Hematology (Amsterdam, Netherlands) · 2014
Symptoms and toxicity of rituximab maintenance relative to observation following immunochemotherapy in patients with follicular lymphoma.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Zhou Xiaolei, Wang Jianmin, Zhang Jessica, Copley-Merriman Catherine, Torigoe Yasuhiro, Reyes Carolina, Seymour John F, Offner Fritz C, Trneny Marek, Salles Gilles Andre
Аннотация
OBJECTIVES: The randomized phase 3 PRIMA trial established that 2 years of rituximab maintenance therapy after attaining disease response to immunochemotherapy as first-line treatment of follicular lymphoma, reduced the risk of disease progression, compared with observation, without adversely affecting patient-reported quality of life (QoL). We now report additional analyses of symptom burden and toxicity.
METHODS: Symptom burden was measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items. The proportion of patients with worsening, no change, or improvement in symptoms from maintenance baseline was compared between rituximab maintenance and observation groups with Pearson χ(2) tests. Improvement in symptoms after 1 and 2 years of maintenance was further analyzed using generalized mixed models. The adverse event (AE) rate was calculated from the toxicity checklist at each visit to explore the frequency and timing of the toxicity AE in each treatment arm. The study protocol was approved by local ethics committees and is registered at ClinicalTrials.gov under NCT00140582.
RESULTS: Being tired, needing to rest, feeling weak, and trouble sleeping were the most frequently reported symptoms at the end of immunochemotherapy. By the end of maintenance, notable improvement was seen for fatigue symptoms, trouble sleeping, shortness of breath, lack of appetite, and nausea, with no significant difference in QoL symptoms between the rituximab maintenance and observation groups. The rate of AEs was low, and hematologic toxicity induced during chemotherapy treatment improved in both rituximab maintenance and observation groups.
DISCUSSION: These results indicated that rituximab maintenance did not negatively impact disease- or treatment-related symptoms.
METHODS: Symptom burden was measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items. The proportion of patients with worsening, no change, or improvement in symptoms from maintenance baseline was compared between rituximab maintenance and observation groups with Pearson χ(2) tests. Improvement in symptoms after 1 and 2 years of maintenance was further analyzed using generalized mixed models. The adverse event (AE) rate was calculated from the toxicity checklist at each visit to explore the frequency and timing of the toxicity AE in each treatment arm. The study protocol was approved by local ethics committees and is registered at ClinicalTrials.gov under NCT00140582.
RESULTS: Being tired, needing to rest, feeling weak, and trouble sleeping were the most frequently reported symptoms at the end of immunochemotherapy. By the end of maintenance, notable improvement was seen for fatigue symptoms, trouble sleeping, shortness of breath, lack of appetite, and nausea, with no significant difference in QoL symptoms between the rituximab maintenance and observation groups. The rate of AEs was low, and hematologic toxicity induced during chemotherapy treatment improved in both rituximab maintenance and observation groups.
DISCUSSION: These results indicated that rituximab maintenance did not negatively impact disease- or treatment-related symptoms.