TORNA ALL’ELENCO

Observation vs. radiotherapy in primary mediastinal B-cell lymphoma patients with complete response to standard immunochemotherapy: The IELSG37 randomized trial in Journal of Clinical Oncology

2023
AOU Città della Salute di Torino

Tipo pubblicazione

Conference Abstract

Autori/Collaboratori (20)Vedi tutti...

Zucca E
Institute of Oncology Research; Clinic of Hematology, Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale; Faculty of Biomedical Science, Universita' della Svizzera italiana; International Extranodal Lymphoma Study Group (IELSG), Bellinzona, Lugano, Switzerland; Southampton Experimental Cancer Medicines Centre, University of Southampton, Southampton, United Kingdom; National Cancer Institute, Kiev, Ukraine; Cancer Epidemiology Unit, CeRMS and CPO Piemonte, Città della Salute e della Scienza, University of Torino, Torino, Italy; Imaging Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland; AOU Citta' della Salute e della Scienza di Torino, Torino, Italy; Guy's Cancer Centre, Guy's & St Thomas' NHS Trust and King's College University, London, United Kingdom; Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland; Rui Jin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China; Inselspital, Bern, Switzerland; University Hospital Brno, Brno, Czech Republic; Oslo University Hospital, Oslo, Norway; Princess Margaret Hospital, Toronto, ON, Canada; Lund University Hospital, Lund, Sweden; IRCCS Humanitas Research Hospital, Rozzano Milano, Italy; ASST Spedali Civili di Brescia, Brescia, Italy; University of Turin, Department of Oncology, Torino, Italy; King's College London, London, United Kingdom; University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; Università La Sapienza Policlinico Umberto I, Roma, Italy
Davies A
Institute of Oncology Research; Clinic of Hematology, Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale; Faculty of Biomedical Science, Universita' della Svizzera italiana; International Extranodal Lymphoma Study Group (IELSG), Bellinzona, Lugano, Switzerland; Southampton Experimental Cancer Medicines Centre, University of Southampton, Southampton, United Kingdom; National Cancer Institute, Kiev, Ukraine; Cancer Epidemiology Unit, CeRMS and CPO Piemonte, Città della Salute e della Scienza, University of Torino, Torino, Italy; Imaging Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland; AOU Citta' della Salute e della Scienza di Torino, Torino, Italy; Guy's Cancer Centre, Guy's & St Thomas' NHS Trust and King's College University, London, United Kingdom; Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland; Rui Jin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China; Inselspital, Bern, Switzerland; University Hospital Brno, Brno, Czech Republic; Oslo University Hospital, Oslo, Norway; Princess Margaret Hospital, Toronto, ON, Canada; Lund University Hospital, Lund, Sweden; IRCCS Humanitas Research Hospital, Rozzano Milano, Italy; ASST Spedali Civili di Brescia, Brescia, Italy; University of Turin, Department of Oncology, Torino, Italy; King's College London, London, United Kingdom; University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; Università La Sapienza Policlinico Umberto I, Roma, Italy
Kryachok I
Institute of Oncology Research; Clinic of Hematology, Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale; Faculty of Biomedical Science, Universita' della Svizzera italiana; International Extranodal Lymphoma Study Group (IELSG), Bellinzona, Lugano, Switzerland; Southampton Experimental Cancer Medicines Centre, University of Southampton, Southampton, United Kingdom; National Cancer Institute, Kiev, Ukraine; Cancer Epidemiology Unit, CeRMS and CPO Piemonte, Città della Salute e della Scienza, University of Torino, Torino, Italy; Imaging Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland; AOU Citta' della Salute e della Scienza di Torino, Torino, Italy; Guy's Cancer Centre, Guy's & St Thomas' NHS Trust and King's College University, London, United Kingdom; Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, Poland; Rui Jin Hospital Affiliated to Shanghai Jiao Tong University, Shanghai, China; Inselspital, Bern, Switzerland; University Hospital Brno, Brno, Czech Republic; Oslo University Hospital, Oslo, Norway; Princess Margaret Hospital, Toronto, ON, Canada; Lund University Hospital, Lund, Sweden; IRCCS Humanitas Research Hospital, Rozzano Milano, Italy; ASST Spedali Civili di Brescia, Brescia, Italy; University of Turin, Department of Oncology, Torino, Italy; King's College London, London, United Kingdom; University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; Università La Sapienza Policlinico Umberto I, Roma, Italy

et alii...

Abstract

Background: Primary mediastinal B-cell lymphoma (PMBCL) has a good prognosis if remission is rapidly achieved with dose-intensive immunochemotherapy. In these patients mediastinal radiotherapy (RT) may consolidate responses; however, it increases the risk of second malignancies and coronary or valvular heart disease. The IELSG37 trial was planned with a non-inferiority design to test whether RT can be omitted in patients who achieve a complete metabolic response (CMR) after immunochemotherapy. Methods: Patients with newly diagnosed PMBCL were eligible. Initial rituximab and anthracycline-based therapy was chosen according to local practice. CMR was defined, upon central review of positron emission computed tomography (PET/CT) scans, as Deauville score 1 to 3, according to the Lugano classification. Responding patients were randomized to observation (OBS) or consolidation RT (30 Gy). Randomization was stratified on gender, chemotherapy regimen, country, and PET/ CT score. The primary endpoint was progression-free survival (PFS) after randomization. The sample size (540 patients to enrol, and 376 to randomize) was calculated assuming a 30-month PFS probability of 0.85 in both arms, with alpha at 0.05, 80% power and a hazard ratio (HR) of 1.77 as non-inferiority margin. Results: At a median follow-up of 30 months, the number of observed events was considerably lower than expected, hence, the Independent Data Monitoring Committee (IDMC) of the trial recommended to complete the planned total accrual without increasing the study size or duration. The primary endpoint analysis was performed, according to the IDMC recommendation, with $80% of patients having a minimum follow-up of 30 months. 545 patients (209 men, 336 women) were enrolled. Induction immunochemotherapy was completed and response assessed in 530 patients, 268 of them (50.6%) achieved a CMR and were randomly allocated to OBS (n = 132) or RT (n = 136). The PFS at 30 months was 98.5% (95%CI, 94.3 - 99.6)

Keywords

anthracycline; rituximab; unclassified drug; adult; B cell lymphoma; cancer patient; cancer radiotherapy; cancer survival; chemotherapy; clinical trial; computer assisted tomography; conference abstract; controlled study; drug combination; drug therapy; female; follow up; gender; human; human tissue; major clinical study; male; metabolism; non-inferiority trial; numbers needed to treat; overall survival; positron emission tomography-computed tomography; probability; professional standard; progression free survival; prospective study; radiotherapy; randomization; randomized controlled trial; remission; risk reduction; sample size;