The present study consists of a retrospective multicentric collection of all consecutive patients with PMBCL diagnosed over the time period considered (13 years, from 2007 to 2019 inclusive).
The study was initially set up as a spontaneous, non-profit study, with ARNAS Garibaldi of Catania (PI Dr Ugo Consoli) as the proposer. Subsequently, the project was expanded to include additional centres belonging to the Italian Lymphoma Foundation, which became the promoter in collaboration with ARNAS Garibaldi of Catania. The information collected is aimed at verifying the application in a "real world" context of the PMBCL diagnosis and therapy protocols suggested in the guidelines and at checking whether they produce results in line with those expected. The therapies considered for the I line of treatment are those described in the literature for the pathology under consideration: * R-CHOP14; R-CHOP21 and R-CHOP like, (R-CHOP: rituximab - cyclophosphamide, doxorubicin, vincristine, prednisone) * R-VACOPB, R-MACOPB and R-VACOPB like, MACOPB like, (R-VACOP-B: Rituximab - etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin. R-MACOP-B: Rituximab - methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin) * R-DA-EPOCH ed R-EPOCH like (DA-R- EPOCH: Dose Adjusted - Rituximab - Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin)
Study Type
OBSERVATIONAL
Enrollment
633
Rate of primary/early refractory disease
The study aims to evaluate the rate of primary/early refractory disease (Primary mediastinal large B-cell lymphoma)
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Overall response rate (ORR)
Overall Response Rate is defined as the percentage of patients in complete remission or in partial remission
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Complete response rate (CRR)
The Complete Response Rate is defined as the percentage of patient in Complete Remission
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Frequency of administration of mediastinal radiation therapy
Analyze the frequency of administration of mediastinal radiation therapy in patients affected by primary mediastinal large B-cell lymphoma
Time frame: four months after completion of chemotherapy
Progression Free Survival (PFS)
The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Overall Survival (OS)
Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause.
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
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U.F. Oncoematologia, IOM (Istituto Oncologico del Mediterraneo)
Viagrande, Catania, Italy
SC Ematologia, A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Clinica di Ematologia, AOU Ospedali Riuniti
Ancona, Italy
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
Divisione di Oncologia e dei Tumori immuno-correlati, IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, Italy
U.O. Ematologia con Trapianto, AOU Policlinico Consorziale
Bari, Italy
U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
Ematologia, Ospedale "Monsignor Raffaele Dimiccoli"
Barletta, Italy
Istituto di Ematologia "Seragnoli", Policlinico S.Orsola-Malpighi
Bologna, Italy
Ematologia, ASST Spedali Civili di Brescia
Brescia, Italy
...and 30 more locations
Acute toxicity
Analyze incidence and type of acute toxicity (haematological and extra haematological toxicity)
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Long-term toxicity
Analyze incidence and type of long-term toxicity (cardiological toxicity and second tumors)
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)