Adherence to European ovarian cancer guidelines and impact on survival: a French multicenter study (FRANCOGYN)

2021 ◽  
pp. ijgc-2021-002934
Author(s):  
Floriane Jochum ◽  
Tamara De Rozario ◽  
Lise Lecointre ◽  
Emilie Faller ◽  
Thomas Boisrame ◽  
...  

ObjectiveThe primary objective of the study was to validate the European Society for Medical Oncology (ESMO)–European Society of Gynecologic Oncology (ESGO) ovarian cancer guideline as a method of assessing quality of care, and to identify patient characteristics predictive of non-adherence to European guideline care. The secondary objectives were to analyze the evolution of practices over the years and to evaluate heterogeneity between centers.MethodsThis retrospective multicenter cohort study of invasive epithelial ovarian cancer reported to the FRANCOGYN database included data from 12 French centers between January 2000 and February 2017. The main outcome was adherence to ESMO–ESGO guidelines, defined by recommended surgical procedures according to the International Federation of Gynecology and Obstetrics (FIGO) stage and appropriate chemotherapy. Mixed multivariable logistic regression analysis with a random center effect was performed to estimate the probability of adherence to the guidelines. Survival analysis was carried out using the Kaplan–Meier method and a mixed Cox proportional hazards model.Results1463 patients were included in the study. Overall, 317 (30%) patients received complete guideline adherent care. Patients received appropriate surgical treatment in 69% of cases, while adequate chemotherapy was administered to 44% of patients. Both patient demographics and disease characteristics were significantly associated with the likelihood of receiving guideline adherent care, such as age, performance status, FIGO stage, and initial burden of disease. In univariate and multivariate survival analysis, adherence to the guidelines was a statistically significant and independent predictor of decreased overall survival. Patients receiving suboptimal care experienced an increased risk of death of more than 100% compared with those treated according to the guidelines (hazard ratio 2.14, 95% confidence interval 1.32 to 3.47, p<0.01). In both models, a significant random center effect was observed, confirming the heterogeneity between centers (p<0.001).ConclusionsAdherence to ESMO–ESGO guidelines in ovarian cancer was associated with a higher overall survival and may be a useful method of assessing quality of care.

2019 ◽  
Vol 29 (4) ◽  
pp. 728-760 ◽  
Author(s):  
N Colombo ◽  
C Sessa ◽  
A du Bois ◽  
J Ledermann ◽  
WG McCluggage ◽  
...  

The development of guidelines is one of the core activities of the European Society for Medical Oncology (ESMO) and European Society of Gynaecologial Oncology (ESGO), as part of the mission of both societies to improve the quality of care for patients with cancer across Europe. ESMO and ESGO jointly developed clinically relevant and evidence-based recommendations in several selected areas in order to improve the quality of care for women with ovarian cancer. The ESMO–ESGO consensus conference on ovarian cancer was held on April 12–14, 2018 in Milan, Italy, and comprised a multidisciplinary panel of 40 leading experts in the management of ovarian cancer. Before the conference, the expert panel worked on five clinically relevant questions regarding ovarian cancer relating to each of the following four areas: pathology and molecular biology, early-stage and borderline tumours, advanced stage disease and recurrent disease. Relevant scientific literature, as identified using a systematic search, was reviewed in advance. During the consensus conference, the panel developed recommendations for each specific question and a consensus was reached. The recommendations presented here are thus based on the best available evidence and expert agreement. This article presents the recommendations of this ESMO–ESGO consensus conference, together with a summary of evidence supporting each recommendation.


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 833-833
Author(s):  
Myo Htut ◽  
Anita D'Souza ◽  
Benedetto Bruno ◽  
Mei-Jie Zhang ◽  
Mingwei Fei ◽  
...  

Abstract Background: Five large prospective trials have shown a lack of improvement in OS from an autologous-allogeneic (auto-allo) HCT approach in MM, whereas 3 trials have demonstrated benefit. In long term follow up of the randomized EBMT-NMAM2000 trial, Gahrton et al* reported that overall survival (OS) after relapse among the auto-allo cohort was superior compared to auto-auto recipients. Objective: Compare OS rates after relapse from upfront auto-allo vs. auto-auto HCT. Eligibility: Recipients (N-1679) of either an upfront tandem autologous (n=1110) or auto-allo HCT (n=569) reported to the CIBMTR. Eligibility included age ≤70, planned tandem HCT and recipients of subsequent allo HCT following relapse were excluded. HLA-matched related (96%) and unrelated grafts (4%) were included. Methods: Cox proportional hazards (PH) regression modeling was used in multivariate analysis of OS after relapse with the clock starting at relapse, and events included death from any cause. Surviving patients were censored at the time of last contact. Results/Discussion: 404 patients relapsed in the auto-auto group and 178 patients in the auto-allo group (Table 1). Median time from diagnosis to 1st HCT was 8 months for auto-allo patients and 7 months for auto-auto patient with most patients receiving 1-2 lines of chemotherapy before 1st HCT (73% in auto-allo and 90% in auto-auto groups). Among auto-allo patients, 46% of relapses occurred in < 6 months from 2nd HSCT, compared to 26% in the auto-auto group suggesting that the auto-allo pts were a higher risk group. The median follow-up after relapse for the auto-allo and auto-auto groups were 102 and 99 months respectively. In univariate survival analysis, patients in the auto-allo group had a similar probability of survival (48%) at 5 years post relapse, compared with the auto-auto arm (41%) (Table-2). 101 patients in auto-allo patients died due to MM (69%) vs. 229 (83%) deaths in auto-auto groups due to MM. In multivariate analysis, a pattern of differential time dependent risk was observed. Both cohorts had a similar risk of death in the 1st year after relapse (HR of 0.72; p=0.12). However, for time points beyond 12 months after relapse, patients in the auto-allo group had superior OS compared with auto-auto cohort (HR for death in auto-auto =1.55; p=0.0052) (Figure-1). Other significant co-variates associated with superior survival were enrollment in a clinical trial for HCT, male sex and novel agent (lenalidomide/bortezomib) use in induction prior to HCT. Conclusion: We extend the post relapse survival findings reported by Gahrton et al in allogeneic HCT with matched sibling donors in a larger real world population of related and unrelated grafts. Despite a higher risk population with increased risk of early relapse undergoing tandem auto-allo HCT, we observed a long term reduction in post relapse mortality. This likely reflects an improved response to salvage therapy due to the donor derived immunologic milieu that potentiates the immune effects of agents such as lenalidomide and pomalidomide. With the availability of other agents that modulate immune mediated disease control such a daratumumab (reduction in T and B regulatory subsets) and check point inhibitors; we anticipate that post allo transplant immune manipulation can further augment these benefits. Table 1 Patients' Baseline characteristics * Gahrton et al. EBMT-NMAM2000 study (Blood 2013; 121 (25):5055-63) Table 1. Patients' Baseline characteristics. / * Gahrton et al. EBMT-NMAM2000 study (Blood 2013; 121 (25):5055-63) Table 2 Univariate survival analysis of patients who relapsed post tandem transplant (time 0 at time of relapse) Table 2. Univariate survival analysis of patients who relapsed post tandem transplant (time 0 at time of relapse) Figure 1 Adjusted overall survival for post relapse patients Figure 1. Adjusted overall survival for post relapse patients Disclosures Krishnan: celgene: Consultancy, Speakers Bureau; takeda: Consultancy, Speakers Bureau; janssen: Consultancy, Speakers Bureau; onyx: Speakers Bureau.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5059-5059
Author(s):  
Mausam Patel ◽  
Thomas Kim ◽  
Chenghui Li ◽  
Ahmed Safar ◽  
Sanjay Maraboyina

5059 Background: Stereotactic body radiotherapy (SBRT) is being increasingly used for renal cell carcinoma (RCC) treatment in non-surgical candidates. However, no studies have compared survival between nephrectomy and SBRT. The National Cancer Database (NCDB) database was used to assess overall survival in patients undergoing SBRT vs nephrectomy. Methods: All cases of T1-T4, N0, M0 RCC diagnosed between 2004 and 2016 were extracted from the NCDB. Only patients undergoing either nephrectomy or SBRT, but not both, were included in the final analysis. Primary outcome was overall survival, defined as time in months from diagnosis to death due to any cause. Descriptive statistics were calculated for all variables. Univariate survival analysis was performed using the Kaplan Meier method and log rank test. Multivariate Cox proportional hazards regression models were performed to determine the predictive performance of covariates with respect to overall survival, reported as hazard ratio [HR] with 95% CIs. Nephrectomy patients were propensity score matched to SBRT patients for sub-cohort survival analysis. Comparisons were considered statistically significant at P < 0.05. Results: There were 243,754 patients meeting inclusion criteria with 243,488 undergoing nephrectomy and 266 undergoing SBRT. Five year OS rates were 53% and 80% for SBRT and nephrectomy, respectively (P < 0.001). On multivariate Cox regression, SBRT was associated with an increased risk of death as compared to nephrectomy (HR, 2.05; 95% CI, 1.72 – 2.44; P < 0.001). Sex, race, insurance coverage, comorbidity index, tumor grade, lymphovascular invasion status, T-stage, tumor size, and academic status of treatment facility were also independent predictors of survival. After propensity score matching of 266 SBRT patients to 266 nephrectomy patients, there were no significant differences in baseline characteristics between the groups. However, SBRT continued to demonstrate worse survival and an increased risk of death as compared to nephrectomy (HR, 1.85; 95% CI, 1.41 – 2.44; P < 0.001). Conclusions: Among node-negative, non-metastatic RCC patients, SBRT is associated with inferior survival outcomes as compared to nephrectomy, even after correcting for underlying differences in demographics, tumor characteristics, socioeconomic status, and comorbidities. These results indicate that nephrectomy should remain the standard of care for RCC patients, with SBRT reserved for non-surgical candidates.


2004 ◽  
Vol 14 (5) ◽  
pp. 779-787 ◽  
Author(s):  
E. Stoeckle ◽  
P. Paravis ◽  
A. Floquet ◽  
L. Thomas ◽  
C. Tunon De Lara ◽  
...  

The objective of the present study was to improve the definitions of optimal and suboptimal surgery in ovarian cancer. A retrospective prognostic factor analysis was done in a series of 433 patients with advanced ovarian cancer (stages III and IV) treated during the cisplatine era from 1980 to 1997 with assessment of postoperative residual disease by number and ranges of size of peritoneal nodules. Mean age of patients was 56.7 years. Median follow-up of patients alive was 138 months (range: 6–266 months). Median overall survival was 23 months. Significant prognostic factors for overall survival in univariate analysis were age, the presence of ascites, FIGO stage, treatment period, histological subtype, grade, results of surgery as defined by size and number of residual nodules. In multivariate analysis, quality of surgery defined by no versus few versus numerous residual nodules showed to remain an independent prognostic factor for outcome (P = 0.003), whereas size of residual nodules did not achieve significance. In conclusion, only complete surgery (no residual nodules) confers a real survival advantage. Cytoreduction to few and small nodules is associated with favorable outcome and could be qualified as optimal. Otherwise, cytoreduction leaving numerous nodules, whatever their size, remains suboptimal. Such patients should be considered for neo-adjuvant chemotherapy.


2019 ◽  
Vol 7 (4) ◽  
pp. 391-399
Author(s):  
Roshan S Prabhu ◽  
Christopher D Corso ◽  
Matthew C Ward ◽  
John H Heinzerling ◽  
Reshika Dhakal ◽  
...  

Abstract Background Adult intracranial ependymoma is rare, and the role for adjuvant radiotherapy (RT) is not well defined. Methods We used the National Cancer Database (NCDB) to select adults (age ≥ 22 years) with grade 2 to 3 intracranial ependymoma status postresection between 2004 and 2015 and treated with adjuvant RT vs observation. Four cohorts were generated: (1) all patients, (2) grade 2 only, (3) grade 2 status post–subtotal resection only, (4) and grade 3 only. The association between adjuvant RT use and overall survival (OS) was assessed using multivariate Cox and propensity score matched analyses. Results A total of 1787 patients were included in cohort 1, of which 856 patients (48%) received adjuvant RT and 931 (52%) were observed. Approximately two-thirds of tumors were supratentorial and 80% were grade 2. Cohorts 2, 3, and 4 included 1471, 345, and 316 patients, respectively. There was no significant association between adjuvant RT use and OS in multivariate or propensity score matched analysis in any of the cohorts. Older age, male sex, urban location, higher comorbidity score, earlier year of diagnosis, and grade 3 were associated with increased risk of death. Conclusions This large NCDB study did not demonstrate a significant association between adjuvant RT use and OS for adults with intracranial ependymoma, including for patients with grade 2 ependymoma status post–subtotal resection. The conflicting results regarding the efficacy of adjuvant RT in this patient population highlight the need for high-quality studies to guide therapy recommendations in adult ependymoma.


2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Yanli Liu ◽  
Yilong Pan ◽  
Yuyao Yin ◽  
Wenhao Chen ◽  
Xiaodong Li

Abstract Background The numbers of confirmed cases of coronavirus disease 2019 (COVID-19) and COVID-19 related deaths are still increasing, so it is very important to determine the risk factors of COVID-19. Dyslipidemia is a common complication in patients with COVID-19, but the association of dyslipidemia with the severity and mortality of COVID-19 is still unclear. The aim of this study is to analyze the potential association of dyslipidemia with the severity and mortality of COVID-19. Methods We searched the PubMed, Embase, MEDLINE, and Cochrane Library databases for all relevant studies up to August 24, 2020. All the articles published were retrieved without language restriction. All analysis was performed using Stata 13.1 software and Mantel–Haenszel formula with fixed effects models was used to compare the differences between studies. The Newcastle Ottawa scale was used to assess the quality of the included studies. Results Twenty-eight studies involving 12,995 COVID-19 patients were included in the meta-analysis, which was consisted of 26 cohort studies and 2 case–control studies. Dyslipidemia was associated with the severity of COVID-19 (odds ratio [OR] = 1.27, 95% confidence interval [CI] 1.11–1.44, P = 0.038, I2 = 39.8%). Further, patients with dyslipidemia had a 2.13-fold increased risk of death compared to patients without dyslipidemia (95% CI 1.84–2.47, P = 0.001, I2 = 66.4%). Conclusions The results proved that dyslipidemia is associated with increased severity and mortality of COVID-19. Therefore, we should monitor blood lipids and administer active treatments in COVID-19 patients with dyslipidemia to reduce the severity and mortality.


2014 ◽  
Vol 24 (1) ◽  
pp. 48-53 ◽  
Author(s):  
Alejandra Martínez ◽  
Cristophe Pomel ◽  
Thomas Filleron ◽  
Marjolein De Cuypere ◽  
Eliane Mery ◽  
...  

ObjectiveThe aim of the study was to report on the oncologic outcome of the disease spread to celiac lymph nodes (CLNs) in advanced-stage ovarian cancer patients.MethodsAll patients who had CLN resection as part of their cytoreductive surgery for epithelial ovarian, fallopian, or primary peritoneal cancer were identified. Patient demographic data with particular emphasis on operative records to detail the extent and distribution of the disease spread, lymphadenectomy procedures, pathologic data, and follow-up data were included.ResultsThe median follow-up was 26.3 months. The median overall survival values in the group with positive CLNs and in the group with negative CLNs were 26.9 months and 40.04 months, respectively. The median progression-free survival values in the group with metastatic CLNs and in the group with negative CLNs were 8.8 months and 20.24 months, respectively (P = 0.053). Positive CLNs were associated with progression during or within 6 months after the completion of chemotherapy (P = 0.0044). Tumor burden and extensive disease distribution were significantly associated with poor progression-free survival, short-term progression, and overall survival. In multivariate analysis, only the CLN status was independently associated with short-term progression.ConclusionsDisease in the CLN is a marker of disease severity, which is associated to a high-risk group of patients with presumed adverse tumor biology, increased risk of lymph node progression, and worst oncologic outcome.


2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Hideki Endo ◽  
Shigehiko Uchino ◽  
Satoru Hashimoto ◽  
Yoshitaka Aoki ◽  
Eiji Hashiba ◽  
...  

Abstract Background The Acute Physiology and Chronic Health Evaluation (APACHE) III-j model is widely used to predict mortality in Japanese intensive care units (ICUs). Although the model’s discrimination is excellent, its calibration is poor. APACHE III-j overestimates the risk of death, making its evaluation of healthcare quality inaccurate. This study aimed to improve the calibration of the model and develop a Japan Risk of Death (JROD) model for benchmarking purposes. Methods A retrospective analysis was conducted using a national clinical registry of ICU patients in Japan. Adult patients admitted to an ICU between April 1, 2018, and March 31, 2019, were included. The APACHE III-j model was recalibrated with the following models: Model 1, predicting mortality with an offset variable for the linear predictor of the APACHE III-j model using a generalized linear model; model 2, predicting mortality with the linear predictor of the APACHE III-j model using a generalized linear model; and model 3, predicting mortality with the linear predictor of the APACHE III-j model using a hierarchical generalized additive model. Model performance was assessed with the area under the receiver operating characteristic curve (AUROC), the Brier score, and the modified Hosmer–Lemeshow test. To confirm model applicability to evaluating quality of care, funnel plots of the standardized mortality ratio and exponentially weighted moving average (EWMA) charts for mortality were drawn. Results In total, 33,557 patients from 44 ICUs were included in the study population. ICU mortality was 3.8%, and hospital mortality was 8.1%. The AUROC, Brier score, and modified Hosmer–Lemeshow p value of the original model and models 1, 2, and 3 were 0.915, 0.062, and < .001; 0.915, 0.047, and < .001; 0.915, 0.047, and .002; and 0.917, 0.047, and .84, respectively. Except for model 3, the funnel plots showed overdispersion. The validity of the EWMA charts for the recalibrated models was determined by visual inspection. Conclusions Model 3 showed good performance and can be adopted as the JROD model for monitoring quality of care in an ICU, although further investigation of the clinical validity of outlier detection is required. This update method may also be useful in other settings.


2020 ◽  
Vol 49 (4) ◽  
pp. 419-425
Author(s):  
Olga Hilda Orasan ◽  
Flaviu Muresan ◽  
Augustin Mot ◽  
Adela Sitar Taut ◽  
Iulia Minciuna ◽  
...  

Background: Pruritus and insomnia are common disorders in hemodialysis (HD) patients, with a major clinical impact as they are associated with poor quality of life and increased mortality. Their coexistence and impact on survival in HD patients have rarely been investigated. Our aim is to investigate the survival of HD patients presenting either none, one, or both disorders and to compare certain features between these groups. Methods: After the inclusion/exclusion criteria, 170 patients treated by HD or online hemodiafiltration were assigned in 4 study groups depending on the presence of either, neither, or both pruritus and insomnia. We analyzed the survival difference between groups after 20 months, and we searched if there were significant differences in terms of clinical and laboratory features. Results: Survival at 20 months was lower in patients with both pruritus and insomnia. Patients with pruritus alone had a lower Kt/V than those with no complaints or insomnia alone. Those with no complaints had lower C-reactive protein and higher albumin levels than patients with insomnia alone or both conditions. Conclusion: Pruritus and insomnia should be actively investigated and correlated with some clinical and laboratory features as they have a significant impact on survival in HD patients.


2018 ◽  
Vol 28 (3) ◽  
pp. 453-458 ◽  
Author(s):  
Parvin Tajik ◽  
Roelien van de Vrie ◽  
Mohammad H. Zafarmand ◽  
Corneel Coens ◽  
Marrije R. Buist ◽  
...  

ObjectiveThe revised version of the International Federation of Gynaecology and Obstetrics (FIGO) staging system (2014) for epithelial ovarian cancer includes a number of changes. One of these is the division of stage IV into 2 subgroups. Data on the prognostic and predictive significance of this classification are scarce. The effect of neoadjuvant chemotherapy (NACT) versus primary debulking surgery (PDS) in relation to the subclassification of FIGO stage IV is also unknown.MethodsWe used data of the EORTC 55971 trial, in which 670 patients with previous stage IIIC or IV epithelial ovarian cancer were randomly assigned to PDS or NACT; 160 patients had previous stage IV. Information on previous FIGO staging and presence of pleural effusion with positive cytology were used to classify tumors as either stage IVA or IVB. We tested the association between stage IVA/IVB and survival to evaluate the prognostic value and interactions between stage, treatment, and survival to evaluate the predictive performance.ResultsAmong the 160 participants with previous stage IV disease, 103 (64%) were categorized as stage IVA and 57 (36%) as stage IVB tumors. Median overall survival was 24 months in FIGO stage IVA and 31 months in stage IVB patients (P = 0.044). Stage IVB patients treated with NACT had 9 months longer median overall survival compared with IVB patients undergoing PDS (P = 0.025), whereas in IVA patients, no significant difference was observed (24 vs 26 months, P = 0.48).ConclusionsThe reclassification of FIGO stage IV into stage IVA or IVB was not prognostic as expected. Compared with stage IVA patients, stage IVB patients have a better overall survival and may benefit more from NACT.


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