LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 10 of total 142

Search options

  1. Article: A David and Goliath set-up: a qualitative study of the challenges of ensuring the introduction of cost-effective new cancer medicines in Finland.

    Ollila, Eeva / Kataja, Vesa / Sailas, Liisa

    Journal of pharmaceutical policy and practice

    2022  Volume 15, Issue 1, Page(s) 52

    Abstract: Background: To combat the global challenge of cancer, priority has been placed on the research and development of new cancer medicines (NCMs). NCMs are often approved for marketing in accelerated processes. Despite significant advances in treating ... ...

    Abstract Background: To combat the global challenge of cancer, priority has been placed on the research and development of new cancer medicines (NCMs). NCMs are often approved for marketing in accelerated processes. Despite significant advances in treating cancer, the overall added value and high prices of NCMs has been questioned. While market authorisations for NCMs are granted at the EU level, the assessment of added value, price negotiations and purchase or reimbursement decisions are made by member states. This article explores the practices in Finland for assessing and deciding on purchasing or reimbursing NCMs.
    Methods: Semi-structured interviews were conducted with 26 civil servants, hospital employees, scientists, and representatives of cancer NGOs and of the pharmaceutical industry in 2019 and 2020. The transcribed interviews were coded inductively using Atlas.ti software and analysed thematically under 3 major themes and 11 sub-themes.
    Results: The clinical value of NCMs is considered to be high, especially regarding NCMs for certain types of cancer. Proper patient selection is important but difficult and not all NCMs can be considered as adding value. The prices are considered to often be very high, leading to concerns about the sustainability and equity of health systems. Equity concerns among cancer patients are raised concerning differences in the availability of NCMs between hospital districts and cost differences for patients between those receiving outpatient and inpatient treatment. The systems and processes in Finland for deciding on the introduction of NCMs are fragmentary, involving separate approaches for outpatient care and hospital medicines by under-resourced evaluation bodies. The scientific evidence available is often limited for evidence-based decisions on introduction. Individual hospital districts sometimes introduce NCMs without assessment by national bodies. This can hamper the proper assessment of some NCMs before their uptake and lead to unequal access to NCMs by hospitals. There is an increasing lack of transparency about pricing, due to the rapid increase of market entry agreements. Lack of transparency on information on prices poses a challenge for authorities responsible for equitable access to cost-effective care within the available resources.
    Conclusions: Robust reform of the national introductory systems is needed. Internationally, efforts are needed to increase price transparency, to revise incentives within the system of market approval and to accumulate and assess evidence of comparable value and cost-effectiveness after the market approval of NCMs.
    Language English
    Publishing date 2022-08-29
    Publishing country England
    Document type Journal Article
    ZDB-ID 2734772-2
    ISSN 2052-3211
    ISSN 2052-3211
    DOI 10.1186/s40545-022-00449-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  2. Article ; Online: Clozapine and the risk of haematological malignancies - Authors' reply.

    Tiihonen, Jari / Tanskanen, Antti / Bell, J Simon / Dawson, Jessica L / Kataja, Vesa / Taipale, Heidi

    The lancet. Psychiatry

    2022  Volume 9, Issue 7, Page(s) 539–540

    MeSH term(s) Antipsychotic Agents/adverse effects ; Clozapine/adverse effects ; Hematologic Neoplasms/drug therapy ; Humans
    Chemical Substances Antipsychotic Agents ; Clozapine (J60AR2IKIC)
    Language English
    Publishing date 2022-06-09
    Publishing country England
    Document type Letter ; Comment
    ISSN 2215-0374
    ISSN (online) 2215-0374
    DOI 10.1016/S2215-0366(22)00204-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  3. Article ; Online: Long-term treatment with clozapine and other antipsychotic drugs and the risk of haematological malignancies in people with schizophrenia: a nationwide case-control and cohort study in Finland.

    Tiihonen, Jari / Tanskanen, Antti / Bell, J Simon / Dawson, Jessica L / Kataja, Vesa / Taipale, Heidi

    The lancet. Psychiatry

    2022  Volume 9, Issue 5, Page(s) 353–362

    Abstract: Background: Clozapine is the most efficacious treatment for schizophrenia and is associated with lower overall mortality than are other antipsychotic drugs, despite the risk of agranulocytosis. Preliminary reports over the past 10 years suggest a ... ...

    Abstract Background: Clozapine is the most efficacious treatment for schizophrenia and is associated with lower overall mortality than are other antipsychotic drugs, despite the risk of agranulocytosis. Preliminary reports over the past 10 years suggest a possible risk of haematological malignancies, but the issue has remained unsettled. We aimed to study the risk of haematological malignancies associated with use of clozapine and other antipsychotics.
    Methods: We did a nationwide case-control (and cohort) study of people with schizophrenia, using prospectively gathered data from Finnish national registers. A nested case-control study was constructed by individually matching cases of lymphoid and haematopoietic tissue malignancy with up to ten controls without cancer by age, sex, and time since first schizophrenia diagnosis. For the case-control study, we restricted inclusion criteria to malignancies diagnosed on a histological basis, and excluded individuals outside of the age range 18-85 years, and any patients that had a previous malignancy. Analyses were done using conditional logistic regression adjusting for comorbid conditions.
    Findings: For the case-control study 516 patients with a first-time diagnosis of lymphoid and haematopoietic tissue malignancy during years 2000-17 and diagnosed after their first diagnosis of schizophrenia were identified. 102 patients were excluded due to diagnosis that was without a histological basis, five patients were excluded because of their age, and 34 were excluded for a previous malignancy, resulting in 375 patients being matched to controls. We selected up to ten controls without cancer (3734 in total) for each case from the base cohort of people with schizophrenia. For the cohort study, data for 55 949 people were included for analysis. Cumulative incidence of haematological malignancies during the mean follow-up of 12·3 years (SD 6·5) was 102 (0·7%) cases among 13 712 patients who had used clozapine (corresponding to event rate of 61 cases per 100 000 person-years), and during mean follow-up of 12·9 years (SD 7·2) was 235 (0·5%) malignancies among 44 171 patients having used other antipsychotic medication than clozapine (corresponding to 41 cases per 100 000 person-years). Of the 375 individuals with haematological malignancies (305 lymphomas, 42 leukaemia, 22 myelomas, 6 unspecified) observed from 2000-17, 208 (55%) were males and 167 (45%) were female. Ethnicity data were not available. Compared with non-use of clozapine (most had used other antipsychotics and a few had used no antipsychotics), clozapine use was associated with increased odds of haematological malignancies in a dose-response manner (adjusted odds ratio 3·35, [95% CI 2·22-5·05] for ≥5000 defined daily dose cumulative exposure, p<0·0001). Exposure to other antipsychotic drugs was not associated with increased odds. A complementary analysis showed that the clozapine-related risk increase was specific for haematological malignancies, because no such finding was observed for other malignancies. Over 17 years of follow-up of the base cohort, 37 deaths occurred due to haematological malignancy among patients exposed to clozapine (26 with ongoing use at time of haematological malignancy diagnosis, and 11 in patients who did not use clozapine at the exact time of their cancer diagnosis), whereas only three deaths occurred due to agranulocytosis.
    Interpretation: Unlike other antipsychotics, long-term clozapine use is associated with increased odds of haematological malignancies. Long-term clozapine use has a higher effect on mortality due to lymphoma and leukaemia than due to agranulocytosis. However, acknowledging that the absolute risk is small compared with the previously observed absolute risk reduction in all-cause mortality is important. Our results suggest that patients and caregivers should be informed about warning signs of haematological malignancies, and mental health clinicians should be vigilant for signs and symptoms of haematological malignancy in patients treated with clozapine.
    Funding: The Finnish Ministry of Social Affairs and Health and Academy of Finland.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Agranulocytosis/chemically induced ; Agranulocytosis/drug therapy ; Antipsychotic Agents/adverse effects ; Case-Control Studies ; Clozapine/adverse effects ; Cohort Studies ; Female ; Finland/epidemiology ; Hematologic Neoplasms/chemically induced ; Hematologic Neoplasms/drug therapy ; Hematologic Neoplasms/epidemiology ; Humans ; Leukemia/chemically induced ; Leukemia/drug therapy ; Male ; Middle Aged ; Schizophrenia/drug therapy ; Schizophrenia/epidemiology ; Young Adult
    Chemical Substances Antipsychotic Agents ; Clozapine (J60AR2IKIC)
    Language English
    Publishing date 2022-03-22
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2215-0374
    ISSN (online) 2215-0374
    DOI 10.1016/S2215-0366(22)00044-X
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  4. Article ; Online: Trends in end-of-life decisions among patients dying in a university hospital oncology ward after implantation of a palliative outpatient clinic.

    Tolppanen, Anna-Maria / Lamminmäki, Annamarja / Länsimies, Helena / Kataja, Vesa / Tyynelä-Korhonen, Kristiina

    Acta oncologica (Stockholm, Sweden)

    2022  Volume 61, Issue 7, Page(s) 881–887

    Abstract: Background: The need for high quality palliative care at end-of-life has been increasingly recognized while regional differences exist in its quality and availability. Basic palliative care is given by oncologists at any stage of the disease, but this ... ...

    Abstract Background: The need for high quality palliative care at end-of-life has been increasingly recognized while regional differences exist in its quality and availability. Basic palliative care is given by oncologists at any stage of the disease, but this does not cover the high need for specialized palliative care. The aim of this study was to assess the trends in end-of-life decisions among patients dying in a university hospital oncology ward before and after the implementation of a palliative outpatient clinic.
    Material and methods: The study population consists of all patients who died in the Kuopio University Hospital oncology ward between 1.1.2010-31.10.2011 and 1.1.2012-31.12.2018. The palliative outpatient clinic was established and set up in November - December 2011. Data on inpatient stays, cancer treatments, treatment decisions, and some background factors were retrieved from electronic records.
    Results: The study population totaled 644 patients dying in the oncology ward at KUH (57.8% males; 42.2% females). The deaths comprise 17.2% (191/1108) of all cancer deaths in 2010-2011 and 11.1% (461/4049) in 2012-2018 in the KUH catchment area (North-Savo Health Care District). In years 2012-2018, 14.1% of patients treated at KUH oncology clinic visited the palliative outpatient clinic. The percentage of DNR (do-not-resuscitate), palliative care, and end-of-life (EOL) care decisions increased significantly in the later period. The decisions were mainly made during the last week of life. The proportion of patients receiving chemotherapy during the last two weeks of life remained stable.
    Conclusion: The proportion of patients receiving DNR, palliative care and EOL care decisions increased after the implementation of the palliative outpatient clinic, but the decisions were still made rather late, mainly during the last days of life.
    MeSH term(s) Ambulatory Care Facilities ; Death ; Female ; Hospitals, University ; Humans ; Male ; Neoplasms/epidemiology ; Neoplasms/therapy ; Palliative Care ; Retrospective Studies ; Terminal Care
    Language English
    Publishing date 2022-04-25
    Publishing country England
    Document type Journal Article
    ZDB-ID 896449-x
    ISSN 1651-226X ; 0349-652X ; 0284-186X ; 1100-1704
    ISSN (online) 1651-226X
    ISSN 0349-652X ; 0284-186X ; 1100-1704
    DOI 10.1080/0284186X.2022.2063068
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  5. Article ; Online: Electronic patient-reported outcomes and machine learning in predicting immune-related adverse events of immune checkpoint inhibitor therapies.

    Iivanainen, Sanna / Ekstrom, Jussi / Virtanen, Henri / Kataja, Vesa V / Koivunen, Jussi P

    BMC medical informatics and decision making

    2021  Volume 21, Issue 1, Page(s) 205

    Abstract: Background: Immune-checkpoint inhibitors (ICIs) have introduced novel immune-related adverse events (irAEs), arising from various organ systems without strong timely dependency on therapy dosing. Early detection of irAEs could result in improved ... ...

    Abstract Background: Immune-checkpoint inhibitors (ICIs) have introduced novel immune-related adverse events (irAEs), arising from various organ systems without strong timely dependency on therapy dosing. Early detection of irAEs could result in improved toxicity profile and quality of life. Symptom data collected by electronic (e) patient-reported outcomes (PRO) could be used as an input for machine learning (ML) based prediction models for the early detection of irAEs.
    Methods: The utilized dataset consisted of two data sources. The first dataset consisted of 820 completed symptom questionnaires from 34 ICI treated advanced cancer patients, including 18 monitored symptoms collected using the Kaiku Health digital platform. The second dataset included prospectively collected irAE data, Common Terminology Criteria for Adverse Events (CTCAE) class, and the severity of 26 irAEs. The ML models were built using extreme gradient boosting algorithms. The first model was trained to detect the presence and the second the onset of irAEs.
    Results: The model trained to predict the presence of irAEs had an excellent performance based on four metrics: accuracy score 0.97, Area Under the Curve (AUC) value 0.99, F1-score 0.94 and Matthew's correlation coefficient (MCC) 0.92. The prediction of the irAE onset was more difficult with accuracy score 0.96, AUC value 0.93, F1-score 0.66 and MCC 0.64 but the model performance was still at a good level.
    Conclusion: The current study suggests that ML based prediction models, using ePRO data as an input, can predict the presence and onset of irAEs with a high accuracy, indicating that ePRO follow-up with ML algorithms could facilitate the detection of irAEs in ICI-treated cancer patients. The results should be validated with a larger dataset. Trial registration Clinical Trials Register (NCT3928938), registration date the 26th of April, 2019.
    MeSH term(s) Electronics ; Humans ; Immune Checkpoint Inhibitors ; Machine Learning ; Patient Reported Outcome Measures ; Quality of Life ; Retrospective Studies
    Chemical Substances Immune Checkpoint Inhibitors
    Language English
    Publishing date 2021-06-30
    Publishing country England
    Document type Clinical Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2046490-3
    ISSN 1472-6947 ; 1472-6947
    ISSN (online) 1472-6947
    ISSN 1472-6947
    DOI 10.1186/s12911-021-01564-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  6. Article ; Online: Incidence of subsequent primary cancers and radiation-induced subsequent primary cancers after low dose-rate brachytherapy monotherapy for prostate cancer in long-term follow-up.

    Vuolukka, Kristiina / Auvinen, Päivi / Palmgren, Jan-Erik / Aaltomaa, Sirpa / Kataja, Vesa

    BMC cancer

    2020  Volume 20, Issue 1, Page(s) 453

    Abstract: Background: As aging is the most significant risk factor for cancer development, long-term prostate cancer (PCa) survivors have an evident risk of developing subsequent primary cancers (SPCs). Radiotherapy itself is an additional risk factor for cancer ... ...

    Abstract Background: As aging is the most significant risk factor for cancer development, long-term prostate cancer (PCa) survivors have an evident risk of developing subsequent primary cancers (SPCs). Radiotherapy itself is an additional risk factor for cancer development and the SPCs appearing beyond 5 years after radiotherapy in the original treatment field can be considered as radiation-induced subsequent primary cancers (RISPCs).
    Methods: During the years 1999-2008, 241 patients with localized PCa who underwent low dose-rate brachytherapy (LDR-BT) with I125 and were followed-up in Kuopio University Hospital, were included in this study. In this study the incidences and types of SPCs and RISPCs with a very long follow-up time after LDR-BT were evaluated.
    Results: During the median follow-up time of 11.4 years, a total of 34 (14.1%) patients developed a metachronous SPC. The most abundant SPCs were lung and colorectal cancers, each diagnosed in six patients (16.7% out of all SPCs). The crude incidence rate of RISPC was 1.7% (n = 4). Half of the SPC cases (50%) were diagnosed during the latter half of the follow-up time as the risk to develop an SPC continued throughout the whole follow-up time with the actuarial 10-year SPC rate of 7.0%. The crude death rates due to metachronous out-of-field SPCs and RISPCs were 50 and 50%, respectively.
    Conclusion: The crude rate of SPC was in line with previously published data and the incidence of RISPC was very low. These results support the role of LDR-BT as a safe treatment option for patients with localized PCa.
    MeSH term(s) Aged ; Brachytherapy/adverse effects ; Finland/epidemiology ; Follow-Up Studies ; Humans ; Incidence ; Male ; Middle Aged ; Neoplasms, Radiation-Induced/epidemiology ; Neoplasms, Radiation-Induced/etiology ; Neoplasms, Radiation-Induced/pathology ; Neoplasms, Second Primary/epidemiology ; Neoplasms, Second Primary/etiology ; Neoplasms, Second Primary/pathology ; Prognosis ; Prostatic Neoplasms/pathology ; Prostatic Neoplasms/radiotherapy ; Radiotherapy Dosage ; Retrospective Studies ; Risk Factors ; Survival Rate
    Language English
    Publishing date 2020-05-20
    Publishing country England
    Document type Journal Article
    ISSN 1471-2407
    ISSN (online) 1471-2407
    DOI 10.1186/s12885-020-06960-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  7. Article ; Online: ePRO symptom follow-up of colorectal cancer patients receiving oxaliplatin-based adjuvant chemotherapy is feasible and enhances the quality of patient care: a prospective multicenter study.

    Iivanainen, Sanna / Ravichandra, Ravi / Jekunen, Antti / Arokoski, Reetta / Mentu, Santeri / Lang, Laura / Ekström, Jussi / Virtanen, Henri / Kataja, Vesa / Koivunen, Jussi P

    Journal of cancer research and clinical oncology

    2023  Volume 149, Issue 10, Page(s) 6875–6882

    Abstract: Purpose: Electronic (e) patient-reported outcomes (PROs) have been shown to improve the quality of life and survival in chemotherapy treated advanced cancer patients. We hypothesized that multidimensional ePRO centered approach could improve symptom ... ...

    Abstract Purpose: Electronic (e) patient-reported outcomes (PROs) have been shown to improve the quality of life and survival in chemotherapy treated advanced cancer patients. We hypothesized that multidimensional ePRO centered approach could improve symptom management, streamline patient flow, and optimize the use of healthcare resources.
    Methods: In this multicenter trial (NCT04081558), colorectal cancer (CRC) patients receiving oxaliplatin-based chemotherapy as adjuvant or in the first- or second-line setting in advanced disease were included in the prospective ePRO cohort, while a comparative retrospective cohort was collected from the same institutes. The investigated tool consisted of a weekly e-symptom questionnaire integrated to an urgency algorithm and laboratory value interface, which generated semi-automated decision support for chemotherapy cycle prescription and individualized symptom management.
    Results: Recruitment to the ePRO cohort occurred 1/2019-1/2021 (n = 43). The comparator group (n = 194) consisted of patients treated in the same institutes 1-7/2017. The analysis was limited to adjuvant treated (n = 36 and n = 35). The feasibility of the ePRO follow-up was good with 98% reporting easy usage and 86% improved care, while health care personnel valued the easy use and logical workflow. In the ePRO cohort, 42% needed a phone call before planned chemotherapy cycles, while this was 100% in the retrospective cohort (p = 1.4e-8). Peripheral sensory neuropathy was detected significantly earlier with ePRO followed (p = 1e-5) but did not translate to earlier dose reduction, delays, or unplanned therapy termination compared to the retrospective cohort.
    Conclusion: The results suggest that the investigated approach is feasible and streamlines workflow. Earlier symptom detection may improve the quality in cancer care.
    MeSH term(s) Humans ; Oxaliplatin ; Follow-Up Studies ; Quality of Life ; Prospective Studies ; Retrospective Studies ; Chemotherapy, Adjuvant ; Patient Care ; Colorectal Neoplasms/drug therapy ; Colorectal Neoplasms/etiology ; Patient Reported Outcome Measures
    Chemical Substances Oxaliplatin (04ZR38536J)
    Language English
    Publishing date 2023-02-21
    Publishing country Germany
    Document type Multicenter Study ; Journal Article
    ZDB-ID 134792-5
    ISSN 1432-1335 ; 0171-5216 ; 0084-5353 ; 0943-9382
    ISSN (online) 1432-1335
    ISSN 0171-5216 ; 0084-5353 ; 0943-9382
    DOI 10.1007/s00432-023-04622-4
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  8. Article ; Online: Long-term efficacy and urological toxicity of low-dose-rate brachytherapy (LDR-BT) as monotherapy in localized prostate cancer.

    Vuolukka, Kristiina / Auvinen, Päivi / Palmgren, Jan-Erik / Voutilainen, Tuuli / Aaltomaa, Sirpa / Kataja, Vesa

    Brachytherapy

    2019  Volume 18, Issue 5, Page(s) 583–588

    Abstract: Purpose: The purpose of this study was to evaluate the incidence of late severe (≥Grade 3) urinary toxicity and the long-term efficacy after low-dose-rate brachytherapy (LDR-BT) in patients with localized prostate cancer (PCa).: Methods and materials!# ...

    Abstract Purpose: The purpose of this study was to evaluate the incidence of late severe (≥Grade 3) urinary toxicity and the long-term efficacy after low-dose-rate brachytherapy (LDR-BT) in patients with localized prostate cancer (PCa).
    Methods and materials: During the years 1999-2008, 241 patients with PCa who underwent LDR-BT with I
    Results: All D'Amico risk groups were represented, as 58.9%, 35.3%, and 5.8% of the patients were classified as low-, intermediate-, and high-risk patients, respectively. With a median followup of 11.4 years after implantation, the incidence of severe urinary toxicity increased throughout the followup period. The risk of Grade 3 urinary toxicity was highest among patients with higher Gleason scores (p = 0.016) and higher initial urine residual volumes (p = 0.017) and the cumulative incidence of severe urinary toxicity was 10.0%. The crude rate for transurethral prostatic resection was 5.8%. The relapse-free survival, the cause-specific survival, and the overall survival were 79.3%, 95.0%, and 66.4%, respectively.
    Conclusions: The treatment was well tolerated as 90% of patients avoided any Grade 3 urinary toxicity. LDR-BT for localized PCa achieved high and durable efficacy. These results support the role of LDR-BT monotherapy as one of the valid primary treatment options for low-risk and favorable intermediate-risk patients.
    MeSH term(s) Aged ; Brachytherapy/adverse effects ; Brachytherapy/methods ; Disease-Free Survival ; Follow-Up Studies ; Humans ; Iodine Radioisotopes/therapeutic use ; Male ; Middle Aged ; Neoplasm Grading ; Prostatic Neoplasms/pathology ; Prostatic Neoplasms/radiotherapy ; Prostatic Neoplasms/surgery ; Radiation Injuries/etiology ; Radiotherapy Dosage ; Risk Factors ; Survival Rate ; Time Factors ; Transurethral Resection of Prostate/statistics & numerical data ; Urologic Diseases/etiology
    Chemical Substances Iodine Radioisotopes ; Iodine-125 (GVO776611R)
    Language English
    Publishing date 2019-06-18
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2098608-7
    ISSN 1873-1449 ; 1538-4721
    ISSN (online) 1873-1449
    ISSN 1538-4721
    DOI 10.1016/j.brachy.2019.05.005
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  9. Article ; Online: Safety and tolerability of long-term treatment with darolutamide in patients with metastatic castration-resistant prostate cancer.

    Jones, Robert Hugh / Fizazi, Karim / James, Nicholas D / Tammela, Teuvo L / Matsubara, Nobuaki / Priou, Frank / Beuzeboc, Philippe / Lesimple, Thierry / Bono, Petri / Kataja, Vesa / Garcia, Jorge A / Protheroe, Andrew / Shore, Neal / Aspegren, John / Joensuu, Heikki / Kuss, Iris / Fiala-Buskies, Sabine / Vjaters, Egils

    Prostate cancer and prostatic diseases

    2023  

    Abstract: Background: In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available.: Methods: Treatment-emergent adverse events (TEAEs) for patients receiving ... ...

    Abstract Background: In patients with metastatic castration-resistant prostate cancer, darolutamide was well tolerated for 25 months, but minimal long-term safety data are available.
    Methods: Treatment-emergent adverse events (TEAEs) for patients receiving darolutamide for a median of 38 months (n = 13) are described in this pooled analysis of individual patient data from phase 1/2 studies.
    Results: All patients reported TEAEs (mostly grade 1/2). The most common TEAEs were diarrhea, abdominal pain, and nausea. Serious TEAEs were reported in six patients (none related to darolutamide). All treatment-related TEAEs (n = 5) were grade 1.
    Conclusions: Long-term darolutamide treatment was well tolerated; no new safety signals observed. In patients with mCRPC, long-term darolutamide treatment was well tolerated and no new safety signals were observed. These findings are consistent with previous reports, demonstrating a favorable safety and tolerability profile of darolutamide.
    Language English
    Publishing date 2023-10-26
    Publishing country England
    Document type Journal Article
    ZDB-ID 1419277-9
    ISSN 1476-5608 ; 1365-7852
    ISSN (online) 1476-5608
    ISSN 1365-7852
    DOI 10.1038/s41391-023-00740-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

  10. Article ; Online: Stereotactic body radiotherapy for localized prostate cancer - 5-year efficacy results.

    Vuolukka, Kristiina / Auvinen, Päivi / Tiainen, Erno / Palmgren, Jan-Erik / Heikkilä, Janne / Seppälä, Jan / Aaltomaa, Sirpa / Kataja, Vesa

    Radiation oncology (London, England)

    2020  Volume 15, Issue 1, Page(s) 173

    Abstract: Background: The use of stereotactic body radiotherapy (SBRT) as the primary treatment modality in clinically localized prostate cancer (PCa) is emerging. The aim of the study was to analyze the long-term results of PCa patients treated with SBRT.: ... ...

    Abstract Background: The use of stereotactic body radiotherapy (SBRT) as the primary treatment modality in clinically localized prostate cancer (PCa) is emerging. The aim of the study was to analyze the long-term results of PCa patients treated with SBRT.
    Methods: This non-selected, real-life patient cohort included 213 patients with localized PCa treated with a robotic SBRT device during 2012-2015.
    Results: The median follow-up was 64 months (range, 10-85 months), and all risk-groups were represented as 47 (22.1%), 56 (26.3%) and 110 (51.6%) patients were classified into D'Amico risk stratification of low, intermediate and high-risk groups, respectively. Androgen deprivation therapy (ADT) was administered to 64.3% of the patients. At cut-off, the biochemical relapse-free survival (bRFS) was 100, 87.5 and 80.0% for patients at low, intermediate and high-risk (p = 0.004), and 92.5, 84.2 and 66.7% for patients with Gleason score ≤ 6, 7 and ≥ 8, respectively (p = 0.001). The actuarial 5-year overall survival (OS) rates were 97.9, 96.4 and 88.6% in the low, intermediate and high-risk groups, respectively, and at the cut-off, the disease-specific survival (DSS) rate of the whole cohort was high (99.1%), as only two high-risk patients died due to PCa.
    Conclusion: Our present results of SBRT delivered with CyberKnife produced excellent long-term bRFS, OS and DSS outcomes among patients with localized PCa. We conclude that SBRT provides an efficient and convenient treatment option for patients with localized PCa, irrespective of the risk-group.
    MeSH term(s) Aged ; Aged, 80 and over ; Androgen Antagonists/therapeutic use ; Humans ; Male ; Middle Aged ; Prostate-Specific Antigen/blood ; Prostatic Neoplasms/mortality ; Prostatic Neoplasms/radiotherapy ; Radiosurgery/methods ; Radiotherapy Dosage ; Retrospective Studies
    Chemical Substances Androgen Antagonists ; Prostate-Specific Antigen (EC 3.4.21.77)
    Language English
    Publishing date 2020-07-14
    Publishing country England
    Document type Journal Article
    ISSN 1748-717X
    ISSN (online) 1748-717X
    DOI 10.1186/s13014-020-01608-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

To top