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Thoracic Imaging 2003 - Society of Thoracic Radiology

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Reporting Tumor Measurements in Oncologic <strong>Imaging</strong><br />

Todd R. Hazelton, M.D.<br />

Assistant Pr<strong>of</strong>essor <strong>of</strong> <strong>Radiology</strong> and Oncology<br />

H. Lee M<strong>of</strong>fitt Cancer Center and Research Institute<br />

At the University <strong>of</strong> South Florida<br />

Objective: To review the role <strong>of</strong> the radiologist in reporting<br />

tumor measurements in thoracic oncology with emphasis on<br />

newer RECIST criteria and older WHO criteria.<br />

In addition to clinical, biochemical, surgical, and pathologic<br />

data, evaluation <strong>of</strong> tumor response by quantitative measurements<br />

on cross-sectional imaging provides objective information<br />

regarding chemotherapy efficacy that is used both clinically and<br />

in the development <strong>of</strong> new anticancer drugs. For these reasons,<br />

radiologists should be familiar with the standards for reporting<br />

tumor measurements that have been established and are widely<br />

used in oncology for clinical trials.<br />

WHO Criteria for Reporting Tumor Response:<br />

The older World Health Organization (WHO) tumor<br />

response assessment criteria were established to standardize the<br />

recording and reporting <strong>of</strong> tumor response outcomes. 1 This<br />

system utilizes bidimensional measurements as a quantitative<br />

component in the assessment <strong>of</strong> tumor response to chemotherapy<br />

drugs. Measurements are reported in centimeters (cm) as the<br />

maximum diameter and the greatest perpendicular diameter (at a<br />

right angle) in the same plane for primary and metastatic lesions<br />

whose margins are clearly defined on CT, MRI, or other imaging<br />

study. With this technique, typically up to three lesions per<br />

organ, whose diameters are greater than the image thickness, are<br />

selected as “measurable” and bidimensional measurement values<br />

are then reported. The same acquisition technique must be<br />

utilized for follow-up studies to ensure comparability <strong>of</strong> subsequent<br />

measurements. Nonmeasurable disease sites are primary<br />

or metastatic lesions which cannot be accurately measured in<br />

two dimensions as they are either measurable in only one<br />

dimension (unidimensional) or are unmeasurable.<br />

In the WHO criteria, the percentage <strong>of</strong> the decreased or<br />

increased tumor measurements is used to determine whether<br />

there is response or progression <strong>of</strong> disease, respectively.<br />

Progression <strong>of</strong> disease (PD) occurs if the surface area approximation<br />

(product <strong>of</strong> the longest diameter by greatest perpendicular<br />

diameter) for one or more measurable lesions increases by<br />

25% or if one or more new lesions appear. A complete<br />

response (CR) is when all lesions disappear and are absent on<br />

two different observations that are no less than four weeks apart.<br />

A partial response (PR) is noted when the measurable lesions<br />

persist, but have decreased in size by 50% or more as measured<br />

on two different observations not less than four weeks apart.<br />

When measurable disease has not increased more than 25% in<br />

size nor decreased greater than 50% in size, the classification <strong>of</strong><br />

“no change (NC)” is given. Both measurable disease and<br />

unmeasurable disease are used in the evaluation <strong>of</strong> the patient,<br />

with assessment <strong>of</strong> response involving all parameters. In measurable<br />

disease, the poorest response designation prevails in the<br />

final response classification. 1, 2<br />

RECIST Criteria for Reporting Tumor Response:<br />

In contrast to the standard bidimensional WHO criteria for<br />

the radiologic assessment <strong>of</strong> response <strong>of</strong> solid tumors, which<br />

were developed prior to helical CT and other digital imaging<br />

techniques, new guidelines which utilize unidimensional measurements<br />

and modern imaging techniques have been widely<br />

adopted for clinical research protocols. A special report published<br />

in 2000 outlined the new “Response Evaluation Criteria<br />

in Solid Tumors (RECIST). 3 The primary changes with the<br />

newer criteria relate to the adoption <strong>of</strong> unidimensional tumor<br />

size measurement, better defining the cut-<strong>of</strong>f point for progressive<br />

disease, and specifying clear-cut guidelines about minimum<br />

lesion size and the number <strong>of</strong> lesions to evaluate when multiple<br />

ones are present.<br />

With the RECIST criteria, only patients with measurable disease<br />

at baseline are included in protocols where objective tumor<br />

response is the primary end point. Measurable disease means<br />

the presence <strong>of</strong> at least one measurable, histologically confirmed<br />

lesion that can be accurately measured in at least one<br />

dimension <strong>of</strong> 2 cm or greater for conventional radiographic, CT,<br />

and MRI techniques and 1 cm or greater with helical CT techniques.<br />

Lesions smaller than these values, as well as bone<br />

lesions, leptomeningeal disease, ascites, pleural effusion, pericardial<br />

effusion, lymphangitic carcinomatosis, cystic lesions,<br />

and abdominal masses that are not confirmed and followed by<br />

imaging techniques are considered non-measurable lesions. The<br />

recommendations favor the use <strong>of</strong> MRI and helical CT given<br />

their reproducibility and ability to consistently display measurable<br />

target lesions. Lesions on chest radiography may be used as<br />

measurable disease if they are clearly defined and surrounded<br />

by aerated lung. Ultrasound (US) should not be used to measure<br />

target lesions for objective tumor response.<br />

With the RECIST criteria, it is important for the radiologist<br />

to properly select and document “target” and “non-target”<br />

lesions. For target lesions, representative measurable lesions up<br />

to a maximum <strong>of</strong> five per organ and ten in total should be identified<br />

and recorded at baseline. These lesions should be selected<br />

with regard to their size, with longer diameter lesions favored,<br />

as well as lesions which are suitable for accurate, repeated<br />

measurements on imaging follow-up. All other lesions or sites<br />

<strong>of</strong> disease should be identified as non-target lesions and should<br />

also be recorded at baseline. These lesions are not measured,<br />

but the presence or absence <strong>of</strong> each should be reported on all<br />

follow-up examinations.<br />

Response criteria with RECIST for target lesions includes<br />

complete response (CR) with the disappearance <strong>of</strong> all lesions,<br />

partial response (PR) with at least a 30% decrease in the sum<br />

total <strong>of</strong> the longest diameters <strong>of</strong> the target lesions compared to<br />

baseline, progressive disease (PD) with the appearance <strong>of</strong> new<br />

lesions or at least a 20% increase in the sum total <strong>of</strong> the longest<br />

diameters <strong>of</strong> the target lesions compared to the smallest sum<br />

total <strong>of</strong> longest diameters since treatment started, and stable disease<br />

(SD) where there is neither significant tumor shrinkage nor<br />

growth to qualify as PR or PD, respectively. 3<br />

Applications in <strong>Thoracic</strong> Oncology:<br />

While new protocols will typically utilize the RECIST criteria<br />

to assess solid tumor response to drug therapy, some older<br />

protocols may still be active which used the older WHO criteria.<br />

219<br />

WEDNESDAY

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