Universidad Autónoma Metropolitana, Unidad Iztapalapa.
Int J Technol Assess Health Care. 2011 Jul;27(3):207-14. doi: 10.1017/S0266462311000201.
In clinical trials of new cancer drugs, reliable data for progression-free survival will often become available far sooner than reliable data for overall survival. The aim of this study was to determine how many months it would be expected that any given new drug for metastatic breast or colorectal cancer will add to overall survival times given that the number of months the drug adds to progression-free survival times relative to a standard drug is roughly already known.
A literature search was conducted over Medline for randomized controlled trials (RCTs) published between January 1980 and August 2008 that assessed the effect of a drug treatment in comparison to an alternative drug treatment on patients with either metastatic breast or metastatic colorectal cancer.
The literature search found 95 and 74 RCTs for metastatic breast and colorectal cancer, respectively, that satisfied the study's inclusion criteria. The results from these trials are consistent, in the case of each of these two metastatic cancers, with gains in time to disease progression being generally associated with no gains or with very slight gains or losses in post-progression survival (i.e., the time between disease progression and death).
It would appear that drugs for metastatic breast or colorectal cancer that extend, by a given amount, the time period between the start of treatment and disease progression (i.e., time to progression) have a strong tendency to extend, by roughly the same amount, the period between the start of treatment and death (i.e., overall survival).
在癌症新药临床试验中,无进展生存期的可靠数据通常会比总生存期的可靠数据更早获得。本研究旨在确定在已知某种新药相对于标准药物可使无进展生存期延长的月数的情况下,转移性乳腺癌或结直肠癌的新药预计会增加多少总生存期。
在 Medline 上进行了文献检索,检索了 1980 年 1 月至 2008 年 8 月期间发表的评估药物治疗对转移性乳腺癌或转移性结直肠癌患者疗效的随机对照试验(RCT)。
文献检索分别找到了 95 项和 74 项满足研究纳入标准的转移性乳腺癌和结直肠癌 RCT。这些试验的结果一致,在这两种转移性癌症中,疾病进展时间的延长通常与无进展生存期的增加或略有增加或减少相关(即疾病进展和死亡之间的时间)。
似乎对于转移性乳腺癌或结直肠癌的药物,在治疗开始和疾病进展(即无进展生存期)之间延长一定时间的药物有很强的倾向,即在治疗开始和死亡(即总生存期)之间延长大致相同的时间。