Standardizing the Methodology of Tumor Measurement at NSMC Dep’t of Radiology September 2, 2009

1. Standardizing the Methodology of Tumor Measurement at NSMC Dep’t of RadiologySeptember 2, 2009 • Chris Semine MD (Moderator) • John Murray MD • Anshu Gupta MD • Alvin Yamamoto MD • Bruce Stewart MD • Rachel Rosovsky MD

2. Rationale • Establish a standardized methodology for tumor measurement to facilitate comparison with prior exams • Reliably and reproducibly determine tumor growth or regression so our colleagues at the Cancer Center can make appropriate treatment decisions

3. Objectives • Define variables • How many lesions to measure • How to compare current and prior studies • How many lesions to count • Standardize how measurements are made • Are measurements saved on PACS? • Review Literature • Define expectations

4. Obstructions • Availability of prior images • Inconsistency of measurements • Unclear expectations • Time consuming

5. New Guidelines to Evaluate the Response to Treatment in Solid Tumors Patrick Therasse, Susan G. Arbuck, Elizabeth A. Eisenhauer, Jantien Wanders, Richard S. Kaplan, Larry Rubinstein, Jaap Verweij, Martine Van Glabbeke, Allan T. van Oosterom, Michaele C. Christian, Steve G. Gwyther Journal of the National Cancer Institute, Vol. 92, No. 3, February 2, 2000 RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) GUIDELINES

6. At baseline, tumor lesions will be categorized as follows: measurable (lesions that can be accurately measured in at least one dimension [longest diameter to be recorded] as equal to or greater than 20 mm with conventional techniques or as equal to or greater than 10 mm with spiral CT scan [see section 2.2]) or nonmeasurable (all other lesions, including small lesions [longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan] and truly nonmeasurable lesions).

7. Evaluation of target lesions

8. Evaluation of non-target lesions Although a clear progression of “non target” lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later on by the review panel (or study chair).

9. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) E.A. Eisenhauera, et al EUROPEAN JOURNAL OF CANCER 45 ( 2 0 0 9 ) 2 2 8 –2 4 7 229

10. Radiologic Measurement of Tumor Size in Clinical Trials: Past, Present, and Future Sanjay Saini AJR:176, February 2001

11. WHO Criteria (area) Complete Response: Tumor Disappearance Partial response 50% decrease in area Progressive Disease 25% increase in area Stable disease Anything between partial response and progressive disease RECIST (diameter) Complete Response: Tumor Disappearance Partial response 30% decrease in diameter Progressive Disease 20% increase in diameter Stable disease Anything between partial response and progressive disease Treatment-response Classifications and Measurement techniques

12. CT Tumor Measurement for Therapeutic Response Assessment: Comparison of Unidimensional, Bidimensional, and Volumetric Techniques— Initial Observations Radiology 2002; 225:416–419 Srinivasa R. Prasad, MD Kartik S. Jhaveri, MD Sanjay Saini, MD, MBA Peter F. Hahn, MD, PhD Elkan F. Halpern, PhD James E. Sumner, BSE

14. In conclusion, compared with unidimensional and bidimensional criteria for evaluating treatment response of liver metastases, the volumetric measurement technique gives different results. The value of volumetric measurement for assessment of treatment response needs to be confirmed by large studies in different patient populations, along with correlation with clinical outcomes.

15. In conclusion, compared with unidimensional and bidimensional criteria for evaluating treatment response of liver metastases, the volumetric measurement technique gives different results. The value of volumetric measurement for assessment of treatment response needs to be confirmed by large studies in different patient populations, along with correlation with clinical outcomes.

16. Evaluating Variability in Tumor Measurements from Same-day Repeat CT Scans of Patients with Non–Small Cell Lung CancerRadiology Vol. 252, No. 1, July 2009Zhao, James, et al

17. Evaluating Variability in Tumor Measurements from Same-day Repeat CT Scans of Patients with Non–Small Cell Lung CancerRadiology, July 2009

18. Evaluating Variability in Tumor Measurements from Same-day Repeat CT Scans of Patients with Non–Small Cell Lung CancerRadiology, July 2009

19. “Chest CT scans are well reproducible. Changes in unidimensional lesion size of 8% or greater exceed the measurement variability of the computer method and can be considered significant when estimating the outcome of therapy in a patient.”

20. Reliable, reproducible measurement of masses is not relevant just to the follow up of tumors in patients on chemo or radiation. Any lesion being followed for any reason needs to be evaluated in a consistent manner.

21. PRACTICE RECOMMENDATIONS ● Annual imaging surveillance is generally sufficient for benign serous cystadenomas 4 cm in size and asymptomatic. ● Asymptomatic thin-walled unilocular cysts 3 cm in size or sidebranch IPMNs should be followed with CT or MRI at 6 months, 12 months, and then annually for 3 years; those with more complex features or with growth rates 1 cm/y should be followed more closely. IPMN Lesions • Symptomatic cysts, neoplasms • with high malignant potential, • and lesions 3 cm in size should • be referred for surgical evaluation. • Endoscopic ultrasound • with fine-needle aspiration can • be used to assess the risk for malignancy • preoperatively.

22. Fleischner Society Guidelines for Management of Small Pulmonary Nodules Detected on CT Scans