Evaluable Disease
An Evaluable Disease is a disease that cannot be measured directly but can be evaluated by other methods specific to a particular clinical trial.
- Example(s):
- an Evaluable Tumor,
- …
- Counter-Example(s):
- See: Evaluable Patient, Clinical Endpoint, Objective Response Rate (ORR), Clinical Benefit Rate (CBR), Duration of Response (DoR), Duration of Clinical Benefit (DoCB).
References
2021
- (Wkipedia) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#E Retrieved:2021-12-30.
- QUOTE: Evaluable disease
- Disease that cannot be measured directly by the size of the tumor but can be evaluated by other methods specific to a particular clinical trial. (NCI)
2013
- (Garnett et al., 2013) ⇒ Sally Anne Garnett, Miguel Martin, Guy Jerusalem, Lubos Petruzelka, Roberto Torres, Igor N. Bondarenko, Rustem Khasanov, Didier Verhoeven, Jose L. Pedrini, Iva Smirnova, Mikhail R. Lichinitser, Kelly Pendergrass, Justin P. O. Lindemann, and Angelo Di Leo (2013). "Comparing duration of response and duration of clinical benefit between fulvestrant treatment groups in the CONFIRM trial: application of new methodology". In: Springer - Breast Cancer Research and Treatment, 138(1). DOI:10.1007/s10549-012-2395-8.
- QUOTE: The CONFIRM trial design has been described in detail previously (...). In brief, CONFIRM was a randomized, phase III, double-blind study in which two different doses of fulvestrant (500 vs 250 mg) were evaluated in postmenopausal patients who had either locally advanced or metastatic ER-positive breast cancer.
Patients who experienced relapse during or within 1 year of completion of adjuvant endocrine therapy were eligible. For patients who experienced relapse after more than 1 year from completion of adjuvant endocrine therapy, or for patients with de novo advanced disease, eligibility required previous treatment with either an anti-estrogen or an aromatase inhibitor as a first-line therapy for metastatic breast cancer. Patients had to have measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) (...) although patients with lytic or mixed bone lesions were permitted to enter the study without evidence of measurable disease(...)
The RECIST criteria assesses, for each patient, the percentage reduction in tumor mass on a visit-by-visit basis over the course of the trial according to the following definitions: complete response (CR), defined as a disappearance of all measurable lesions and no new lesions; partial response (PR), defined as at least a 30 % reduction in the sum of the longest diameter of the measurable lesions and no progression of non-target lesions and no new lesions; stable disease (SD), defined as disease in which there is neither sufficient shrinkage to qualify for CR or PR, nor sufficient increase to qualify for progressive disease (PD) of measurable lesions, and there is no progression of non-measurable lesions and no new lesions; PD, defined as at least a 20 % increase in the sum of the longest diameter of target lesions or the progression of non-measurable lesions or the appearance of new lesions. Disease for which there was insufficient data to allocate a response was defined as not evaluable (NE).
- QUOTE: The CONFIRM trial design has been described in detail previously (...). In brief, CONFIRM was a randomized, phase III, double-blind study in which two different doses of fulvestrant (500 vs 250 mg) were evaluated in postmenopausal patients who had either locally advanced or metastatic ER-positive breast cancer.