Muggia F M, Vafai D, Natale R, Israel V, Zaretsky S, McRae A, Rogers M, Jeffers S
University of Southern California-Norris Cancer Center, Los Angeles 90033, USA.
Semin Oncol. 1995 Aug;22(4 Suppl 9):63-6.
Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) by 3-hour infusion was combined with carboplatin in a phase I/II study directed to patients with non-small cell lung cancer. Carboplatin was given at a fixed target area under the concentration-time curve of 6.0 by the Calvert formula, whereas paclitaxel was escalated in patient cohorts from 150 mg/m2 (dose level I) to 175, 200, 225, and 250 mg/m2. The 225 mg/m2 level was expanded for the phase II study since the highest level achieved (250 mg/m2) required modification because of nonhematologic toxicities (arthralgia and sensory neuropathy). Therapeutic effects were noted at all dose levels, with objective responses in 17 (two complete and 15 partial regressions) of 41 previously untreated patients. Toxicities were compared with a cohort of patients in a phase I trial of paclitaxel alone at identical dose levels. Carboplatin did not appear to add to the hematologic toxicities observed, and the paclitaxel/carboplatin combination could be dosed every 3 weeks.
在一项针对非小细胞肺癌患者的I/II期研究中，将3小时静脉输注的紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）与卡铂联合使用。卡铂按照卡尔弗特公式给予固定的目标浓度时间曲线下面积6.0，而紫杉醇在不同患者队列中从150mg/m²（剂量水平I）逐步增加到175、200、225和250mg/m²。由于非血液学毒性（关节痛和感觉神经病变），最高达到的剂量水平（250mg/m²）需要调整，因此在II期研究中扩大了225mg/m²剂量水平的研究。在所有剂量水平均观察到治疗效果，41例既往未接受过治疗的患者中有17例出现客观缓解（2例完全缓解和15例部分缓解）。将毒性与一组接受相同剂量水平单药紫杉醇I期试验的患者进行比较。卡铂似乎并未增加所观察到的血液学毒性，紫杉醇/卡铂联合方案每3周给药一次。
