吉西他滨和 S-1 治疗晚期胰腺癌的 II 期临床试验。
Phase II trial of gemcitabine and S-1 for patients with advanced pancreatic cancer.
机构信息
Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, #170 Gwanpyeng-ro, Dongahn gu, Anyang, GyeongGi-Do, 431-070, Republic of Korea.
出版信息
Cancer Chemother Pharmacol. 2013 Oct;72(4):845-52. doi: 10.1007/s00280-013-2265-z. Epub 2013 Aug 27.
PURPOSE
To evaluate the efficacy and safety of combined gemcitabine and S-1 as first-line chemotherapy for patients with locally advanced or metastatic pancreatic cancer.
METHODS
This study included patients who had been diagnosed with unresectable, locally advanced or metastatic adenocarcinoma arising from the pancreas, which was histologically or cytologically confirmed and involved at least 1 unidimensionally measurable lesion. The regimen consisted of intravenous 1,000 mg/m(2) gemcitabine on day 1 and 8 combined with oral S-1 on days 1-14 every 21 days. The dosage of S-1 was based on the body surface area (BSA) as follows: 40 mg bid (total 80 mg/day) for a BSA of <1.25, 50 mg bid (total 100 mg/day) for a BSA of ≥1.25 but <1.5, and 60 mg bid (total 120 mg/day) for a BSA of ≥1.5. Treatment consisted of at least 2 courses unless rapid disease progression was noted. The primary end points were the response and disease control rates, and the secondary end points were toxicity and survival.
RESULTS
Thirty-seven patients were enrolled between August 2005 and December 2010. The median number of chemotherapy cycles was 4 (range 1-28 cycles). Response to treatment could be evaluated in 31 patients. None of the patients showed complete response, but 5 achieved partial response. The response rate was thus 13.5 % [95 % confidence interval (CI) 2.7-24.3 %] in the intent-to-treat population. Sixteen patients (43.2 %; 95 % CI 27-59.5 %) showed stable disease, and the overall disease control rate was 56.8 % (95 % CI 40.6-72.9 %). For all 37 patients, the median progression-free survival was 4.6 months (95 % CI 1.8-7.6 month), and the median overall survival was 9.4 month (95 % CI 5.8-12.6 month). Chemotherapy-related grade 3/4 hematological toxicities were neutropenia (36.1 %), leucopenia (22.2 %), and anemia (13.9 %). The non-hematological toxicities were generally mild.
CONCLUSIONS
Combination chemotherapy with gemcitabine and S-1 was effective, convenient, and safe in patients with advanced pancreatic cancer.
目的
评估吉西他滨联合替吉奥作为局部晚期或转移性胰腺癌一线化疗的疗效和安全性。
方法
本研究纳入了经组织学或细胞学证实至少有 1 个可测量的一维病灶，诊断为不可切除的局部晚期或转移性胰腺腺癌的患者。方案包括第 1 天静脉滴注 1000mg/m²吉西他滨，第 1 天至第 14 天每天口服替吉奥 80mg，每 21 天 1 次。替吉奥的剂量基于体表面积（BSA）如下：BSA<1.25 者，每次 80mg bid（总剂量 160mg/天）；BSA≥1.25 但<1.5 者，每次 100mg bid（总剂量 200mg/天）；BSA≥1.5 者，每次 120mg bid（总剂量 240mg/天）。治疗至少 2 个疗程，除非出现疾病快速进展。主要终点是反应率和疾病控制率，次要终点是毒性和生存。
结果
2005 年 8 月至 2010 年 12 月期间共纳入 37 例患者。中位化疗周期数为 4 个（范围 1-28 个）。31 例患者可评估治疗反应。无完全缓解病例，但 5 例部分缓解。因此，意向治疗人群的客观缓解率为 13.5%（95%置信区间 2.7-24.3%）。16 例（43.2%；95%置信区间 27-59.5%）患者疾病稳定，总体疾病控制率为 56.8%（95%置信区间 40.6-72.9%）。所有 37 例患者的中位无进展生存期为 4.6 个月（95%置信区间 1.8-7.6 个月），中位总生存期为 9.4 个月（95%置信区间 5.8-12.6 个月）。化疗相关的 3/4 级血液学毒性为中性粒细胞减少症（36.1%）、白细胞减少症（22.2%）和贫血（13.9%）。非血液学毒性一般较轻。
结论
吉西他滨联合替吉奥治疗晚期胰腺癌疗效确切，使用方便，安全性好。
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