Measuring response in solid tumors: comparison of RECIST and WHO response criteria.
BACKGROUND
Objective tumor response is a common endpoint in daily practice as well as in clinical trials to evaluate the efficacy of anti-cancer agents. Traditionally, the standard World Health Organization (WHO) criteria has been adopted in these contexts. However, the recent development of new classes of anti-cancer agents and progress in imaging technology have required new methodology to evaluate response to treatment. Recently, the Response Evaluation Criteria in Solid Tumors Group (RECIST) proposed new guidelines using unidimensional measurement. Theoretically, the simple sum of the maximum diameters of individual tumors is more linearly related to cell kill than is the sum of the bidimensional products. To validate these new guidelines, we have compared the standard WHO response criteria with the new RECIST guidelines in the same patient population.


METHODS
Data from 79 patients enrolled in eight prospective phase II studies at Samsung Medical Center were retrospectively re-analyzed to determine the concordance between the two response criteria. The two response criteria were applied separately, and the results were compared using the kappa statistic to test concordance for overall response rate.


RESULTS
The overall response rate according to the WHO criteria was 31.6%. Using the RECIST criteria, nine patients were reclassified and the overall response rate was 30.4%. There was excellent agreement between the unidimensional and bidimensional criteria in 23 of 25 responses (92%). The kappa statistic for concordance for overall response was 0.91.


CONCLUSIONS
We conclude that the new RECIST guidelines are comparable to the old response criteria in evaluating response in solid tumors. Moreover, the new guidelines are just as simple and reproducible in the measurement of response in daily practice as they are in clinical trials.
Park
Joon Oh
JO
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Lee
Soon Il
SI
Song
Seo Young
SY
Kim
Kihyun
K
Kim
Won Seog
WS
Jung
Chul Won
CW
Park
Young Suk
YS
Im
Young-Hyuk
YH
Kang
Won Ki
WK
Lee
Mark Hong
MH
Lee
Kyung Soo
KS
Park
Keunchil
K
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy; D017322:Clinical Trials, Phase II as Topic / Q000592:standards*; D005069:Evaluation Studies as Topic; D017408:Guidelines as Topic; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy; D008175:Lung Neoplasms / Q000188:drug therapy; D009369:Neoplasms / Q000188:drug therapy*; D012189:Retrospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy; D014944:World Health Organization
D000970:Antineoplastic Agents