Sledge G W
Indiana University School of Medicine, Indianapolis 46202, USA.
Semin Oncol. 1996 Oct;23(5 Suppl 11):57-9.
The recognition of the activity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) in metastatic breast cancer led to attempts to combine this drug with other active agents. Two agents that have received particular attention are doxorubicin and cisplatin. Initial pilot and phase I trials by the Eastern Cooperative Oncology Group (ECOG) led to the development of a three-arm, prospective randomized trial comparing single-agent doxorubicin, single-agent paclitaxel, and the combination of doxorubicin and paclitaxel (E 1193). This trial is currently closed to accrual and the initial results are being analyzed. Based on data from Gianni et al (J Clin Oncol 13:2688-2699, 1995), the ECOG is currently involved in two trials attempting both to confirm the superior activity of the regimen used by Gianni et al and, in a phase I/II trial, to ameliorate its cardiac toxicity through the addition of dexrazoxane. Similarly, both the ECOG and the Hoosier Oncology Group were unable to confirm the strikingly positive results obtained by the Vancouver group when cisplatin was combined with paclitaxel (Semin Oncol 22:108-111, 1995 [suppl 6]: Proc Am Soc Clin Oncol 13:71, 1994 [abstr 88]). Indiana University investigators are currently involved in a phase I trial attempting to combine carboplatin and paclitaxel in a biweekly schedule.
对紫杉醇（泰素；百时美施贵宝公司，新泽西州普林斯顿）治疗转移性乳腺癌活性的认识促使人们尝试将这种药物与其他活性药物联合使用。受到特别关注的两种药物是阿霉素和顺铂。东部肿瘤协作组（ECOG）最初的试点和I期试验促成了一项三臂前瞻性随机试验的开展，该试验比较了单药阿霉素、单药紫杉醇以及阿霉素与紫杉醇的联合用药（E1193）。这项试验目前已停止入组，初步结果正在分析中。基于詹尼等人的数据（《临床肿瘤学杂志》13:2688 - 2699, 1995），ECOG目前正在参与两项试验，一是试图确认詹尼等人所用方案的 superior 活性，二是在一项I/II期试验中，通过添加右丙亚胺来改善其心脏毒性。同样，ECOG和印第安纳肿瘤协作组都无法证实温哥华组在顺铂与紫杉醇联合使用时所获得的显著阳性结果（《肿瘤学综述》22:108 - 111, 1995 [增刊6]；《美国临床肿瘤学会会议论文集》13:71, 1994 [摘要88]）。印第安纳大学的研究人员目前正在参与一项I期试验，试图每两周一次将卡铂和紫杉醇联合使用。
