Multiple myeloma: patient outcomes in real-world practice.

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.

Multiple myeloma: practice patterns across Europe.

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.

Quality of life in adults with acute lymphoblastic leukemia in France: results from a French cross-sectional study.

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.

[Real-life study of 7-year survival in patients treated with trastuzumab for HER2+ early breast cancer]. / Étude en vie réelle de la survie à 7 ans des patientes traitées avec trastuzumab pour un cancer du sein précoce HER2.

BACKGROUND AND RATIONALE: 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). METHODS: 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. RESULTS: 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-]. CONCLUSIONS: 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.

The Healthcare Professionals' Perspective on Impact and Actions Taken Following Severe Infusion Reaction Events in Oncology Centers in Europe.

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.

Management of EGFR Inhibitor-induced Skin Toxicity and Factors Impacting Patients' Adherence to Skin Toxicity Treatment: Health Care Provider and Patient Surveys in European Oncology Centers.

INTRODUCTION: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Health-Related Quality of Life of Patients With Multiple Myeloma Treated in Routine Clinical Practice in France.

INTRODUCTION: 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. PATIENTS AND METHODS: 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). RESULTS: 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). CONCLUSION: Effective treatment options in MM can help maintain HRQoL by influencing treatment response levels and delaying disease progression.

Healthcare resource utilization among patients with relapsed multiple myeloma in the UK, France, and Italy.

AIMS: 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. METHODS: Retrospective medical chart review of characteristics, time to progression, level of response, HRU during treatment, and adverse events (AEs). Data collection started on June 1, 2015 and was completed on July 15, 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 the 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. RESULTS: Physicians provided data for 1,282 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. LIMITATIONS: 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. CONCLUSIONS: 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.

Making decisions on resectability and injectability status of lesions in the management of advanced melanoma in Germany, France and the UK.

There is anecdotal evidence of variation in the treatment of patients with metastatic melanoma. We aimed to describe the decision-making process physicians use to define resectability and injectability in patients with metastatic melanoma, and to identify patient characteristics associated with unresectable and injectable lesions. Physicians in Germany, France and the UK who manage patients with metastatic melanoma completed a questionnaire and case report forms on lesion resectability and injectability. In total, 122 physicians participated in the study, collecting data on 1,193 patients. Physicians' resection history was the main factor impacting their resection decisions; those who had frequently performed resections in the past were more likely to consider a lesion resectable than those who had rarely performed resections. A physician's decision to resect varied according to field of expertise; 46% of oncologists rarely performed resections, but this was the case for only 10% of dermatologists and 26% of dermato-oncologists. Another important factor affecting resectability status was the number of in-transit lesions; 49% of patients with three or more in-transit lesions were considered resectable compared with 73% of patients with fewer than three in-transit lesions. Lesion location impacted on injectability status; cutaneous and regional lymph node lesions were often considered injectable, whereas distant lesions in the bone, brain, lung, and liver were considered uninjectable. Assessment of resectability status was influenced by physicians' resection history; this varied according to field of expertise, and may reflect the lack of clear guidance on resection for patients with advanced melanoma.

[Satisfaction of Breast Cancer patients treated by chemotherapy outpatient clinics: Results of the TemporELLES survey]. / Satisfaction des patientes traitées par chimiothérapie en hôpital de jour pour un cancer du sein : résultats de l'enquête TemporELLES.

Three thousand eight hundred and twelve patients participated in the TemporELLES survey; these patients were treated for breast cancer with intravenous chemotherapy in 105 different outpatient clinics in France. The survey shows that patients spend on average 3hours in the outpatient clinic per chemotherapy session, which includes on average 50minutes of waiting time. Forty percent of patients would like to reduce this waiting time. Availability of new dosage forms and ready to use medications will address the need for reduced waiting time while freeing up time for providing support to the patients.

Perceptions in 7700 patients with rheumatoid arthritis compared to their families and physicians.

OBJECTIVE: To compare perceptions of patients with rheumatoid arthritis (RA) to those of their families and usual physicians regarding pain and subjective experience of the disease. METHODS: Questionnaires were mailed to patients listed in the files of a non-profit patient organization (Association Française des Polyarthritiques). Each patient, one family member (or close friend), and the usual physician were each asked to complete a questionnaire. Concordance among replies made by patients, family/friends, and physicians was evaluated using the kappa coefficient. RESULTS: Questionnaires were sent to 20,468 patients, among whom 7702 (38%) mailed back adequate data. The family member was usually the spouse (70%) and the usual physician a rheumatologist (68%). Joint pain was described by patients as variable (80%) and unpredictable (68%). Patients reported a need to push themselves (86%), frustration (86%), anxiety about possible disease progression (89%), and being prevented from making plans for the future (6%). A negative impact was reported on recreational activities (84%), work (56%), and family life and sexuality (51%). Concordance was excellent for pain severity (kappa>0.90) and good for the main joint-pain characteristics and experience of the disease (kappa>0.70), although family members tended to overestimate, and physicians to underestimate, the intensity of the pain. CONCLUSION: We found good overall agreement between perceptions of patients, their families, and their physicians, despite differences between these last two groups. Our qualitative analysis showed not only a major physical impact of the disease, but also marked negative psychosocial effects.

[Parcours de femmes 2001, a French survey on the management and needs of women with breast and gynecological cancer: what's new after 8 years?]. / Parcours de femmes 2001.

The aim of the survey Parcours de Femmes 2001 was to evaluate at a national level, the overall management of patients with breast or gynecological cancers and to determine their needs. Eligible patients had either received at least 3 months of treatment or had completed treatment less than 1 year before the study. from February to November 2001, 2 839 questionnaires were distributed ; 1 870 were returned (66% response rate); 87% of patients had breast cancer and 76% de novo cancer (primary management). Overall, 92% of women received information/explanations with an acceptable quality. Information of patients clearly improved during last years but insufficiencies persist for two points : adverse events of treatments and disease progression, especially for recurrent patients. Fatigue (78%), anxiety (66%) and chemotherapy adverse events were the most frequent problems and were well managed by caregivers, except for fatigue due to diagnostic and treatment difficulties. Problems relating to daily life (48% of patients reported difficulty in doing housework), material and social life were poorly identified and remained largely unmanaged. Information given to female cancer patients must be improved particularly in relapsed patients. Psychosocial management requires a more holistic approach through new channels together with the coordination of existing structures.