Department of Internal Medicine, Soon Chun Hyang University College of Medicine, Seoul, Korea.
Cancer Res Treat. 2004 Jun;36(3):173-7. doi: 10.4143/crt.2004.36.3.173. Epub 2004 Jun 30.
The prognosis of patients with advanced non-small-cell lung cancer (NSCLC) is extremely poor. Many prospective randomized trials on patients with advanced NSCLC suggested systemic chemotherapy improves both the survival and quality of life. A phase II trial was conducted to evaluate the efficacy and safety profile of the combination chemotherapy of gemcitabine and cisplatin in advanced NSCLC.
Forty-four patients with locally advanced or metastatic NSCLC were enrolled. The patients received a cisplatin, 75 mg/m(2), infusion over 30 minutes on days 1, followed by a gemcitabine, 1,250 mg/m(2), infusion over 30 minutes on days 1 and 8 every 3 weeks.
The median age of the patients was 64 years (range: 27 approximately 75). Forty-one patients were assessable for response and toxicity analyses. The overall response rate was 53.6%, but with no complete remissions. The median time to progression was 5.6 months (range: 1 approximately 15.4). The median survival was 14.2 months (95% confidence interval (CI), 13.8 approximately 22.5). A total of 179 cycles were administered, with a median of 4 cycles of chemotherapy, ranging from 2 to 9 cycles. The most common hematological toxicities were NCI grades 3/4 neutropenia (24%) and thrombocytopenia (7.8%). The most common non-hematological toxicity was fatigue (42.4%). There were no life-threatening toxicity or treatment related mortalities. The median duration of follow up was 9.4 months, ranging from 1.6 to 30.3 months.
In this trial, the combination of gemcitabine and cisplatin showed significant activity, with acceptable and manageable toxicities as a first-line regimen for patients with advanced NSCLC.
晚期非小细胞肺癌（NSCLC）患者的预后极差。许多针对晚期 NSCLC 患者的前瞻性随机试验表明，系统化疗可提高生存质量和生活质量。进行了一项 II 期试验，以评估吉西他滨和顺铂联合化疗治疗晚期 NSCLC 的疗效和安全性。
纳入 44 例局部晚期或转移性 NSCLC 患者。患者接受顺铂 75mg/m2 静脉输注 30 分钟，第 1 天，随后吉西他滨 1250mg/m2 静脉输注 30 分钟，第 1 天和第 8 天，每 3 周一次。
患者中位年龄为 64 岁（范围：27-75）。41 例患者可评估反应和毒性分析。总缓解率为 53.6%，但无完全缓解。中位无进展生存期为 5.6 个月（范围：1-15.4）。中位总生存期为 14.2 个月（95%置信区间（CI），13.8-22.5）。共给予 179 个周期，中位数为 4 个周期的化疗，范围为 2-9 个周期。最常见的血液学毒性是 NCI 3/4 级中性粒细胞减少（24%）和血小板减少（7.8%）。最常见的非血液学毒性是疲劳（42.4%）。无危及生命的毒性或治疗相关死亡。中位随访时间为 9.4 个月，范围为 1.6-30.3 个月。
在这项试验中，吉西他滨和顺铂联合方案显示出显著的活性，作为晚期 NSCLC 患者的一线治疗方案，毒性可接受且易于管理。
