Efficacy assessment criteria (a) CR criteria.
1. All clinically and imaging detectable lesions disappear, and disease-related symptoms existing before treatment disappear and biochemical indicators (such as LDH) return to normal.
2. All lymph nodes and masses must be reduced to the prescribed normal size. (i.e. the maximum transverse diameter >1.5cm before treatment is reduced to ≤1.5cm; the maximum transverse diameter 1.1~1.5cm before treatment is reduced to ≤1cm); or the sum of products of greatest diameters (SPD) is reduced >75%. Dong Lihua, Department of Hematology, Henan Cancer Hospital
3. The enlarged spleen found on CT scan before treatment must be retracted and cannot be retrieved on physical examination (because of the difficulty in accurately assessing the size of liver and spleen, the normal size is not specified in the standard); the masses monitored by imaging of other organs before treatment should disappear; the diffuse enlargement of other organs (such as liver and kidney) before treatment must be reduced if lymphoma invasion is considered.
4. In case of pre-treatment bone marrow invasion, the lesion should be confirmed to have disappeared by repeated puncture biopsy of the same site (sufficient bone marrow biopsy samples should be obtained to draw conclusions, e.g., using ≥20 mm biopsy cores). Currently, flow cytometry, molecular or cytogenetic testing is mainly for research purposes and is not routinely used as a basis for the presence of disease.
(ii) CRu criteria.
Meet the above CR criteria 1 and 3, and have 1 or 2 of the following characteristics.
1. The maximum diameter of the residual lymph node mass is >1.5 cm but the SPD is reduced by >75% compared with that before treatment. If the lymph nodes fused before treatment become multiple lymph nodes after treatment, the SPD of the multiple lymph nodes after treatment should be reduced by >75% compared with that of the fused mass before treatment.
2. Indeterminate bone marrow invasion (meaning an increase in the number of lymphocytes or aggregation into clusters without abnormal cytological and structural changes).
(iii) PR criteria.
1. 6 largest lymph nodes or lymph node masses with SPD reduction ≥ 50%. The criteria for the selected lymph nodes or lymph node masses were: 1) two pendulous diameters could be accurately measured; 2) different parts of the body as far as possible; 3) if the mediastinum and retroperitoneum were invaded, these parts should be included.
2. Other lymph nodes (lymph nodes other than the 6 selected lymph nodes), liver and spleen are not enlarged.
3. The SPD of the spleen and liver nodes is reduced by >50%.
4. Invasion of organs other than spleen and liver nodes were considered evaluable non-measurable lesions, and these lesions did not progress.
5. Bone marrow invasion is an evaluable non-measurable lesion and is considered irrelevant to the evaluation of PR, but if positive, the pathological type of lymphoma should be clarified.
6. No new lesions.
(iv) SD criteria.
Those who neither meet PR nor PD.
(E) Relapse criteria (for those who obtained CR/CRu).
1. The appearance of any new lesion or ≥50% increase in the invasion site before treatment.
2. Any lymph node with a short axis greater than 1 cm and its longest diameter increased by ≥ 50% or more than one lymph node with SPD ≥ 50% before treatment.
(F) PD criteria (for PR or treatment non-responders).
1. Any pre-treatment identified abnormal lymph nodes with ≥ 50% increase compared to the previous SPD minimum.
2. The appearance of new lesions during or at the end of treatment.
NHL efficacy criteria
Efficacy
Physical examination
Lymph nodes
Lymph node mass
Bone marrow
CR
Normal
Normal
Normal
Normal
CRu
Normal
Normal
Normal
Uncertain
Normal
Normal
Shrinkage >75%
Normal or indeterminate
PR
Normal
Normal
Normal
Positive
normal
Shrinkage ≥50%
Shrinkage ≥50%
no correlation
Hepatic/splenic shrinkage
Shrinkage ≥50%
Shrinkage ≥50%
No relation
Relapse/PD
Enlarged liver/spleen new lesion
New lesion or enlargement
New lesion or enlargement
Recurrence