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Sökning: WFRF:(Lundin Evelyn)

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1.
  • Falconer, Henrik, et al. (författare)
  • Robot-assisted approach to cervical cancer (RACC) : An international multi-center, open-label randomized controlled trial
  • 2019
  • Ingår i: International Journal of Gynecological Cancer. - : Wiley-Blackwell. - 1048-891X .- 1525-1438. ; 29:6, s. 1072-1076
  • Tidskriftsartikel (refereegranskat)abstract
    • Background Radical hysterectomy with pelvic lymphadenectomy represents the standard treatment for early-stage cervical cancer. Results from a recent randomized controlled trial demonstrate that minimally invasive surgery is inferior to laparotomy with regards to disease-free and overall survival. Primary Objective To investigate the oncologic safety of robot-assisted surgery for early-stage cervical cancer as compared with standard laparotomy. Study Hypothesis Robot-assisted laparoscopic radical hysterectomy is non-inferior to laparotomy in regards to recurrence-free survival with the advantage of fewer post-operative complications and superior patient-reported outcomes. Trial Design Prospective, multi-institutional, international, open-label randomized clinical trial. Consecutive women with early-stage cervical cancer will be assessed for eligibility and subsequently randomized 1:1 to either robot-assisted laparoscopic surgery or laparotomy. Institutional review board approval will be required from all participating institutions. The trial is coordinated from Karolinska University Hospital, Sweden. Major Inclusion/Exclusion Criteria Women over 18 with cervical cancer FIGO (2018) stages IB1, IB2, and IIA1 squamous, adenocarcinoma, or adenosquamous will be included. Women are not eligible if they have evidence of metastatic disease, serious co-morbidity, or a secondary invasive neoplasm in the past 5 years. Primary Endpoint Recurrence-free survival at 5 years between women who underwent robot-assisted laparoscopic surgery versus laparotomy for early-stage cervical cancer. Sample Size The clinical non-inferiority margin in this study is defined as a 5-year recurrence-free survival not worsened by >7.5%. With an expected recurrence-free survival of 85%, the study needs to observe 127 events with a one-sided level of significance (α) of 5% and a power (1-β) of 80%. With 5 years of recruitment and 3 years of follow-up, the necessary number of events will be reached if the study can recruit a total of 768 patients. Estimated Dates for Completing Accrual and Presenting Results Trial launch is estimated to be May 2019 and the trial is estimated to close in May 2027 with presentation of data shortly thereafter. Trial Registration The trial is registered at ClinicalTrials.gov (NCT03719547).
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2.
  • Tikk, Kaja, et al. (författare)
  • Prolactin Determinants in Healthy Women : A Large Cross-Sectional Study within the EPIC Cohort
  • 2014
  • Ingår i: Cancer Epidemiology, Biomarkers and Prevention. - 1055-9965 .- 1538-7755. ; 23:11, s. 2532-2542
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Experimental and epidemiologic data suggest that higher circulating prolactin is associated with breast cancer risk; however, how various risk factors for breast cancer influence prolactin levels in healthy women is not clear. Methods: We analyzed cross-sectional associations between several suggested reproductive and lifestyle risk factors for breast cancer and circulating prolactin among pre- and postmenopausal women, taking into account the use of current postmenopausal hormone therapy, among 2,560 controls from a breast cancer nested case-control study within the EPIC cohort. Results: Adjusted geometric mean prolactin levels were significantly higher among premenopausal women, and among postmenopausal women using hormone therapy compared with nonusers (8.2, 7.0, and 6.3 ng/mL, respectively; P-cat = <0.0001). Furthermore, prolactin levels were significantly higher among users of combined estrogen-progestin hormone therapy compared with users of estrogen-alone hormone therapy (6.66 vs. 5.90 ng/mL; P-cat = 0.001). Prolactin levels were lower among parous women compared with nulliparous women (8.61 vs. 10.95 ng/mL; P-cat = 0.0002, premenopausal women); the magnitude of this difference depended on the number of full-term pregnancies (22.1% lower, >= 3 vs. 1 pregnancy, P-trend = 0.01). Results for parity were similar but lower in magnitude among postmenopausal women. Prolactin did not vary by other studied factors, with the exception of lower levels among postmenopausal smokers compared with never smokers. Conclusions: Our study shows that current hormone therapy use, especially the use of combined hormone therapy, is associated with higher circulating prolactin levels in postmenopausal women, and confirms prior findings of lower circulating prolactin in parous women. Impact: Our study extends the knowledge linking various breast cancer risk factors with circulating prolactin.
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3.
  • Lundin, Evelyn, et al. (författare)
  • A prospective randomized assessment of quality of life between open and robotic hysterectomy in early endometrial cancer
  • 2019
  • Ingår i: International Journal of Gynecological Cancer. - : BMJ Publishing Group Ltd. - 1048-891X .- 1525-1438. ; 29:4, s. 721-727
  • Tidskriftsartikel (refereegranskat)abstract
    • Objective There are limited prospective data on the evaluation of quality of life in patients undergoing robotic hysterectomy for endometrial cancer. Our objective was to determine whether post-operative recovery differs between robotic and abdominal hysterectomy.Methods At a Swedish tertiary referral university hospital, 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included in a randomized trial. Surgery was performed according to principles for minimal invasive surgery. Anesthesia and peri-operative care followed a standardized enhanced recovery after surgery program in both groups. The EuroQol Group form EQ-5D and the Short Form-36 were used to evaluate patients' health-related quality of life. The Swedish Postoperative Symptoms Questionnaire assessed symptoms pre-operatively, daily for 7 days from the day of surgery, and then weekly until 6 weeks post-operatively. Data were analyzed by means of non-parametric tests and repeated measures ANOVA. To evaluate the time-dependent occurrence of complications, Kaplan-Meier survival and Cox proportional-hazard models were used.Results A total of 50 women were enrolled in the study (25 robotic and 25 abdominal hysterectomy). Median age (68 years vs 67 years), estimated blood loss (50 mL vs 50 mL), length of hospital stay de facto (53 hours vs 51 hours), and time to meet discharge criteria (36 hours vs 36 hours) in the robotic and abdominal groups, respectively, did not differ significantly (p>0.05) Women in the robotic hysterectomy group recovered significantly faster (p=0.01) in the EQ-5D health index, and reached their pre-operative level after approximately 3 weeks, nearly 2 weeks earlier than the abdominal group. Differences regarding improvement in health-related quality of life (Short Form-36) were statistically significant in general health and social functioning only, and were in favor of robotic hysterectomy. Consumption of analgesics, pain intensity, and symptom sum score post-operatively were equal. Occurrence of complications was an independent risk factor and influenced significantly the EQ-5D health index, length of hospital stay, pain intensity, opioid consumption, and symptom sum score adversely.Conclusion Robotic hysterectomy in the setting of an enhanced recovery after surgery program led to faster recovery in health-related quality of life compared with abdominal hysterectomy.
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4.
  • Lundin, Evelyn, et al. (författare)
  • Cost-effectiveness of robotic hysterectomy versus abdominal hysterectomy in early endometrial cancer
  • 2020
  • Ingår i: International Journal of Gynecological Cancer. - : BMJ PUBLISHING GROUP. - 1048-891X .- 1525-1438. ; 30:11, s. 1719-1725
  • Tidskriftsartikel (refereegranskat)abstract
    • Objectives To compare total costs for hospital stay and post-operative recovery between robotic and abdominal hysterectomy in the treatment of early-stage endometrial cancer provided in an enhanced recovery after surgery (ERAS) setting. Costs were evaluated in relation to health impact, taking a societal perspective. Methods Cost analysis was based on data from an open randomized controlled trial in an ERAS setting at a Swedish tertiary referral university hospital: 50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included; 25 women were allocated to robotic and 25 to abdominal hysterectomy. We compared the total time in the operating theater, procedure costs, post-operative care, length of hospital stay, readmissions, informal care, and sick leave as well as the health-related quality of life until 6 weeks after surgery. The comparison was made by using the EuroQoL group form with five dimensions and three levels (EQ-5D). The primary outcome measure was total cost; secondary outcomes were quality-adjusted life-years (QALYs) and cost per QALY. The costs were calculated in Swedish Krona (SEK). Results Age (median (IQR) 68 (63-72) vs 67 (59-75) years), duration of hospital stay (ie, time to discharge criteria were met) (median (IQR) 36 (36-36) vs 36 (36-54) hours), and sick leave (median (IQR) 25 (17-30) vs 31 (36-54) days) did not differ between the robotic and abdominal group. Time of surgery was significantly longer in the robotic group than in the abdominal group (median (IQR) 70 (60-90) vs 56 (49-84) min; p<0.05). The robotic group recovered significantly faster as measured by the EQ-5D health index and gained 0.018 QALYs until 6 weeks after surgery. Total costs were 20% higher for the robotic procedure (SEK71 634 vs SEK59 319). The total cost per QALY gained for women in the robotic group was slightly under SEK700 000. Conclusions Robotic hysterectomy used in an ERAS setting in the treatment of early endometrial cancer improved health within 6 weeks after the operation at a high cost for the health gained compared with abdominal hysterectomy. The productivity loss and informal care were lower for robotic hysterectomy, while healthcare had a higher procedure cost that could not be offset by the higher cost due to complications in the abdominal group.
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5.
  • Lundin, Evelyn, et al. (författare)
  • Markers of tissue damage and inflammation after robotic and abdominal hysterectomy in early endometrial cancer: a randomised controlled trial
  • 2020
  • Ingår i: Scientific Reports. - : NATURE PUBLISHING GROUP. - 2045-2322. ; 10:1
  • Tidskriftsartikel (refereegranskat)abstract
    • The aim of this study was to analyse the dynamics of tissue damage and inflammatory response markers perioperatively and whether these differ between women operated with robotic and abdominal hysterectomy in treating early-stage endometrial cancer. At a Swedish university hospital fifty women with early-stage low-risk endometrial cancer were allocated to robotic or abdominal hysterectomy in a randomiszed controlled trial. Blood samples reflecting inflammatory responses (high sensitivity CRP, white blood cells (WBC), thrombocytes, IL-6, cortisol) and tissue damage (creatine kinase (CK), high-mobility group box 1 protein (HMGB1)) were collected one week preoperatively, just before surgery, postoperatively at two, 24 and 48hours, and one and six weeks postoperatively. High sensitivity CRP (p=0.03), WBC (p<0.01), IL-6 (p=0.03) and CK (p=0.03) were significantly lower in the robotic group, but fast transitory. Cortisol returned to baseline two hours after robotic hysterectomy but remained elevated in the abdominal group comparable to the preoperative high levels for both groups just before surgery (p<0.0001). Thrombocytes and HMGB1 were not affected by the mode of surgery. Postoperative inflammatory response and tissue damage were lower after robotic hysterectomy compared to abdominal hysterectomy. A significant remaining cortisol elevation two hours after surgery may reflect a higher stress response in the abdominal group.
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6.
  • Lundin, Evelyn S., et al. (författare)
  • Single-dose tranexamic acid in advanced ovarian cancer surgery reduces blood loss and transfusions: double-blind placebo-controlled randomized multicenter study
  • 2014
  • Ingår i: Acta Obstetricia et Gynecologica Scandinavica. - : Informa Healthcare / Wiley. - 0001-6349 .- 1600-0412. ; 93:4, s. 335-344
  • Tidskriftsartikel (refereegranskat)abstract
    • ObjectiveTo determine whether single-dose tranexamic acid given intravenously immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and blood transfusions. DesignA randomized double-blind, placebo-controlled multicenter study. SettingTwo university hospitals and two central hospitals in the southeast health region of Sweden. PopulationOne hundred women with presumed advanced ovarian cancer scheduled for radical debulking surgery between March 2008 and May 2012 who complied with inclusion/exclusion criteria were randomized; 50 were allocated to receive tranexamic acid and 50 to receive placebo. Analysis was performed according to intention-to-treat principles. MethodsThe volume of tranexamic acid (15mg/kg body weight, 100mg/mL tranexamic acid) or the same volume of placebo (0.9% NaCl) was added to a 100-mL saline solution plastic bag. The study medication was given immediately before the start of surgery. Data were analyzed by means of non-parametric statistics and multivariate models adjusted for confounding factors. Main outcome measuresBlood loss and red blood cell transfusions. ResultsThe total blood loss volume and transfusion rate were significantly lower in the tranexamic acid group compared with the placebo group. Median total blood loss was 520 and 730mL, respectively (p=0.03). Fifteen (30%) and 22 (44%), respectively received transfusions (odds ratio 0.44; upper 95% CI 0.97; p=0.02). ConclusionA single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates significantly in advanced ovarian cancer surgery. Tranexamic acid may be recommended as standard prophylactic treatment in advanced ovarian cancer surgery.
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7.
  • Serreyn Lundin, Evelyn, 1969- (författare)
  • On Quality Improvement in Gynaecological Cancer Surgery
  • 2020
  • Doktorsavhandling (övrigt vetenskapligt)abstract
    • Objectives: The overall purpose of this thesis was to find medical and surgical treatment methods of improving the perioperative care of gynaecological cancer patients. The specific objectives were to determine whether a single dose tranexamic acid given immediately before surgery for presumed advanced ovarian cancer reduces perioperative blood loss and the need for blood transfusions, and to determine whether postoperative recovery, tissue damage, and inflammatory response markers differ between women operated with robotic and abdominal hysterectomy for low-risk endometrial cancer in an enhanced recovery after surgery (ERAS) programme, and to evaluate costs for hospital stay and postoperative recovery in relation to health impact. Material and Methods: The thesis was based on two randomised trials. The first trial was a randomised double-blind placebo-controlled multicentre study conducted in four hospitals in the southeast and central of Sweden between March 2008 and May 2012. One hundred women with presumed advanced ovarian cancer who had been scheduled for radical debulking surgery were included; 50 received tranexamic acid and 50 received a placebo. The main outcomes were blood loss and red blood cell transfusions. The second trial was a randomised open single centre trial at a Swedish university hospital, which included 50 women with low-risk endometrial cancer scheduled for radical surgery between February 2012 and May 2016; 25 women underwent robotic hysterectomy and 25 had abdominal hysterectomy. Anaesthesia and perioperative care followed an ERAS protocol in both groups. The EuroQol Group form EQ-5D-3L and the Short Form-36 evaluated the health-related quality of life. The Swedish Postoperative Symptoms Questionnaire assessed symptoms perioperatively until six weeks postoperatively. Venous blood samples were collected on several occasions until six weeks postoperatively and were analysed for markers reflecting inflammatory response and tissue damage. In addition, a health economic evaluation was conducted comparing total costs, qualityadjusted life years (QALYs) and cost per QALY between the surgical methods. Results: Total blood loss volume and transfusion rate following surgery in advanced ovarian cancer were significantly lower in the tranexamic group compared with the placebo group. Women with early endometrial cancer treated by robotic hysterectomy recovered significantly faster in the EQ-5D health index, and reached their preoperative level nearly two weeks earlier than the abdominal group. Differences regarding improvement in health-related quality of life (Short Form-36) comprising general health and social functioning were more favourable in the robotic hysterectomy group. Consumption of analgesics, pain intensity, postoperative symptom sum score and length of hospital stay were equal between the groups. The occurrence of complications was an independent risk factor and influenced most of the outcome measures adversely. Postoperative inflammatory response and tissue damage were lower after robotic hysterectomy compared with the abdominal approach. The robotic group gained more QALYs until six weeks after surgery than the abdominal group but the total costs were higher. The total cost per QALY gained was quite high for the robotic procedure. Conclusions: A single dose of tranexamic acid given immediately before surgery reduces blood loss and transfusion rates in advanced ovarian cancer surgery. Robotic hysterectomy in an ERAS programme treating early endometrial cancer leads to a faster recovery in the health-related quality of life than abdominal hysterectomy, the latter being strongly influenced by perioperative complications. Less tissue damage and inflammation might contribute to a faster recovery in the robotic group. Robotic hysterectomy provides more QALYs until six weeks postoperatively but with a substantially higher total cost for the society.
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