Published Ahead of Print on May 10, 2018, as doi: /haematol Copyright 2018 Ferrata Storti Foundation.
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1 Published Ahead of Print on May 10, 2018, as doi: /haematol Copyright 2018 Ferrata Storti Foundation. Rituximab plus Bendamustine as front line treatment in frail elderly (>70 years) patients with diffuse large B-cell non-hodgkin s lymphoma: a phase II multicenter study of the Fondazione Italiana Linfomi by Sergio Storti, Michele Spina, Emanuela Anna Pesce, Flavia Salvi, Michele Merli, Alessia Ruffini, Giuseppina Cabras, Annalisa Chiappella, Emanuele Angelucci, Alberto Fabbri, Anna Marina Liberati, Monica Tani, Gerardo Musuraca, Annalia Molinari, Maria Pia Petrilli, Carmela Palladino, Rosanna Ciancia, Andrea Ferrario, Cristiana Gasbarrino, Federico Monaco, Vincenzo Fraticelli, Annalisa De Vellis, Francesco Merli, and Stefano Luminari Haematologica 2018 [Epub ahead of print] Citation: Sergio Storti, Michele Spina, Emanuela Anna Pesce, Flavia Salvi, Michele Merli, Alessia Ruffini, Giuseppina Cabras, Annalisa Chiappella, Emanuele Angelucci, Alberto Fabbri, Anna Marina Liberati, Monica Tani, Gerardo Musuraca, Annalia Molinari, Maria Pia Petrilli, Carmela Palladino, Rosanna Ciancia, Andrea Ferrario, Cristiana Gasbarrino, Federico Monaco, Vincenzo Fraticelli, Annalisa De Vellis, Francesco Merli, and Stefano Luminari. Rituximab plus Bendamustine as front line treatment in frail elderly (>70 years) patients with diffuse large B-cell non-hodgkin s lymphoma: a phase II multicenter study of the Fondazione Italiana Linfomi. Haematologica. 2018; 103:xxx doi: /haematol Publisher's Disclaimer. E-publishing ahead of print is increasingly important for the rapid dissemination of science. Haematologica is, therefore, E-publishing PDF files of an early version of manuscripts that have completed a regular peer review and have been accepted for publication. E-publishing of this PDF file has been approved by the authors. After having E-published Ahead of Print, manuscripts will then undergo technical and English editing, typesetting, proof correction and be presented for the authors' final approval; the final version of the manuscript will then appear in print on a regular issue of the journal. All legal disclaimers that apply to the journal also pertain to this production process.
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24 Supplementary Methods. Patient eligibility Eligible patients were elderly patients aged 70 years with a newly diagnosed, histologically proven, DLBCL. As indicated in the manuscript, patient had a FRAIL profile, defined with comprehensive geriatric assessment (CGA) originally reported as part of pre-therapy assessment. All patients had to sign the informed consent form before study enrollment. A negative serology for hepatitis B, hepatitis C and HIV were required; patients with HBcAb positivity were included but had to receive Lamivudine prophylaxis. Patients with history of other malignancies within 5 years prior to study entry (except for adequately treated carcinoma in situ) or those with Central Nervous System (CNS) involvement by lymphoma, or evidence of any severe active acute or chronic infection were excluded. Patients with any other co-existing medical or psychological condition that could precluded participation in the study or compromised ability to give informed consent or with Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy, were excluded from the study. Study procedure Mandatory baseline assessments included blood counts and biochemistry tests, chest abdomen and pelvis CT scan, electrocardiogram (ECG), bidimensional cardiac assessment of Left Ventricular Ejection Fraction (LVEF). FDG-PET, Bone Marrow Biopsy (BMB) and Bone Marrow Aspirate (BMA) with flow cytometry analysis were optional. At the end of treatment, blood tests, chest, abdomen and pelvis CT scan, ECG, LVEF assessment, were performed. BMB was recommended if performed at diagnosis with positive result. Total body FDG-PET scan was optional. During the follow up, blood tests and physical examinations were required every three months. Every six months chest x-ray, ECG and cardiac assessment. Chest, abdomen and pelvis CT-scan was performed every year. Concomitant medication During treatment, patients could receive prophylaxis with G-CSF, valacyclovir and cotrimoxazole. Prophylaxis with quinolones and antifungals was administered in case of grade 3 neutropenia. Erythropoietin use was allowed according to ASH/ASCO guidelines. In patients HBcAb+, prophylaxis against hepatitis B reactivation with Lamivudine 100 mg/die from the start of the treatment to one year after the end of the treatment were recommended. All concomitant medications for medical conditions other than B-NHL were permitted, as clinically Indicated. All supportive therapies other than anti-cancer treatment needed for the management of patients enrolled in this study were permitted.
25 Supplementary Table 1. Comorbidities CIRS-G 2 and CIRS-G 3/4. Comorbidity CIRS-G 2 CIRS-G 3/4 N (%) N (%) Cardiac 12 (27) 6 (13) Hypertension 17 (38) 2 (4) Vascular 13 (29) 2 (4) Respiratory 5 (11) 6 (13) Eye, ear, nose, throat, larynx 9 (20) 0 Upper gastrointestinal 3 (7) 0 Lower gastrointestinal 4 (9) 0 Hepatic 1 (2) 0 Renal 2 (4) 1 (2) Others (urinary, genitals) 8 (18) 0 Musculo-skeletal 11 (24) 1 (2) Neurological 8 (18) 2 (4) Endocrine-metabolic 14 (31) 2 (4) Psychiatric 10 (22) 0 CIRS-G: Cumulative Illness Rating Scale, geriatric
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