efficient&workflows&for&recist&and&other&quanitaive&imaging ... ·...
TRANSCRIPT
Tumor size as an imaging biomarker Although imperfect, tumor size is an imaging biomarker widely accepted as a surrogate endpoint in oncology clinical trials and is increasingly used in oncology clinical prac:ce to follow chemotherapy response and manage cancer pa:ents. In par:cular, the RECIST (Response Evalua:on Criteria in Solid Tumors) 1.01 and 1.12 standards are the most widely used imaging endpoints in regulatory drug trials of new chemotherapy agents and regimens. Companion surveys of radiologists3 and oncologists4 revealed that a large majority of both special:es agreed that tumor measurements were important in both the clinical trial seKng and in rou:ne clinical care, and that these measurements, par:cularly on the first study, were the responsibility of the radiologist. Most oncologists believed that pa:ent care suffered when tumor measurements were not obtained. However, there was wide disagreement as to how many lesions to measure and whether to obtain unidimensional measurements, as called for in RECIST, or bidimensional measurements as called for in the earlier World Health Organiza:on (WHO) standard. Formal RECIST measurements were rarely obtained outside the clinical trial seKng, even in the major cancer centers surveyed, and were assumed to be even less common in the non-‐academic seKng.
Requirements for efficient workflow
Based on these considera:ons, and on input from radiologists, oncologists, and soUware developers a set of criteria were developed for an efficient soUware workflow engine. Key requirements include:
Flexible vendor neutral client server architecture Full DICOM compliance Mul:ple user roles with secure access Clinical trial management module Image analysis and measurement module Automated loading of corresponding image sets Dedicated measurement tools Repor:ng module Structured report generator Full regulatory compliance GMP, QSR, GCP, HIPAA, and Part 11 Built in response criteria conformance checker Automated response class determina:on Op:ons to use mul:ple response criteria WHO, RECIST 1.0, RECIST 1.1, Choi5 “Response engine” to add future criteria Cheson6, Volumes, PERCIST
The OncoTrac™/Mint Lesion™ soUware was designed to meet these requirements. It is in clinical and research use at the German Cancer Research Center and at several other clinical sites in Europe, and is available for clinical and research use in North America.
Comparison of RECIST 1.0 and 1.1
Response under RECIST 1.0 is calculated from simpler unidimensional tumor measurements, rather than the bidimensional measurements required in the earlier WHO standard, based on mul:ple studies showing equivalent results. Similarly, RECIST 1.1 has reduced the required number of target lesions based on studies showing no significant degrada:on of response assessment when fewer lesions are followed.7 Important changes introduced with RECIST 1.1 Include: Target lesions-‐up to 5 per organ, 10 total under 1.0,
up to 2 per organ, 5 total under 1.1 Lymph nodes-‐under RECIST 1.1, measure short axis.
must be ≥15 mm to be target For PD, RECIST 1.1 added requirement for ≥20% and ≥5mm absolute increase in SLD RECIST 1.1 strengthened criteria for unequivocal
progression of nontarget disease RECIST 1.1 added imaging guidance
The importance of workflow Assessment of quan:ta:ve tumor response using standards such as RECIST, in the absence of dedicated soUware, is labor intensive, :me consuming, and prone to error. The vast majority (86%) of surveyed radiologists agreed that providing tumor measurements slows workflow, and that they would be more likely to do so if they had soUware to simplify the procedure.4 The complexity of manual response assessment methodology can be appreciated from the sample case report form (CRF) page below. Mul:ple measurements for each :me point need to be made on the images, tabulated, and entered manually on the case report form. Measurements for target and non-‐target lesions then need to be summed, and a response category assigned, with poten:al for error at each step of the process.
Directory Screen Case Informa3on Screen Analysis Screen Report Screen
References: 1. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors (RECIST Guidelines). J Natl Cancer Inst 2000;92:205–16 2. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evalua:on criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45 : 228–247 3. Jaffe TA, Wickersham NW, Sullivan DC. Quan:ta:ve imaging in oncology pa:ents: Part 1, Radiology prac:ce paqerns at major U.S. cancer centers. AJR 2010;195 : 101–106. 4. Jaffe TA, Wickersham NW, Sullivan DC. Quan:ta:ve imaging in oncology pa:ents: Part 2, Oncologists opinions and expecta:ons at major U.S. cancer centers. AJR 2010;195 : W19-‐W30. 5. Choi H. Cri:cal issues in response evalua:on on computed tomography: lessons from the gastrointes:nal stromal tumor model. Curr Oncol Rep 2005;7 : 307–311 6. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;10:579–86 7. Moskowitz CS, Jia X, Schwartz LH, Gonen M. A simula:on study to evaluate the impact of the number of lesions measured on response assessment. Eur J Cancer 2009;45:300–10
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For more informa.on contact: in North America [email protected], in Europe info@mint-‐medical.de
Please note: Pa:ent names have been anonymized, and pseudonyms subs:tuted for demonstra:on purposes.
Efficient workflows for RECIST and other quanItaIve imaging standards in cancer research and clinical pracIce
Transla:onal Sciences Corpora:on, Cambridge, MA USA Mint Medical GmbH, Heidelberg, Germany