Efficacy and Tolerability of a 2-Year Rituximab Maintenance Therapy in Patients with Advanced Follicular Lymphoma after Induction of Response with Rituximab-Containing First Line-Regimens (HUSOM Study)
| Autor: | Zita Borbényi, András Rosta, Judit Demeter, Miklos Egyed, Tamás Schneider, Péter Dombi, Árpád Illés, János Jakucs, László Szerafin, Antal Tóth, György Ujj, Tamás Masszi, János László Iványi, G. Radványi, Hajna Losonczy, Zoltán Gasztonyi |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty medicine.medical_treatment Follicular lymphoma Kaplan-Meier Estimate Disease Klinikai orvostudományok Disease-Free Survival Maintenance Chemotherapy Pathology and Forensic Medicine 03 medical and health sciences Antineoplastic Agents Immunological 0302 clinical medicine Maintenance therapy Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Adverse effect Lymphoma Follicular Aged Aged 80 and over Chemotherapy business.industry Orvostudományok Induction Chemotherapy General Medicine Middle Aged medicine.disease Surgery Clinical trial Treatment Outcome Tolerability 030220 oncology & carcinogenesis Female 030211 gastroenterology & hepatology Rituximab business medicine.drug |
| Zdroj: | Pathology & Oncology Research. 24:199-205 |
| ISSN: | 1532-2807 1219-4956 |
| DOI: | 10.1007/s12253-017-0234-2 |
| Popis: | Follicular lymphoma is a lymphoid malignancy commonly showing slow progression which makes the treatment of the disease challenging. Rituximab monotherapy and rituximab added to standard chemotherapy has been proven to increase survival among patients with advanced stage of the disease. However, the benefit of a rituximab maintenance therapy after induction was still unclear at the time of the initiation of this study. HUSOM was a phase III open-label, single-arm, multi-centre study aimed to assess the efficacy and the safety of the 12 cycles of rituximab (375 mg/m2 every 8 weeks) maintenance therapy in patients had already presented partial or complete response to R-CVP or R-CHOP. Efficacy endpoints such as event-free survival and overall survival were estimated. Adverse events were recorded during the entire course of the study. A total number of 124 patients were enrolled by 15 Hungarian study sites. Out of these, 86 patients received 12 cycles of rituximab and 69 patients completed the 3-year follow-up phase as well. The probabilities of the event free survival and progression at 4.3 years were estimated to be 70.3% and 74.4%, respectively. The overall and the disease free survival at 4 years were estimated to be 90.7% and 87.9%, respectively. A total number of 85 adverse events were reported during the study out of which 5 AEs were considered to be related to the administration of rituximab. Analyses of the efficacy variables have revealed comparable results to those reported by controlled clinical trials (EORTC 20981, PRIMA) conducted in parallel with the HUSOM study. |
| Databáze: | OpenAIRE |
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