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37 result(s) for "Angioli, R"
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Randomised study of systematic lymphadenectomy in patients with epithelial ovarian cancer macroscopically confined to the pelvis
No randomised trials have addressed the value of systematic aortic and pelvic lymphadenectomy (SL) in ovarian cancer macroscopically confined to the pelvis. This study was conducted to investigate the role of SL compared with lymph nodes sampling (CONTROL) in the management of early stage ovarian cancer. A total of 268 eligible patients with macroscopically intrapelvic ovarian carcinoma were randomised to SL ( N =138) or CONTROL ( N =130). The primary objective was to compare the proportion of patients with retroperitoneal nodal involvement between the two groups. Median operating time was longer and more patients required blood transfusions in the SL arm than the CONTROL arm (240 vs 150 min, P <0.001, and 36 vs 22%, P =0.012, respectively). More patients in the SL group had positive nodes at histologic examination than patients on CONTROL (9 vs 22%, P =0.007). Postoperative chemotherapy was delivered in 66% and 51% of patients with negative nodes on CONTROL and SL, respectively ( P =0.03). At a median follow-up of 87.8 months, the adjusted risks for progression (hazard ratio [HR]=0.72, 95%CI=0.46–1.21, P =0.16) and death (HR=0.85, 95%CI=0.49–1.47, P =0.56) were lower, but not statistically significant, in the SL than the CONTROL arm. Five-year progression-free survival was 71.3 and 78.3% (difference=7.0%, 95% CI=–3.4–14.3%) and 5-year overall survival was 81.3 and 84.2% (difference=2.9%, 95% CI=−7.0–9.2%) respectively for CONTROL and SL. SL detects a higher proportion of patients with metastatic lymph nodes. This trial may have lacked power to exclude clinically important effects of SL on progression free and overall survival.
Secondary Cytoreduction in Platinum-Resistant Recurrent Ovarian Cancer: A Single-Institution Experience
Background The purpose of this study was to observe the role of secondary cytoreductive surgery in platinum-resistant recurrent ovarian cancer (OC) patients. Methods We collected data of patients affected by recurrent OC treated between 1995 and 2013. Inclusion criteria were: invasive epithelial OC histologically documented, cytoreductive surgery and platinum-based chemotherapy at first-line treat ment with evidence of complete response to treatment, disease-free interval <6 months, and no concomitant neoplasia. Patients considered susceptible of cytoreductive surgery (group A) were compared with a historical series of patients with similar characteristics but not eligible for surgery (group B). Results Of 122 platinum-resistant patients, 18 met the inclusion criteria for the study and were enrolled. They were compared with a historical series of 18 patients not surgically treated with analogous clinical and pathological features. The most frequent sites of relapse included pelvic and aortic lymph nodes (39 %), peritoneum (33 %), bowel (28 %), and pelvis (22 %). A low rate of intraoperative and postoperative complications was reported. No deaths were recorded. Overall survival was significantly longer in cytoreductive group when compared with the control group ( P  = 0.035). Median overall survival was 44 months. Estimated 5-year overall survival rates were 57 versus 23.5 % for groups A and B, respectively. Conclusions Surgery could represent a useful adjunct to chemotherapy in the management of platinum-resistant recurrent OC patients, carefully selected, in highly selected centers. Larger prospective trials are needed to further confirm our experience.
Systematic lymphadenectomy in ovarian cancer at second-look surgery: a randomised clinical trial
Background: The role of systematic aortic and pelvic lymphadenectomy (SAPL) at second-look surgery in early stage or optimally debulked advanced ovarian cancer is unclear and never addressed by randomised studies. Methods: From January 1991 through May 2001, 308 patients with the International Federation of Gynaecology and Obstetrics stage IA–IV epithelial ovarian carcinoma were randomly assigned to undergo SAPL ( n =158) or resection of bulky nodes only ( n =150). Primary end point was overall survival (OS). Results: The median operating time, blood loss, percentage of patients requiring blood transfusions and hospital stay were higher in the SAPL than in the control arm ( P <0.001). The median number of resected nodes and the percentage of women with nodal metastases were higher in the SAPL arm as well (44% vs 8%, P <0.001 and 24.2% vs 13.3%, P :0.02). After a median follow-up of 111 months, 171 events (i.e., recurrences or deaths) were observed, and 124 patients had died. Sites of first recurrences were similar in both arms. The adjusted risk for progression and death were not statistically different (hazard ratio (HR) for progression=1.18, 95% confidence interval (CI)=0.87–1.59; P =0.29; 5-year progression-free survival (PFS)=40.9% and 53.8%; HR for death=1.04, 95% CI=0.733–1.49; P =0.81; 5-year OS=63.5% and 67.4%, in the SAPL and in the control arm, respectively). Conclusion: SAPL in second-look surgery for advanced ovarian cancer did not improve PFS and OS.
EPV256/#150 Preoperative frailty assessment in patients undergoing gynecologic oncology surgery: a systematic review
ObjectivesThe aim of the present article was to discuss currently available evidence on the impact of frailty assessment on adverse postoperative outcomes and survival in patients undergoing surgery for gynecological cancer.MethodsSystematic search of Medline (PubMed) and Embase databases until September 30, 2020. Key inclusion criteria were: (1) randomized or observational studies; (2) patients undergoing non-emergent surgery for gynecological malignancies; (3) preoperative frailty assessment.ResultsThrough the process of evidence acquisition, twelve studies including 85,672 patients were selected and six tools were evaluable: 30-item frailty index, 40-item frailty index, modified frailty index (mFI), John Hopkins Adjusted Clinical Groups index, Fried frailty criteria, Driver’s tool. The prevalence of frailty varied roughly from 6.1% to 60% across different series included. The mFI was the most adopted and predictive instrument. Pooled results underlined that frail patients were more likely to develop 30-day postoperative complications (OR, 4.16; 95% CI, 1.49–11.65; p=0.007), non-home discharge (OR, 4.41; 95% CI, 4.09–4.76; p<0.001), ICU admission (OR:3.99; 95% CI, 3.76–4.24; p<0.001) than the non-frail counterpart. Additionally, frail patients experienced worse oncologic outcomes (disease-free and overall survivals) than non-frail patients.ConclusionsThe present systematic review demonstrated that preoperative frailty assessment among gynecologic oncology patients is essential to predict adverse outcomes and tailor a personalized treatment. The mFI appeared as the most used and feasible tool in daily practice, suggesting that tailored therapeutic strategies should be considered for patients with 3 or more frailty-defining items.
10 The adoption of sentinel node mapping with or without backup lymphadenectomy in endometrial cancer
Introduction/Background*Sentinel node mapping (SNM) has replaced lymphadenectomy for staging surgery in apparent early-stage endometrial cancer (EC). Here, we evaluate the long-term survival of three different approaches of nodal assessment in low, intermediate, and high-risk EC.MethodologyThis is a multi-institutional retrospective study evaluating long-term outcomes (at least 3 years of follow-up) of EC patients having nodal assessment between 2006 and 2016. In order to reduce possible confounding factors, we applied a propensity-matched algorithm.Result(s)*Charts of 940 patients were evaluated: 174 (18.5%), 187 (19.9%), and 579 (61.6%) having SNM, SNM followed by backup lymphadenectomy and lymphadenectomy, respectively. Applying a propensity score matching algorithm (1:1:2) we selected 500 patients: 125 SNM vs. 125 SNM plus backup lymphadenectomy vs. 250 lymphadenectomy. Baseline characteristics of the study population were similar between groups. The prevalence of nodal disease was 14%, 16%, and 12% in patients having SNM, SNM followed by backup lymphadenectomy and lymphadenectomy, respectively. Overall, 19 (7.6%) patients were diagnosed with low volume nodal disease (7 and 12 patients with micrometastasis and isolated tumor cells). The mean (SD) follow-up time was 62 (±11) months. The survival analysis comparing the three techniques did not show statistical differences in terms of disease-free (p=0.750) and overall survival (p=0.899). Similarly, the type of nodal assessment did not impact survival outcomes after stratification on the basis of uterine risk factors.Conclusion*Our study highlighted that SNM provides similar long-term oncologic outcomes than lymphadenectomy. Further evidence is warranted to assess the prognostic value of low-volume disease detected by ultrastaging and the role of molecular/genomic profiling.
O004/#393 Does intensive follow-up improve overall survivalin endometrial cancer patients? Results from the totem randomized controlled trial
ObjectivesIn endometrial cancer few randomized controlled trials were conducted to assess the role of different settings of follow-up in improving overall survival. The TOTEM study (NCT00916708) was planned to compare an intensive (INT) vs minimalist (MIN) 5-year follow-up regimen in endometrial cancer patients in terms of overall survival (OS).MethodsPatients surgically treated for endometrial cancer, were stratified by center and in low (LoR) or high (HiR) risk of recurrence and then randomized to INT or MIN hospital-based follow-up regimens. The aim of the study was to demonstrate an improvement from 75% to 80% (expected hazard ratio, HR=0.78) of the 5-year OS with the INT regimen. Secondary objectives were to compare relapse free survival (RFS) and health-related quality of life (HRQL).Results1884 patients were randomized in 42 centers between 2008 and 2018, and 1847 patients were available for the final analysis. After a median follow-up of 66 months, the 5-year OS was 91.3%, 90.6% in the INT and 91.9% in the MIN arms, respectively (HR=1.12, 95%CI 0.85–1.48, p=0.429). Comparing the INT vs MIN arms, the 5-year OS were 94.1% and 96.8% (HR=1.48, 0.92–2.37, p=0.104) in the LoR and 85.3% and 84.7% (HR=0.96, 0.68–1.36, p=0.814) in the HiR group. The two arms did not show differences in terms of RFS and HRQL.ConclusionsIntensive follow-up in endometrial cancer treated patients did not improve OS, even in HiR patients, nor influenced health-related quality of life. Frequent routine use of imaging and laboratory exams in these patients should be discouraged.
EPV140/#62 Survival outcomes in endometrial cancer patients having lymphadenectomy, sentinel node mapping plus back-up lymphadenectomy and sentinel node mapping alone
ObjectivesSentinel node mapping (SNM) has replaced lymphadenectomy for staging surgery in apparent early-stage endometrial cancer (EC). Here, we evaluate the long-term survival of three different approaches of nodal assessment in low, intermediate, and high-risk EC.MethodsThis is a multi-institutional retrospective study evaluating long-term outcomes (at least 3 years of follow-up) of EC patients having nodal assessment between 2006 and 2016. In order to reduce possible confounding factors, we applied a propensity-matched algorithm.ResultsCharts of 940 patients were evaluated: 174 (18.5%), 187 (19.9%), and 579 (61.6%) having SNM, SNM followed by backup lymphadenectomy and lymphadenectomy, respectively. Applying a propensity score matching algorithm (1:1:2) we selected 500 patients: 125 SNM vs. 125 SNM plus backup lymphadenectomy vs. 250 lymphadenectomy. Baseline characteristics of the study population were similar between groups. The prevalence of nodal disease was 14%, 16%, and 12% in patients having SNM, SNM followed by backup lymphadenectomy and lymphadenectomy, respectively. Overall, 19 (7.6%) patients were diagnosed with low volume nodal disease (7 and 12 patients with micrometastasis and isolated tumor cells). The mean (SD) follow-up time was 62 (±11) months. The survival analysis comparing the three techniques did not show statistical differences in terms of disease-free (p=0.750) and overall survival (p=0.899). Similarly, the type of nodal assessment did not impact survival outcomes after stratification on the basis of uterine risk factors.ConclusionsSNM provides similar long-term oncologic outcomes than lymphadenectomy. Further evidence is warranted to assess the prognostic value of low-volume disease detected by ultrastaging and the role of molecular/genomic profiling
Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials
Individual patient data from two randomised trials comparing neoadjuvant chemotherapy with upfront debulking surgery in advanced tubo-ovarian cancer were analysed to examine long-term outcomes for patients and to identify any preferable therapeutic approaches for subgroup populations. We did a per-protocol pooled analysis of individual patient data from the European Organisation for Research and Treatment of Cancer (EORTC) 55971 trial (NCT00003636) and the Medical Research Council Chemotherapy Or Upfront Surgery (CHORUS) trial (ISRCTN74802813). In the EORTC trial, eligible women had biopsy-proven International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or IV invasive epithelial tubo-ovarian carcinoma. In the CHORUS trial, inclusion criteria were similar to those of the EORTC trial, and women with apparent FIGO stage IIIA and IIIB disease were also eligible. The main aim of the pooled analysis was to show non-inferiority in overall survival with neoadjuvant chemotherapy compared with upfront debulking surgery, using the reverse Kaplan-Meier method. Tests for heterogeneity were based on Cochran's Q heterogeneity statistic. Data for 1220 women were included in the pooled analysis, 670 from the EORTC trial and 550 from the CHORUS trial. 612 women were randomly allocated to receive upfront debulking surgery and 608 to receive neoadjuvant chemotherapy. Median follow-up was 7·6 years (IQR 6·0–9·6; EORTC, 9·2 years [IQR 7·3–10·4]; CHORUS, 5·9 years [IQR 4·3–7·4]). Median age was 63 years (IQR 56–71) and median size of the largest metastatic tumour at diagnosis was 8 cm (IQR 4·8–13·0). 55 (5%) women had FIGO stage II–IIIB disease, 831 (68%) had stage IIIC disease, and 230 (19%) had stage IV disease, with staging data missing for 104 (9%) women. In the entire population, no difference in median overall survival was noted between patients who underwent neoadjuvant chemotherapy and upfront debulking surgery (27·6 months [IQR 14·1–51·3] and 26·9 months [12·7–50·1], respectively; hazard ratio [HR] 0·97, 95% CI 0·86–1·09; p=0·586). Median overall survival for EORTC and CHORUS patients was significantly different at 30·2 months (IQR 15·7–53·7) and 23·6 months (10·5–46·9), respectively (HR 1·20, 95% CI 1·06–1·36; p=0·004), but was not heterogeneous (Cochran's Q, p=0·17). Women with stage IV disease had significantly better outcomes with neoadjuvant chemotherapy compared with upfront debulking surgery (median overall survival 24·3 months [IQR 14·1–47·6] and 21·2 months [10·0–36·4], respectively; HR 0·76, 95% CI 0·58–1·00; p=0·048; median progression-free survival 10·6 months [7·9–15·0] and 9·7 months [5·2–13·2], respectively; HR 0·77, 95% CI 0·59–1·00; p=0·049). Long-term follow-up data substantiate previous results showing that neoadjuvant chemotherapy and upfront debulking surgery result in similar overall survival in advanced tubo-ovarian cancer, with better survival in women with stage IV disease with neoadjuvant chemotherapy. This pooled analysis, with long-term follow-up, shows that neoadjuvant chemotherapy is a valuable treatment option for patients with stage IIIC–IV tubo-ovarian cancer, particularly in patients with a high tumour burden at presentation or poor performance status. National Cancer Institute and Vlaamse Liga tegen kanker (Flemish League against Cancer).
Bulky lymph node resection in patients with recurrent epithelial ovarian cancer: impact of surgery
The aim of this study was to evaluate the role of systematic lymphadenectomy, feasibility, complications rate, and outcome in epithelial ovarian cancer (EOC) patients with recurrent bulky lymph node disease. A prospective observational study of EOC patients with pelvic/aortic lymph node relapse was conducted between January 1995 and June 2005. After a clinical and laparoscopic staging, secondary cytoreduction, including systematic lymphadenectomy, were performed. The eligibility criteria were as follows: disease-free interval ≥6 months, radiographic finding suggestive of bulky lymph node recurrence, and patients' consent to be treated with chemotherapy. Forty-eight EOC patients with lymph node relapse were recruited. Twenty-nine patients were amenable to cytoreductive surgery. Postoperatively, all patients received adjuvant treatment. The median numbers of resected aortic and pelvic nodes were 15 (2–32) and 17 (8–47), respectively. The median numbers of resected aortic and pelvic positive lymph nodes were 4 (1–18) and 3 (1–17), respectively. The mean size of bulky nodes was 3.3 cm. Four patients (14%) experienced one severe complication. No treatment-related deaths were observed. After a median follow-up of 26 months, among cytoreduced patients, 18 women were alive with no evidence of disease, nine were alive with disease. Among the 11 patients not amenable to surgery, five women were alive with persistent disease, six patients died of disease, at a median follow-up of 18 months. Estimated 5-year overall survival and disease-free interval for operated women were 87% and 31%, respectively. In conclusion, patients with bulky lymph node relapse can benefit from systematic lymphadenectomy in terms of survival. The procedure is feasible with an acceptable morbidity rate
The Role of Deep Neuromuscular Blockade and Sugammadex in Laparoscopic Hysterectomy: A Randomized Controlled Trial
Background/Objectives: Laparoscopic gynecologic surgery is widely utilized due to its minimally invasive nature. Postoperative discomfort, including intra-abdominal and referred shoulder pain, remains a challenge. This study evaluates the impact of deep neuromuscular blockade (NMB) reversed with sugammadex compared to moderate NMB reversed with neostigmine on postoperative pain, recovery, and surgical conditions in patients undergoing laparoscopic hysterectomy. Methods: This double-blind, randomized controlled trial included 228 patients undergoing laparoscopic hysterectomy under standardized pneumoperitoneum pressure (12 mmHg). Participants were randomized into two groups: deep NMB with sugammadex (SUG) and moderate NMB with neostigmine (NEO). Primary outcomes included postoperative pain (NRS) and neuromuscular recovery time (TOF ratio ≥ 0.9). Secondary outcomes were surgical conditions, surgeon satisfaction, extubation and recovery times, incidence of postoperative nausea and vomiting (PONV), and analgesic consumption. Results: The SUG group exhibited lower pain scores up to 24 h compared to the NEO group (p < 0.05). Pain reductions remained statistically significant up to 6 h postoperatively after Bonferroni correction, while differences beyond this time were not significant after adjustment. Neuromuscular recovery was markedly faster in the SUG group (147.58 ± 82.26 s vs. 488.02 ± 223.07 s, p < 0.05). Patients in the SUG group had shorter extubation (ΔT1), awakening (ΔT2), and recovery room transfer times (ΔT3). PONV was significantly lower in the SUG group. Deep NMB did not contribute to the improvement of surgical workspace conditions. Conclusions: Deep NMB with sugammadex enhances postoperative pain control and accelerates neuromuscular recovery in laparoscopic hysterectomy. These findings support the adoption of deep NMB with sugammadex as a valid anesthetic approach in laparoscopic hysterectomy procedures.