Automatic Tool of Response Evaluation in Solid Tumors

Authors:: Poster Author(s)

Ding, Alec, FDA/CDER (Student); Wang, Yaning, FDA/CDR (Mentor)

Center:: Contributing Office

Center for Drug Evaluation and Research

Abstract

Poster Abstract

Introduction

Response evaluation criteria in solid tumors (RECIST) is a set of guidelines used to evaluate the response of anti-cancer drugs. The response is necessary to determine the effectiveness of the tumor treatment. A complete response (CR) is the disappearance of all tumors. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesions, taking the baseline sum LD as reference. A stable disease (SD) is neither sufficient shrinkage nor increase to qualify for either PR or PD. A progressive disease (PD) is at least a 20% increase in the sum of LD of the target lesions, taking as reference the smallest sum of LD recorded since treatment started.

Objective

Generating an in-house R program to apply the guidelines of RECIST 1.1. The program needs to generate consistent and accurate results.

Method

Tumor data containing the sizes and conditions of tumors as well as the sponsor’s assigned response were used for analysis. An R program was coded in-house to analyze tumor response according to RECIST criteria. Analysis results regarding CR, PR, SD, PD were compared with those generated from the sponsor.

Results

We found that the RECIST response categories produced by the in-house R program were approximately 90% accurate to those provided by the independent sponsors. The inconsistency with the sponsor’s defined categories is likely due to the fact that the sponsor used the old guidelines of RECIST 1.0, while the in-house R program used the new guidelines of RECIST 1.1. (Data of CR, PR, SD, PD will be added once I get my FDA laptop.)

Conclusion

The existing in-house R program can be used to generate tumor response categories according to RECIST 1.1. However, modification is required because the 10% inconsistency with the sponsor’s results needs to be addressed before we can use it for decision-making.