Quality of Life Evaluation in Patients with Follicular Cell Lymphoma: A Real-World Study in Europe and the United States.

INTRODUCTION: Follicular lymphoma (FL) is an indolent subtype of non-Hodgkin's lymphoma (NHL), characterized by a long natural course of remissions/relapses. We aimed to evaluate real-world quality of life (QoL) in patients with FL, by line of therapy (LOT), and across countries. METHODS: Data were drawn from the Adelphi FL Disease Specific Programme™, a cross-sectional survey of physicians and their patients in Europe [France, Germany, Italy, Spain, the United Kingdom (UK)], and the United States (US) from June 2021 to January 2022. Patients provided demographics and patient-reported outcomes via the European Organisation for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30). Bivariate analysis assessed QoL versus NHL, across LOT [first line (1L), second line (2L), third line or later (3L+)] and country. RESULTS: Patients (n = 401) had a mean [standard deviation (SD)] age of 66.0 (9.24) years, 58.1% were male, and 41.9%/22.9% were Ann Arbor stage III/IV. Patients with FL mean EORTC global health status (GHS)/QoL, nausea/vomiting, pain, dyspnea, appetite loss, and diarrhea scores were statistically significantly worse (p < 0.05) versus the NHL reference values. Mean (SD) GHS/QoL worsened from 1L [56.5 (22.21)] to 3L+ [50.4 (20.11)]. Physical and role functioning, fatigue, pain, dyspnea, and diarrhea scores also significantly worsened across later LOTs (p < 0.05). Across all functional domains, mean scores were significantly lower (p < 0.05) and almost all symptom scores (excluding diarrhea) were significantly higher (p < 0.05) for European versus US patients. CONCLUSIONS: Patients with FL at later LOTs had significantly worse scores in most QoL aspects than earlier LOTs. European patients had significantly lower functioning and higher symptom burden than in the US. These real-world findings highlight the need for novel FL therapies that alleviate patient burden, positively impacting QoL.

There is little information about the effects of follicular lymphoma and treatments on quality of life as assessed by patients. We surveyed doctors and their patients with follicular lymphoma across France, Germany, Italy, Spain, the United Kingdom, and the United States (US), and asked patients to complete a form reporting their quality of life. A total of 401 patients were included.In general, patients with follicular lymphoma treated across all lines of treatment had worse quality of life and symptoms of nausea and vomiting, pain, shortness of breath, appetite loss, and diarrhea compared to a reference group of patients with non-Hodgkin's lymphoma (NHL). Overall quality of life and physical, role, and social functioning of patients with follicular lymphoma worsened from the first to the third line of treatment. Fatigue, pain, dyspnea, and diarrhea symptom scores also worsened across the lines of therapies. European patients had worse quality of life, functioning, and symptoms compared to US patients. Better treatments are needed to improve symptoms, functions, and quality of life for patients with follicular lymphoma.

Incurable but treatable: Understanding, uncertainty and impact in chronic blood cancers-A qualitative study from the UK's Haematological Malignancy Research Network.

OBJECTIVE: Most blood cancers are incurable and typically follow unpredictable remitting-relapsing pathways associated with varying need for treatment, which may be distressing for patients. Our objective was to conduct a qualitative study to explore understanding among patients with such malignancies, including the explanations given by HCPs and the impact of uncertain trajectories, to generate evidence that could guide improvements in clinical practice. METHODS: The study is set within a population-based patient cohort (the Haematological Malignancy Research Network), in which care is delivered across 14 hospitals according to national guidelines. In-depth interviews were conducted with 35 patients with chronic lymphocytic leukaemia, follicular lymphoma, marginal zone lymphoma or myeloma; and 10 accompanying relatives. Purposive sampling ensured selection of information-rich participants and the data were interrogated using reflective thematic analysis. RESULTS: Rich data were collected and four themes (11 sub-themes) were identified: 1) Knowledge and understanding of chronic haematological malignancies; 2) Incurable but treatable; 3) Uncertainty about the future; and 4) Treatable (but still incurable): Impact on patients. Patients had rarely heard of blood cancer and many expressed difficulty understanding how an incurable malignancy that could not be removed, was treatable, often for long periods. While some were reassured that their cancer did not pose an immediate survival threat, others were particularly traumatised by the uncertain future it entailed, suffering ongoing emotional distress as a result, which could be more burdensome than any physical symptoms. Nonetheless, most interviewees understood that uncertain pathways were caused by the unpredictability of their disease trajectory, and not information being withheld. CONCLUSIONS: Many participants lacked knowledge about chronic haematological malignancies. HCPs acted to reassure patients about their diagnosis, and while this was appropriate and effective for some, it was less so for others, as the cancer-impact involved struggling to cope with ongoing uncertainty, distress and a shortened life-span.

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.

Health-related quality of life was a secondary endpoint in the phase III GALLIUM study in previously untreated patients with follicular lymphoma who were treated with rituximab- or obinutuzumab-chemotherapy. Patients were randomized 1:1 to receive induction therapy with obinutuzumab- or rituximab-chemotherapy and maintenance in responders. Health-related quality of life was assessed using the Functional Assessment of Cancer Treatment-Lymphoma questionnaire, incorporating well-being and lymphoma-specific subscales. Assessments were performed at baseline, and during induction, maintenance, and follow-up (maximum 84 months). Clinically meaningful responses were defined by minimally important difference values. Of 1202 randomized patients (median follow-up 57.4 months), 557/601 (92.7%; obinutuzumab-chemotherapy) and 548/601 (91.2%; rituximab-chemotherapy) completed all Functional Assessment of Cancer Treatment-Lymphoma scales at baseline. Mean baseline health-related quality of life scores were similar between both arms, with all patients having some functional impairment and lymphoma symptoms. Over the course of treatment, mean health-related quality of life remained similar in both arms. Equal proportions of patients in both arms achieved minimally important difference by the Functional Assessment of Cancer Treatment-Lymphoma lymphoma-specific subscale and summary scales throughout induction, maintenance, and follow-up. On each summary scale, ~ 50% of patients in each arm achieved minimally important difference by maintenance month 2. In GALLIUM, similar improvements in health-related quality of life were seen with obinutuzumab- and rituximab-chemotherapy, suggesting that both treatments reduced lymphoma-related symptoms, and treatment-related side effects did not abrogate these improvements in well-being. ClinicalTrials.gov identifier: NCT01332968.

The Myeloma Patient Outcome Scale is the first quality of life tool developed for clinical use and validated in patients with follicular lymphoma.

OBJECTIVES: The development of novel agents and an ageing population has led to an increasing number of patients with follicular lymphoma (FL) living longer with their disease. Health-related quality of life (HRQOL) is a priority for patients and should guide clinical decisions. The Myeloma Patient Outcome Scale (MyPOS), originally developed for myeloma, was validated in a cross-sectional survey recruiting 124 FL patients. METHODS: Content and construct validity, structural validity using confirmatory factor analyses, reliability and acceptability were evaluated. RESULTS: Three subscales were indicated: symptoms and function, emotional response, and healthcare support. MyPOS symptom and function scores were higher (worse) in participants with poorer ECOG performance status (F=26.2, P<.000) and discriminated between patients on and off treatment. Good convergent and discriminant validity in comparison to the EORTC-QLQ-C30 and FACT-Lym were demonstrated. Internal consistency was good; α coefficient 0.70-0.95 for the total MyPOS score and subscales. CONCLUSION: The MyPOS is valid, reliable and acceptable, and can be used to support clinical care of FL patients. This is the first measurement tool developed specially for use in clinical practice that has been validated for use in people with FL. Further longitudinal validation is now required to support its use in outcome measurement.

Impact of therapy and disease-related symptoms on health-related quality of life in patients with follicular lymphoma: results of the population-based PHAROS-registry.

OBJECTIVES: The increasing number of longer living patients with follicular lymphoma (FL) and serious side effects of treatment urged us to study the health-related quality of life (HRQoL) and persistent (treatment-related) symptoms in unselected patients after different treatment modalities and compare HRQoL of patients with a normative population. METHODS: The population-based Eindhoven Cancer Registry was used to select patients diagnosed with FL during 2004-2010. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was completed twice, with a 1-yr interval. This questionnaire was also completed by an age- and sex-matched normative population (N = 580). Detailed data on treatment were extracted from the cancer registry and Population-based HAematological Registry for Observational Studies (PHAROS). RESULTS: Of the 181 patients who were invited, 148 responded (82%, T1). Patients treated with immunochemotherapy reported clinically relevant higher mean fatigue scores than those who underwent radiotherapy (P = 0.02). No differences were observed on the other HRQoL scales between treatment groups. Mean HRQoL scores were worse for FL patients treated with immunochemotherapy compared with a normative population (P < 0.01). A quarter to 50% of patients persistently reported to be slowed down, lethargic, or persistently worried about future health or was limited in social activities. Subsequently, patients reporting these symptoms/worries had a lower global health status/HRQoL. CONCLUSION: Alertness for persistent symptoms that occur during and after treatment of FL patients is needed and may help to avoid lasting negative influence on their HRQoL.

Delusional disorder and oncology: review of the literature and case report.

OBJECTIVE: Delusional disorder is an infrequent diagnosis in outpatient clinical practice. While delusional thought processes are a fairly common part of symptom clusters in chronic psychiatric disorders such as schizophrenia and bipolar disorders, true delusional disorders are believed to be fairly rare. METHOD: In this article, we review scientific data on incidence, diagnosis, and treatment of delusional disorders. This was done by PubMed search utilizing the search terms "delusional disorder," "oncology," "diagnosis," and "treatment." Relevant articles were excluded if they dealt predominantly with schizophrenia instead of primary delusional disorder. RESULTS: We present a case of a patient diagnosed with follicular lymphoma and an apparent longstanding history of persecutory delusions. The patient's symptoms eventually led to intervention in the oncology practice involving the medical center faculty and staff, as well as local police and the court system. CONCLUSIONS: Delusional disorder is an under-researched condition, and limited information is known regarding the treatment of this condition when it impacts upon medical care. Future research directions are proposed.

Decision making and distress among individuals diagnosed with follicular lymphoma.

Follicular lymphoma (FL) is an indolent lymphoma that generally responds well to treatment. However, individuals with FL commonly face multiple complex treatment decision-making (TDM) experiences because it frequently follows a relapsing and remitting course. This study explored TDM and distress among individuals with FL (N = 32). Results indicated that most participants reported little decisional conflict or regret and wanted to be actively involved in TDM. However, more than 25% of participants reported clinically-relevant cancer-specific distress, and 60% indicated moderate or higher anxiety symptoms. Research is needed to clarify the cause and course of the psychological distress revealed in this study.

The impact of high-dose chemotherapy, autologous stem cell transplant and conventional chemotherapy on quality of life of long-term survivors with follicular lymphoma.

In this study we investigated the quality of life (QoL) of long-term survivors with follicular lymphoma (FL) after high-dose chemotherapy (HDCT) and autologous stem cell transplant (ASCT) using two standardized questionnaires. Altogether, 124 patients with FL were included in the study. A total of 63 patients received HDCT with ASCT, and this group was compared with 61 patients who were treated with rituximab and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy and supplementary radiation. In addition, the QoL of the patients was compared to the QoL of healthy people on the basis of two studies about the general health status of the German population. When the QoLs of the HDCT group and the conventional therapy group were compared, there was a tendency for better QoL in the HDCT group, maybe due to a higher proportion of patients in complete remission (CR) or a longer follow-up period in the HDCT group (8.5 years vs. 4.5 years in the conventional therapy group). In both the HDCT group and the conventional therapy group, the results of the questionnaires showed a reduced QoL compared to the healthy population. In this study, there was a tendency for better QoL in the HDCT group compared to the conventional therapy group. However, the negative impact of both HDCT and conventional therapy on the QoL of patients with follicular lymphoma should not be underestimated and should lead to the development of less toxic therapy strategies.

The impact of follicular (FL) and other indolent non-Hodgkin's lymphomas (NHL) on work productivity-a preliminary analysis.

INTRODUCTION: Although much is known about the efficacy, toxicity, and direct costs of treatment for follicular lymphoma (FL), there is no data assessing the impact of this diagnosis on the work productivity of affected individuals. METHODS: We conducted a cross-sectional survey study of consecutive patients attending a malignant haematology clinic at a large multi-disciplinary cancer centre. Patients with a diagnosis of FL or other indolent non-Hodgkin's lymphoma completed questionnaires assessing health status, work productivity, and activity impairment. RESULTS: Eighty-four patients completed the survey study (95% response). Patients who continued to work reported a minimal impact on their work productivity (10%+/-standard deviation SD 20; 0%=no effect and 100%=complete impairment of activity) and on their daily activities (13%+/-SD 25) attributable to their cancer. Prior to lymphoma diagnosis, over 71% of patients were working while 14% were retired. At the time of survey administration, only 41% of patients were still able to work with a significant proportion of patients having transitioned to retirement (36%), sick leave (10%), or unemployment (4%). On multivariate analysis, significant activity impairment (daily activity impairment>50%) was predicted by poor self-rated health status (OR 32.1; 95% CI: 5.9-174.2; p<0.0001) and active chemotherapy treatment (OR 14.5; 95% CI: 0.91-230.9; p=0.059). CONCLUSIONS: Although few patients with indolent lymphoma identified significant impairment in productivity, many were unable to continue employment following diagnosis, needed to miss days from work, or imposed a significant burden on caregivers. The greatest impact on activity is apparent in patients who rate their health status as poor and in those who are currently receiving systemic therapy.

Patient benefits of maintenance immunotherapy.

Rituximab maintenance therapy after effective induction has been shown to prolong progression-free and even overall survival, compared with no further treatment until relapse, in randomized, prospective phase III clinical trials in follicular lymphoma. In addition, the use of rituximab maintenance therapy is likely to have an important psychological and emotional impact for many patients. Currently, all patients are expected to relapse eventually following induction treatment: the knowledge that they are being actively treated to delay relapse for as long as possible may provide significant reassurance and emotional support. Similarly, the experience of relapse itself is also likely to be a traumatic event for patients: reducing the frequency of relapse with rituximab maintenance may thus spare patients some of this trauma. Overall, therefore, rituximab maintenance therapy might be expected to improve quality of life for patients with follicular lymphoma over and above the observed clinical benefits in progression-free and overall survival. At present, however, this can only be speculated from observations and experience. Formal quality-of-life and patient preference assessments will be required to demonstrate this conclusively.

A nurse's experience of isolation.

A nurse specialist in infection control, describes how it felt to be on the receiving end of protective isolation.