顺铂/5-氟尿嘧啶和帕尼单抗在日本头颈部鳞状细胞癌患者中的可行性。

Feasibility of cisplatin/5-fluorouracil and panitumumab in Japanese patients with squamous cell carcinoma of the head and neck.

机构信息

Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Chiba

Shizuoka Cancer Center, Shizuoka.

出版信息

Jpn J Clin Oncol. 2014 Jul;44(7):661-9. doi: 10.1093/jjco/hyu063. Epub 2014 May 16.

DOI:10.1093/jjco/hyu063

PMID:24837597

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4071043/

Abstract

OBJECTIVE

In Japan, cisplatin/5-fluorouracil 80/800 (cisplatin 80 mg/m2, 5-fluorouracil 800 mg/m2) is widely used to treat recurrent/metastatic squamous cell carcinoma of the head and neck, whereas cisplatin/5-fluorouracil 100/1000 (1000 mg/m2/24 h by continuous intravenous infusion on Days 1-4 plus cisplatin 100 mg/m2 on Day 1 in 3-week cycles) is the standard treatment in Europe and North America.

METHODS

We prospectively evaluated the feasibility of cisplatin/5-fluorouracil 100/1000 in Japanese patients enrolled in the global Phase 3 study of panitumumab 9 mg/kg combined with cisplatin/5-fluorouracil 100/1000 (Arm 1) versus cisplatin/5-fluorouracil 100/1000 alone (Arm 2).

RESULTS

Twenty Japanese patients were enrolled and received treatment (Arm 1, n=13; Arm 2, n=7). Grade 3/4 adverse events included neutropenia, hypomagnesemia, stomatitis, hyponatremia, paronychia, febrile neutropenia, decreased appetite and hypokalemia. There were no fatal adverse events. Median overall survival was not estimable in Arm 1 and 15.4 months in Arm 2. Median progression-free survival was 6.9 months in Arm 1 and 5.7 months in Arm 2. The median number of infusions (cycles) of cisplatin was 5 in Arm 1 and 4 in Arm 2; the median number of infusions (cycles) of 5-fluorouracil was 6 in both arms. The mean administered dose for cisplatin was 93.6 mg/m2 in Arm 1 and 97.2 mg/m2 in Arm 2, and 3732.6 and 3880 mg/m2 in Arm 1 and Arm 2, respectively, for 5-fluorouracil.

CONCLUSIONS

These results suggested that cisplatin/5-fluorouracil 100/1000 was feasible for recurrent/metastatic squamous cell carcinoma of the head and neck in Japanese patients.

摘要

目的

在日本，顺铂/5-氟尿嘧啶 80/800（顺铂 80mg/m2，5-氟尿嘧啶 800mg/m2）被广泛用于治疗复发性/转移性头颈部鳞状细胞癌，而顺铂/5-氟尿嘧啶 100/1000（在 3 周周期中，第 1-4 天持续静脉输注 1000mg/m2/24 小时，第 1 天给予顺铂 100mg/m2）是欧洲和北美的标准治疗方法。

方法

我们前瞻性评估了在全球 3 期帕尼单抗 9mg/kg 联合顺铂/5-氟尿嘧啶 100/1000（第 1 组）与顺铂/5-氟尿嘧啶 100/1000 单独治疗（第 2 组）的头颈部复发性/转移性鳞状细胞癌患者中使用顺铂/5-氟尿嘧啶 100/1000 的可行性。

结果

20 名日本患者入组并接受治疗（第 1 组，n=13；第 2 组，n=7）。3/4 级不良事件包括中性粒细胞减少症、低镁血症、口腔炎、低钠血症、甲床炎、发热性中性粒细胞减少症、食欲下降和低钾血症。无致命不良事件。第 1 组中位总生存期不可估计，第 2 组为 15.4 个月。第 1 组中位无进展生存期为 6.9 个月，第 2 组为 5.7 个月。第 1 组顺铂的中位输注（周期）数为 5 个，第 2 组为 4 个；两组中 5-氟尿嘧啶的中位输注（周期）数均为 6 个。第 1 组顺铂的平均给药剂量为 93.6mg/m2，第 2 组为 97.2mg/m2；5-氟尿嘧啶在第 1 组和第 2 组中的给药剂量分别为 3732.6mg/m2 和 3880mg/m2。