgroup Analysis of Three Phase II Trials

机译:至少75岁的转移性结直肠癌患者以奥沙利铂为基础的化疗:三个II期临床试验的术后亚组分析

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Patients older than 75 years of age are usually excluded from metastatic colorectal cancer studies based on a combination chemotherapy containing oxaliplatin. Our group conducted three phase II trials in elderly patients in recent years. A post-hoc subgroup analysis of 67 patients aged at least 75 years was included in this study. Oxaliplatin was combined with capecitabine in two trials and with uracil-tegafur (UFT) plus folinic acid in the third trial. In one study, bevacizumab was also added to chemotherapy. The median age of patients was 77 years, and all had a good performance status (0 to 1). The observed overall response rate was 45%, comparable to younger patients (51%, p = 0.49). The estimated median progression-free survival (PFS) time and overall survival (OS) time were 8.7 and 19.3 months, respectively. These results did not significantly differ from those in younger patients (8.0 months for PFS ( p = 0.58) and 19.7 months for OS ( p = 0.94), respectively). The most common grade 3–4 adverse events included diarrhea (13%), fatigue (13%), peripheral neuropathy (10%), and neutropenia (7%). Moreover, the toxicity was never statistically different from that in younger patients. The efficacy of oxaliplatin-based combination was maintained in fit elderly patients ≥75 years.
机译:基于包含奥沙利铂的联合化疗,通常将75岁以上的患者排除在转移性结直肠癌研究之外。近年来,我们小组对老年患者进行了三期II期试验。本研究包括对67名年龄在75岁以上的患者的事后亚组分析。奥沙利铂在两个试验中与卡培他滨合用,在第三次试验中与尿嘧啶-替加氟(UFT)加亚叶酸合用。在一项研究中,贝伐单抗也被添加到化疗中。患者的中位年龄为77岁,所有患者的表现良好(0至1)。观察到的总缓解率为45%,与年轻患者相当(51%,p = 0.49)。估计中位无进展生存时间(PFS)和总体生存时间(OS)分别为8.7和19.3个月。这些结果与年轻患者的结果无显着差异(PFS分别为8.0个月(p = 0.58)和OS为19.7个月(p = 0.94))。最常见的3-4级不良事件包括腹泻(13%),疲劳(13%),周围神经病变(10%)和中性粒细胞减少症(7%)。此外,毒性与年轻患者在统计学上没有差异。以奥沙利铂为基础的联合治疗在≥75岁的老年患者中保持疗效。

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