Sample size determination for the weighted log-rank test with the Fleming-Harrington class of weights in cancer vaccine studies

Pharm Stat. Mar-Apr 2014;13(2):128-35. doi: 10.1002/pst.1609. Epub 2014 Feb 5.

Abstract

In recent years, immunological science has evolved, and cancer vaccines are available for treating existing cancers. Because cancer vaccines require time to elicit an immune response, a delayed treatment effect is expected. Accordingly, the use of weighted log-rank tests with the Fleming-Harrington class of weights is proposed for evaluation of survival endpoints. We present a method for calculating the sample size under assumption of a piecewise exponential distribution for the cancer vaccine group and an exponential distribution for the placebo group as the survival model. The impact of delayed effect timing on both the choice of the Fleming-Harrington's weights and the increment in the required number of events is discussed.

Keywords: Fleming-Harrington class of weights; delayed treatment effect; piecewise exponential distribution; sample size; weighted log-rank test.

MeSH terms

  • Cancer Vaccines / therapeutic use*
  • Clinical Trials as Topic*
  • Humans
  • Neoplasms / therapy*
  • Sample Size*

Substances

  • Cancer Vaccines