| 1. |
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| 2. |
- Abalo, Kossi, et al.
(author)
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Secondary malignancies among mantle cell lymphoma patients
- 2023
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In: European Journal of Cancer. - : Elsevier. - 0959-8049 .- 1879-0852. ; 195
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Journal article (peer-reviewed)abstract
- Purpose:With modern treatments, mantle cell lymphoma (MCL) patients more frequently experience long-lasting remission resulting in a growing population of long-term survivors. Follow-up care includes identification and management of treatment-related late-effects, such as secondary malignancies (SM). We conducted a populationbased study to describe the burden of SM in MCL patients.Methods:All patients with a primary diagnosis of MCL, aged >= 18 years and diagnosed between 2000 and 2017 in Sweden were included along with up to 10 individually matched population comparators. Follow-up was from twelve months after diagnosis/matching until death, emigration, or December 2019, whichever occurred first. Rates of SM among patients and comparators were estimated using the Anderson-Gill method (accounting for repeated events) and presented as hazard ratios (HR) with 95% confidence intervals (CI) adjusted for age at diagnosis, calendar year, sex, and the number of previous events.Results:Overall, 1 452 patients and 13 992 comparators were followed for 6.6 years on average. Among patients, 230 (16%) developed at least one SM, and 264 SM were observed. Relative to comparators, patients had a higher rate of SM, HRadj= 1.6 (95%CI:1.4-1.8), and higher rates were observed across all primary treatment groups: the Nordic-MCL2 protocol, R-CHOP, R-bendamustine, ibrutinib, lenalidomide, and R-CHOP/Cytarabine. Compared to Nordic-MCL2, treatment with R-bendamustine was independently associated with an increased risk of SM, HRadj= 2.0 (95%CI:1.3-3.2). Risk groups among patients were those with a higher age at diagnosis (p < 0.001), males (p = 0.006), and having a family history of lymphoma (p = 0.009). Patients had preferably higher risk of melanoma, other neoplasms of the skin and other hematopoietic and lymphoid malignancies.Conclusions:MCL survivors have an increased risk of SM, particularly if treated with R-bendamustine. The intensive treatments needed for long-term remissions are a concern, and transition to treatment protocols with sustained efficacy but with a lower risk of SM is needed.
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| 3. |
- Aggestam, Emil, 1992, et al.
(author)
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Optimisation of slab track design considering dynamic train–track interaction and environmental impact
- 2022
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In: Engineering Structures. - : Elsevier BV. - 1873-7323 .- 0141-0296. ; 254
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Journal article (peer-reviewed)abstract
- Modern railway tracks for high-speed traffic are often built based on a slab track design. A major disadvantage of slab track compared to conventional ballasted track is that the environmental impact of the construction is higher due to the significant amount of concrete required. In this paper, the dimensions of the rectangular cross-sections and the types of concrete used in slab tracks are optimised with the objective to minimise greenhouse gas emissions, while considering the constraint that the design must pass the static dimensioning analysis described in the European standard 16432-2. The optimised track design is also analysed using a three-dimensional (3D) model of vertical dynamic vehicle–track interaction, where the rails are modelled as Rayleigh–Timoshenko beams and the concrete parts are represented by quadratic shell elements. Wheel–rail contact forces and the time-variant stress field of the concrete parts are calculated using a complex-valued modal superposition for the finite element model of the track. For the studied traffic scenario, it is concluded that the thickness of the panel can be reduced compared to the optimised design from the standard without the risk of crack initiation due to the dynamic vehicle load. In parallel, a model of reinforced concrete is developed to predict crack widths, the bending stiffness of a cracked panel section and to assess in which situations the amount of steel reinforcement can be reduced. To reduce the environmental impact even further, there is potential for an extended geometry optimisation by excluding much of the concrete between the rails.
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| 4. |
- Antonson, Hans, et al.
(author)
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Kulturhistoriska värden i ett förändrat klimat. Hot, risker och hanteringkopplat till vägar och banor
- 2021
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Reports (peer-reviewed)abstract
- Klimatförändringar utgör en bred palett av risker för kulturmiljö och landskap,inklusive de kulturhistoriska lämningar som har en nära eller direkt kopplingtill transportinfrastruktur. I detta projekt tittade vi på ett antal av dessa riskeri syfte att hjälpa Trafikverket att utveckla tjänster för bättre förutsägelse ochhantering av riskerna i anslutning till vägar och banor. Forskningen inleddesgenom en översikt av befintliga offentliga publikationer om klimatförändringenshot, risker, metoder, anpassningsåtgärder och kulturmiljö. Detta följdesav en undersökning av upplevelsen av dessa frågor bland offentligt anställdaexperter som medverkar i planeringen. Geografiska informationssystem (GIS)användes för att identifiera kulturhistoriska lämningar som är klimatologisktriskutsatta sig i riskzonen för tre undersökningsområden, följt av fältbesökför att bedöma tillförlitligheten i GIS-resultaten. Analysen visade att en enkelGIS-analys kan vara till hjälp för att identifiera riskutsatta platser, men ocksåatt fältarbete kan medverka till att identifiera ytterligare risker men också problemmed noggrannheten i underliggande datamaterial. Projektet tillhandahållerockså grundläggande statistik om i vilken utsträckning olika typer avkulturhistoriska lämningar på nationell nivå riskerar att hotas enligt nuvarandeklimatförändringsmodeller. Projektet genomförde också fallstudier av 1) vägsaltetsrisker för milstolpar och andra arkeologiska företeelser i anslutning tillvägar, och 2) de historiska kartornas potential att användas för att identifierariskutsatta områden vid framtida klimatförändringar. Slutligen diskuteras konsekvensernaav dessa resultat för prioriteringar av klimatanpassningsaktivitetersamt presenterar förslag på metoder och modeller för att identifiera transportinfrastrukturenskulturmiljöer som är hotas av klimatförändringar.
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| 5. |
- Brännström, Mats, 1958, et al.
(author)
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Live birth after robotic-assisted live donor uterus transplantation.
- 2020
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In: Acta obstetricia et gynecologica Scandinavica. - : Wiley. - 1600-0412 .- 0001-6349. ; 99:9, s. 1222-1229
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Journal article (peer-reviewed)abstract
- The proof-of-concept of uterus transplantation, as a treatment for absolute uterine factor infertility, came with the first live birth after uterus transplantation, which took place in Sweden in 2014. This was after a live donor procedure, with laparotomy in both donor and recipient. In our second, ongoing trial we introduced a robotic-assisted laparoscopic surgery of the donor to develop minimal invasive surgery for this procedure. Here, we report the surgery and pregnancy behind the first live birth from that trial.In the present study, within a prospective observational study, a 62-year-old mother was the uterus donor and her 33-year-old daughter with uterine absence as part of the Mayer-Rokitansky-Küster-Hauser syndrome, was the recipient. Donor surgery was mainly done by robotic-assisted laparoscopy, involving dissections of the utero-vaginal fossa, arteries and ureters. The last part of surgery was by laparotomy. Recipient laparotomy included vascular anastomoses to the external iliac vessels. Data relating to in vitro fertilization, surgery, follow up, obstetrics and postnatal growth are presented.Three in vitro fertilization cycles prior to transplantation gave 12 cryopreserved embryos. The surgical time of the donor in the robot was 360minutes, according to protocol. The durations for robotic surgery for dissections of the utero-vaginal fossa, arteries and ureters were 30, 160 and 84minutes, respectively. The remainder of donor surgery was by laparotomy. Recipient surgery included preparations of the vaginal vault, three end-to-side anastomoses (one arterial, two venous) on each side to the external iliacs and fixation of the uterus. Ten months after transplantation, one blastocyst was transferred and resulted in pregnancy, which proceeded uneventfully until elective cesarean section in week 36+1 . A healthy boy (Apgar 9-10-10) was delivered. Follow up of child has been uneventful for 12months.This is the first report of a live birth after use of robotic-assisted laparoscopy in uterus transplantation and is thereby a proof-of-concept of use of minimal invasive surgery in this new type of transplantation.
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| 6. |
- Bäckström, Torbjörn, et al.
(author)
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A randomized, double-blind study on efficacy and safety of sepranolone in premenstrual dysphoric disorder
- 2021
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In: Psychoneuroendocrinology. - : Elsevier BV. - 0306-4530 .- 1873-3360. ; 133
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Journal article (peer-reviewed)abstract
- Women with premenstrual dysphoric disorder (PMDD) experience mood symptoms related to the increase in progesterone and the neuroactive steroid allopregnanolone. Our hypothesis is that allopregnanolone is the symptom provoking factor. The rationale for the present study was to treat PMDD patients with the GABAA receptor modulating steroid antagonist, sepranolone (isoallopregnanolone). Patients (n = 206) with PMDD from 12 European centers were randomized in a parallel double-blind study and treated with placebo, sepranolone 10 mg and 16 mg. Patients administered sepranolone subcutaneously every 48 h during the 14 premenstrual days of three consecutive menstrual cycles. After obtaining informed consent, the PMDD diagnosis was confirmed according to DSM-5 and verified with two menstrual cycles of daily symptom ratings using the Daily Record of Severity of Problems (DRSP) scale in an eDiary. Inclusion and exclusion criteria stipulated that the women should be essentially healthy, not pregnant, have no ongoing psychiatric disorder or take interfering medications, and have regular menstrual cycles. The study's primary endpoint was the Total symptom score (Sum21, the score for all 21 symptom questions in the DRSP). In the prespecified statistical analysis the average score of the 5 worst premenstrual days in treatment cycles 2 and 3 were subtracted from the corresponding average score in the two diagnostic cycles. The treatment effects were tested using analysis of variance in a hierarchal order starting with the combined active sepranolone treatments vs. placebo. The prespecified analysis of Sum21 showed a large treatment effect of all three treatments but no statistically significant difference to placebo. However, the ratings of distress showed a significant treatment effect of sepranolone compared to placebo (p = 0.037) and the ratings of impairment showed a trend to greater treatment effect of sepranolone compared to placebo. Many women with PMDD had symptoms during a longer period than the late luteal phase. It has previously been shown that 9 premenstrual days may be more representative for comparison of PMDD symptom periods than the 5 worst premenstrual days. A post hoc analysis was undertaken in the per protocol population investigating the treatment effect during 9 premenstrual days in the third treatment cycle. The Sum21 results of this analysis showed that the sepranolone 10 mg was significantly better than placebo (p = 0.008). Similar significant treatment effects were found for the impairment and distress scores. A significantly larger number of individuals experienced no or minimal symptoms (Sum21 <42 points) with the 10 mg sepranolone treatment compared to placebo (p = 0.020). The results indicate that there is an attenuating effect by sepranolone on symptoms, impairment, and distress in women with PMDD especially by the 10 mg dosage. Sepranolone was well tolerated, and no safety concerns were identified.
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| 7. |
- Bäckström, Torbjörn, et al.
(author)
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Isoallopregnanolone inhibits estrus cycle-dependent aggressive behavior
- 2023
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In: Biomolecules. - : MDPI. - 2218-273X. ; 13:6
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Journal article (peer-reviewed)abstract
- Among female rats, some individuals show estrus cycle-dependent irritability/aggressive behaviors, and these individual rats may be used as a model for premenstrual dysphoric disorder (PMDD). We wanted to investigate if these behaviors are related to the estrus cycle phase containing moderately increased levels of positive GABA-A receptor-modulating steroids (steroid-PAM), especially allopregnanolone (ALLO), and if the adverse behavior can be antagonized. The electrophysiology studies in this paper show that isoallopregnanolone (ISO) is a GABA-A-modulating steroid antagonist (GAMSA), meaning that ISO can antagonize the agonistic effects of positive GABA-A receptor-modulating steroids in both α1β2γ2L and α4β3δ GABA-A receptor subtypes. In this study, we also investigated whether ISO could antagonize the estrus cycle-dependent aggressive behaviors in female Wistar rats using a resident–intruder test. Our results confirmed previous reports of estrus cycle-dependent behaviors in that 42% of the tested rats showed higher levels of irritability/aggression at diestrus compared to those at estrus. Furthermore, we found that, during the treatment with ISO, the aggressive behavior at diestrus was alleviated to a level comparable to that of estrus. We noticed an 89% reduction in the increase in aggressive behavior at diestrus compared to that at estrus. Vehicle treatment in the same animals showed a minimal effect on the diestrus-related aggressive behavior. In conclusion, we showed that ISO can antagonize Steroid-PAM both in α1β2γ2L and α4β3δ GABA-A receptor subtypes and inhibit estrus cycle-dependent aggressive behavior.
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| 8. |
- Ekberg, Sofie, et al.
(author)
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Does the menstrual cycle influence aerobic capacity in endurance-trained women?
- 2023
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In: Research Quarterly for Exercise and Sport. - : Routledge. - 0270-1367 .- 2168-3824.
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Journal article (peer-reviewed)abstract
- Purpose: The aim was to study if aerobic capacity varies during different phases of the menstrual cycle (MC) in endurance-trained female athletes.Methods: Ten endurance-trained eumenorrheic women performed a submaximal test followed by an incremental test until exhaustion three times during one MC, early follicular phase (EFP), late follicular phase (LFP), and midluteal phase (MLP). During the submaximal test, the respiratory exchange ratio (RER) and utilization of fat and carbohydrates were analyzed; and, during the incremental test, VO2 peak, maximal heart rate, utilization of fat and carbohydrates, and RER were analyzed. Lactate levels were analyzed at rest, during the submaximal test, and after the incremental test. The anaerobic threshold was determined at RER = 1.Results: No significant differences (p <.05) between the MC phases were seen in a maximal heart rate or VO2peak. Similarly, VO2, heart rate, RER, fatty acid oxidation, and carbohydrate oxidation at 70, 80, 90, and 100% of VO2peak did not differ significantly between MC phases. There were no significant differences between these phases in resting lactate before the test or during the submaximal tests, though there was a significant difference in lactate concentration 3 minutes after the incremental test between the EFP and the LFP (p =.043).Conclusion: This study did not display variations in physiological parameters between EFP, LFP, and MLP, indicating similar aerobic capacity despite hormonal variations. This knowledge may be useful when planning for competition in aerobic events.
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| 9. |
- Ekberg, Sara, et al.
(author)
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Impact of the COVID-19 pandemic on lymphoma incidence and short-term survival - a Swedish Lymphoma Register Study
- 2024
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In: Acta Oncologica. - : Medical Journals Sweden. - 0284-186X .- 1651-226X. ; 63, s. 164-168
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Journal article (peer-reviewed)abstract
- Background & purpose: The COVID-19 pandemic posed a large challenge for healthcare systems across the world. Comprehensive data on the impact of the COVID-19 pandemic on incidence and mortality in lymphoma are lacking.Patients/methods: Using data from the Swedish lymphoma register, we compare incidence and 1-year survival of lymphoma patients in Sweden before (2017-2019) and during the pandemic (2020 and 2021).Results: Fewer patients were diagnosed with lymphomas during March-June 2020, but the annual incidence rates for 2020 and 2021 were similar to those of 2017-2019. A larger proportion of patients presented with stage IV disease during 2021. There were no differences in other base-line characteristics nor application of active treatment in pre-pandemic and pandemic years. One-year overall survival was not inferior among lymphoma patients during the pandemic years compared to pre-pandemic years i.e., 2017-2019.Interpretation: The COVID-19 pandemic had limited impact on the incidence and mortality of lymphoma in Sweden.
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| 10. |
- Ekberg, Sara, et al.
(author)
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Late effects in patients with mantle cell lymphoma treated with or without autologous stem cell transplantation
- 2023
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In: Blood Advances. - : Elsevier. - 2473-9529 .- 2473-9537. ; 7:5, s. 866-874
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Journal article (peer-reviewed)abstract
- Studies on late effects in patients with mantle cell lymphoma (MCL) are becoming increasingly important as survival is improving, and novel targeted drugs are being introduced. However, knowledge about late effects is limited. The aim of this population-based study was to describe the magnitude and panorama of late effects among patients treated with or without high-dose chemotherapy with autologous stem cell transplantation (HD-ASCT). The study cohort included all patients with MCL, recorded in the Swedish Lymphoma Register, aged 18 to 69 years, diagnosed between 2000 and 2014 (N = 620; treated with HD-ASCT, n = 247) and 1:10 matched healthy comparators. Patients and comparators were followed up via the National Patient Register and Cause of Death Register, from 12 months after diagnosis or matching to December 2017. Incidence rate ratios of the numbers of outpatient visits, hospitalizations, and bed days were estimated using negative binomial regression models. In relation to the matched comparators, the rate of specialist and hospital visits was significantly higher among patients with MCL. Patients with MCL had especially high relative risks of infectious, respiratory, and blood disorders. Within this observation period, no difference in the rate of these complications, including secondary neoplasms, was observed between patients treated with and without HD-ASCT. Most of the patients died from their lymphoma and not from another cause or treatment complication. Taken together, our results imply that most of the posttreatment health care needs are related to the lymphoma disease itself, thus, indicating the need for more efficient treatment options.
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| 11. |
- Ekberg, Sara, et al.
(author)
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Patient trajectories after diagnosis of diffuse large B-cell lymphoma—a multistate modelling approach to estimate the chance of lasting remission
- 2022
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In: British Journal of Cancer. - : Springer Science and Business Media LLC. - 0007-0920 .- 1532-1827. ; 127:9, s. 1642-1649
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Journal article (peer-reviewed)abstract
- Background: Achieving lasting remission for at least 2 years is a good indicator for favourable prognosis long term after Diffuse large B-cell lymphoma (DLBCL). The aim of this study was to provide real-world probabilities, useful in risk communication and clinical decision-making, of the chance for lasting remissions by clinical characteristics. Methods: DLBCL patients in remission after primary treatment recorded in the Swedish Lymphoma register 2007–2014 (n = 2941) were followed for relapse and death using multistate models to study patient trajectories. Flexible parametric models were used to estimate transition rates. Results: At 2 years, 80.7% (95% CI: 79.0–82.2) of the patients were predicted to remain in remission and 13.2% (95% CI: 11.9–14.6) to have relapsed. The relapse risk peaked at 7 months, and the annual decline of patients in remission stabilised after 2 years. The majority of patients in the second remission transitioned into a new relapse. The probability of a lasting remission was reduced by 20.4% units for patients with IPI 4–5 compared to patients with IPI 0–1, and time in remission was shortened by 3.5 months. Conclusion: The long-term prognosis was overall favourable with 80% achieving durable first remissions. However, prognosis varied by clinical subgroups and relapsing patients seldom achieved durable second remissions.
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| 12. |
- Ekberg, Sara, et al.
(author)
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Trends in the prevalence, incidence and survival of non-Hodgkin lymphoma subtypes during the 21st century - a Swedish lymphoma register study
- 2020
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In: British Journal of Haematology. - : Wiley. - 0007-1048 .- 1365-2141. ; 189:6, s. 1083-1092
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Journal article (peer-reviewed)abstract
- Non-Hodgkin lymphoma (NHL) prognosis has improved in recent years, yet the number of patients living with the diagnosis, i.e. the prevalence, has seldom been reported. The prevalence provides a measure of the burden of disease, useful for healthcare planning and to optimise resource allocation. We provide a systematic presentation of temporal trends in absolute numbers of prevalent patients by NHL subtypes, linking them to trends in incidence, survival and mortality. Patients diagnosed 2000-2016 were identified in the national Swedish lymphoma register. Incidence and mortality rates, relative survival and prevalence were estimated for NHL overall and for major clinical and morphological subtypes. Poisson regression was used to test for temporal trends. Increasing incidence and improved survival have led to a 47% increase in the five-year prevalence of NHL overall in 2016 compared to 2004. An increasing prevalence was observed for all investigated subtypes during the study period, but most notably for diffuse large B cell lymphomas among aggressive subtypes (66%), and marginal zone lymphomas among indolent subtypes (135%). This dramatic increase in NHL prevalence underscores the need to develop and evaluate alternative follow-up schemes to use resources efficiently and still ensure optimal care of lymphoma survivors.
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| 13. |
- Glimelius, Ingrid, 1975-, et al.
(author)
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Stable use of radiotherapy in lymphoma patients over time : A comprehensive national overview of radiotherapy use in Sweden with focus on older patients
- 2024
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In: Clinical and Translational Radiation Oncology. - : Elsevier. - 2405-6308. ; 46
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Journal article (peer-reviewed)abstract
- Background and purposeThe role of radiotherapy (RT) in lymphoma is constantly refined with the advent of novel treatments. However, RT is still an effective treatment and tolerability is high. Therefore, we aimed to describe the use of RT in primary treatment of lymphoma over calendar time, with a specific focus on older patients (age ≥ 70 years) with non-Hodgkin lymphoma (NHL) subtypes.Materials & MethodsAll adult patients diagnosed with lymphoma from 2007 to 2018 in Sweden were included and followed for survival until end of 2020. Patient characteristics and relative survival (RS) were described for patients with NHL by subtype and RT use.ResultsIn the cohort of lymphoma patients aged ≥ 70 years (n = 12,698) 11 % received RT as part of primary treatment. No decline in use of RT over calendar period was seen. Use of RT as monotherapy was associated with stage I-II disease and older age among patients with stage III-IV disease. Patients with indolent lymphomas aged ≥ 70 years who were selected for treatment with RT as monotherapy with a dose of ≥ 20 Gy had 2-year RS rate of 100 % which remained similar at five years. For patients with DLBCL, RT as monotherapy with a dose of ≥ 20 Gy was mostly administered to patients aged ≥ 85 years with a 2-year RS rate of 68 %.ConclusionThe use of RT in first-line lymphoma treatment was stable over calendar time. RT monotherapy is associated with encouraging outcomes among patients with NHL aged ≥ 70 years who were selected to receive this.
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| 14. |
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| 15. |
- Jerkeman, Mats, et al.
(author)
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Nationwide Assessment of Patient Trajectories in Mantle Cell Lymphoma : The Swedish MCLcomplete Project
- 2023
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In: HemaSphere. - : Ovid Technologies (Wolters Kluwer Health). - 2572-9241. ; 7:8
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Journal article (peer-reviewed)abstract
- Mantle cell lymphoma (MCL) is a B-cell malignancy currently considered incurable. Although some patients obtain prolonged remission after first-line chemoimmunotherapy, many will need several treatment lines. Here, we present a nationwide assessment of treatment strategies, time to progression and survival in MCL. All patients diagnosed with MCL 2006-2018 were identified in the Swedish Lymphoma Register. Information on all lines of therapy was extracted from the medical records. Overall and progression-free survival (OS and PFS) were assessed through August 2021. In total, 1367 patients were included (median age, 71 years) and median follow-up was 6.8 years. Two hundred and one (15%) were managed initially with watch-and-wait, but 1235 (90%) eventually received treatment. The most frequently used first-line regimens were rituximab-bendamustine (BR) (n = 368; 30%) and Nordic MCL2 (n = 342; 28%). During follow-up, 630 patients (46%) experienced relapse/progression and 546 (40%) received second-line treatment. The most frequently used second-line regimen was BR (n = 185; 34%) but otherwise a wide variety of second-line treatments were used. Further, 382 and 228 patients experienced a second or third relapse/progression, respectively. Median PFS after first (PFS-1), second (PFS-2), third (PFS-3), and fourth (PFS-4) treatment lines was 29.4, 8.9, 4.3, and 2.7 months. Patients with early progression, defined as a PFS-1 <24 months, had an inferior median OS of 13 versus 37 months in patients with later relapse. For patients treated with frontline BR, however, time to relapse had no impact on later outcome. By use of nationwide population-based data, we provide important benchmarks for future studies of all treatment lines in MCL.
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| 16. |
- Nilsson, Karin, et al.
(author)
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Physicians' experiences of challenges in working conditions related to the provision of care during the initial response to the COVID-19 pandemic in Sweden
- 2022
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In: International Journal of Health Governance. - : Emerald Group Publishing Limited. - 2059-4631. ; 27:3, s. 254-267
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Journal article (peer-reviewed)abstract
- Purpose: This aim of this study was to explore how hospital-based physicians in Sweden experienced the challenges in working conditions related to the provision of care during the initial response to the COVID-19 pandemic in 2020 when hospitals transitioned to pandemic care. Design/methodology/approach: The study has a qualitative design. Twenty-five hospital-based physicians were interviewed about their experiences from working in a hospital while healthcare organisations initially responded to COVID-19 pandemic in 2020. A thematic analysis was used to analyse the empirical material. Findings: The analysis resulted in four themes: involuntary self-management, a self-restrictive bureaucracy, passive occupational safety and health (OSH) management, and information overload. These themes reflect how the physicians perceived their work situation during the pandemic and how they tried to maintain quality care for their patients. Practical implications: The study gives valuable insights for formulating preparedness in regard to crisis management plans that can secure the provision of care for future emergencies in the healthcare services. Originality/value: This paper shows that a crisis management plans in the healthcare services should include decision structures and management, measures of risk assessment and OSH management, and the maintenance of personnel wellbeing. A prepared healthcare management can preserve quality care delivery while under crisis.
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| 17. |
- Nourbakhsh, Nima, et al.
(author)
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Effects of Corticosteroid Treatment on Mycophenolic Acid Exposure in Renal Transplant Patients—Results From the SAILOR Study
- 2021
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In: Frontiers in Pharmacology. - : Frontiers Media SA. - 1663-9812. ; 12:September 2021
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Journal article (peer-reviewed)abstract
- Background: Mycophenolic acid (MPA) is a potent immunosuppressive agent used in solid organ transplantation. MPA exhibits large interindividual variation in dose-normalized plasma concentrations but is nevertheless usually prescribed as a fixed dose without use of therapeutic drug monitoring (TDM). Data on the effect of corticosteroid (CS) treatment on MPA concentrations during concomitant tacrolimus treatment remains sparse. Methods: Data is based on TDM of MPA area under the concentration curve (AUC) in 210 renal transplant recipients participating in the prospective, randomized, controlled, multi-center trial (SAILOR) where a steroid-free immunosuppressive regimen with mycophenolate mofetil (MMF) and low-dose tacrolimus was compared with a conventional prednisolone-based treatment regimen. Multilevel mixed-effects linear regression post-hoc analyses of MPA AUC was performed. Results: Median MPA AUC at baseline (within the first 2 weeks post-transplant) in patients taking 2 g MMF daily was 53 mg*h/L (interquartile range: 43–69 mg*h/L, min: 24—max: 117 mg*h/L). Between-patient variation in MPA AUC was up to 5-fold on the same MMF dose. Patients in the steroid-free group had 12.5% lower (95% CI; 3.2–20.9%, p = 0.01) MPA AUC levels at baseline compared to the steroid treated group. During follow-up (14 days–2 years post-transplant) there were no significant differences in MPA AUC between the groups with MPA AUC being 4.2% lower (95% CI: −4.8%−12,5%, p = 0.35) in the steroid-free vs standard treatment group in restricted analysis after multivariate adjustment for tacrolimus trough level, body weight, time after transplantation and MMF dose. MMF dose was positively correlated with MPA AUC (p < 0.001) whereas body weight was negatively correlated with MPA AUC (p < 0.001). MPA AUC was 0.4% (95% CI: 0.2–0.6%, p < 0.001) lower per 1 kg increase in weight. Tacrolimus trough levels had no significant effect on MPA AUC. Conclusion: Immunosuppression with CS during concomitant tacrolimus treatment was shortly after transplantation associated with a significantly higher MPA exposure but the effect was small and not maintained during follow-up. Low body weight was associated with higher MPA exposure, which suggests a potential for weight adjusted MMF dosing.
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| 18. |
- Weibull, Caroline E., et al.
(author)
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Survival by First-line Treatment Type and Timing of Progression Among Follicular Lymphoma Patients : A National Population-based Study in Sweden
- 2023
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In: HemaSphere. - : Wolters Kluwer. - 2572-9241. ; 7:3
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Journal article (peer-reviewed)abstract
- In follicular lymphoma (FL), progression of disease <= 24 months (POD24) has emerged as an important prognostic marker for overall survival (OS). We aimed to investigate survival more broadly by timing of progression and treatment in a national population-based setting. We identified 948 stage II-IV indolent FL patients in the Swedish Lymphoma Register diagnosed 2007-2014 who received first-line systemic therapy, followed through 2020. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated by first POD at any time during follow-up using Cox regression. OS was predicted by POD using an illness-death model. During a median follow-up of 6.1 years (IQR: 3.5-8.4), 414 patients experienced POD (44%), of which 270 (65%) occurred <= 24 months. POD was represented by a transformation in 15% of cases. Compared to progression-free patients, POD increased all-cause mortality across treatments, but less so among patients treated with rituximab(R)-single (HR = 4.54, 95% CI: 2.76-7.47) than R-chemotherapy (HR = 8.17, 95% CI: 6.09-10.94). The effect of POD was similar following R-CHOP (HR = 8.97, 95% CI: 6.14-13.10) and BR (HR = 10.29, 95% CI: 5.60-18.91). The negative impact of POD on survival remained for progressions up to 5 years after R-chemotherapy, but was restricted to 2 years after R-single. After R-chemotherapy, the 5-year OS conditional on POD occurring at 12, 24, and 60 months was 34%, 46%, and 57% respectively, versus 78%, 82%, and 83% if progression-free. To conclude, POD before but also beyond 24 months is associated with worse survival, illustrating the need for individualized management for optimal care of FL patients.
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| 19. |
- Wennerberg, Johan, et al.
(author)
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Results from a prospective, randomised study on (accelerated) preoperative versus (conventional) postoperative radiotherapy in treatment of patients with resectable squamous cell carcinoma of the oral cavity : The ARTSCAN 2 study
- 2022
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In: Radiotherapy and Oncology. - : Elsevier. - 0167-8140 .- 1879-0887. ; 166, s. 26-32
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Journal article (peer-reviewed)abstract
- Background and purposeAn earlier prospective randomised multicentre study (ARTSCAN) in head and neck cancer patients that compared conventionally fractionated radiotherapy (CF) with accelerated radiotherapy (AF) was inconclusive. In the subgroup of oral cavity squamous cell cancer (OCSCC) a large absolute, but not statistically significant, difference in local control was seen in favour of AF. This difference was more pronounced in resectable tumours. The finding raised the hypothesis that AF could be beneficial for OCSCC patients. In addition, the longstanding controversy on pre- or postoperative radiotherapy was addressed.Materials and methodsPatients with OCSCC, judged to withstand and likely benefit from combined therapy, were recruited. Subjects were randomised to either preoperative AF with 43 fractions given as a concomitant boost with two fractions/day to the tumour bearing volume to a total dose of 68 Gy in 4.5 weeks followed by surgery, or primary surgery with postoperative CF, total dose 60 or 66 Gy in 6–7 weeks. For patients whose tumours had high-risk features, 66 Gy and concomitant cisplatin was prescribed.Results250 patients were randomised. Median follow-up was 5 years for locoregional control (LRC) and 9 years for overall survival (OS). There were no statistically significant differences between the two treatment arms regarding LRC and OS. LRC at five years was 73% (95% CI, 65–82) in preoperative AF and 78% (95% CI, 70–85) in postoperative CF.Toxicity was more pronounced in preoperative AF.ConclusionThis study does not support that AF prior to surgery improves outcome in oral cavity cancer compared with postoperative CF.
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