Greco F Anthony, Thompson Dana S, Morrissey Lisa H, Erland Joan B, Burris Howard A, Spigel David R, Joseph Geetha, Corso Steven W, Spremulli Ellen, Hainsworth John D
Sarah Cannon Research Institute, Nashville, Tennessee 37203, USA.
Oncologist. 2005 Oct;10(9):728-33. doi: 10.1634/theoncologist.10-9-728.
To compare the combination of paclitaxel (Taxol; Bristol-Myers Squibb, Princeton, NJ, http://www.bms.com) and topotecan (Hycamtin; Glaxo SmithKline, Philadelphia, http://www.gsk.com) with paclitaxel, carboplatin (Paraplatin; Bristol-Myers Squibb), and etoposide (Etopophos, VePesid; Bristol-Myers Squibb) in patients with previously untreated extensive-stage small cell lung cancer.
In this phase II trial, 120 patients were randomly allocated to receive either topotecan (1.5 mg/m(2) i.v. days 1, 2, and 3) and paclitaxel (175 mg/m(2) i.v. day 1) every 21 days orpaclitaxe l (200 mg/m(2) i.v. day 1), carboplatin (area under the concentration-time curve 6 i.v. day 1), and etoposide (50 mg/100 mg alternating daily by mouth days 1-10) every 21 days, each regimen for a maximum of eight cycles. The primary end points were objective response rate and time to progression.
The paclitaxel-carboplatin-etoposide combination produced a significantly higher overall response rate (78% versus 48%), longer median time to progression (7.6 months versus 5.5 months), and greater number of patients free from progression at 1 year (14% versus 8%) compared with paclitaxel plus topotecan. There was no difference in overall survival. Toxicities were similar in the two treatment arms.
The paclitaxel-carboplatin-etoposide combination produced a superior overall response rate and time to progression in patients with extensive-stage small cell lung cancer compared with paclitaxel plus topotecan. The platinum compounds continue to be a necessary component of the initial therapy for these patients.
比较紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿，http://www.bms.com）与拓扑替康（和美新；葛兰素史克公司，费城，http://www.gsk.com）联合用药方案和紫杉醇、卡铂（波铂；百时美施贵宝公司）及依托泊苷（磷依托泊苷、威克；百时美施贵宝公司）联合用药方案，用于治疗既往未接受过治疗的广泛期小细胞肺癌患者。
在这项II期试验中，120例患者被随机分配，每21天接受拓扑替康（1.5 mg/m²静脉注射，第1、2和3天）和紫杉醇（175 mg/m²静脉注射，第1天）联合治疗，或每21天接受紫杉醇（200 mg/m²静脉注射，第1天）、卡铂（浓度-时间曲线下面积为6，静脉注射，第1天）及依托泊苷（50 mg/100 mg交替口服，第1 - 10天）联合治疗，每种方案最多进行8个周期。主要终点为客观缓解率和疾病进展时间。
与紫杉醇加拓扑替康相比，紫杉醇 - 卡铂 - 依托泊苷联合方案产生了显著更高的总缓解率（78%对48%）、更长的中位疾病进展时间（7.6个月对5.5个月），且1年时无疾病进展的患者数量更多（14%对8%）。总生存期无差异。两个治疗组的毒性相似。
与紫杉醇加拓扑替康相比，紫杉醇 - 卡铂 - 依托泊苷联合方案在广泛期小细胞肺癌患者中产生了更高的总缓解率和更长的疾病进展时间。铂类化合物仍然是这些患者初始治疗的必要组成部分。
