Thomas A L, Cox G, Sharma R A, Steward W P, Shields F, Jeyapalan K, Muller S, O'Byrne K J
Department of Oncology, Leicester Royal Infirmary, UK.
Eur J Cancer. 2000 Dec;36(18):2329-34. doi: 10.1016/s0959-8049(00)00341-5.
The aim of this phase I/II dose escalating study was to establish the maximum tolerated dose (MTD) of gemcitabine and paclitaxel given in combination in non-small cell lung cancer (NSCLC). 12 patients with stage IIIB and IV NSCLC received paclitaxel administered intravenously over 1 h followed by gemcitabine given over 30 min on days 1, 8 and 15 every 28 days. Pneumonitis was the principal side-effect observed with 4 patients affected. Of these, 1 experienced grade 3 toxicity after one cycle of treatment and the others had grade 2 toxicity. All 4 cases responded to prednisolone. No other significant toxicities were observed. Of the 8 evaluable patients, 3 had a partial response and 2 had minor responses. The study was discontinued due to this dose-limiting toxicity. The combination of paclitaxel and gemcitabine shows promising antitumour activity in NSCLC, however, this treatment schedule may predispose to pneumonitis.
这项I/II期剂量递增研究的目的是确定吉西他滨与紫杉醇联合用于非小细胞肺癌（NSCLC）时的最大耐受剂量（MTD）。12例IIIB期和IV期NSCLC患者每28天在第1、8和15天接受1小时静脉输注紫杉醇，随后30分钟内输注吉西他滨。肺炎是观察到的主要副作用，有4例患者受影响。其中，1例在一个治疗周期后出现3级毒性，其他患者为2级毒性。所有4例病例对泼尼松龙均有反应。未观察到其他显著毒性。在8例可评估患者中，3例部分缓解，2例轻微缓解。由于这种剂量限制性毒性，该研究提前终止。紫杉醇与吉西他滨联合在NSCLC中显示出有前景的抗肿瘤活性，然而，这种治疗方案可能易引发肺炎。
