Clinical usefulness of ramucirumab plus paclitaxel for unresectable and recurrent gastric cancer
Clinical usefulness of ramucirumab plus paclitaxel for unresectable and recurrent gastric cancer
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DOI：
10.5387/fms.2018-12
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发表时间：
2019-01-01
影响因子：
0.8
通讯作者：
Kono, Koji
中科院分区：
文献类型：
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作者：
Hayase, Suguru;Yamada, Leo;Kono, Koji
简介最近在日本，雷莫芦单抗（RAM）成为第一个被批准用于胃癌二线治疗的抗血管生成药物。在本研究中，我们旨在评估RAM加紫杉醇（PTX）在我们机构中不可切除和复发的胃癌患者中的有效性和安全性。患者和方法受试者是2015年6月至2017年9月期间在我们医院接受RAM加PTX作为二线或二线治疗的11名不可切除和复发的胃癌患者，在之前尝试的治疗失败后。我们评估了RAM加PTX的疗效和安全性，并进行了比较，年龄= 75（n=5）的患者之间，通过进行回顾性分析，从日常临床实践中获得的数据为胃癌treatment.ResultsObjective肿瘤反应的基础上观察到的11例患者（9.1%）的部分反应，和疾病控制被认为是在其余的10（90.9%）。患者的中位总生存期（OS）和无进展生存期（PFS）分别为20.8个月（95% CI 7.8-NA（不适用））和11.3个月（95% CI 6.5-NA）。未发生严重不良事件。≥ 75岁组的中位OS分别为NA（由于随访期短）和20.8个月（p = 0.336），其各自的中位PFS率分别为9.4和11.3个月（= 0.492）。在本研究中，两个年龄组的不良事件发生率的差异不显着，虽然不良事件的数量是不够的。ConclusionThe结果表明，本研究的联合化疗的RAM和PTX是有效的不可切除和复发的胃癌患者作为二线或以后的治疗，并已被证明是安全和可行的老年患者。
IntroductionRecently in Japan, Ramucirumab (RAM) became the first anti angiogenic agent to be approved for second-line treatment of gastric cancer. In the present study, we aimed to evaluate the efficacy and safety of RAM plus paclitaxel (PTX) in patients with unresectable and recurrent gastric cancer in our institution.Patients and MethodsThe subjects were 11 patients with unresectable and recurrent gastric cancer who received RAM plus PTX as a second- or later-line treatment at our hospital between June 2015 and September 2017, after the failure of previously-attempted treatments. We assessed the efficacy and safety of RAM plus PTX, and also compared them between patients aged = 75 (n=5), by performing a retrospective analysis based on the data obtained from daily clinical practice for gastric cancer treatment.ResultsObjective tumor response was observed in one of the 11 patients (9.1%) with partial response, and disease control was seen in the remaining 10 (90.9%). The median overall survival (OS) and progression-free survival (PFS) of the patients were 20.8 months (95% CI 7.8-NA (not applicable)) and 11.3 months (95% CI 6.5-NA), respectively. There were no serious adverse events. The median OS for the = 75 years group was NA (due to short follow-up period) and 20.8 months (p = 0.336), respectively, and their respective median PFS rates were 9.4 and 11.3 months = 0.492). The difference of rate of adverse events was not significant between the two age groups in the present study, though the number of adverse events was not sufficient.ConclusionThe results of the present study suggest that the combination chemotherapy of RAM and PTX was effective in unresectable and recurrent gastric cancer patients as a second- or later-line therapy, and has been shown to be safe and feasible in elderly patients.