SINGLE-AGENT ACTIVITY OF WEEKLY GEMCITABINE IN ADVANCED NON-SMALL-CELL LUNG-CANCER - A PHASE-II STUDY
SINGLE-AGENT ACTIVITY OF WEEKLY GEMCITABINE IN ADVANCED NON-SMALL-CELL LUNG-CANCER - A PHASE-II STUDY
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DOI：
10.1200/jco.1994.12.9.1821
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发表时间：
1994-09-01
影响因子：
45.3
通讯作者：
HANSEN, HH
中科院分区：
文献类型：
--
作者：
ANDERSON, H;LUND, B;HANSEN, HH
目的：为了评估吉西他滨的疗效和安全性，嘧啶抗代谢活性对solid tumors.Patients和方法：82例患者与不可切除的状态IIIa至IV非小细胞肺癌（NSCLC）进入。前54例患者接受吉西他滨800 mg/m2，随后患者接受1，000 mg/m2，在第0、7和14天静脉输注30分钟。每28天重复治疗一次。结果：79例可评价疗效的患者中有16例（20%; 95%可信区间[CI]，12%~ 31%）有独立验证的部分缓解，中位持续时间为7个月。总的中位生存期为7个月。吉西他滨改善了疾病相关症状（70%的患者），并提高了WHO体能状态（44%）。毒性一般为轻度和可逆的。患者几乎没有发生WHO 3级和4级毒性反应，4例（5%）患者发生贫血，1例（1%）患者发生血小板减少，6例（7%）患者发生白细胞减少，18例（22%）患者发生中性粒细胞减少。在研究期间，9名患者（12%）发生了感染（4名为血小板减少症），但没有发生WHO 3级或4级感染。10例患者（12%）发生WHO 3级和4级生化毒性，转氨酶一过性升高。2例患者的血清肌酐水平评价为一过性WHO 3级，2例在吉西他滨末次给药后4周和6周发生急性肾衰竭。没有WHO 4级症状性毒性。31名患者（38%）发生WHO 3级呕吐，1名患者（1%）发生3级脱发。36例患者（44%）的流感样症状与吉西他滨给药相关。26例（32%）患者出现发热（1%WHO3级），33例（40%）出现踝关节水肿（不伴心力衰竭），31例（38%）出现嗜睡，11例（13%）出现呼吸困难。该方案与轻微脱发或骨髓抑制相关。吉西他滨需要在其他恶性肿瘤中以及与其他药物联合治疗中进行进一步研究。(C)1994年美国临床肿瘤学会。
Purpose: To evaluate the efficacy and safety of gemcitabine, a pyrimidine antimetabolite with activity against solid tumours.Patients and Methods: Eighty-two patients with unresectable state IIIa to IV non-small-cell lung cancer (NSCLC) were entered. The first 54 patients received gemcitabine 800 mg/m(2), and subsequent patients 1,000 mg/m(2), as a 30-minute intravenous infusion on days 0, 7, and 14. Courses of therapy were repeated every 28 days. Twenty percent dosage escalation was permitted after course no. 1 if World Health Organization (WHO) toxicity was less than or equal to 1.Results: Sixteen (20%; 95% confidence interval [CI], 12% to 31%) of 79 patients assessable for response had independently validated partial responses, with a median duration of 7 months. The overall median survival duration was 7 months. Gemcitabine improved disease-related symptoms (70% patients) and increased WHO performance status (44%). Toxicity was generally mild and reversible. Patients experienced little WHO grade 3 and 4 toxicity, with anemia in four (5%), thrombocytopenia in one (1%), leukopenia in six (7%), and neutropenia in 18 (22%). Infection occurred in nine patients (12%) during the study (four were neutropenic), but there were no episodes of WHO grade 3 or 4 infection. WHO grade 3 and 4 biochemical toxicity occurred with transient elevations of transaminases in 10 patients (12%). Two patients had transient WHO grade 3 evaluation of serum creatinine levels, and two developed acute renal failure 4 and 6 weeks after the last dose of gemcitabine. There was no WHO grade 4 symptomatic toxicity. WHO grade 3 vomiting occurred in 31 patients (38%) and grade 3 alopecia in one (1%). Flu-like symptoms were associated with gemcitabine administration in 36 patients (44%). Twenty-six patients (32%) experienced fever (1% WHO grade 3), 33 (40%) ankle edema not associated with cardiac failure, 31 (38%) lethargy, and 11 (13%) dyspnea.Conclusion: Gemcitabine is an active new agent in the treatment of NSCLC. This schedule was associated with little alopecia or myelosuppression. Gemcitabine warrants further investigation in other malignancies and in combination with other agents. (C) 1994 American Society of Clinical Oncology.