Targeted therapies: What have we learned from SHIVA?

The SHIVA trial compared the efficacy of targeted agents selected on the basis of tumour molecular profiling (using an algorithmic approach) with that of physician's choice across multiple solid tumours; the trial was negative for the primary end point. We now discuss the challenges associated with precision medicine trial design and propose solutions learned from this trial.

[1]  R. Yelensky,et al.  Cancer Therapy Directed by Comprehensive Genomic Profiling: A Single Center Study. , 2016, Cancer research.

[2]  Chris Sander,et al.  Emerging landscape of oncogenic signatures across human cancers , 2013, Nature Genetics.

[3]  R. Schilsky,et al.  Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-analysis of Clinical Trials Leading to FDA Approval. , 2015, Journal of the National Cancer Institute.

[4]  Nicolas Servant,et al.  Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial. , 2015, The Lancet. Oncology.

[5]  Michael Bittner,et al.  Pilot study using molecular profiling of patients' tumors to find potential targets and select treatments for their refractory cancers. , 2010, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[6]  S. Lippman,et al.  Precision Oncology: The UC San Diego Moores Cancer Center PREDICT Experience , 2016, Molecular Cancer Therapeutics.

[7]  Roman Rouzier,et al.  Treatment Algorithms Based on Tumor Molecular Profiling: The Essence of Precision Medicine Trials , 2015, Journal of the National Cancer Institute.

[8]  Razelle Kurzrock,et al.  Assessing PIK3CA and PTEN in early-phase trials with PI3K/AKT/mTOR inhibitors. , 2014, Cell reports.

[9]  V. Servois,et al.  The spectrum of clinical trials aiming at personalizing medicine. , 2014, Chinese clinical oncology.

[10]  C. Cui,et al.  Chemotherapy, biochemotherapy and anti-VEGF therapy in metastatic mucosal melanoma. , 2014, Chinese clinical oncology.