What is RECIST?
RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatments. The criteria were published in February, 2000 by an international collaboration including the European Organization for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI) of the United States, and the National Cancer Institute of Canada Clinical Trials Group. Today, the majority of clinical trials evaluating cancer treatments for objective response in solid tumors are using RECIST.

What are the challenges in using RECIST in cancer trials?
Cancer trials today are increasingly complex, involving dozens or even hundreds of investigators from centers around the world. While the RECIST rules are highly dependent upon measurement of tumor size, different clinicians may vary greatly in their methods for performing these measurements. Certain situations may make consistently following the rules even more challenging, such as when two tumors start to merge into one. When many investigators vary in how they follow RECIST as a trial endpoint, the study results may be placed in jeopardy by significant levels of variability.

How can Perceptive help improve cancer trials?
Perceptive Informatics offers two solutions for improving cancer trial endpoints:

- RECIST Kiosk
The RECIST Kiosk is a computer-based training center designed to improve how investigators apply RECIST in cancer trials. Investigators can review a brief on-line tutorial, and may then apply RECIST to specific case studies with on-screen images. The RECIST Kiosk is supported by on-site Perceptive Radiologists with expertise in standardizing cancer trial endpoints, and may be customized for specific protocols and featured at trial investigator meetings. The RECIST Kiosk is being featured at the 2003 annual meeting of the American Society of Clinical Oncology (ASCO), and is available only from Perceptive Informatics.

- Independent Endpoint Review
Even with good investigator training, variability in assessments of tumor response by different investigators may limit the ability of data to support decision-making (such as continuing or terminating a study) or regulatory submissions (such as seeking a new drug approval). Perceptive offers independent endpoint review services, including the central collection of all patient images (CT, MRI, etc), quality control of study images, development of a central digital warehouse of all images, and an independent review by blinded Radiologists and Oncologists. At the conclusion of the study, the digital images, measurements, and data may be compiled to support an electronic submission to regulatory authorities. Perceptive is a recognized leader in developing charters and executing a standardized endpoint review for cancer trials.

For more information on how Perceptive can help improve your next cancer trial, please contact:

t: +1.914.366.7445
e: info@perceptive.com

Perceptive Informatics is a leading provider of technology-based products and services for the pharmaceutical and biotechnology industries. To learn more about Perceptive Informatics, please visit www.perceptive.com.

For a copy of the RECIST article or to view up-to-date frequently asked questions, please visit www.eortc.be/recist.

1 In accordance with the 1992 FDA Modernization Act, tumor response has been identified as a surrogate endpoint reasonable likely to predict clinical benefit to support accelerated oncology drug approvals. Most recent accelerated cancer drug approvals have been based on objective tumor response, including Velcade for multiple myeloma (Millennium Pharmaceuticals, 5/13/03), Iressa for non-small cell lung cancer (AstraZeneca, 5/5/03), and Gleevec for chronic myeloid leukemia (Novartis, 12/2/02). RECIST is the most widely used response criteria for evaluating objective response in solid tumors.

2 Perceptive Informatics' customers include 14 of the 15 top pharmaceutical companies in the world.