Carella, G* Dotaz Zobrazit nápovědu
Advances in blood disorders ; vol. 2
453 s. : il.
- Klíčová slova
- Buňky kmenové, Transplantace kmenových buněk,
- MeSH
- kmenové buňky MeSH
- transplantace kostní dřeně MeSH
First published xi, 217 stran : ilustrace, tabulky ; 24 cm
Handbook of Bone Marrow Transplantation presents a practical overview of a selection of topics relating to new and controversial issues in bone marrow transplantation. Nakladatelská anotace. Kráceno
- MeSH
- hematologie MeSH
- transplantace kostní dřeně MeSH
- Publikační typ
- příručky MeSH
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- onkologie
- hematologie a transfuzní lékařství
First published xv, 528 stran : ilustrace, tabulky ; 25 cm
- Konspekt
- Patologie. Klinická medicína
- NLK Obory
- hematologie a transfuzní lékařství
- NLK Publikační typ
- kolektivní monografie
- MeSH
- elektromyografie metody využití MeSH
- končetiny chirurgie patofyziologie patologie MeSH
- lidé MeSH
- magnetická rezonanční tomografie metody využití MeSH
- plastická chirurgie metody využití MeSH
- plexiformní neurofibrom diagnóza chirurgie patologie MeSH
- počítačová rentgenová tomografie metody využití MeSH
- retrospektivní studie MeSH
- statistika jako téma MeSH
- výsledky a postupy - zhodnocení (zdravotní péče) MeSH
- zákroky plastické chirurgie metody využití MeSH
- Check Tag
- lidé MeSH
BACKGROUND: High-dose melphalan plus autologous stem-cell transplantation (ASCT) is the standard approach in transplant-eligible patients with newly diagnosed myeloma. Our aims were to compare consolidation with high-dose melphalan plus ASCT versus chemotherapy (cyclophosphamide and dexamethasone) plus lenalidomide, and maintenance with lenalidomide plus prednisone versus lenalidomide alone. METHODS: We did an open-label, randomised, multicentre, phase 3 study at 59 centres in Australia, Czech Republic, and Italy. We enrolled transplant-eligible patients with newly diagnosed myeloma aged 65 years or younger. Patients received a common induction with four 28-day cycles of lenalidomide (25 mg, days 1-21) and dexamethasone (40 mg, days 1, 8, 15, and 22) and subsequent chemotherapy with cyclophosphamide (3 g/m(2)) followed by granulocyte colony-stimulating factor for stem-cell mobilisation and collection. Using a 2 × 2 partial factorial design, we randomised patients to consolidation with either chemotherapy plus lenalidomide (six cycles of cyclophosphamide [300 mg/m(2), days 1, 8, and 15], dexamethasone [40 mg, days 1, 8, 15, and 22], and lenalidomide [25 mg, days 1-21]) or two courses of high-dose melphalan (200 mg/m(2)) and ASCT. We also randomised patients to maintenance with lenalidomide (10 mg, days 1-21) plus prednisone (50 mg, every other day) or lenalidomide alone. A simple randomisation sequence was used to assign patients at enrolment into one of the four groups (1:1:1:1 ratio), but the treatment allocation was disclosed only when the patient reached the end of the induction and confirmed their eligibility for consolidation. Both the patient and the treating clinician did not know the consolidation and maintenance arm until that time. The primary endpoint was progression-free survival assessed by intention-to-treat. The trial is ongoing and some patients are still receiving maintenance. This study is registered at ClinicalTrials.gov, number NCT01091831. FINDINGS: 389 patients were enrolled between July 6, 2009, and May 6, 2011, with 256 eligible for consolidation (127 high-dose melphalan and ASCT and 129 chemotherapy plus lenalidomide) and 223 eligible for maintenance (117 lenalidomide plus prednisone and 106 lenalidomide alone). Median follow-up was 52·0 months (IQR 30·4-57·6). Progression-free survival during consolidation was significantly shorter with chemotherapy plus lenalidomide compared with high-dose melphalan and ASCT (median 28·6 months [95% CI 20·6-36·7] vs 43·3 months [33·2-52·2]; hazard ratio [HR] for the first 24 months 2·51, 95% CI 1·60-3·94; p<0·0001). Progression-free survival did not differ between maintenance treatments (median 37·5 months [95% CI 27·8-not evaluable] with lenalidomide plus prednisone vs 28·5 months [22·5-46·5] with lenalidomide alone; HR 0·84, 95% CI 0·59-1·20; p=0·34). Fewer grade 3 or 4 adverse events were recorded with chemotherapy plus lenalidomide than with high-dose melphalan and ASCT; the most frequent were haematological (34 [26%] of 129 patients vs 107 [84%] of 127 patients), gastrointestinal (six [5%] vs 25 [20%]), and infection (seven [5%] vs 24 [19%]). Haematological serious adverse events were reported in two (2%) patients assigned chemotherapy plus lenalidomide and no patients allocated high-dose melphalan and ASCT. Non-haematological serious adverse events were reported in 13 (10%) patients assigned chemotherapy plus lenalidomide and nine (7%) allocated high-dose melphalan and ASCT. During maintenance, adverse events did not differ between groups. The most frequent grade 3 or 4 adverse events were neutropenia (nine [8%] of 117 patients assigned lenalidomide plus prednisone vs 14 [13%] of 106 allocated lenalidomide alone), infection (eight [8%] vs five [5%]), and systemic toxicities (seven [6%] vs two [2%]). Non-haematological serious adverse events were reported in 13 (11%) patients assigned lenalidomide plus prednisone versus ten (9%) allocated lenalidomide alone. Four patients died because of adverse events, three from infections (two during induction and one during consolidation) and one because of cardiac toxic effects. INTERPRETATION: Consolidation with high-dose melphalan and ASCT remains the preferred option in transplant-eligible patients with multiple myeloma, despite a better toxicity profile with chemotherapy plus lenalidomide. FUNDING: Celgene.
- MeSH
- adjuvantní chemoterapie MeSH
- autologní transplantace MeSH
- časové faktory MeSH
- cyklofosfamid terapeutické užití MeSH
- dexamethason terapeutické užití MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- melfalan terapeutické užití MeSH
- mnohočetný myelom diagnóza mortalita terapie MeSH
- prednison škodlivé účinky terapeutické užití MeSH
- přežití po terapii bez příznaků nemoci MeSH
- progrese nemoci MeSH
- proporcionální rizikové modely MeSH
- protokoly antitumorózní kombinované chemoterapie škodlivé účinky terapeutické užití MeSH
- rizikové faktory MeSH
- senioři MeSH
- thalidomid škodlivé účinky analogy a deriváty terapeutické užití MeSH
- transplantace hematopoetických kmenových buněk * škodlivé účinky mortalita MeSH
- udržovací chemoterapie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Geografické názvy
- Austrálie MeSH
- Česká republika MeSH
- Itálie MeSH
INTRODUCTION: To optimize the use of nontransplantable organs in their own territory, the European Commission, as part of a project led by Italy, has promoted the use of an information technology (IT) portal, the COORENOR portal, developed by the Czech Republic in 2012, which evolved to become FOEDUS in 2015. METHODS: To evaluate the impact of the portal on our reality, we analyzed the number and type of offers received and organs imported in the previous 48 months (period A) as well as the 48 months after the introduction of the portal (period B). We also examined the origin and the offer mode. RESULTS: The offers received were 404 and 753, respectively, in the two periods, with 315 (41.8%) organs received through the portal. The organs transplanted were 53 and 64, respectively, in the two periods; 20 (31.2%) were sent through the portal. The most commonly offered organs are lungs (36.7% and 29.3% of offers in periods A and B, respectively). The most transplanted organ is the liver (59.4% and 45% of transplants in periods A and B, respectively). The use of the portal has gradually increased, growing from 16.4% of the offer mode in 2012 to 84.7% in 2016. CONCLUSIONS: The increase of offers related to the increase of donations and the attitude to the sharing of resources has determined an increase of 19.2% of total transplants, especially for certain types such as pediatric transplants. The portal, ensuring speed and simultaneity of offer, real time sharing of information and transparency of allocation, is also used for trade in the International Partnership Agreements. Therefore, transplants have been conditioned by the existing agreements with Greece, Malta, and the countries of the South Transplant Alliance.
- MeSH
- Evropská unie MeSH
- informační technologie * MeSH
- lidé MeSH
- transplantáty statistika a číselné údaje MeSH
- získávání tkání a orgánů metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Česká republika MeSH
- Itálie MeSH
- Řecko MeSH
Purpose Rituximab (R) plus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy is the standard of care in previously untreated diffuse large B-cell lymphoma (DLBCL). Obinutuzumab (G) is a glycoengineered, type II, anti-CD20 monoclonal antibody. GOYA was a randomized phase III study that compared G-CHOP with R-CHOP in patients with previously untreated advanced-stage DLBCL. Methods Patients (N = 1,418) were randomly assigned to receive eight 21-day cycles of G (n = 706) or R (n = 712), plus six or eight cycles of CHOP. Primary end point was investigator-assessed progression-free survival (PFS). Results After median observation of 29 months, the number of investigator-assessed PFS events was similar between G (201; 28.5%) and R (215; 30.2%), stratified hazard ratio was 0.92 (95% CI, 0.76 to 1.11; P = .39), and 3-year PFS rates were 70% and 67%, respectively. Secondary end points of independently reviewed PFS, other time-to-event end points, and tumor response rates were similar between arms. In exploratory subgroup analyses, patients with germinal-center B cell-like subtype had a better PFS than did patients with activated B cell-like subtype, irrespective of treatment. Frequencies of grade 3 to 5 adverse events (AEs; 73.7% v 64.7%, respectively) and serious AEs (42.6% v 37.6%, respectively) were higher with G-CHOP compared with R-CHOP. Fatal AE frequencies were 5.8% for G-CHOP and 4.3% for R-CHOP. The most common AEs were neutropenia (G-CHOP, 48.3%; R-CHOP, 40.7%), infusion-related reactions (G-CHOP, 36.1%; R-CHOP, 23.5%), nausea (G-CHOP, 29.4%; R-CHOP, 28.3%), and constipation (G-CHOP, 23.4%; R-CHOP, 24.5%). Conclusion G-CHOP did not improve PFS compared with R-CHOP in patients with previously untreated DLBCL. AEs reported with G were consistent with the known safety profile. Biomarker analyses may help define a future role for G in DLBCL.
- MeSH
- cyklofosfamid aplikace a dávkování MeSH
- difúzní velkobuněčný B-lymfom farmakoterapie MeSH
- dospělí MeSH
- doxorubicin aplikace a dávkování MeSH
- humanizované monoklonální protilátky aplikace a dávkování MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- myší monoklonální protilátky aplikace a dávkování MeSH
- prednison aplikace a dávkování MeSH
- protokoly antitumorózní kombinované chemoterapie aplikace a dávkování terapeutické užití MeSH
- rituximab aplikace a dávkování MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- vinkristin aplikace a dávkování MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý 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
The FOEDUS-EOEO platform was relaunched in 2015 to allocate deceased donor organs across European borders when there are no suitable recipients in the donor's country. We analyzed organ offers from 01.06.2015-31.12.2021 and present the number of offers and transplants, and utilization as percentage of transplanted organs. 1,483 organs were offered, 287 were transplanted (19.4% utilization). Yearly number of offers and transplants increased from 2017 to 2021, while utilization stabilized after 2018. Utilization was highest for organs offered by Slovakia (47.2%), followed for organs offered by Lithuania, France, Greece, and Czechia (19.3%-22.9%). The most frequently offered organ was the heart (n = 405; 27.3%), followed by the lungs (n = 369; 24.9%) and the liver (n = 345; 23.3%). Utilization differed significantly by organ type (highest for liver, 35.7%; followed by heart, 18.8%; and kidney, 18.3%) and by donor age (highest for 1 to 5 year-old donors (25.0%)). FOEDUS-EOEO allowed for many European patients receiving a long-awaited transplant, especially for very young pediatric patients waiting for a liver, a heart, or a kidney. The increasing number of participating countries has increased both the number of offered organs and, to a lesser extent, the number of transplanted organs.
GOYA was a randomized phase 3 study comparing obinutuzumab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) vs standard-of-care rituximab plus CHOP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). This retrospective analysis of GOYA aimed to assess the association between progression-free survival (PFS) and overall survival (OS) with positron emission tomography (PET)-based complete response (CR) status. Overall, 1418 patients were randomly assigned to receive 8 21-day cycles of obinutuzumab (n = 706) or rituximab (n = 712) plus 6 or 8 cycles of CHOP. Patients received a mandatory fluoro-2-deoxy-d-glucose-PET/computed tomography scan at baseline and end of treatment. After a median follow-up of 29 months, the numbers of independent review committee-assessed PFS and OS events in the entire cohort were 416 (29.3%) and 252 (17.8%), respectively. End-of-treatment PET CR was highly prognostic for PFS and OS according to Lugano 2014 criteria (PFS: hazard ratio [HR], 0.26; 95% confidence interval [CI], 0.19-0.38; P < .0001; OS: HR, 0.12; 95% CI, 0.08-0.17; P < .0001), irrespective of international prognostic index score and cell of origin. In conclusion, the results from this prospectively acquired large cohort corroborated previously published data from smaller sample sizes showing that end-of-treatment PET CR is an independent predictor of PFS and OS and a promising prognostic marker in DLBCL. Long-term survival analysis confirmed the robustness of these data over time. Additional meta-analyses including other prospective studies are necessary to support the substitution of PET CR for PFS as an effective and practical surrogate end point. This trial was registered at www.clinicaltrials.gov as #NCT01287741.
- MeSH
- difúzní velkobuněčný B-lymfom * diagnostické zobrazování farmakoterapie MeSH
- doba přežití bez progrese choroby MeSH
- lidé MeSH
- PET/CT * MeSH
- pozitronová emisní tomografie MeSH
- protokoly antitumorózní kombinované chemoterapie terapeutické užití MeSH
- retrospektivní studie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH