Hayase Suguru, Yamada Leo, Ujiie Daisuke, Nirei Azuma, Tada Takeshi, Hanayama Hiroyuki, Monma Tomoyuki, Saze Zenichiro, Ohki Shinji, Kono Koji
Department of Gastrointestinal Tract Surgery Fukushima Medical University.
Fukushima J Med Sci. 2019;65(1):6-12. doi: 10.5387/fms.2018-12.
Introduction Recently 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 Methods The 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 years (n=6) and those aged ≥75 (n=5), by performing a retrospective analysis based on the data obtained from daily clinical practice for gastric cancer treatment.Results Objective 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 and ≥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 (p = 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.Conclusion The 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.
引言 最近在日本,雷莫西尤单抗(RAM)成为首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联合紫杉醇(PTX)在我院不可切除和复发性胃癌患者中的疗效和安全性。
患者与方法 研究对象为11例不可切除和复发性胃癌患者,他们于2015年6月至2017年9月在我院接受RAM联合PTX作为二线或后续治疗,此前尝试的治疗均失败。我们通过对胃癌治疗日常临床实践中获得的数据进行回顾性分析,评估了RAM联合PTX的疗效和安全性,并比较了年龄<75岁(n = 6)和年龄≥75岁(n = 5)患者之间的差异。
结果 11例患者中有1例(9.1%)出现部分缓解,观察到客观肿瘤反应,其余10例(90.9%)病情得到控制。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 - 不可用(NA))和11.3个月(95%CI 6.5 - NA)。未发生严重不良事件。<75岁组和≥75岁组的中位OS分别为不可用(由于随访期短)和20.8个月(p = 0.336),各自的中位PFS率分别为9.4个月和11.3个月(p = 0.492)。本研究中两个年龄组之间不良事件发生率的差异不显著,尽管不良事件数量不足。
结论 本研究结果表明,RAM和PTX联合化疗作为二线或后续治疗对不可切除和复发性胃癌患者有效,并且在老年患者中已证明是安全可行的。