Abratt R P, Bezwoda W R, Goedhals L, Hacking D J
University of Cape Town, South Africa.
J Clin Oncol. 1997 Feb;15(2):744-9. doi: 10.1200/JCO.1997.15.2.744.
The aim of this study was to examine the efficacy of a regimen of initial gemcitabine followed by cisplatin in patients with advanced non-small-cell lung cancer (NSCLC).
Fifty-three patients (36 men and 17 women; age range, 35 to 74 years) were enrolled. Patients had bidimensionally measurable disease. Gemcitabine (phase-specific agent) was administered on days 1, 8, and 15 at a dose of 1,000 mg/m2. Cisplatin (cycle-specific agent) was administered on day 15 (100 mg/m2). Chemotherapy was administered in 28-day cycles.
Of 53 patients enrolled, 50 were assessable for response. The overall response rate was 52%. There were two complete responses (4%) and 24 partial responses (48%). The median survival duration was 13 months and the 1-year survival rate was 61%. The regimen was generally well tolerated. World Health Organization (WHO) grade 3 and 4 neutropenia occurred in 38.8% and 19.2% of patients, respectively. Grade 3 and 4 thrombocytopenia occurred in 13.3% and 7.7% of patients, respectively. Most patients experienced mild nausea and vomiting. Few patients had hair loss and oral toxicity was mild. Relatively few patients required dose modifications for any of the three weekly doses of chemotherapy. For the first two cycles of chemotherapy, the dose-intensity per infusion was 947 mg/m2 for gemcitabine and 85 mg/m2 for cisplatin.
This regimen of gemcitabine and cisplatin was effective, with high response and survival rates and few dosage modifications during its administration. Prospective randomized studies with other cisplatin-based combination chemotherapy regimens are indicated.
本研究旨在探讨吉西他滨初始治疗后序贯顺铂方案对晚期非小细胞肺癌（NSCLC）患者的疗效。
纳入53例患者（36例男性和17例女性；年龄范围35至74岁）。患者具有可双向测量的疾病。吉西他滨（时相特异性药物）于第1、8和15天给药，剂量为1000mg/m²。顺铂（周期特异性药物）于第15天给药（100mg/m²）。化疗以28天为周期进行。
53例纳入患者中，50例可评估疗效。总缓解率为52%。有2例完全缓解（4%）和24例部分缓解（48%）。中位生存时间为13个月，1年生存率为61%。该方案总体耐受性良好。世界卫生组织（WHO）3级和4级中性粒细胞减少分别发生在38.8%和19.2%的患者中。3级和4级血小板减少分别发生在13.3%和7.7%的患者中。大多数患者经历轻度恶心和呕吐。少数患者有脱发，口腔毒性较轻。相对较少的患者需要对三周化疗的任何一剂进行剂量调整。在前两个化疗周期中，吉西他滨每次输注的剂量强度为947mg/m²，顺铂为85mg/m²。
吉西他滨和顺铂方案有效，缓解率和生存率高，给药期间剂量调整少。有必要开展与其他基于顺铂的联合化疗方案的前瞻性随机研究。
