IMPORTANCE Current guidelines recommend a 28-day course of enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The high cost of this medication and the low adherence rates observed in prior studies provide an opportunity to benefit patients by demonstrating the safety of a more cost-effective, easier to use thromboprophylactic. OBJECTIVE To investigate the safety and efficacy of an oral treatment alternative for thromboprophylaxis in postoperative patients with gynecologic cancer. DESIGN, SETTING, AND PARTICIPANTS This was a patient-based, multicenter, open-label, blinded, end point, randomized clinical trial conducted May 2015 to March 2019 in outpatient and inpatient gynecologic oncology settings. Women undergoing surgery for suspected or confirmed gynecologic cancer were approached for recruitment. The trial compared rates of major bleeding and clinically relevant nonmajor bleeding events during a 90-day follow-up period in patients taking apixaban or enoxaparin for postoperative thromboprophylaxis using a modified intent-to-treat analysis. Data analysis was performed from October to December 2019. INTERVENTIONS Women were randomized to 28 days of apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously daily). MAIN OUTCOMES AND MEASURES The primary outcome was major bleeding and clinically relevant nonmajor bleeding events. Secondary outcomes included incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction. RESULTS Of 500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received apixaban and 196 received enoxaparin. Treatment groups did not differ in terms of race/ethnicity, cancer stage, or surgery modality (open vs robotic). There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%]; OR, 1.88; 95% CI, 0.87-4.1; P = .11), venous thromboembolic events (2 patients [1.0%] vs 3 patients [1.5%]; OR, 1.57; 95% CI, 0.26-9.50; P = .68), adverse events, medication adherence, or quality of life between the groups. Participant satisfaction was significantly greater in the apixaban group with regard to ease of taking the medication (186 patients [98.9%] vs 110 (continued) Key Points Question Is there an efficacious and safe oral treatment for thromboprophylaxis in postoperative patients with suspected gynecologic malignant neoplasms? Findings This multicenter randomized clinical trial included 400 women randomized to either oral apixaban or subcutaneous enoxaparin. There were no differences between groups for rates of major bleeding (0.5% vs 0.5%), clinically relevant nonmajor bleeding (5.4% vs 9.7%), and venous thromboembolic events (1.0% vs 1.5%); although adherence rates did not d...
Objectives.-Stage I, grade 1 endometrial cancers have low recurrence rates and often do not receive adjuvant therapy. We compared recurrent cases to matched non-recurrent controls to evaluate for molecular markers associated with higher risk of recurrence. Methods.-A case-control study including all cases of recurrent stage I, grade 1 endometrioid endometrial cancer at one institution in a ten-year period. Cases were matched to controls by age, BMI, weight and stage. Molecular testing and immunohistochemistry were performed on archival tumor specimens: microsatellite instability (MSI-H), mismatch repair status, POLE mutational status, and next-generation sequencing.
Objective Early specialty palliative care is underutilized for patients with advanced gynecologic malignancies. We sought to understand how gynecologic oncologists’ views influence outpatient specialty palliative care referral to help inform strategies for improvement. Methods/materials We conducted a qualitative interview study at six National Cancer Institute-designated cancer centers with well-established outpatient palliative care services. Between September 2015 and March 2016, 34 gynecologic oncologists participated in semi-structured telephone interviews focused on attitudes, experiences, and preferences related to outpatient specialty palliative care. A multidisciplinary team analyzed transcripts using constant comparative methods to inductively develop a coding framework. Through an iterative, analytic process codes were classified, grouped, and refined into themes. Results Mean participant age was 47 (SD 10) years. Mean interview length was 25 (SD 7) minutes. Three main themes emerged regarding how gynecologic oncologists view outpatient specialty palliative care: (1) long-term relationships with patients is a unique and defining aspect of gynecologic oncology that influences referral, (2) gynecologic oncologists value palliative care clinicians’ communication skills and third-party perspective to increase prognostic awareness and help negotiate differences between patient preferences and physician recommendation, and (3) gynecologic oncologists prefer specialty palliative care services embedded within gynecologic oncology clinics. Conclusions Gynecologic oncologists value longitudinal relationships with patients and utilize specialty palliative care to negotiate conflict surrounding prognostic awareness or the treatment plan. Embedding specialty palliative care within gynecologic oncology clinics may promote communication between clinicians and facilitate gynecologic oncologist involvement throughout the illness course.
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