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Updated: Feb 14, 2026

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Revisited analysis of a SHIVA01 trial cohort using functional mutational analyses successfully predicted treatment

Maud Kamal1, Gabi Tarcic2, Sylvain Dureau3

  • 1Department of Drug Development and Innovation, Institut Curie, Paris & Saint-Cloud, France.

Molecular Oncology
|February 22, 2018
PubMed

Insights

Functional interpretation of molecular profiles using FACT accurately predicts patient response to molecularly targeted agents (MTAs) in oncology. This approach improves progression-free survival (PFS) in cancer patients receiving MTAs.

Area of Science:

  • Oncology
  • Genomics
  • Molecular Biology

Background:

  • Molecular profiling guides cancer therapy, but classifying variants of unknown significance (VUS) remains challenging.
  • Implementing treatment decisions based on VUS is difficult, impacting patient outcomes.

Purpose of the Study:

  • To assess the oncogenic activity of VUS and mutations in patients treated with molecularly targeted agents (MTAs).
  • To evaluate the predictive accuracy of the Functional Annotation for Cancer Treatment (FACT) tool for MTA response.

Main Methods:

  • Assessed oncogenic activity of VUS and mutations using FACT in 12 patients from the SHIVA01 trial.
  • Performed in vitro MTA response prediction blinded to clinical trial outcomes.
  • Correlated FACT-based survival predictions with actual progression-free survival (PFS).

Main Results:

  • Patients with positive FACT predictions showed a significantly longer median PFS (5.8 months) compared to those with negative predictions (1.7 months).
  • The P-value was less than 0.05, indicating statistical significance.

Conclusions:

  • Functional interpretation of molecular profiles using FACT is crucial for predicting MTA response in oncology.
  • This approach can aid in optimizing cancer treatment strategies and improving patient outcomes.
Keywords:
drug responsein vitro functional assaymutationoncogenic activityvariant with unknown significance

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