The purpose of this study is to evaluate the prognostic value of clinical and biological factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.
The main aim of this study is to compare the prognostic value of R-IPI at diagnosis and relapse, relating it with the obtained response after second line
Study Type
OBSERVATIONAL
Enrollment
158
R-IPI Index (Revised International Prognostic Index)
Data will be recorded from diagnosis to second line response, an expected average of 7 months
Time frame: At diagnoses
R-IPI Index (Revised International Prognostic Index)
The IPI is based on the evaluation of 5 clinical factors: age \> 60 years Ann Arbor stage III or IV disease \> 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) \_ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.
Time frame: At the beginning of the 2nd line of treatment, an average of 2 years
Predictive Value of R-IPI at Diagnosis
Time frame: At diagnosis
Bcl-2 Expression
immunohistochemical reaction of cells with Bcl-2 antibody
Time frame: At diagnosis
Bcl-2 Expression
immunohistochemical reaction of cells with Bcl-2 antibody
Time frame: At the beginning of the 2nd line of treatment
Bcl-6 Expression
immunohistochemical reaction of cells with Bcl-6 antibody
Time frame: At diagnosis
Bcl-6 Expression
immunohistochemical reaction of cells with Bcl-6 antibody
Time frame: At the beginning of the second line of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital de Elda
Elda, Alicante, Spain
H. U. Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clinic i Provincial
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Vall D'Hebrón
Barcelona, Barcelona, Spain
Hospital General de Granollers
Granollers, Barcelona, Spain
ICO-DYR
L'Hospitalet de Llobregat, Barcelona, Spain
Althaia
Manresa, Barcelona, Spain
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital Parc Taulí
Sabadell, Barcelona, Spain
...and 46 more locations
p-53 Expression
immunohistochemical reaction of cells with p-53 antibody
Time frame: At diagnosis
p53 Expression
immunohistochemical reaction of cells with p-53 antibody
Time frame: At the beginning of the 2nd line of treatment
Multiple Myeloma Oncogene 1 (MUM-1) Expression
immunohistochemical reaction of cells with MUM-1 antibody
Time frame: At diagnosis
MUM-1 Expression
immunohistochemical reaction of cells with MUM-1 antibody
Time frame: At the beginning of the 2nd line of treatment
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status
ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus
Time frame: At the beginning of the 2nd line of treatment
Ann Arbor Staging
Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition
Time frame: At the beginning of the 2nd line of treatment
Response to First Line of Treatment
Complete Response (CR), Disappearance of all target lesions for at least 8 weeks. Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment.
Time frame: After first line treatment
Response to Second Line of Treatment
Complete Response (CR), Disappearance of all target lesions for at least 8 weeks. Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment.
Time frame: After second line of treatment
Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis
Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse
Time frame: At diagnosis