Gatzemeier U, Shepherd F A, Le Chevalier T, Weynants P, Cottier B, Groen H J, Rosso R, Mattson K, Cortes-Funes H, Tonato M, Burkes R L, Gottfried M, Voi M
Krankenhaus Grosshansdorf, Germany.
Eur J Cancer. 1996 Feb;32A(2):243-8. doi: 10.1016/0959-8049(95)00444-0.
Gemcitabine is a novel nucleoside analogue with activity in solid tumours. This study assessed the objective response rate to gemcitabine given weekly intravenously at a dose of 1250 mg/m2 for 3 weeks followed by 1 week of rest (one cycle) in chemonaive patients with inoperable non-small cell lung cancer (NSCLC). 161 patients with NSCLC were recruited from 10 sites in nine countries. Most patients had stage IIIb (31.3%) or IV (64.6%) disease, and 93.8% had a performance status of 0 or 1 according to the WHO scale. Of 151 evaluable patients, there were 3 complete responses and 30 partial responses lasting at least 4 weeks for an objective response rate of 21.8% (95% CI 15.5-29.3%). All responses were validated by an extramural Oncology Review Board. The mean duration of response was 8.8 months. The mean survival for all patients (16.1% of patients still alive 26 months after last patient started treatment) was 11.5 months. Improvements were also observed in secondary efficacy parameters such as performance status, weight, analgesic requirement, pain, and other disease-related symptoms including cough, dyspnoea, haemoptysis, anorexia, somnolence and hoarseness. Haematological and non-haematological toxicity was mild given the biological activity of gemcitabine. This study confirms gemcitabine as one of the most active agents in NSCLC with the added benefit of a modest toxicity profile and ease of administration on an out-patient basis. Gemcitabine is a suitable candidate for combination chemotherapy in patients with NSCLC.
吉西他滨是一种新型核苷类似物，对实体瘤具有活性。本研究评估了初治的不可切除非小细胞肺癌（NSCLC）患者静脉注射吉西他滨的客观缓解率，剂量为1250mg/m²，每周1次，共3周，随后休息1周（1个周期）。161例NSCLC患者来自9个国家的10个地点。大多数患者为Ⅲb期（31.3%）或Ⅳ期（64.6%）疾病，93.8%的患者根据WHO标准的体能状态为0或1。在151例可评估患者中，有3例完全缓解和30例部分缓解持续至少4周，客观缓解率为21.8%（95%CI 15.5-29.3%）。所有缓解均经外部肿瘤学审查委员会验证。缓解的平均持续时间为8.8个月。所有患者的平均生存期为11.5个月（16.1%的患者在最后1例患者开始治疗后26个月仍存活）。在次要疗效参数如体能状态、体重、镇痛需求、疼痛以及其他与疾病相关的症状包括咳嗽、呼吸困难、咯血、厌食、嗜睡和声音嘶哑等方面也观察到改善。鉴于吉西他滨的生物学活性，血液学和非血液学毒性较轻。本研究证实吉西他滨是NSCLC中最具活性的药物之一，具有毒性较轻和门诊给药方便的额外益处。吉西他滨是NSCLC患者联合化疗的合适候选药物。
