ABSTRACT
The vaginal contraceptive ring is very effective and user dependent. In this article, we will discuss the different types of vaginal contraceptive rings, namely, the etonogestrel/ethinyl estradiol (ENG/EE) ring (NuvaRing, Merck, Rahway, NJ, USA) and the segesterone acetate (SA)/EE (Annovera, Mayne Pharma, Raleigh, NC, USA) ring. The details of dosing and administration, indications, advantages, disadvantages, and cost-effectiveness are presented. This literature review was conducted using PubMed and Google Scholar. The search terms included 'vaginal contraceptive ring', 'etonogestrel/ethinyl estradiol ring', and 'segesterone acetate/ethinyl estradiol ring'. The search was then sorted by year from 2000 until present, and the most recent articles were reviewed. The purpose of this article is to provide a comprehensive reference on the two vaginal contraceptive rings widely used in the United States for clinicians to guide management. Both vaginal contraceptive rings are combination of hormonal contraceptives that suppress ovulation and create physiologic conditions unfavorable for pregnancy. The ENG/EE ring is designed to be replaced monthly, while the SA/EE ring is a single device used over the course of 1 year. Common side effects of both devices include headaches, nausea, vomiting, and vaginitis. Serious adverse reactions can occur with the vaginal contraceptive rings including venous thromboembolism, psychiatric events, and hypersensitivity. Both devices are contraindicated in patients at high risk for arterial or venous thrombotic events, patients with a history of breast cancer or other estrogen/progesterone cancers, and patients with severe liver disease. Overall, the vaginal contraceptive ring is well tolerated and liked by patients. Patients should be well counseled on known severe adverse reactions. The vaginal contraceptive ring is more expensive than other forms of contraception and this should be an important point of discussion with patients.
PMID:37465002 | PMC:PMC10350750 | DOI:10.1177/26334941231186733
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PubMed articles on: Cancer & VTE/PE
A nomogram for predicting the risk of venous thromboembolism in patients with solid cancers
J Thromb Thrombolysis. 2023 Jul 18. doi: 10.1007/s11239-023-02856-0. Online ahead of print.
ABSTRACT
Cancer patients with venous thromboembolism (VTE) are prone to poor prognoses. Thus, we aimed to develop a nomogram to predict the risk of VTE in these patients. We retrospectively analyzed 791 patients diagnosed with solid tumors between January 2017 and May 2021 at Tongji Hospital. Univariate logistic analysis and multivariate logistic regression were adopted in this study. Our results indicated that age ≥ 60 years, tumor stages III-IV, platelet distribution width (PDW) ≤ 12.6%, albumin concentration ≤ 38.8 g/L, lactate dehydrogenase (LDH) concentration ≥ 198 U/L, D-dimer concentration ≥ 1.72 µg/mL, blood hemoglobin concentration ≤ 100 g/dL or the use of erythropoiesis-stimulating agents and cancer types were independent risk factors. The nomogram prediction model was developed based on the regression coefficients of these variables. We assessed the performance of the nomogram by calibration plot and the area under the receiver operating characteristic curve and compared it with the Khorana score. The concordance index (C- index) of the nomogram was 0.852 [95% confidence interval (CI) 0.823 to 0.880], while the Khorana score was 0.681 (95% CI 0.639 to 0.723). Given its performance, this nomogram could be used to select cancer patients at high risk for VTE and guide thromboprophylaxis treatment in clinical practice, provided it is validated in an external cohort.
PMID:37462901 | DOI:10.1007/s11239-023-02856-0
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Comorbidities and high in-hospital mortality of cancer-associated pulmonary embolism: findings from a real-world registry study
Chin Med J (Engl). 2023 Jul 17. doi: 10.1097/CM9.0000000000002670. Online ahead of print.
NO ABSTRACT
PMID:37461237 | DOI:10.1097/CM9.0000000000002670
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Burden of serious harms from diagnostic error in the USA
BMJ Qual Saf. 2023 Jul 17:bmjqs-2021-014130. doi: 10.1136/bmjqs-2021-014130. Online ahead of print.
ABSTRACT
BACKGROUND: Diagnostic errors cause substantial preventable harms worldwide, but rigorous estimates for total burden are lacking. We previously estimated diagnostic error and serious harm rates for key dangerous diseases in major disease categories and validated plausible ranges using clinical experts.
OBJECTIVE: We sought to estimate the annual US burden of serious misdiagnosis-related harms (permanent morbidity, mortality) by combining prior results with rigorous estimates of disease incidence.
METHODS: Cross-sectional analysis of US-based nationally representative observational data. We estimated annual incident vascular events and infections from 21.5 million (M) sampled US hospital discharges (2012-2014). Annual new cancers were taken from US-based registries (2014). Years were selected for coding consistency with prior literature. Disease-specific incidences for 15 major vascular events, infections and cancers ('Big Three' categories) were multiplied by literature-based rates to derive diagnostic errors and serious harms. We calculated uncertainty estimates using Monte Carlo simulations. Validity checks included sensitivity analyses and comparison with prior published estimates.
RESULTS: Annual US incidence was 6.0 M vascular events, 6.2 M infections and 1.5 M cancers. Per 'Big Three' dangerous disease case, weighted mean error and serious harm rates were 11.1% and 4.4%, respectively. Extrapolating to all diseases (including non-'Big Three' dangerous disease categories), we estimated total serious harms annually in the USA to be 795 000 (plausible range 598 000-1 023 000). Sensitivity analyses using more conservative assumptions estimated 549 000 serious harms. Results were compatible with setting-specific serious harm estimates from inpatient, emergency department and ambulatory care. The 15 dangerous diseases accounted for 50.7% of total serious harms and the top 5 (stroke, sepsis, pneumonia, venous thromboembolism and lung cancer) accounted for 38.7%.
CONCLUSION: An estimated 795 000 Americans become permanently disabled or die annually across care settings because dangerous diseases are misdiagnosed. Just 15 diseases account for about half of all serious harms, so the problem may be more tractable than previously imagined.
PMID:37460118 | DOI:10.1136/bmjqs-2021-014130
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PubMed articles on: Cancer & VTE/PE
Incidence of venous thromboembolism following head and neck surgery
Eur Arch Otorhinolaryngol. 2023 Jul 17. doi: 10.1007/s00405-023-08112-8. Online ahead of print.
ABSTRACT
PURPOSE: Venous thromboembolism (VTE) is associated with significant morbidity and mortality in patients undergoing surgery, but conflicting data exist on VTE risk in patients undergoing head and neck surgery for malignant and non-malignant conditions. Our aim was to examine the risk of VTE among patients with and without cancer undergoing head and neck surgery.
METHODS: We conducted a nationwide cohort study to examine the risk of VTE among patients with an otolaryngological diagnosis using data from the Danish National Patient Register between 2010 and 2018. Analyses were stratified by cancer and anatomical areas of the surgical procedure.
RESULTS: In total, 116,953 patients were included of whom 10% (n = 12,083) had active cancer. After 3 months, 1.2% of the patients with cancer and 0.3% of the patients without cancer experienced VTE, respectively. For patients undergoing mouth/throat surgery, 0.8% with cancer and 0.2% without cancer had VTE, respectively. After nose/sinuses surgery 0.7% and 0.2%, respectively. No patients experienced VTE after ear surgery; and after endoscopies the numbers were 1.3% and 0.6% respectively.
CONCLUSIONS: While the minority of patients undergoing head and neck surgery develop VTE postoperatively, the risk increases among those with cancer. To support clinical decision making on anticoagulation, risk stratification tools could be further developed to recognize this hazard in patients with cancer undergoing head and neck surgery.
PMID:37458791 | DOI:10.1007/s00405-023-08112-8
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PubMed articles on: Cancer & VTE/PE
Acute pulmonary tumour embolism and right systolic dysfunction in a hidden intrahepatic cholangiocarcinoma: case report
Eur Heart J Case Rep. 2023 Jun 28;7(7):ytad291. doi: 10.1093/ehjcr/ytad291. eCollection 2023 Jul.
ABSTRACT
BACKGROUND: Pulmonary tumour embolism is a rare entity that can arise from a wide variety of neoplasms. It can initially manifest as a pulmonary embolism with right heart failure and be refractory to thrombolytic therapy. Cholangiocarcinoma is a rare malignancy that arises from the epithelium of the biliary tree, representing 3% of all the gastrointestinal malignancies, being the intrahepatic cholangiocarcinoma the second most common liver tumour after hepatocellular carcinoma.
CASE SUMMARY: This case regards a patient that presented to our centre with acute pulmonary embolism, deep vein thrombosis, and unrevealing previous medical history. Imaging studies revealed pulmonary embolism, an ovarian mass, and multiple hepatic hypodensities. Throughout the hospitalization, the patient's haemodynamic state and right heart failure worsened, eventually leading to multi-organ failure and death. Post-mortem evaluation revealed cholangiocarcinoma cells on the pulmonary arteries.
DISCUSSION: Pulmonary tumour embolism is a rare pathology that can present with acute right heart failure. The diagnosis of occult cancer can be challenging, and the appropriate treatment for this entity remains an unexplored subject.
PMID:37457051 | PMC:PMC10347672 | DOI:10.1093/ehjcr/ytad291
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Optimal D-dimer cut-off values for diagnosing deep vein thrombosis in patients with comorbid malignancies
Ann Vasc Surg. 2023 Jul 14:S0890-5096(23)00513-7. doi: 10.1016/j.avsg.2023.06.033. Online ahead of print.
ABSTRACT
BACKGROUND: Patients with malignancy are at high risk of VTE, and early diagnosis is important. The Khorana score is known as a risk assessment for cancer-related thrombosis during chemotherapy, but there are still few reports on its diagnostic potential, the optimal D-dimer cut-off values for indications other than chemotherapy and the use of the Khorana score in combination with D-dimers. In this study, we examined the clinical appropriateness of increasing the D-dimer cut-off value.
METHODS: We retrospectively studied 208 malignancies out of 556 patients who underwent lower extremity venous ultrasonography at our hospital over a two-year period from January 2018 to December 2019. The optimal D-dimer cut-off value for predicting DVT in patients with malignancy was calculated by the Youden index. The usefulness of the Khorana score alone and the model combining the Khorana score with D-dimer for predicting DVT diagnosis was compared using receiver operating characteristic analysis.
RESULTS: Of 208 eligible patients, 59 (28.4%) had confirmed DVT. The optimal D- dimer cut-off value for predicting DVT comorbidity in patients with malignancy was 3.96 μg/mL. When the new D-dimer cut-off value was set at 4.0 μg/mL, the odds ratio for DVT diagnosis was 4.23 (95% CI 2.10-8.55, p<0.001),
CONCLUSIONS: The optimal D-dimer cut-off value for the diagnosis of DVT in patients with malignancy was 4.0 μg/mL. It was also suggested that the combination of the Khorana score with the D-dimer level was more accurate in diagnosing DVT than the Khorana score alone.
PMID:37454901 | DOI:10.1016/j.avsg.2023.06.033
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Heparin reversal with protamine sulfate after Percutaneous Hepatic Perfusion (PHP): is less more?
Cancer Imaging. 2023 Jul 14;23(1):68. doi: 10.1186/s40644-023-00590-7.
ABSTRACT
PURPOSE: Percutaneous hepatic perfusion (PHP) is a palliative intraarterial therapy for unresectable hepatic malignancies. During PHP, high-dose melphalan is infused via the hepatic artery to saturate tumor in the liver with the chemotherapeutic substance. The venous hepatic blood is filtered by an extracorporeal melphalan specific filtration system. Blood clotting in the extracorporeal filter system is prevented by administering unfractionated heparin (UFH) in high doses, which might be reversed with protamine sulfate after the procedure. Aim of this retrospective two-center-study was to analyze the potential effect of UFH reversal with protamine sulfate on complication rates following PHP.
MATERIALS AND METHODS: All patients receiving PHP treatment between 10/2014 and 04/2021 were classified according to their intraprocedural coagulation management: 92 patients/192 PHP received full UFH reversal with protamine (groupPROTAMINE); 13 patients/21 PHP in groupREDUCED_PROTAMINE received a reduced amount of protamine, and 28 patients/43 PHP did not receive UFH reversal with protamine (groupNO_PROTAMINE). Periinterventional clinical reports, findings and laboratory values were retrospectively evaluated. Complications and adverse events were classified according to Common Terminology Criteria for Adverse Events (CTCAEv5.0).
RESULTS: Thromboembolic events were recorded after 10 PHP procedures (5%) in groupPROTAMINE, six of which (3%) were major events (CTCAE grade 3-5). No (0%) thromboembolic events were recorded in groupREDUCED_PROTAMINE and groupNO_PROTAMINE. Hemorrhagic events were registered after 24 PHP (13%) in groupPROTAMINE, two of which (1%) were major (CTCAE grade 3-4). In groupREDUCED_PROTAMINE, only minor bleeding events were recorded, and one major hemorrhagic event was documented in groupNO_PROTAMINE (2%). There was a significant difference between the percentage of post-interventional thrombopenia in groupPROTAMINE (39%) and groupREDUCED_PROTAMINE (14%) versus groupNO_PROTAMINE (23%) (p=.00024). In groupPROTAMINE one patient suffered from a severe anaphylactic shock after the administration of protamine.
CONCLUSION: Our retrospective study implies that there might be a link between the practice of protamine sulfate administration to reverse the full hemodilutive effect of UFH after PHP and the post-interventional risk of thromboembolic events as well as clinically significant thrombopenia. Our data suggest that the standard use of protamine sulfate after PHP in low-risk patients without clinical signs of active bleeding should be critically re-evaluated.
PMID:37452405 | PMC:PMC10349410 | DOI:10.1186/s40644-023-00590-7
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Pembrolizumab plus lenvatinib as first-line therapy for advanced non-clear-cell renal cell carcinoma (KEYNOTE-B61): a single-arm, multicentre, phase 2 trial
Lancet Oncol. 2023 Jul 11:S1470-2045(23)00276-0. doi: 10.1016/S1470-2045(23)00276-0. Online ahead of print.
ABSTRACT
BACKGROUND: Immunotherapy-based combinations including pembrolizumab plus lenvatinib are the standard of care for patients with first-line clear-cell renal cell carcinoma, but these combinations are not well characterised in non-clear-cell renal cell carcinoma. We aimed to assess the activity and safety of pembrolizumab plus lenvatinib as a first-line treatment for patients with advanced non-clear-cell renal cell carcinoma.
METHODS: KEYNOTE-B61 is a single-arm, phase 2 trial being conducted at 48 sites (hospitals and cancer centres) in 14 countries (Australia, Canada, France, Hungary, Ireland, Italy, Poland, South Korea, Russia, Spain, Türkiye, Ukraine, the UK, and the USA). Adult patients (aged ≥18 years) with previously untreated stage IV non-clear-cell renal cell carcinoma and a Karnofsky performance status of 70% or higher were eligible for enrolment. All enrolled patients received pembrolizumab 400 mg intravenously every 6 weeks for up to 18 cycles (2 years) plus lenvatinib 20 mg orally once daily or until disease progression, unacceptable toxicity, or withdrawal; lenvatinib could be continued beyond 2 years. The primary endpoint was the proportion of patients with a confirmed objective response as per adjusted Response Evaluation Criteria in Solid Tumours (version 1.1) assessed by independent central review. Activity and safety were analysed in all patients who received at least one dose of study treatment (the as-treated population). This trial is registered with ClinicalTrials.gov (NCT04704219) and is no longer recruiting participants but is ongoing.
FINDINGS: Between Feb 23, 2021, and Jan 21, 2022, 215 patients were screened; 158 were enrolled and received treatment. Median age at baseline was 60 years (IQR 52-69), 112 (71%) of 158 patients were male, 46 (29%) were female, 128 (81%) were White, 12 (8%) were Asian, three (2%) were Black or African American, and 15 (9%) were missing data on race. As of data cutoff (Nov 7, 2022), median study follow-up was 14·9 months (IQR 11·1-17·4). 78 of 158 patients had a confirmed objective response (49%; 95% CI 41-57), including nine (6%) patients with a confirmed complete response and 69 (44%) with a confirmed partial response. Grade 3-4 treatment-related adverse events occurred in 81 (51%) of 158 patients, the most common of which were hypertension (37 [23%] of 158), proteinuria (seven [4%]), and stomatitis (six [4%]). Serious treatment-related adverse events occurred in 31 (20%) of 158 patients. Eight (5%) patients died due to adverse events, none of which was considered related to the treatment by the investigators (one each of cardiac failure, peritonitis, pneumonia, sepsis, cerebrovascular accident, suicide, pneumothorax, and pulmonary embolism).
INTERPRETATION: Pembrolizumab plus lenvatinib has durable antitumour activity in patients with previously untreated advanced non-clear-cell renal cell carcinoma, with a safety profile consistent with that of previous studies. Results from KEYNOTE-B61 support the use of pembrolizumab plus lenvatinib as a first-line treatment option for these patients.
FUNDING: Merck Sharp & Dohme (a subsidiary of Merck & Co, NJ, USA), and Eisai.
PMID:37451291 | DOI:10.1016/S1470-2045(23)00276-0
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PubMed articles on: Cancer & VTE/PE
Diagnostic management of acute pulmonary embolism: a prediction model based on a patient data meta-analysis
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High-intensity interval training and thromboembolic events during chemotherapy for testicular cancer: a retrospective analysis from the Body & Cancer cohort
Acta Oncol. 2023 Jun;62(6):666-672. doi: 10.1080/0284186X.2023.2225145. Epub 2023 Jul 14.