Suciu S, Sylvester R, Iversen P, Christensen I, Denis L
EORTC Data Center, Brussels, Belgium.
Cancer. 1990 Sep 1;66(5 Suppl):1029-34. doi: 10.1002/cncr.1990.66.s5.1029.
Very often not enough patients are entered and/or the follow-up is insufficient to be able to draw valid conclusions in cancer clinical trials. In this article, we discuss the possibility of pooling the data from two or more trials asking the same or similar questions in order to overcome such problems. How comparable the studies should be for combining their data, in terms of design, patient population, follow-up, and end-points, is discussed in the first part of this paper. Whether these general considerations were completely or partially fulfilled in the two prostatic studies of the EORTC and DAPROCA is the subject of the second part of this article. Problems of interpreting apparently contradictory results, like the superiority of zoladex and flutamide over orchidectomy in terms of time to progression with no clear superiority in terms of overall duration of survival, is also discussed.
在癌症临床试验中,常常出现入组患者数量不足和/或随访不充分的情况,以至于无法得出有效的结论。在本文中,我们探讨了合并来自两个或更多针对相同或相似问题的试验数据以克服此类问题的可能性。本文第一部分讨论了就设计、患者群体、随访和终点而言,各项研究在合并数据时应具有多大的可比性。本文第二部分的主题是欧洲癌症研究与治疗组织(EORTC)和前列腺癌研究协作组(DAPROCA)的两项前列腺研究是否完全或部分满足了这些一般考量。文中还讨论了解读明显相互矛盾的结果所面临的问题,比如就进展时间而言,戈舍瑞林和氟他胺优于睾丸切除术,但就总生存期而言却没有明显优势。