Criteria for evaluating the efficacy of solid tumors

1.Measurement of tumor lesions (1)Definition of tumor lesion baseline Tumor lesion baseline is divided into: measurable lesions: lesions that can be accurately measured with conventional techniques, lesions with diameter length >20mm or spiral CT >10mm. Non-measurable lesions: all other lesions (including small lesions i.e. conventional techniques with length diameter <20mm or spiral CT <10mm) including bone lesions, meningeal lesions, ascites, pleural fluid, pericardial effusion, inflammatory breast cancer, cancerous lymphangitis of the skin or lung, abdominal masses and cystic lesions that cannot be diagnosed and followed up by imaging. (2) Measurements The same techniques and methods are applied to assess lesions at baseline and follow-up. (a) Clinically superficial lesions such as palpable lymph nodes or skin nodules can be used as measurable lesions, and color photographs with scale size should be used for skin lesions. (b) Chest X-ray: a clear and definite lesion can be used as a measurable lesion, but a CT scan is preferable. (c) CT and MRI: For determining measurable target lesions to evaluate the efficacy, CT and MRI are currently the best and repeatable follow-up methods. For thoracic, abdominal, and pelvic cavities, CT and MRI are scanned with 10 mm or thinner layers, spiral CT with continuous scans at 5 mm layers, and special protocols are used for head and neck and special sites. (d) Ultrasound pick-up: When the endpoinst of the study is objective tumor efficacy, ultrasound cannot be used to measure tumor lesions, but only superficially palpable lymph nodes, subcutaneous nodules and thyroid nodules, and can be used to confirm the complete disappearance of superficial lesions after clinical examination. (e) Endoscopy and laparoscopy: as objective tumor efficacy evaluation has not been widely and fully applied so far, only in controversial lesions or in high level study centers with clear validation purposes. Biopsy specimens obtained by this method can confirm CR on pathological tissues. (f) Tumor markers: cannot be applied alone to determine efficacy. However, when tumor markers are higher than normal levels before treatment, all markers need to be restored to normal when CR is clinically evaluated. The requirement for disease progression is that an increase in tumor markers must be accompanied by visible lesion progression. (g) Cytology and pathological histology: In a few cases, cytology and pathological histology can be used to differentiate between CR and PR and to distinguish between benign or residual malignant lesions after treatment. Cytology is needed to differentiate tumor remission, stability and progression for any exudate that occurs during treatment. 2. Evaluation of tumor remission (1) Evaluation of tumor lesions at baseline To establish the full tumor load at baseline, which is compared in subsequent measurements, at least one measurable target lesion, such as a limited number of arc-standing lesions need to be histopathologically confirmed. (a) Measurable target lesions: should be representative of all organs involved, with a maximum of 5 lesions per organ and a maximum of 10 total lesions as target lesions, measured and recorded at baseline. Target lesions should be selected based on lesion length and diameter size and accurate repeatability of measurement. The sum of the lengths of all target lesions is used as the reference baseline for effective remission recording. (b) Non-target lesions: all other lesions should be treated as non-target lesions and recorded at baseline, and lesions not requiring measurement should be noted for their presence or absence during follow-up. (2) Criteria for remission Evaluation of target lesions CR: All target lesions disappeared. PR: >30% reduction in the total length diameter of the baseline lesions. PD: Increase in the total length diameter of baseline lesions >20% or appearance of new lesions. SD: Baseline lesions with a reduction in total length but not PR or an increase but not PD. Evaluation of non-target lesions CR: All non-target lesions disappeared and tumor marker levels were normal. SD: persistence of one or more non-target lesions and/or tumor markers above normal. PD: the presence of one or more new lesions or/and the presence of progression of non-target lesions.