Summary
With increasing number of therapies available for the treatment of multiple myeloma, it is timely to examine the course of patients' journeys. We investigated patient characteristics, ...treatment durations and outcomes, and symptom burden across the treatment pathway in Belgium, France, Germany, Italy, Spain, Switzerland and the UK. In total, 435 physicians retrospectively reviewed 4997 patient charts. Profiles of patients diagnosed with multiple myeloma during the last 12 months were similar across countries; bone pain was the most common presentation. Median duration of first‐line therapy was 6 months, followed by a median treatment‐free interval of 10 months; both these decreased with increasing lines of therapy, as did time to progression. Depth of response, as assessed by the treating physician, also decreased with each additional line of therapy: 74% of patients achieved at least a very good partial response at first line, compared with only 11% at fifth line. Deeper responses were associated with longer time to progression, although these were physician‐judged. Toxicities and co‐morbidities increased with later treatment lines, and were more likely to have led to discontinuation of treatment. These real‐world data provide an insight into patient outcomes and treatment decisions being made in clinical practice.
Summary
Real‐world data describing management of patients with multiple myeloma are limited. A European (Belgium, France, Germany, Italy, Spain, Switzerland, UK) observational chart review was ...conducted to address this. Physicians completed questionnaires for every patient seen during a 2–4‐week observation period, regardless of treatment status. A total of 435 physicians completed 7635 cross‐sectional chart reviews. Overall, 47% of patients were undergoing anti‐tumour drug treatment, 42% had previously received ≥1 line of treatment and 12% had never received anti‐tumour drug treatment. Of the patients treated by oncologists, onco‐haematologists or internists, 95% received, or were expected to receive, at least one line of anti‐tumour drug treatment, 61% received ≥2 lines of therapy and 38% received ≥3 lines. Except in the UK, the most commonly used induction therapies contained bortezomib (48%); lenalidomide was the most commonly used first‐line maintenance therapy (45%) and second‐ and third‐line agent overall (60% and 52% of patients at those lines, respectively). Bortezomib retreatment was used in 47% of patients who received it first line. Treatment patterns became more diverse with subsequent treatment lines. This study provides insight into real‐world treatment patterns in Europe. While treatment practices are broadly similar across countries, some notable differences in the agents used exist.
Purpose
The study aim was to describe the management strategies used for severe infusion-related reactions (SIRs) and understand the impact of such events in oncology day hospitals in France, ...Germany, Spain, and the UK.
Methods
The study was based on qualitative telephone interviews and quantitative self-completion questionnaires and asked healthcare professionals about the impact of SIRs and consequent actions taken.
Results
The procedures to prevent and manage SIRs were similar across countries and settings. In all countries, they were part of a larger risk-assessment and adverse events-prevention process. Preventive measures included patient history, risk assessment, pre-medication, and close monitoring of high-risk patients. The management procedures comprised stopping the infusion, triggering of the emergency chain, administering corticosteroids ± antihistamines, and hospitalization if necessary. The recalled SIRs had important consequences to affected patients, healthcare providers, and hospital organizational plans. All affected patients needed to be monitored closely for a prolonged time, thus blocking hospital beds. 44% of patients needed to be hospitalized, 17% needed resuscitation, and one patient died of cardiac arrest immediately after the start of the infusion. Importantly, 82% of patients were not re-challenged with the presumedly SIR-causing regimen or re-challenged in a later line.
Conclusion
SIRs are unpredictable in nature, may have an extremely rapid onset, and are potentially fatal. Such events have a profound impact on the affected and surrounding patients, the care team and the organizational plan of the day-hospitals. Specific tools to reliably identify high-risk patients and predict the occurrence of events are needed.
Introduction: In adult patients with acute lymphoblastic leukemia (ALL), the presence of a minimal residual disease (MRD+), defined as the persistence of tumoral cells at a submicroscopic level, is ...widely recognized as the most sensitive prognostic factor for relapse and death regardless of treatment choice and risk classification. Although ALL specific treatment guidelines and protocols recommend MRD testing, there is little published literature on how the MRD status would impact on the quality of life (QoL) of adult patients with ALL. This research study aims to describe and assess the impact of MRD status on QoL of different subgroup of adult patients with ALL.
Methods: In this French, multi-center, non-interventional, cross-sectional study, a retrospective section consisted of collecting sociodemographic and clinical data extracted from patient medical records of enrolled patients, and a prospective section comprised the following 3 patient reported outcome (PRO) questionnaires that patients completed: the “EuroQol-five-dimensions-3 levels” questionnaire (EQ-5D-3L, a generic PRO from the European Quality-of-life EuroQol group), the “Quality of Life Questionnaire - Core 30” (QLQ-C30 , a cancer-specific PRO from the European Organization for Research and Treatment of Cancer EORTC), and the “Functional Assessment of Cancer Therapy-Leukemia” questionnaire (FACT-Leu, a leukemia-specific PRO from the Functional Assessment of Chronic Illness Therapy FACIT). Adult patients with ALL seen during the inclusion period, regardless of treatment setting and status were enrolled in this Study through hematologists who participated in the study.
Results: The study enrolled 221 patients and the analysis was performed on 151 patients who have data on last MRD status. Only 28 patients were MRD+. Median age at the time of inclusion was 57 years (range: 21-83) for MRD+ patients and 53 years (range:19-79) for MRD- patients, 61% and 62% were male, respectively. Median time from diagnosis was 0.5 years and 2.2 years and median age at diagnosis was 53.0 years (range: 5-83) and 48.8 years (range: 5-79), respectively. Less than 40% of the patients received a HSCT prior to inclusion. Most patients (91.9%) who were MRD- at the last testing had an ECOG score 0-1, compared with 71.4% MRD+ patients. More MRD- than MRD+ patients were receiving a frontline therapy (82.1% vs 60.7%) and nearly all (98.4%) MRD- patients had reached a CR at the time of inclusion in this study (vs 50.0% MRD+ patients).
Results on all PROs (EQ-5D-3L, QLQ-C30 and FACT-Leu questionnaires) were consistent, showing a lower QoL score in MRD+ patients compared with MRD- patients (Table 1)
Using EQ-5D-3L, a higher proportion of patients with MRD+ reported at least one problem that impacted “usual activities”, “pain/discomfort” and “selfcare” dimensions; no differences were seen between MRD+ and MRD- patients on “mobility” and “anxiety/depression” dimensions. Using QLQ-C30, symptoms scales and 3 single items (“dyspnea”, “insomnia” and “appetite loss”) were higher in patients with MRD+ at the last testing than in patients with MRD-, representing a higher level of symptomatology/problems in this group. Using FACT-Leu, all primary QoL domains (except for “social/family well-being” domain) were lower in patients with MRD+ than in patients with MRD-.
Conclusions: This study shows that QoL is impaired in patients with MRD+.
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Kutikova:Amgen: Employment. Makhloufi:Amgen (France) SAS: Employment. Chauny:Amgen (France) SAS: Employment. Désaméricq:Amgen (France) SAS: Employment.
Health-related quality of life (HRQoL) is an important consideration in the management of multiple myeloma (MM); however, real-world data are lacking. This observational study assessed the ...associations between treatment factors and HRQoL. Higher HRQoL scores were associated with good treatment response, few adverse events, and longer treatment duration. Effective MM treatments can therefore help improve and sustain HRQoL.
New therapies for multiple myeloma (MM) have improved life expectancy, but health-related quality of life (HRQoL) data from patients with MM in the real-world setting are lacking. This study, conducted in France, explored the associations between treatment outcomes and HRQoL in patients with MM.
This observational, cross-sectional, multicenter study enrolled patients (≥ 18 years old) with symptomatic MM who had consulted a physician at least once between February and March 2016. HRQoL was assessed using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire (QLQ-C30) and the Quality of Life Multiple Myeloma module (QLQ-MY20).
In total, 445 patients were included in the study; 402 (90%) completed the EORTC QLQ-C30 and QLQ-MY20 questionnaires. HRQoL decreased significantly with treatment line. Patients in the first treatment-free interval had relatively high scores. At later lines, patients receiving active treatment had better scores than those whose treatment had ended. High EORTC QLQ-C30 global health status scores were associated with good treatment response, few adverse events, and long duration of treatment, and were strongly influenced by the Eastern Cooperative Oncology Group performance status. Global health status scores correlated well with the 4 items of the QLQ-MY20 (future perspective, 0.46; body image, 0.41; disease symptoms, −0.57; side effects of treatment, −0.53).
Effective treatment options in MM can help maintain HRQoL by influencing treatment response levels and delaying disease progression.
Bien que la mise à disposition du trastuzumab ait considérablement amélioré le pronostic des cancers du sein précoces HER2+, des récidives sont observées notamment dans certains sous-groupes de ...patientes. L’objectif de cette étude en vie réelle menée en France est d’évaluer à sept ans la survie sans maladie (DFS) et la survie sans métastases à distance (MFS).
Il s’agit d’une étude observationnelle rétrospective multicentrique documentant les patientes ayant reçu trastuzumab en adjuvant pour un cancer du sein précoce HER2+ diagnostiqué entre le 1er janvier 2009 et le 31 décembre 2010. La DFS et la MFS ont été évaluées en fonction du statut hormonal et de l’atteinte ganglionnaire.
Parmi les 2311 patientes documentées, l’analyse à sept ans de la DFS et de la MFS selon l’existence (N+) ou non (N−) d’une atteinte ganglionnaire montre des différences significatives p<0,001 : à sept ans, la DFS est 66,8 % chez les N+ vs 87,2 % pour les N− et la MFS de 74,9 % pour les N+ vs 94,7 % pour les N−. Selon le statut hormonal, négatif (RH−) ou positif (RH+), les différences sont également significatives p<0,001 : à sept ans, la DFS est de 69,2 % dans le sous-groupe RH− vs 80,5 % pour le RH+, tandis que la MFS est estimée dans les RH− à 77,7 % vs 88,0 % ; pour les RH+.
Malgré l’amélioration du pronostic des cancers du sein précoces HER2+, les patientes N+ ou RH− présentent un risque élevé de récidive métastatique à sept ans et justifiant la recherche d’alternatives thérapeutiques plus efficaces.
Despite improved prognosis of HER2 since the introduction of trastuzumab in the adjuvant setting of early breast cancer, disease recurrences still occur, particularly in certain patient subgroups. The objective of this real-life study conducted in France is to evaluate after 7 years, disease-free survival (DFS) and distant metastatic-free survival (MFS).
This was a multi-center, retrospective, observational study assessing early HER2+ breast cancer patients diagnosed between January 1st, 2009 and December 31st, 2010 treated with adjuvant trastuzumab. DFS and MFS were evaluated within subgroups according to hormonal and nodal status.
Based on 2311 patients documented, according to nodal status, the 7-year DFS rate was significantly higher for N− than for N+ patients 87.2% vs. 66.8%; P<0.001, and the 7-year MFS rate 94.7% for N− vs. 74.9% for N+; P<0.001. According to hormonal status, the 7-year DFS rate was significantly higher for HR+ than for HR− patients 80.5% vs. 69.2%; P<0.001, and the 7-year MFS rate 88.0% for HR+ vs. 77.7% HR−.
Despite the overall improvement in the prognosis of early HER2+ breast cancers, patients in the N+ and RH− subgroups have a high risk of metastatic recurrence at seven years, justifying the search for more effective treatment alternatives.
This study aimed to provide a description of existing measures for the prevention and management of epidermal growth factor receptor inhibitor monoclonal antibody-induced skin toxicities and factors ...impacting patients’ adherence to those measures in France, Germany, and Spain.
The study consisted of 2 separate surveys. Health care professionals (HCPs; oncologists and nurses) in France, Germany, and Spain were interviewed, and patients with metastatic colorectal cancer and head-and-neck cancer in France and Germany self-completed questionnaires. The study was conducted between February and July 2018.
A total of 53 oncologists, 44 nurses, and 143 patients participated in the study. HCPs stated that skin toxicities moderately (52%) or severely (28%) impacted patient care. Ninety percent of HCPs reported routine provision of prophylactic measures. The great majority of patients self-reported adherence with the prophylactic (80% to 88% depending on the type of measures) and reactive (93% to drug prescription) skin toxicity recommendations. HCPs estimated patient adherence to be 45% for full adherence and 40% for partial adherence. Most HCPs reported a positive or very positive impact of preventive measures and recommendations on skin toxicity incidence and severity, patients' quality of life, and various aspects of quality of anti-cancer treatment.
Skin toxicities are an important adversity negatively impacting on patient care. However, despite the positive perception of the effectiveness of skin toxicity prophylaxis, almost one-third of oncology centers did not provide formal guidelines, and 10% of HCPs did not provide routine prophylactic measures. Patient adherence appears to be high for epidermal growth factor receptor inhibitor monoclonal antibody-induced skin toxicity prevention measures.
Certain drugs used to treat metastatic colorectal cancer may induce skin toxicities. Doctors, nurses, and patients were interviewed to understand how skin toxicities are managed within oncology centers in Europe. About one-third of centers did not provide formal guidelines, but patients’ adherence to recommended measures such as patient education and the prescription of skin ointments appears to be high.
In recent years, treatment of acute lymphoblastic leukemia (ALL) has improved substantially, leading to longer survival. This has necessitated a greater focus on health-related quality of life ...(HRQoL), but data are lacking. In a part-prospective, part-retrospective study, we enrolled 219 adults with ALL in France to assess the impact of key disease and treatment characteristics on HRQoL. Overall HRQoL and most specific QoL domain scores were consistently better among patients receiving front-line therapy, those currently in complete remission, and those who had previously received hematopoietic stem-cell transplantation. Furthermore, HRQoL was consistently impaired in patients with minimal residual disease present (MRD+). In multivariate analyses, multiple lines of therapy, MRD+, leukopenia, comorbidities, and anemia were significantly associated with impaired HRQoL. This study provides real-world data on HRQoL in adults with ALL in France and shows the positive impact of MRD-negative status on HRQoL.
Celotno besedilo
Dostopno za:
DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
To assess the real-world healthcare resource utilization (HRU) and costs associated with different treatment regimens used in the management of patients with relapsed multiple myeloma in the UK, ...France, and Italy.
Retrospective medical chart review of characteristics, time to progression, level of response, HRU during treatment, and adverse events (AEs). Data collection started on 1 June 2015 and was completed on 15 July 2015. In the 3 months before record abstraction, eligible patients had either disease progression after receiving one of their country's most commonly prescribed regimens or had received best supportive care and died. Costs were calculated based on HRU and country-specific diagnosis-related group and/or unit reference costs, amongst other standard resources.
Physicians provided data for 1282 patients (387 in the UK, 502 in France, 393 in Italy) who met the inclusion criteria. Mean median total healthcare costs associated with a single line of treatment were €51,717 35,951 in the UK, €37,009 32,538 for France, and €34,496 42,342 for Italy, driven largely by anti-myeloma medications costs (contributing 95.0%, 90.0%, and 94.2% of total cost, respectively). During active treatment, the highest costs were associated with lenalidomide- and pomalidomide-based regimens. Mean cost per month was lowest for patients achieving a very good partial response or better. Unscheduled events (i.e., not considered part of routine management, whether or not related to multiple myeloma, such as unscheduled hospitalization, AEs, fractures) accounted for 1%-9% of total costs and were highest for bendamustine.
The use of retrospective data means that clinical practice (e.g. use of medical procedures, evaluation of treatment response) is not standardized across participating countries/centers, and some data (e.g., low-grade AEs) may be incomplete or differently adjudicated/reported. The centers involved may not be fully representative of national practice.
Drug costs are the main contributor to total HRU costs associated with multiple myeloma. The duration of active treatment may influence the average total costs, as well as response, associated with a single line of therapy. Improved treatment outcomes, and reductions in unscheduled events and concomitant medication use may, therefore, reduce the overall HRU and related costs of care in multiple myeloma.
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