Heinemann V, Wilke H, Mergenthaler H G, Clemens M, König H, Illiger H J, Arning M, Schalhorn A, Possinger K, Fink U
Klinikum Grosshadern, Medizinisches Klinik III, München, Germany.
Ann Oncol. 2000 Nov;11(11):1399-403. doi: 10.1023/a:1026595525977.
This phase II study was initiated to determine the efficacy and safety of gemcitabine plus cisplatin in patients with pancreatic cancer.
Gemcitabine 1000 mg/m2 was given on days 1, 8, and 15 of a 28-day schedule, and cisplatin 50 mg/m2 on days 1 and 15 to chemonaive patients with locally advanced or metastatic pancreatic cancer.
Of the 41 patients enrolled (median age 57, and 61% male), median Karnofsky performance status was 80%. Patients received a median of 4.2 cycles (range 1-11). In 35 evaluable patients, one complete response (CR) and three partial responses (PR) were observed, for an overall response rate of 11% (95% confidence interval (95% CI): 3.2% -26.7%). Stable disease (SD) > 3 months occurred in 20 (57%) patients; 6 survived > or = 1 year. Median time to progressive disease was 4.3 months (95% CI: 3.0-5.7 months). For all patients, median survival was 8.2 months (95% CI: 6.1-10.6 months) with a one-year survival rate of 27%. Therapy was well tolerated. Grade 3-4 neutropenia (no grade 3-4 infection), thrombocytopenia (no bleeding), nausea/vomiting, and alopecia were reported in 29%, 13%, and 2.6% of patients, respectively.
The combination of gemcitabine and cisplatin is a moderately active treatment for patients with locally advanced and metastatic pancreatic cancer without compromising tolerability.
开展这项II期研究以确定吉西他滨联合顺铂治疗胰腺癌患者的疗效和安全性。
对于初治的局部晚期或转移性胰腺癌患者，在28天疗程的第1、8和15天给予吉西他滨1000mg/m²，在第1天和第15天给予顺铂50mg/m²。
入组的41例患者（中位年龄57岁，61%为男性）中，卡氏评分中位数为80%。患者接受的中位疗程数为4.2个周期（范围1 - 11个周期）。在35例可评估患者中，观察到1例完全缓解（CR）和3例部分缓解（PR），总缓解率为11%（95%置信区间（95%CI）：3.2% - 26.7%）。20例（57%）患者疾病稳定（SD）超过3个月；6例存活≥1年。疾病进展的中位时间为4.3个月（95%CI：3.0 - 5.7个月）。所有患者的中位生存期为8.2个月（95%CI：6.1 - 10.6个月），1年生存率为27%。该治疗耐受性良好。分别有29%、13%和2.6%的患者报告出现3 - 4级中性粒细胞减少（无3 - 4级感染）、血小板减少（无出血）、恶心/呕吐和脱发。
吉西他滨和顺铂联合方案是治疗局部晚期和转移性胰腺癌患者的一种中度有效的治疗方法，且不影响耐受性。
