Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan;
Anticancer Res. 2024 Mar;44(3):1227-1232. doi: 10.21873/anticanres.16918.
BACKGROUND/AIM: Although gemcitabine plus cisplatin (GC) prolongs survival in patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) compared with fluorouracil plus cisplatin, no study has evaluated the efficacy and safety of GC in nonendemic regions, including Japan, yet. Therefore, we assessed the safety and efficacy of GC in Japanese patients with R/M NPC.
We retrospectively reviewed patients with R/M NPC who received GC treatment at the Aichi Cancer Center Hospital from January 2017 to March 2020. The main eligibility criteria were histologically confirmed NPC, Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2, and locally recurrent disease unsuitable for local treatment or metastatic disease. The regimen was administered every 3 weeks (gemcitabine, 1,000 mg/m on days 1 and 8; cisplatin, 80 mg/m on day 1).
Fourteen patients (median age, 58 years) were included in the study. Two patients had an ECOG PS of 2 and 11 exhibited nonkeratinizing histology. Of the eight patients with measurable lesions, one exhibited complete response and seven exhibited partial response, with an objective response rate of 75%. Median progression-free survival and overall survival were 7.7 and 24.2 months, respectively. Common grade 3 or 4 adverse events included neutropenia (64%), thrombocytopenia (14%), and febrile neutropenia (14%). The median relative dose intensity of gemcitabine and cisplatin was 62% and 60%, respectively. No treatment-related deaths occurred.
The GC regimen demonstrates promising activity and is tolerable in Japanese patients with R/M NPC.
背景/目的：与氟尿嘧啶联合顺铂（5-FU/CDDP）相比，吉西他滨联合顺铂（GC）可延长复发性或转移性鼻咽癌（R/M NPC）患者的生存期，但尚无研究评估 GC 在包括日本在内的非流行地区的疗效和安全性。因此，我们评估了 GC 在日本 R/M NPC 患者中的疗效和安全性。
我们回顾性分析了 2017 年 1 月至 2020 年 3 月在爱知县癌症中心医院接受 GC 治疗的 R/M NPC 患者。主要入选标准为组织学证实的 NPC、东部肿瘤协作组体力状态（ECOG PS）0-2 分、局部复发不适宜局部治疗或远处转移。方案为每 3 周给药 1 次（吉西他滨，第 1、8 天 1000mg/m2；顺铂，第 1 天 80mg/m2）。
本研究纳入了 14 例患者（中位年龄 58 岁）。2 例患者 ECOG PS 为 2 分，11 例患者为非角化型组织学。8 例可测量病灶患者中，1 例达完全缓解，7 例达部分缓解，客观缓解率为 75%。中位无进展生存期和总生存期分别为 7.7 个月和 24.2 个月。常见的 3 级或 4 级不良事件包括中性粒细胞减少（64%）、血小板减少（14%）和发热性中性粒细胞减少（14%）。吉西他滨和顺铂的中位相对剂量强度分别为 62%和 60%。无治疗相关死亡。
GC 方案在日本 R/M NPC 患者中显示出有前景的疗效和可耐受性。
