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| 2. |
- Falconer, Henrik, et al.
(författare)
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Robot-assisted approach to cervical cancer (RACC) : an international multi-center, open-label randomized controlled trial
- 2019
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Ingår i: International Journal of Gynecological Cancer. - : BMJ Publishing Group Ltd. - 1048-891X .- 1525-1438. ; 29:6, s. 1072-1076
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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 (alpha) of 5% and a power (1-beta) 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.
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| 3. |
- Johansen, Gry, et al.
(författare)
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Reproductive and oncologic outcome following robot-assisted laparoscopic radical trachelectomy for early stage cervical cancer.
- 2016
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Ingår i: Gynecologic Oncology. - : Elsevier BV. - 1095-6859 .- 0090-8258.
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Tidskriftsartikel (refereegranskat)abstract
- Objective To investigate the reproductive and oncologic outcome following robotic radical trachelectomy for early stage cervical cancer. Methods All women with early stage cervical cancer planned for fertility-sparing robotic trachelectomy between December 2007 and April 2015 at two tertiary referral centers in Sweden were identified. Perioperative- and follow-up data was retrieved from prospective databases used for all robotic procedures at the respective institution and an additional review of computerized patient files was performed. Reproductive outcome evaluation was restricted to women with ≥ 12 months follow-up and an active wish to conceive. Oncological outcome was evaluated for all patients. Results Fifty-six women (3 stage IA1, 14 stage IA2 and 39 stage IB1) were included. The median age was 29 years (range 23-41). Median follow-up was 24 months (range 1-89). Seven trachelectomies were aborted in favor of a radical hysterectomy and/or chemoradiation due to nodal metastases or insufficient margins; two distant recurrences occurred in these women. A local recurrence was seen in two of the 49 women (4%) in whom the procedure was completed as planned. Seventeen of the 21 women (81%) in the reproductive follow-up group conceived - 16 naturally and one following IVF. Sixteen women (94%) delivered in the third trimester, 12 women (71%) in gestational week ≥ 36. One (6%) second trimester delivery occurred. Conclusion The high fertility rate, low rate of premature deliveries and an acceptable rate of recurrence support the feasibility of robotic fertility-sparing radical trachelectomy in women with early stage cervical cancer.
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| 4. |
- Lueck, Jenna, et al.
(författare)
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Persistent organic pollutants in the Atlantic and southern oceans and oceanic atmosphere
- 2017
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Ingår i: Science of the Total Environment. - : Elsevier BV. - 0048-9697 .- 1879-1026. ; 583, s. 64-71
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Tidskriftsartikel (refereegranskat)abstract
- Persistent organic pollutants (POPs) continue to cycle through the atmosphere and hydrosphere despite banned or severely restricted usages. Global scale analyses of POPs are challenging, but knowledge of the current distribution of these compounds is needed to understand the movement and long-term consequences of their global use. In the current study, air and seawater samples were collected Oct. 2007- Jan. 2008 aboard the Icebreaker Oden en route from Göteborg, Sweden to McMurdo Station, Antarctica. Both air and surface seawater samples consistently contained α-hexachlorocyclohexane (α-HCH), γ-HCH, hexachlorobenzene (HCB), α-Endosulfan, and polychlorinated biphenyls (PCBs). Sample concentrations for most POPs in air were higher in the northern hemisphere with the exception of HCB, which had high gas phase concentrations in the northern and southern latitudes and low concentrations near the equator. South Atlantic and Southern Ocean seawater has a high ratio of α-HCH to γ-HCH, indicating persisting levels from technical grade sources. The Atlantic and Southern Ocean continue to be net sinks for atmospheric α-, γ-HCH, and Endosulfan despite declining usage.
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| 5. |
- Persson, Jan, et al.
(författare)
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Pelvic Sentinel lymph node detection in High-Risk Endometrial Cancer (SHREC-trial)—the final step towards a paradigm shift in surgical staging
- 2019
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Ingår i: European Journal of Cancer. - : Elsevier BV. - 0959-8049 .- 1879-0852. ; 116, s. 77-85
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Tidskriftsartikel (refereegranskat)abstract
- Study aims: To prospectively assess the diagnostic accuracy of a pelvic sentinel lymph node (SLN) algorithm in high-risk endometrial cancer (HREC). Patients and methods: Consecutive women with presumed FIGO stage I-II HREC underwent robotic surgery at two academic centres by five accredited surgeons. An anatomically based algorithm was adhered to, following cervical injection of indocyanine green (ICG), with reinjection of tracer in case of non-display of predefined lymphatic pathways. After removal of SLNs, a pelvic and infrarenal para-aortic lymphadenectomy was performed. Primary end-point was sensitivity of the SLN-ICG algorithm. Secondary end-points were sensitivity of the overall SLN algorithm (including macroscopically suspect nodes as SLNs), SLN mapping rates and morbidity of the SLN procedure. Results: Two hundred fifty-seven women were analysed; 54 had pelvic lymph node metastases (LNMs), and 52 of those were correctly identified by the SLN-ICG algorithm. In two women (one with false-negative ICG-SLNs and one non-mapped woman), the pelvic LNMs were identified by the overall SLN algorithm. The SLN-ICG algorithm had a sensitivity of 98% (95% confidence interval [CI] 89–100) and a negative predictive value of 99.5% (95% CI 97–100). The sensitivity of the overall SLN algorithm was 100% (95% CI 92–100) and the negative predictive value was 100% (95% CI 98–100). The bilateral mapping rate was 95%. Two women (1%) had isolated para-aortic metastases. No adverse events occurred during the SLN procedure. Conclusion: With a complete sensitivity to detect pelvic LNMs, the described pelvic SLN algorithm can, in the hands of experienced surgeons, exclude overall nodal involvement in 99% and thereby safely replace a full lymphadenectomy in HREC.
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| 6. |
- Salehi, Sahar, et al.
(författare)
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Cardiophrenic lymph node resection in advanced ovarian cancer : surgical outcomes, pre- and postoperative imaging
- 2018
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Ingår i: Acta Oncologica. - 0284-186X. ; 57:6, s. 820-824
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To evaluate the accuracy of preoperative imaging in the diagnosis of cardiophrenic lymph node (CPLN) metastases and to report perioperative outcomes after resection of CPLN at the time of cytoreductive surgery for advanced epithelial ovarian cancer (EOC). Furthermore, to assess clearance of CPLN by postoperative imaging. Methods: All women with stage IIIC/IV EOC subjected to surgery at our institution from January 2014 to October 2016 were retrospectively identified from a database. Among these, women subjected to CPLN resection during surgery were identified. Pre- and postoperative computed tomography (CT) scans, pathology reports, surgical approach and outcomes were reviewed. Results: One hundred and eighty women with stage IIIC/IV EOC subjected to surgery with curative intent were identified. Twenty-four (13%) of these women underwent CPLN resection. All had CT imaging suggestive of CPLN metastases. 20/24 (83%) had confirmed metastases upon final pathology. CPLN resection was associated with longer operation time, more often advanced upper abdominal surgery and more postoperative complications but there was no difference in days from surgery to initiation of chemotherapy. Postoperative CT was still indicative of CPLN metastases in 13/22 (59%) women despite resection with confirmative pathology. Conclusions: Resection of CPLN metastases is highly feasible without considerable added morbidity. Concern regarding surgical clearance is raised since postoperative imaging was indicative of metastases in the majority of women. The prognostic significance of stage IV disease based exclusively on CPLN metastases is unclear and any survival benefit from the procedure is yet to be determined.
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| 7. |
- Salehi, Sahar, et al.
(författare)
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Long-term quality of life after comprehensive surgical staging of high-risk endometrial cancer - results from the RASHEC trial
- 2018
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Ingår i: Acta Oncologica. - : TAYLOR & FRANCIS LTD. - 0284-186X .- 1651-226X. ; 57:12, s. 1671-1676
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: The health-related quality of life (HRQoL) outcomes after comprehensive surgical staging including infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer (EC) are unknown. Our aim was to investigate the long-term HRQoL between robot-assisted laparoscopic surgery (RALS) and laparotomy (LT). Patients and Methods: A total of 120 women with high-risk stage I-II EC were randomised to RALS or LT for hysterectomy, bilateral salpingoophorectomy, pelvic and infrarenal paraaortic lymphadenectomy in the previously reported Robot-Assisted Surgery for High-Risk Endometrial Cancer trial. The HRQoL was measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-30) and its supplementary questionnaire module for endometrial cancer (QLQ-EN24) questionnaire. Women were assessed before and 12 months after surgery. In addition, the EuroQol Eq5D non-disease specific questionnaire was used for descriptive analysis. Results: There was no difference in the functional scales (including global health status) in the intention to treat analysis, though LT conferred a small clinically important difference (CID) over RALS in cognitive functioning albeit not statistically significant -6 (95% CI-14 to 0, p = .06). LT conferred a significantly better outcome for the nausea and vomiting item though it did not reach a CID, 4 (95% CI 1 to 7, p = .01). In the EORTC-QLQ/QLQ-EN24, no significant differences were observed. Eq5D-3L questionnaire demonstrated a higher proportion of women reporting any extent of mobility impairment 12 months after surgery in the LT arm (p = .03). Conclusion: Overall, laparotomy and robot-assisted surgery conferred similar HRQoL 12 months after comprehensive staging for high-risk EC.
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| 8. |
- Salehi, Sahar, et al.
(författare)
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Robot-assisted laparoscopy versus laparotomy for infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer: A randomised controlled trial
- 2017
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Ingår i: European Journal of Cancer. - : ELSEVIER SCI LTD. - 0959-8049 .- 1879-0852. ; 79, s. 81-89
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: To investigate if robot-assisted laparoscopic surgery (RALS) was non-inferior to laparotomy (LT) in harvesting infrarenal paraaortic lymph nodes in patients with presumed stage IeII high-risk endometrial cancer. Patients and methods: Patients with histologically proven endometrial cancer, presumed stage IeII with high-risk tumour features, were randomised to hysterectomy, bilateral salpingo-oophorectomy, pelvic and paraaortic lymphadenectomy by either RALS or LT. Primary outcome was paraaortic lymph node count. Secondary outcomes were perioperative events, postoperative complications and total health care cost. Results: Overall 120 patients were randomised and 96 patients were included in the per protocol analysis. Demographic, clinical and tumour characteristics were evenly distributed between groups. Mean (+/- SD) paraaortic lymph node count was 20.9 (+/- 9.6) for RALS and 22 (+/- 11, p = 0.45) for LT. The difference of means was within the non-inferiority margin (-1.6, 95% CI -5.78, 2.57). Mean pelvic node count was lower after RALS (28 +/- 10 versus 22 +/- 8, p amp;lt; 0.001). There was no difference in perioperative complications or readmissions between the groups. Operation time was longer (p amp;lt; 0.001) but total blood loss less (amp;lt;0.001) and hospital stay shorter (amp;lt;0.001) in RALS group than LT group. Health care costs for RALS was significantly lower (mean difference $1568 USD/(sic)1225 Euro, p amp;lt; 0.05). Conclusion: Our results demonstrate non-inferiority in paraaortic lymph node count, comparable complication rates, shorter hospital length and lower total cost for RALS over laparotomy. Generalisability of the latter finding requires a high-volume setting and high surgical proficiency. In women with high-risk endometrial cancer confined to the uterus, RALS is a valid treatment modality. Clinical trials registrations: ClinicalTrials.gov NCT01847703. (C) 2017 Elsevier Ltd. All rights reserved.
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