Quality of life assessment in diffuse large B-cell lymphoma (DLBCL) in REFLECT: a prospective, non-interventional, multicenter, German study, assessing Sandoz rituximab in combination with CHOP

Health-related quality of life (HRQoL) data are important indicators of health status in patients with lymphoma. The objective of this analysis was to assess the impact of treatment with Sandoz rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) on HRQoL in treatment-naïve adult patients with diffuse large B-cell lymphoma (DLBCL) included in the prospective, real-world REFLECT study. REFLECT is the first prospective study to assess HRQoL in patients with DLBCL treated with a rituximab biosimilar. HRQoL was assessed via the patient-reported European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire at baseline, mid-treatment (month 3), end of treatment (month 6), and follow-up (months 9 and 12). Subgroup analyses were performed to evaluate the influence of baseline characteristics on HRQoL, and associations between baseline HRQoL and treatment response. HRQoL was assessed in 169 patients. Mean global health status score remained stable from baseline (54.8) to mid-treatment (month 3; 54.7), before steadily improving through to end of treatment (month 6; 61.4), and follow-up month 9 (64.9) and month 12 (68.8). Similar trends were observed across most functional and symptom subscales. Higher cognitive, physical, or role functioning, and less appetite loss, diarrhea, fatigue, or pain at baseline, were all associated with an improved likelihood of reaching a complete versus partial response at the end of treatment. Overall, these findings confirm the HRQoL benefits of R-CHOP therapy in treatment-naïve adult patients with DLBCL, and suggest that baseline HRQoL may be predictive of treatment response. Supplementary Information The online version contains supplementary material available at 10.1007/s00277-024-05850-5.

For global health status and functional scales, positive change from baseline = improvement in health status / functioning from baseline to timepoint; negative change from baseline = worsening in health status / functioning from baseline to timepoint.For symptom scales, positive change from baseline = worsening in symptom from baseline to timepoint; negative change from baseline = improvement in symptom from baseline to timepoint.EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire.At baseline: n=64 <65 years (except for insomnia, n=63); n=101 ≥65 years (except for role and social functioning, n=100).

Supplementary Table 4
Mean change from baseline to months 3, 6, 9, and 12 in EORTC QLQ-C30 domains stratified by sex For global health status and functional scales, positive change from baseline = improvement in health status / functioning from baseline to timepoint; negative change from baseline = worsening in health status / functioning from baseline to timepoint.For symptom scales, positive change from baseline = worsening in symptom from baseline to timepoint; negative change from baseline = improvement in symptom from baseline to timepoint.EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire.At baseline: n=86 females (except for insomnia, role functioning and social functioning, n=85); n=79 males.

Supplementary Table 5
Mean change from baseline to months 3, 6, 9, and 12 in EORTC QLQ-C30 domains stratified by disease stage at baseline For global health status and functional scales, positive change from baseline = improvement in health status / functioning from baseline to timepoint; negative change from baseline = worsening in health status / functioning from baseline to timepoint.For global health status and functional scales, positive change from baseline = improvement in health status / functioning from baseline to timepoint; negative change from baseline = worsening in health status / functioning from baseline to timepoint.For symptom scales, positive change from baseline = worsening in symptom from baseline to timepoint; negative change from baseline = improvement in symptom from baseline to timepoint.EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire; IPI, International Prognostic Index.At baseline: n=83 IPI 0-2 (except for social functioning and insomnia, n=82); n=56 IPI 3-4 (except for role functioning, n=55 For global health status and functional scales, positive change from baseline = improvement in health status / functioning from baseline to timepoint; negative change from baseline = worsening in health status / functioning from baseline to timepoint.For symptom scales, positive change from baseline = worsening in symptom from baseline to timepoint; negative change from baseline = improvement in symptom from baseline to timepoint.CM, concomitant medication.Key CM defined as corticosteroids for systemic use, analgesics, antiemetics and antinauseants, antibacterial for systemic use, and antihistamines for systemic use.At baseline: n=23 for no use of key CM; n=142 for use of key CM (except for insomnia, role functioning and social functioning, n=141).

Supplementary Table 8
Mean change from baseline to months 3, 6, 9, and 12 in EORTC QLQ-C30 domains stratified by presence of any medical event in patient history at baseline For global health status and functional scales, positive change from baseline = improvement in health status / functioning from baseline to timepoint; negative change from baseline = worsening in health status / functioning from baseline to timepoint.For symptom scales, positive change from baseline = worsening in symptom from baseline to timepoint; negative change from baseline = improvement in symptom from baseline to timepoint.At baseline: n=46 for no history of medical event (except for role functioning and insomnia, n=45); n=119 for history of medical event (except for social functioning, n=118 For symptom scales, positive change from baseline = worsening in symptom from baseline to timepoint; negative change from baseline = improvement in symptom from baseline to timepoint.EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire.At baseline: n=90 Stage I/II (except for insomnia, n=89); n=74 Stage III/IV (except for role and social functioning, n=73).

Table 2
Supplementary Table 1 EORTC QLQ-C30 functional subscales by domain and visit (FAS population) European Organization for Research and Treatment of Cancer quality of life questionnaire; FAS, full analysis set; SD, standard deviation.EORTC QLQ-C30 symptom scales by domain and visit (FAS population) European Organization for Research and Treatment of Cancer quality of life questionnaire; FAS, full analysis set; SD, standard deviation.

Table 3
Mean change from baseline to months 3, 6, 9, and 12 in EORTC QLQ-C30 domains stratified by age at baseline

Supplementary Table 6
Mean change from baseline to months 3, 6, 9, and 12 in EORTC QLQ-C30 domains stratified by IPI score at baseline