American Statistical Association
New York City
Metropolitan Area Chapter

Memorial Sloan Kettering Cancer Center
Department of Epidemiology and Biostatistics
Biostatistics Seminar Series


Xavier Paoletti, Ph.D.
Department of Biostatistics
Curie Institute, Paris, France

DESIGNS AND CHALLENGES FOR PERSONALIZED MEDICINE
STUDIES IN ONCOLOGY: FOCUS ON THE SHIVA TRIAL

Personalized medicine is defined by the National Cancer Institute as "a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, and treat disease." In oncology, the term "personalized medicine" arose with the emergence of molecularly targeted agents. The prescription of approved molecularly targeted agents to cancer patients currently relies on the primary tumor location and histological subtype. Predictive biomarkers of efficacy of these modern agents have been exclusively validated in specific tumor types.

A major concern today is to determine whether the prescription of molecularly targeted therapies based on tumor molecular abnormalities, independently of primary tumor location and histology, would improve the outcome of cancer patients. This new paradigm requires prospective validation before being implemented in clinical practice.

In this communication, we present the SHIVA trial, a randomized proof-of-concept phase II trial comparing therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer. We will emphasize various aspects of implementation, underlying statistical and design questions, limits and strengths and review the results of this trial. In particular, we will focus on an alternative measure of intervention effect, the progression free survival ratio (or tumor modulation index) originally proposed by Von Hoff (1996) and formalized by Mick et al (2001), which appears as a promising mean to use each patient as his (her) own control. After presenting the PFS ratio analysis in the SHIVA trial, we will explore this measure in a simulation study to evaluate the expected distribution under various scenarios and to highlight the interpretation of the previous results.


Date: Wednesday, November 1, 2017
Time: 4:00 - 5:00 P.M.
Location: Memorial Sloan Kettering Cancer Center
Department of Epidemiology and Biostatistics
485 Lexington Avenue
(Between 46th & 47th Streets)
2nd Floor, Conference Room B
New York, New York

**Outside visitors please email celeat@mskcc.org for building access.
You must be on the security list to enter the floor.

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