Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
Division of Pharmacy, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Int J Clin Oncol. 2017 Dec;22(6):1009-1014. doi: 10.1007/s10147-017-1152-8. Epub 2017 Jun 14.
Although gemcitabine is thought to play a critical role in the treatment of nasopharyngeal cancer, no research to evaluate the efficacy and toxicity of gemcitabine monotherapy has been conducted in Japan.
We retrospectively reviewed eight nasopharyngeal carcinoma patients treated with gemcitabine monotherapy at National Cancer Center Hospital East between May 2015 and August 2016. The main eligibility criteria were (1) histopathologically proven NPC; (2) tumor recurrence or an initial M1 TNM stage diagnosis; (3) at least two other types of systemic chemotherapy prior to gemcitabine; (4) no other active malignant tumor during treatment.
All patients were administered gemcitabine 800-1000 mg/m on days 1, 8, and 15, repeated every 4 weeks. Gemcitabine was given as third-line systemic chemotherapy in six (74%) patients, as fourth-line in one (13%) and as fifth-line in one (13%). One patient had a complete response and one had a partial response, giving an overall response rate of 25%; four patients (50%) had stable disease and two (25%) experienced disease progression. The main toxicity was myelosuppression, with grade 3 leukopenia in three (38%) patients and neutropenia in four (50%). There were no treatment-related deaths. Median dose intensity and relative dose intensity of gemcitabine were 620 mg/m/week and 97.5%, respectively.
Our findings suggest that GEM monotherapy is well tolerated and has potential as an active agent in Japanese patients with recurrent/metastatic NPC who have been heavily pretreated.
尽管吉西他滨被认为在鼻咽癌的治疗中起着关键作用，但在日本尚未开展评估吉西他滨单药治疗疗效和毒性的研究。
我们回顾性分析了 2015 年 5 月至 2016 年 8 月在国立癌症中心医院东分院接受吉西他滨单药治疗的 8 例鼻咽癌患者。主要入选标准为：（1）组织病理学证实的 NPC；（2）肿瘤复发或初始 M1 TNM 分期诊断；（3）在接受吉西他滨治疗前至少接受过两种其他类型的全身化疗；（4）治疗期间无其他活动性恶性肿瘤。
所有患者均接受吉西他滨 800-1000 mg/m2 治疗，第 1、8 和 15 天给药，每 4 周重复一次。吉西他滨作为三线全身化疗用于 6 例（74%）患者，四线用于 1 例（13%），五线用于 1 例（13%）。1 例患者完全缓解，1 例部分缓解，总缓解率为 25%；4 例（50%）患者疾病稳定，2 例（25%）患者疾病进展。主要毒性为骨髓抑制，3 例（38%）患者出现 3 级白细胞减少症，4 例（50%）患者出现中性粒细胞减少症。无治疗相关死亡。吉西他滨的中位剂量强度和相对剂量强度分别为 620 mg/m/周和 97.5%。
我们的研究结果表明，GEM 单药治疗在日本复发/转移性 NPC 患者中具有良好的耐受性，且具有作为一种有效药物的潜力，这些患者先前已接受了大量治疗。
