“Sufficient Life Expectancy”: An Amazing Inclusion Criterion in Cancer Phase II-III Trials

TO THE EDITOR: A tremendous change in eligibility criteria has been observed during the past two decades in the majority of clinical trials. The number of eligibility criteria has notably increased and they are more and more factual. They may include the biologic signature of the tumor. For example, some ongoing studies investigating HER or KIT antagonists consider only patients without k-ras or with specific KIT (D816H/V) mutations. In such a context of sophistication of eligibility criteria, the concept of sufficient life expectancy (SLE) appears as an amazing and rather subjective eligibility criterion. With this in mind, we reviewed all the study protocols of phase II or III trials (n 123) carried out in our institution between 1991 and 2008. We assessed how frequently the SLE criterion was requested and which types of studies required it. Eighty-four studies (68%) were phase II trials, and 81 (66%) were industry sponsored. In one study protocol, the SLE criterion coexisted with 51 other eligibility criteria. The primary end points were response rate (86 trials; 70%), survival (19 trials; 16%), and quality-of-life measurements (18 trials; 14%). The most frequent tumors were breast cancers (27 trials; 22%), sarcomas (13 trials; 10%), and colorectal cancers (10 trials; 8%). The SLE criterion was required in 75 of 123 trials (61%). The most frequent SLE cut-offs were 4 and 6 months (24% and 33%, respectively). All these 75 study protocols required both the SLE criteria and a “good performance status.” None of them provided any tool or relevant reference that could enlighten the investigator in properly assessing the SLE. Overall, the SLE criterion was significantly more frequent in industrysponsored studies (odds ratio [OR], 6.1; range, 2.7 to 13.8), in trials