Lymphoma, Large B-Cell, Diffuse
Conditions
Keywords
PET; Diffuse large B-cell lymphoma; Prognosis; Radiomics;
Brief summary
This study aims to investigate the prognostic value of 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) radiomics in diffuse large B-cell lymphoma (DLBCL) and its additional value to the International Prognostic Index (IPI).
Detailed description
Several studies have shown that 18F-FDG PET radiomics is predictive of survival in DLBCL. However, to the best of the investigator's knowledge, a multi-feature radiomic signature for prognosis assessment of DLBCL has not yet been described. Furthermore, it remains unclear whether PET-based radiomics could add more prognostic values to the IPI in DLBCL. This study aims to develop 18F-FDG PET radiomic signature, and investigate whether the radiomic signature could improve the prognostic value of the IPI score in predicting progression-free survival (PFS) and overall survival (OS) in DLBCL.
Interventions
OTHERFDG PET radiomic feature evaluation
A total of 1245 radiomic features will be calculated and extracted from baseline FDG PET scans. These features include shape features, first order features, textural features and wavelet features. In the second part, based on the results of least absolute shrinkage and selection operator Cox regression algorithm, the most significant radiomic features will be selected to construct the radiomic signature.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. histopathologically confirmed diffuse large B-cell lymphoma (DLBCL); 2. Over 18 years old when diagnosed; 3. Have undergone pre-treatment 18F-FDG PET/CT; 4. Have been initially treated with the combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin).
Exclusion criteria
1. Have primary central nervous system (CNS) lymphoma or second primary cancer; 2. Have undergone surgical resection; 3. With an incomplete follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years | the period from the initial diagnosis to the death from any cause |
| Progression-free Survival | From date of the initial diagnosis until the date of first documented progression, relapse or death from any cause, whichever came first, up to 8 years | the period from the initial diagnosis to the progression, relapse or death from any cause |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Training Cohort Patients diagnosed between July 2013 and March 2017 | 100 |
| Validation Cohort Patients diagnosed between April 2017 and July 2019 | 52 |
| Total | 152 |
Baseline characteristics
| Characteristic | Training Cohort | Validation Cohort | Total |
|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 14.6 | 59.4 years STANDARD_DEVIATION 15.7 | 58.3 years STANDARD_DEVIATION 14.9 |
| Ann Arbor stage Ⅰ-Ⅱ | 38 Participants | 15 Participants | 53 Participants |
| Ann Arbor stage Ⅲ-Ⅳ | 62 Participants | 37 Participants | 99 Participants |
| B symptoms No | 72 Participants | 32 Participants | 104 Participants |
| B symptoms Yes | 28 Participants | 20 Participants | 48 Participants |
| Cell of origin germinal center B-cell like | 28 Participants | 14 Participants | 42 Participants |
| Cell of origin non-germinal center B-cell like | 72 Participants | 38 Participants | 110 Participants |
| Chemotherapy regimens R-CHOP | 95 Participants | 48 Participants | 143 Participants |
| Chemotherapy regimens R-EPOCH | 5 Participants | 4 Participants | 9 Participants |
| Extranodal sites < 2 | 71 Participants | 30 Participants | 101 Participants |
| Extranodal sites ≥ 2 | 29 Participants | 22 Participants | 51 Participants |
| International Prognostic Index ≤ 2 | 54 Participants | 30 Participants | 84 Participants |
| International Prognostic Index > 2 | 46 Participants | 22 Participants | 68 Participants |
| lactate dehydrogenase Elevated | 55 Participants | 31 Participants | 86 Participants |
| lactate dehydrogenase Normal | 45 Participants | 21 Participants | 66 Participants |
| Performance status < 2 | 76 Participants | 32 Participants | 108 Participants |
| Performance status ≥ 2 | 24 Participants | 20 Participants | 44 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment China | 100 participants | 52 participants | 152 participants |
| Sex: Female, Male Female | 52 Participants | 24 Participants | 76 Participants |
| Sex: Female, Male Male | 48 Participants | 28 Participants | 76 Participants |
| Treatment Chemotherapy alone | 72 Participants | 41 Participants | 113 Participants |
| Treatment Chemotherapy + autologous stem cell transplantation | 3 Participants | 1 Participants | 4 Participants |
| Treatment Chemotherapy + radiotherapy | 25 Participants | 10 Participants | 35 Participants |
| β2-microglobulin Elevated | 33 Participants | 21 Participants | 54 Participants |
| β2-microglobulin Normal | 67 Participants | 31 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 27 / 100 | 14 / 52 |
| other Total, other adverse events | 0 / 100 | 0 / 52 |
| serious Total, serious adverse events | 0 / 100 | 0 / 52 |
Outcome results
Primary
Overall Survival
the period from the initial diagnosis to the death from any cause
Time frame: From date of the initial diagnosis until the date of death from any cause, whichever came first, up to 8 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Training Cohort | Overall Survival | 56 months |
| Validation Cohort | Overall Survival | 29 months |
Primary
Progression-free Survival
the period from the initial diagnosis to the progression, relapse or death from any cause
Time frame: From date of the initial diagnosis until the date of first documented progression, relapse or death from any cause, whichever came first, up to 8 years
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Training Cohort | Progression-free Survival | 52.5 months |
| Validation Cohort | Progression-free Survival | 28 months |