Could the Long-Term Oncological Safety of Laparoscopic Surgery in Low Risk Endometrial Cancer be also valid for the High Intermediate and High-Risk Patients? A Multi-center Turkish Gynecologic Oncology Group Study Conducted with 2745 Endometrial Cancer Cases. (TRSGO-End-001)

2021 ◽  
Author(s):  
Mehmet Ali Vardar ◽  
Ahmet Baris Guzel ◽  
Salih Taşkın ◽  
Mete Güngör ◽  
Nejat Özgül ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Laparoscopic Surgery ◽  
High Risk ◽  
Gynecologic Oncology ◽  
Gynecologic Oncology Group ◽  
Oncological Safety ◽  
High Risk Patients ◽  
Risk Patients ◽  
Disease Free

Abstract Could the Long-Term Oncological Safety of Laparoscopic Surgery in Low Risk Endometrial Cancer be also valid for the High Intermediate and High-Risk Patients? A Multi-center Turkish Gynecologic Oncology Group Study Conducted with 2745 Endometrial Cancer Cases. (TRSGO-End-001)Aim: to compare the long-term oncological outcomes of laparotomy and laparoscopic surgeries in endometrial cancer under the light of 2016 ESMO-ESGO-ESTRO risk classification system with particular focus on the high intermediate and high-risk categories.Methods: Using multicentric database between January 2005 and January 2016, disease-free and overall survivals of 2745 endometrial cancer cases were compared according to the surgery route, laparotomy vs laparoscopy. The high intermediate and high-risk patients were defined with respect to the 2016 ESMO-ESGO-ESTRO risk classification system and they were analyzed with respect to difference in survival rates.Results: Of the 2745 patients 1743 (63.5%) were operated by laparotomy, and the remaining were operated with laparoscopy. The total numbers of high intermediate and high-risk endometrial cancer cases were 734 (45%) patients in the LT group and 307 (30.7%) patients in the LS group. Disease-free and overall survivals were not statistically different when compared between laparoscopy and laparotomy groups in terms of low, intermediate, high intermediate and high-risk endometrial cancer.Conclusions: Regardless of the endometrial cancer risk category, long-term oncological outcomes of laparoscopic approach were found to be comparable to those treated with laparotomy. Our results are encouraging to consider laparoscopic surgery for high intermediate and high-risk endometrial cancer cases.

scholarly journals Could the Long-Term Oncological Safety of Laparoscopic Surgery in Low-Risk Endometrial Cancer Also Be Valid for the High–Intermediate- and High-Risk Patients? A Multi-Center Turkish Gynecologic Oncology Group Study Conducted with 2745 Endometrial Cancer Cases. (TRSGO-End-001)

2021 ◽  
Vol 28 (6) ◽  
pp. 4328-4340
Author(s):  
Mehmet Ali Vardar ◽  
Ahmet Baris Guzel ◽  
Salih Taskin ◽  
Mete Gungor ◽  
Nejat Ozgul ◽  
...  
Keyword(s):  
Endometrial Cancer ◽  
Laparoscopic Surgery ◽  
High Risk ◽  
Classification System ◽  
Risk Classification ◽  
High Risk Patients ◽  
Oncological Outcomes ◽  
Risk Patients ◽  
Disease Free

This study was conducted to compare the long-term oncological outcomes of laparotomy and laparoscopic surgeries in endometrial cancer under the light of the 2016 ESMO-ESGO-ESTRO risk classification system, with particular focus on the high–intermediate- and high-risk categories. Using multicentric databases between January 2005 and January 2016, disease-free and overall survivals of 2745 endometrial cancer cases were compared according to the surgery route (laparotomy vs. laparoscopy). The high–intermediate- and high-risk patients were defined with respect to the 2016 ESMO-ESGO-ESTRO risk classification system, and they were analyzed with respect to differences in survival rates. Of the 2745 patients, 1743 (63.5%) were operated by laparotomy, and the remaining were operated with laparoscopy. The total numbers of high–intermediate- and high-risk endometrial cancer cases were 734 (45%) patients in the laparotomy group and 307 (30.7%) patients in the laparoscopy group. Disease-free and overall survivals were not statistically different when compared between laparoscopy and laparotomy groups in terms of low-, intermediate-, high–intermediate- and high-risk endometrial cancer. In conclusion, regardless of the endometrial cancer risk category, long-term oncological outcomes of the laparoscopic approach were found to be comparable to those treated with laparotomy. Our results are encouraging to consider laparoscopic surgery for high–intermediate- and high-risk endometrial cancer cases.

Two Cycles of Risk-Adapted Consolidation Leads to a Favorable Long-Term Prognosis in Patients with Acute Promyelocytic Leukemia After Standard AIDA Induction: Results From 141 Patients Treated in the SAL-AIDA-2000 Trial

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 765-765 ◽  
Author(s):  
Uwe Platzbecker ◽  
Ulrich Schuler ◽  
Martin Bornhäuser ◽  
Michael Kramer ◽  
Markus Schaich ◽  
...  
Keyword(s):  
High Risk ◽  
Acute Promyelocytic Leukemia ◽  
Promyelocytic Leukemia ◽  
Induction Treatment ◽  
Term Survival ◽  
Consolidation Treatment ◽  
High Risk Patients ◽  
Risk Patients ◽  
Disease Free

Abstract Abstract 765 Background: The combination of ATRA and idarubicin (AIDA) for induction therapy of acute promyelocytic leukemia (APL) yields complete remission (CR) rates of > 90%. If this is followed by intensive consolidation treatment, about 85% of patients are disease free and alive after 6 years. In fact, three cycles of consolidation treatment are considered the therapeutic standard; however, it is unclear how much treatment intensity is necessary for long-term survival. In order to address this question, we analyzed the clinical course of patients enrolled into the APL study of the German Study Alliance Leukemia (SAL), which contained only two courses of consolidation. Patients and Methods: All patients ≥ 18 years diagnosed with cytogenetically confirmed APL were eligible for inclusion in the risk-adapted SAL-AIDA-2000 trial. Enrolled patients received standard induction treatment with ATRA (45 mg/m2/d until CR) and idarubicin (12 mg/m2 for 4 doses every other day). After CR, non-high-risk patients (WBC ≤ 10,000/μL) received daunorubicin (45/60 mg/m2 days 1–3, dose depending on age) as first consolidation and mitoxantrone (10 mg/m2 days 2–4) as second consolidation. High-risk patients received additional cytarabine in both consolidation cycles (100/200 mg/m2 continuous infusion over 7 days in 1st consolidation and 1000/3000 mg/m2 twice daily on 4 days in 2nd consolidation, dose depending on age). After 2 cycles of consolidation, all patients were scheduled for 24 months of maintenance with 6-mercaptopurin (90 mg/m2 daily), methotrexate (15 mg/m2 weekly), and ATRA (45 mg/m2 for 15 days every 3 months). The following outcomes were analyzed: CR rate, induction deaths, disease-free survival (DFS), and overall survival (OS). Results: Between January 1999 and October 2010, 141 patients were enrolled in the trial. The median age at diagnosis was 51 years (range, 19–82), and 41 (29%) patients had a WBC >10,000/μL (high risk). The CR rate was 92% in the entire cohort; 95% in patients ≤ 60 and 86% in patients > 60 years (p=0.082). No significant differences in CR rates were seen between high-risk and non-high-risk patients (88% vs 94%, p=0.213). Three patients died during induction treatment (2%). After a median follow up of 55 months, the median DFS and OS were not reached. The estimated 6-year DFS was 80% (95%–CI 72%–88%) in all patients; 84% in patients ≤ 60 and 72% in patients > 60 years (p=0.140). The estimated 6-year OS was 77% in all patients; 84% (95%–CI 76%–92%) in the younger and 62% (95%–CI 47%–78%) in the elderly group (p=0.004). No significant survival differences between the high-risk and the non-high-risk patients were observed, neither for DFS (6-year DFS 78% (95%–CI 64–93%) vs 81% (95%–CI 72%–91%), p=0.625) nor for OS (6-year OS 71% (95%–CI 57%–86%) vs 79% (95%–CI 70–89), p=0.207). Conclusions: Our results confirm the efficacy of a risk-adapted approach both in high-risk and non-high-risk APL patients. The similarity for DFS and OS times between these two groups demonstrate the efficacy of cytarabine added to anthracyclines during consolidation in high-risk patients. Both CR rates and survival outcomes are comparable to the results obtained in the AIDA0493 and AIDA2000 trials by the GIMEMA group, which used three cycles of higher-dosed consolidation. In light of the data, modification in number and intensity of consolidation cycles may result in a less toxic but equally effective option for the treatment of APL and should be considered for further evaluation in a randomized clinical trial. Disclosures: No relevant conflicts of interest to declare.

Long-term outcomes of Japan-specific dosage of rivaroxaban in high-risk patients with non-valvular atrial fibrillation: analysis from the XAPASS

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
T Ikeda ◽  
S Ogawa ◽  
T Kitazono ◽  
J Nakagawara ◽  
K Minematsu ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
High Risk ◽  
Major Bleeding ◽  
Factor Xa ◽  
Incidence Rates ◽  
Funding Source ◽  
High Risk Patients ◽  
Reduced Dose ◽  
Risk Patients

Abstract Background XAPASS is a real-world, prospective, single-arm, observational study conducted as a post-marketing surveillance mandated by the health authority in Japan. Nowadays, direct oral anticoagulant therapy using factor Xa or thrombin inhibitor has been the standard of care for patients with non-valvular atrial fibrillation (NVAF) to prevent ischemic stroke. However, the clinical impact of reduced dosage (approved dose of 15 or 10 mg once daily in Japan is relatively reduced compared to global dosage) factor Xa inhibitor rivaroxaban in high-risk patients remains unclear. Purpose The present sub-analysis of XAPASS was carried out to assess long-term safety and effectiveness of reduced-dose rivaroxaban in high-risk NVAF patients for bleeding and thromboembolism. Methods All patients with NVAF who were newly started on rivaroxaban were eligible for surveillance. The principal safety outcome was a composite of major and non-major bleeding events, and the primary effectiveness outcome was a composite of ischaemic stroke, haemorrhagic stroke, non-central nervous system systemic embolism (non-CNS SE), and myocardial infarction (MI). In this present sub-analysis, high-risk patients were defined as those who had two of the following three risk factors: elderly (≥75 years old), low body weight (≤50 kg), and renal impairment (CrCl <50 mL/min). Results In total, 11,308 patients were enrolled between April 2012 and June 2014 from 1,419 hospitals, and overall data were analysed from 10,664 patients from whom data were collected. Among them, 3,694 patients matched the criteria for the high-risk patients defined in this sub-analysis, and 6,970 patients did not match the criteria (non-high-risk patients). The mean treatment duration was 791±673 days in the high-risk patients and 944±709 days in the non-high-risk patients. Mean patient age was 80.9±5.5 years and 69.0±9.0 years at baseline, respectively. Mean CHADS2 score was 2.8 and 1.8, and CHA2DS2-VASc score was 4.4 and 2.9, respectively. The rates of CHADS2 component comorbidities were lower in the non-high-risk patients except for diabetes mellitus. The incidence rates of any bleeding, major bleeding, and the primary effectiveness outcomes were 4.8, 1.6, and 2.1%/patient-year in the high-risk patients. The incidence rates of these clinical events in the non-high-risk patients were 3.3, 0.9, and 1.0%/patient-year, respectively. Conclusions Incidence rates of long-term bleeding and thromboembolism were higher in the high-risk patients than in the non-high-risk patients. However, the rates of these outcomes using the Japan-specific reduced dose were not so high. Furthermore, the balance between safety and effectiveness outcomes was within an acceptable range. The present study provides useful information for physicians to stratify high-risk patients using the reduced dose in daily clinical practice. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Bayer Yakuhin Ltd.

scholarly journals TCT-543 Long-term outcome after successful MitraClip implantation in high-risk patients

2017 ◽  
Vol 70 (18) ◽  
pp. B224
Author(s):  
Edith Lubos ◽  
Eike Tigges ◽  
Daniel Kalbacher ◽  
Christina Thomas ◽  
Florian Deuschl ◽  
...  
Keyword(s):  
High Risk ◽  
Term Outcome ◽  
Long Term Outcome ◽  
High Risk Patients ◽  
Risk Patients
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