Survival gains seen with assignment to experimental group in cancer trials

For patients with solid tumors, assignment to an experimental group in trials of investigational drugs yields significant survival gains, according to a review published online April 30 in the Annuals of Internal Medicine.

Renata Iskander, from McGill University in Montreal, and colleagues estimated progression-free survival and overall survival advantage of assignment to experimental groups in randomized trials of investigational drugs for six solid tumors. A total of 128 trials with 141 comparisons of a new drug and comparator were included in the sample, with 47,050 patients.

The researchers found that the pooled hazard ratio was 0.80 for progression-free survival, indicating significant benefit for patients in experimental groups and corresponding to a median progression-free survival advantage of 1.25 months. For overall survival, the pooled hazard ratio was 0.92, corresponding to a 1.18-month increase in survival. The absolute risk for a serious adverse event was 29.56 percent for comparator group patients compared with a 7.40 percent increase in risk for patients in experimental groups.

"Our findings provide a reassuring picture of current practices in drug regulation and research and can also help inform decisions about patient referral to trials, research policy, and consent discussions," the authors write.