Tumor measurement criteria
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1- Increase of two-fold or higher per RECIST 1.1 criteria OR 50% or higher increase in tumor burden compared to pretreatment imaging |
2- Time to progression less than 3 cycles of therapy (2 months) |
3- 2-fold or higher increase in progression pace |
4- Progression of new lesions |
Patient symptoms criteria
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5- Rapid decrease in baseline performance status or worsening of symptoms related to the disease progression |
6- New onset of complications related to disease progression i.e. SVC, increase pleural effusion |
Laboratory Criteria
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7- LDH > upper limit of normal
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Measurement Methods
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Tumor Growth Rate (TGR) 3 D difference in tumor volume per month, related to the sum of the target lesion(s) diameter(s) as well as the time between imaging evaluations. |
Tumor Growth Kinetics (TGK) 2D as a function of tumor diameter over time. |
Potential Factors associated with HYD
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1. Increased Age
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2. Higher tumor burden with 2 or more metastatic sites with one of the liver
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3. High LDH
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