Department of Hemato-oncology, Konkuk University Medical Center, 4-12 Hwayang-dong, Gwangjin-gu, Seoul 143-729, Republic of Korea.
Gastric Cancer. 2012 Oct;15(4):389-95. doi: 10.1007/s10120-011-0128-z. Epub 2012 Jan 12.
A chemotherapy regimen with oxaliplatin, fluorouracil, and leucovorin is commonly used to treat advanced gastric cancer (AGC). This study was designed to compare the efficacy and the safety of oxaliplatin plus fluorouracil/leucovorin administered biweekly (mFOLFOX6) between elderly patients aged over 65 years and younger counterparts with AGC.
This analysis included 82 AGC patients (≥65:31, <65:51). Patients with previously untreated chemo-naïve advanced adenocarcinoma of the stomach received oxaliplatin 85 mg/m(2), 5-FU bolus 400 mg/m(2) on day 1 and 5-FU 1,500 mg/m(2), leucovorin 75 mg/m(2) 22 h infusion on days 1 and 2 every 2 weeks. The aim of the study was to compare efficacy and safety, including response rate (RR), progression-free survival (PFS), overall survival, and grade ≥3 adverse events, between patients aged ≥65 years and patients aged <65 years.
Median progression-free survival (PFS) was not significantly different between both groups (≥65: 5.8 months, <65: 5.7 months, respectively, HR 0.77, 95% CI: 0.44-1.16, P = 0.18). Median overall survival was not significantly different between both groups (≥65: 10.3 months, <65: 9.5 months HR 0.83, 95% CI: 0.50-1.37, P = 0.46). The rate of grade 3 or 4 neutropenia did not differ with age group (≥65: 51.6%, <65: 43.1%); nor did the rates of neutropenic fever (≥65: 16.1%, <65: 5.9%), and infection without neutropenia (≥65: 3.2%, <65: 3.9%). Rates of grade ≥3 toxicities such as thrombocytopenia, nausea/vomiting, or peripheral neuropathy were not significantly different between the two groups.
mFOLFOX6 maintains its efficacy and safety in elderly patients aged over 65 years in comparison with AGC patients aged <65 years. Its judicious use should be considered regardless of age.
奥沙利铂、氟尿嘧啶和亚叶酸钙组成的化疗方案常用于治疗晚期胃癌（AGC）。本研究旨在比较奥沙利铂联合氟尿嘧啶/亚叶酸钙（mFOLFOX6）治疗 65 岁以上和 65 岁以下晚期胃癌患者的疗效和安全性。
该分析纳入 82 例 AGC 患者（≥65 岁：31 例，<65 岁：51 例）。初治、化疗敏感的胃腺癌患者接受奥沙利铂 85mg/m2，氟尿嘧啶 400mg/m2 静脉推注（第 1 天），氟尿嘧啶 1500mg/m2，亚叶酸钙 75mg/m2 持续输注（第 1 和第 2 天），每 2 周 1 次。本研究旨在比较 65 岁以上和<65 岁患者的疗效和安全性，包括缓解率（RR）、无进展生存期（PFS）、总生存期和≥3 级不良事件。
两组中位 PFS 无显著差异（≥65 岁：5.8 个月，<65 岁：5.7 个月，HR 0.77，95%CI：0.44-1.16，P=0.18）。两组中位总生存期无显著差异（≥65 岁：10.3 个月，<65 岁：9.5 个月，HR 0.83，95%CI：0.50-1.37，P=0.46）。3/4 级中性粒细胞减少的发生率与年龄无关（≥65 岁：51.6%，<65 岁：43.1%）；中性粒细胞减少性发热的发生率（≥65 岁：16.1%，<65 岁：5.9%）和无中性粒细胞减少的感染发生率（≥65 岁：3.2%，<65 岁：3.9%）也无差异。两组≥3 级血小板减少、恶心/呕吐或周围神经病变等毒性反应发生率无显著差异。
与<65 岁患者相比，mFOLFOX6 治疗 65 岁以上晚期胃癌患者的疗效和安全性相当。应考虑其合理应用，而与年龄无关。
