Shiva: Randomized Phase Ii Trial Comparing Molecularly Targeted Therapy Based On Tumor Molecular Profiling Versus Conventional Therapy In Patients With Refractory Cancer-Pfs Ratio From Patients Who Crossed-Over.

2535Background: Several studies used the ratio of progression-free survival (PFS) on genotype-matched treatment to PFS on genotype-unmatched treatment to assess the efficacy of therapy guided by patients’ tumor molecular profiling [von Hoff et al., JCO 2010; Tsimberidou et al., CCR 2012]. We evaluated the PFS ratio from patients included in the SHIVA trial who crossed-over [Le Tourneau et al., Lancet Oncol 2015] (NCT01771458). Methods: The primary endpoint of the SHIVA trial was to compare PFS on molecularly targeted agents (MTAs) based on tumor molecular profiling and treatment at physician’s choice (TPC) in patients with any kind of cancer who had failed standard-of-care therapy. Experimental treatment included only marketed MTAs given outside their indications according to a pre-specified treatment algorithm. Patients were allowed to cross-over at disease progression. Response was evaluated according to RECIST 1.1 at randomization and at cross-over. We evaluated the proportion of patients with a PFS ra...