Targeted Treatment and Quality of Life in Patients with Follicular Lymphoma
The GALLIUM clinical trial evaluated chemotherapy in combination with targeted treatment using rituximab or obinutuzumab in previously untreated patients with advanced follicular lymphoma (FL). A secondary aim of the study was to assess the health-related quality of life. The results of the analysis were recently published in the journal Annals of Hematology.
Treatment of Follicular Lymphoma
Rituximab, a first-generation monoclonal antibody against the CD20 antigen, in combination with chemotherapy improves outcomes for patients with FL. Despite this, 20-35% of patients experience disease progression, relapse, or death within 2 years of starting treatment. Obinutuzumab, the first glycosylated humanized second-generation anti-CD20 antibody, offers stronger antibody-dependent cellular toxicity compared to first-generation antibodies. In the Czech Republic, obinutuzumab treatment of FL is covered from 1st October 2020, already in the first line, and in the second line, it can also be administered to patients after progression on rituximab.
Methodology of the GALLIUM Study
The open-label phase III study included 1202 patients with previously untreated stage 1-3a FL, who were randomized 1:1 to 6-8 cycles of induction chemotherapy, using cyclophosphamide/(doxorubicin)/vincristine/prednisone (CHOP/CVP regimens) or bendamustine, combined either with rituximab or obinutuzumab. Patients who responded at least partially to treatment then continued with maintenance therapy using the assigned antibody for up to 2 years or until disease progression.
Health-related quality of life (HRQoL) was assessed using the Functional Assessment of Cancer Treatment - Lymphoma (FACT-Lym) questionnaire, which includes both general assessments of physical, functional, emotional, and social well-being, as well as a lymphoma-specific assessment scale. Evaluations were conducted at study entry, during induction therapy, at the end of induction therapy, at months 2 and 12 of maintenance therapy, and then every 12 months until follow-up completion (median 57.4 months, up to 7 years). Clinically significant improvement was defined as the minimum difference in scores that patients considered important (MID - minimally important difference).
Results
92.7% of patients in the obinutuzumab arm and 91.2% in the rituximab arm completed the questionnaire at study entry. Baseline HRQoL scores were comparable between both groups, with all patients reporting some functional impairment and the presence of lymphoma-related symptoms.
During treatment, the trend of changes in average HRQoL scores was similar in both arms. A rapid improvement in lymphoma-related symptoms was observed after treatment initiation, and scores continued to rise during therapy. Approximately half of the patients in each group achieved clinically significant improvement from the start of treatment through the 2nd month of maintenance therapy.
Conclusion
The GALLIUM clinical trial observed comparable improvements in HRQoL for patients with advanced FL regardless of whether they were treated with chemotherapy combined with rituximab or obinutuzumab. Both regimens reduced the occurrence of lymphoma-related symptoms, and the side effects of the treatments did not negate this effect.
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Source: Davies A., Trask P., Demeter J. et al. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol 2020 Apr 20, doi: 10.1007/s00277-020-04021-6 [Epub ahead of print].
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