PURPOSE: The study sought to understand the experiences of working age adults with myeloma and their partner/family members, living in Czechia, Germany, and Poland. METHODS: Qualitative interviews were conducted with 36 working age adults living with myeloma, and three family members. Data were collected from May to October 2022. Thematic analysis was applied to the data. RESULTS: Healthcare and state support within each country are described. The degree of work engagement was informed by patients' symptom burden, treatment needs, state financial aid, and family/financial obligations. Many did not conceptualise their status as involving 'return to work' as they had continued to be engaged with their jobs throughout. For some, remote working enabled them to manage treatments/side-effects and their job, while avoiding infection. In some cases, patients did not tell their employer or colleagues about their illness, for fear of discrimination. CONCLUSION: While experiences varied between countries, common across accounts was a struggle to balance ongoing treatments with employment, at a time when participants were expected to finance their own households and maintain their income and roles. Implications for Cancer Survivors To improve quality of life, clinical discussions around treatment decision-making should take into account patients' attitudes/approach to work, type of work engaged in, and other activities considered important to them. European Union and national cancer plans should set out optimum standards for employers, to ensure an equitable benchmark for how employees are supported. Such approaches would improve legal protections and better enforcement of employer policies to accommodate patients' limitations in the workplace.
- Klíčová slova
- Disclosing diagnosis, Discrimination, Myeloma, Support, Work,
- MeSH
- dospělí MeSH
- kvalita života * MeSH
- kvalitativní výzkum MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom * psychologie terapie epidemiologie mortalita MeSH
- přežívající onkologičtí pacienti * psychologie statistika a číselné údaje MeSH
- rozhovory jako téma MeSH
- zaměstnanost * statistika a číselné údaje MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika epidemiologie MeSH
- Německo epidemiologie MeSH
- Polsko epidemiologie MeSH
BACKGROUND: Daratumumab, an anti-CD38 monoclonal antibody, has been approved for the treatment of multiple myeloma. Data are needed regarding the use of daratumumab for high-risk smoldering multiple myeloma, a precursor disease of active multiple myeloma for which no treatments have been approved. METHODS: In this phase 3 trial, we randomly assigned patients with high-risk smoldering multiple myeloma to receive either subcutaneous daratumumab monotherapy or active monitoring. Treatment was continued for 39 cycles, for 36 months, or until confirmation of disease progression, whichever occurred first. The primary end point was progression-free survival; progression to active multiple myeloma was assessed by an independent review committee in accordance with International Myeloma Working Group diagnostic criteria. RESULTS: Among the 390 enrolled patients, 194 were assigned to the daratumumab group and 196 to the active-monitoring group. With a median follow-up of 65.2 months, the risk of disease progression or death was 51% lower with daratumumab than with active monitoring (hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.67; P<0.001). Progression-free survival at 5 years was 63.1% with daratumumab and 40.8% with active monitoring. A total of 15 patients (7.7%) in the daratumumab group and 26 patients (13.3%) in the active-monitoring group died (hazard ratio, 0.52; 95% CI, 0.27 to 0.98). Overall survival at 5 years was 93.0% with daratumumab and 86.9% with active monitoring. The most common grade 3 or 4 adverse event was hypertension, which occurred in 5.7% and 4.6% of the patients in the daratumumab group and the active-monitoring group, respectively. Adverse events led to treatment discontinuation in 5.7% of the patients in the daratumumab group, and no new safety concerns were identified. CONCLUSIONS: Among patients with high-risk smoldering multiple myeloma, subcutaneous daratumumab monotherapy was associated with a significantly lower risk of progression to active multiple myeloma or death and with higher overall survival than active monitoring. No unexpected safety concerns were identified. (Funded by Janssen Research and Development; AQUILA ClinicalTrials.gov number, NCT03301220.).
- MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- doutnající mnohočetný myelom * diagnóza mortalita terapie MeSH
- injekce subkutánní MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom * diagnóza epidemiologie prevence a kontrola MeSH
- monoklonální protilátky * aplikace a dávkování škodlivé účinky MeSH
- pozorné vyčkávání * statistika a číselné údaje MeSH
- progrese nemoci MeSH
- protinádorové látky * aplikace a dávkování škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- daratumumab MeSH Prohlížeč
- monoklonální protilátky * MeSH
- protinádorové látky * MeSH
- MeSH
- lidé MeSH
- mnohočetný myelom * epidemiologie terapie MeSH
- rizikové faktory MeSH
- věkové faktory MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- dopisy MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Skandinávie a severské státy epidemiologie MeSH
Smoldering multiple myeloma (SMM) is an asymptomatic precursor to active multiple myeloma (MM). The aim of this study was to report clinical characteristics and outcomes of patients with SMM stratified based on their risk of progression to MM using the Mayo 20/2/20 criteria. Data were leveraged from the Czech Myeloma Group Registry of Monoclonal Gammopathies (RMG). Key outcomes included progression-free survival from SMM diagnosis to active MM diagnosis or death (PFS), progression-free survival from SMM diagnosis to progression on first line (1 L) MM treatment or death (PFS2), and overall survival (OS). Of 498 patients, 174 (34.9%) were classified as high risk and 324 (65.1%) as non-high risk. Median follow-up was approximately 65 months. During follow-up, more patients in the high-risk vs non-high-risk group received 1 L MM treatment (76.4% vs 46.6%, p < 0.001). PFS, PFS2, and OS were significantly shorter in high-risk vs non-high-risk patients (13.2 vs 56.6 months, p < 0.001; 49.9 vs 84.9 months, p < 0.001; 93.2 vs 131.1 months, p = 0.012, respectively). The results of this study add to the growing body of evidence that patients with high-risk vs non-high-risk SMM have significantly worse outcomes, including OS.
- MeSH
- doba přežití bez progrese choroby MeSH
- doutnající mnohočetný myelom * diagnóza epidemiologie terapie MeSH
- lidé MeSH
- mnohočetný myelom * diagnóza epidemiologie terapie MeSH
- registrace MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Česká republika epidemiologie MeSH
Studies of survival in hematological malignancies (HMs) have generally shown an improvement over time, although most of these studies are limited by a short follow-up period. Using the NORDCAN database with data from Denmark, Finland, Norway and Sweden, we follow periodic increases in relative survival in seven HMs through half a century up to 2015-2019. Five-year survival improved in all seven HMs, reaching 90% for Hodgkin lymphoma (HL), myeloproliferative neoplasias and chronic lymphocytic leukemia (CLL), 60% for multiple myeloma (MM) and chronic myeloid leukemias (CMLs), 50% for the myelodysplastic syndromes and 30% for acute myeloid leukemia (AML). Improvements in survival over 50 years ranged from 20% to more than 50% units across the different HMs. The likely reasons for such progress include earlier diagnoses, improved risk stratification and advances in treatment. We observed differing temporal trends in improvements in survival. The gradual increases observed in HL, CLL and AML highlight the impact of optimization of existing therapies and improvements in diagnostics and risk stratification, whereas the rapid increases observed in the CMLs and MM highlight the impact of novel therapies. Recent therapeutic advances may further improve survival in HMs where survival remains low such as in AML.
- MeSH
- akutní myeloidní leukemie * terapie MeSH
- chronická lymfatická leukemie * MeSH
- hematologické nádory * epidemiologie terapie MeSH
- Hodgkinova nemoc * MeSH
- lidé MeSH
- mnohočetný myelom * epidemiologie terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Skandinávie a severské státy epidemiologie MeSH
Multiple myeloma (MM) is a hematological malignancy caused by the clonal expansion of plasma cells. The incidence of MM worldwide is increasing with greater than 140 000 people being diagnosed with MM per year. Whereas 5-year survival after a diagnosis of MM has improved from 28% in 1975 to 56% in 2012, the disease remains essentially incurable. In this review, we summarize our current understanding of MM including its epidemiology, genetics and biology. We will also provide an overview of MM management that has led to improvements in survival, including recent changes to diagnosis and therapies. Areas of unmet need include the management of patients with high-risk MM, those with reduced performance status and those refractory to standard therapies. Ongoing research into the biology and early detection of MM as well as the development of novel therapies, such as immunotherapies, has the potential to influence MM practice in the future.
- Klíčová slova
- clinical presentation, plasma cell disease, risks factors, survival, treatment,
- MeSH
- cyklin D1 genetika MeSH
- exozom genetika MeSH
- genetická predispozice k nemoci MeSH
- histondemethylasy genetika MeSH
- imunoterapie metody MeSH
- lidé MeSH
- míra přežití MeSH
- mnohočetný myelom diagnóza epidemiologie genetika terapie MeSH
- mutace MeSH
- nádorové biomarkery genetika MeSH
- plazmatické buňky imunologie patologie MeSH
- represorové proteiny genetika MeSH
- rizikové faktory MeSH
- transkripční elongační faktory genetika MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- přehledy MeSH
- Názvy látek
- CCND1 protein, human MeSH Prohlížeč
- CDCA7L protein, human MeSH Prohlížeč
- cyklin D1 MeSH
- DIS3 protein, human MeSH Prohlížeč
- ELL2 protein, human MeSH Prohlížeč
- exozom MeSH
- histondemethylasy MeSH
- KDM1A protein, human MeSH Prohlížeč
- nádorové biomarkery MeSH
- represorové proteiny MeSH
- transkripční elongační faktory MeSH
- MeSH
- křehkost diagnóza epidemiologie MeSH
- lidé MeSH
- mnohočetný myelom diagnóza epidemiologie MeSH
- osmdesátníci MeSH
- proporcionální rizikové modely MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- dopisy MeSH
- Klíčová slova
- clinical practice guidelines, diagnosis, follow-up, multiple myeloma, prognosis, treatment,
- MeSH
- lidé MeSH
- mnohočetný myelom * diagnóza epidemiologie terapie MeSH
- následné studie MeSH
- společnosti lékařské MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- směrnice pro lékařskou praxi MeSH
The etiology of multiple myeloma (MM) is poorly understood. Summary data from genome-wide association studies (GWASs) of multiple phenotypes can be exploited in a Mendelian randomization (MR) phenome-wide association study (PheWAS) to search for factors influencing MM risk. We performed an MR-PheWAS analyzing 249 phenotypes, proxied by 10 225 genetic variants, and summary genetic data from a GWAS of 7717 MM cases and 29 304 controls. Odds ratios (ORs) per 1 standard deviation increase in each phenotype were estimated under an inverse variance weighted random effects model. A Bonferroni-corrected threshold of P = 2 × 10-4 was considered significant, whereas P < .05 was considered suggestive of an association. Although no significant associations with MM risk were observed among the 249 phenotypes, 28 phenotypes showed evidence suggestive of association, including increased levels of serum vitamin B6 and blood carnitine (P = 1.1 × 10-3) with greater MM risk and ω-3 fatty acids (P = 5.4 × 10-4) with reduced MM risk. A suggestive association between increased telomere length and reduced MM risk was also noted; however, this association was primarily driven by the previously identified risk variant rs10936599 at 3q26 (TERC). Although not statistically significant, increased body mass index was associated with increased risk (OR, 1.10; 95% confidence interval, 0.99-1.22), supporting findings from a previous meta-analysis of prospective observational studies. Our study did not provide evidence supporting any modifiable factors examined as having a major influence on MM risk; however, it provides insight into factors for which the evidence has previously been mixed.
OBJECTIVES: Health-related quality of life (HRQoL) is particularly important during maintenance therapy (MT) in newly diagnosed multiple myeloma post-transplant, when disease symptoms are limited. METHODS: We assessed HRQoL in patients randomised to 26 cycles of MT (ixazomib vs placebo) in TOURMALINE-MM3 (NCT02181413). RESULTS: The characteristics at study entry were well-balanced between ixazomib (n = 386) and placebo (n = 251) arms. At study entry, EORTC QLQ-C30 and MY20 scores were high for functional scales and low for symptom scales and were comparable with those of the general population. Changes in subscale scores across intervals, analysed over 30 four-week intervals using a linear mixed-effects model, were generally small and similar between arms for the EORTC QLQ-C30 Global Health Status/QoL, Physical Functioning, and Pain subscales and EORTC QLQ-MY20 Disease Symptoms subscale and Peripheral Neuropathy item. EORTC QLQ-C30 Nausea/Vomiting and Diarrhoea subscales were consistently worse for ixazomib than for placebo, in line with the ixazomib toxicity profile. Even when least-squares mean differences between arms were statistically significant, none reached the established minimal important clinical difference of 10 in multiple myeloma. CONCLUSIONS: In addition to improvement in progression-free survival with ixazomib, HRQoL was maintained in both arms. Active treatment with ixazomib did not have an adverse impact on HRQoL.
- Klíčová slova
- HRQoL, TOURMALINE-MM3, ixazomib, maintenance, placebo-controlled,
- MeSH
- adherence k farmakoterapii MeSH
- dospělí MeSH
- glycin aplikace a dávkování škodlivé účinky analogy a deriváty terapeutické užití MeSH
- hodnocení výsledků péče pacientem MeSH
- kombinovaná terapie MeSH
- kvalita života * MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom diagnóza epidemiologie mortalita terapie MeSH
- protinádorové látky aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky terapeutické užití MeSH
- senioři MeSH
- sloučeniny boru aplikace a dávkování škodlivé účinky terapeutické užití MeSH
- transplantace hematopoetických kmenových buněk MeSH
- udržovací chemoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- glycin MeSH
- ixazomib MeSH Prohlížeč
- protinádorové látky MeSH
- sloučeniny boru MeSH