Incidence and risk of venous thromboembolism according to primary treatment type in women with endometrial cancer: a population-based study.

BACKGROUND: Current prophylaxes and treatments for venous thromboembolism (VTE) in women with gynecologic cancer are mainly guided by studies on solid cancers because studies in gynecologic cancer did not provide sufficient data. Large-scale studies evaluating the incidence and risk of VTE according to therapeutic modality may guide prophylaxis and treatment of VTE in gynecologic cancer. This study was performed to determine the incidence and risk of VTE according to primary treatment type in Korean women with endometrial cancer. METHODS: We selected 26,256 women newly diagnosed with endometrial cancer between 2009 and 2018 from the Korean Health Insurance Review and Assessment Service database. During the total follow-up period and first six months after primary treatments initiation, the incidence and risk of VTE were evaluated according to primary treatment type, that is, no treatment, surgery, radiotherapy, chemotherapy, or hormone therapy. RESULTS: VTE occurred in 136 per 10,000 women during the total follow-up period and in 54 per 10,000 women during the first six months with the highest frequency in women that underwent chemotherapy. During the first year, the monthly incidence of VTE decreased with time among women that underwent no treatment, surgery, or hormone therapy and remained unchanged in those that received radiotherapy or chemotherapy. Compared with women that received no treatment, VTE risk, especially of PE significantly increased in women that underwent chemotherapy (VTE: hazard ratio (HR), 2.334; 95% CI, 1.38-3.949; P = 0.002) (PE: HR, 2.742; 95% CI, 1.424-5.278; P = 0.003) or hormone therapy (VTE: HR, 2.073; 95% CI, 1.356-3.17; P = 0.001) (PE: HR, 2.086; 95% CI, 1.19-3.657; P = 0.01) during the total follow-up period and women that underwent only chemotherapy during the first six months (VTE: HR, 2.532; 95% CI, 1.291-4.966; P = 0.007) (PE: HR, 3.366; 95% CI, 1.496-7.576; P = 0.003). CONCLUSIONS: In this cohort study, the incidence and risk of VTE were highest in women with endometrial cancer that underwent chemotherapy as a primary treatment. Notably, the incidence of VTE decreased over time in women that received no treatment, surgery, or hormone therapy. This study can help guide therapies for prophylaxis and treatment of VTE in women with endometrial cancer.

Dienogest and the Risk of Reoperation in Endometriosis.

BACKGROUND: This retrospective cohort study aimed to determine whether there is a difference in reoperation rates between patients who used dienogest (DNG) and patients who did not use DNG. METHODS: Using Health Insurance Review and Assessment Service (HIRA) data generated between 1 January 2010 and 30 June 2018, we identified women with an endometriosis diagnosis code who used GnRH agonists after gynecological surgery. Among them, women prescribed DNG were selected as the DNG group, and those who did not receive DNG were selected as the control group. A survival analysis of the reoperation between the two groups was performed. RESULTS: DNG and control groups were extracted from 9735 people each. The reoperation rates were 0.4% and 0.6% in the DNG and control groups, respectively, without adjusting. In the Cox proportional risk analysis, DNG use increased the reoperation rate {hazard ratio (HR), 1.599; 95% confidence interval (CI), 1.005-2.545}. The site of endometriosis and the number of GnRH agonist injections were not associated with reoperation (HR, 1.008; 95% CI, 0.739-1.374; HR, 1.062; 95% CI, 0.690-1.635). In the subgroup survival analysis, according to the period between the last GnRH agonist injection and the first DNG dose, DNG did not increase the reoperation rates up to 9 months (~3 months: HR, 0.968; 95% CI, 0.551-1.699; 4~6 months: HR, 1.094; 95% CI, 0.58-2.063; 7~9 months: HR, 2.419; 95% CI, 0.735-7.962), but DNG increased the reoperation rate from 10 months onwards (10~12 months: HR, 3.826; 95% CI, 1.164-12.579 and ~13 months: HR, 8.436; 95% CI, 4.722-15.072). CONCLUSIONS: Women who used DNG had a higher endometriosis reoperation rate than women who did not use DNG. However, the initiation of DNG treatment within nine months after the last GnRH agonist injection did not affect the endometriosis reoperation rate.

Incidence and risk factors of VTE in patients with cervical cancer using the Korean national health insurance data.

This study investigated incidence and risk factors for venous thromboembolism (VTE) in patients with cervical cancer. We selected 49,514 patients newly diagnosed with cervical cancer from the Korean Health Insurance Review and Assessment Service databases. During the total follow-up period and first 6 months after initiation of primary treatments, incidence of VTE, and association of risk factors with VTE occurrence were evaluated according to primary treatments or no treatment, surgery, radiotherapy, and chemotherapy. VTE occurred in 1.15% of patients with cervical cancer. Regardless of the period after initiation of primary treatments, and of VTE, the incidence of thromboembolism was highest in chemotherapy. During the first 12 months, monthly incidence of VTE was highest in chemotherapy and decreased with time in all primary treatments. Compared with no treatment, VTE risk significantly increased for all primary treatments (surgery: HR 1.492; 95% CI 1.186-1.877) (radiotherapy: HR 2.275; 95% CI 1.813-2.855) (chemotherapy: HR 4.378; 95% CI 3.095-6.193) and for chemotherapy during the first 6 months (HR 3.394; 95% CI 2.062-5.588). In this cohort study, incidence and risk of VTE in patients with cervical cancer were the highest when chemotherapy was the primary cancer treatment, and incidence of VTE decreased with time.

Efficacy and safety of ferric carboxymaltose versus ferrous sulfate for iron deficiency anemia during pregnancy: subgroup analysis of Korean women.

BACKGROUND: We performed a post-hoc subgroup analysis in Korean women who participated in the Phase III FER-ASAP (FERric carboxymaltose-Assessment of SAfety and efficacy in Pregnancy) study to compare the efficacy and safety of ferric carboxymaltose (FCM) with oral ferrous sulfate (FS). METHODS: Pregnant Korean women (gestational weeks 16-33) with iron-deficiency anemia (IDA) were randomized 1:1 to FCM (n = 46; 1000-1500 mg iron) or FS (n = 44; 200 mg iron/day) group for 12 weeks. The primary objective was to compare the mean hemoglobin (Hb) increase at week 3; secondary objectives included change in iron parameters, quality of life (QoL), and safety. RESULTS: Baseline characteristics of the Korean subgroup were consistent with those of non-Korean FER-ASAP population except for lower body-mass index and higher maternal age. Hb level increases were comparable between the two treatment groups in Korean women at week 3 (FCM 1.23 ± 0.89 g/dL vs FS 1.14 ± 1.72 g/dL). Iron parameters improved over time as secondary endpoints were significantly in favor of FCM. In terms of QoL, FCM treatment significantly improved the mental and physical components as well as vitality prior to delivery. Both treatments were well tolerated. CONCLUSIONS: FCM provided significantly greater improvements in iron parameters and QoL compared to FS in the Korean subgroup. FCM may be a preferable alternative to currently available treatments for IDA during pregnancy.

Development of Korean Academy of Medical Sciences Guideline rating the physical impairment; kidney, bladder, urethra, male and female reproductive systems (preliminary report).

For the evaluation of the kidney impairment, serum creatinine concentrations or glomerular filtration rates are mainly used, and the conditions of solitary or transplanted kidney and chronic dialysis are also taken into the considerations. Some symptoms and signs of the chronic renal disability in spite of adequate treatment add one additional grade. For evaluating bladder and urethral impairment, the criteria include voiding symptoms and signs. The patients with urinary diversions have impairment grades depending on the alteration of upper urinary tract function. For penile impairment, the degrees are evaluated using the international index of erectile function, nocturnal penile tumescence and color doppler ultrasonography. For evaluating impairment of other male reproductive organs, functional and anatomical changes of these organs, analysis of the semen or hormones and the state of solitary testis are used as the criteria. For evaluating impairment of female reproductive organs, pregnancy potential, requirement of continuous treatment and the ability of sexual intercourse are used. Also, degree of impairment is modified according to the ages in evaluating female reproductive systems. We have tried to make this evaluation system objective, scientific, and convenient, but still find it leaving much to be desired.

Comparative study of induction of labor in nulliparous women with premature rupture of membranes at term compared to those with intact membranes: duration of labor and mode of delivery.

AIM: To evaluate the effect of premature rupture of membranes (PROM) at term on the duration of labor and mode of delivery in comparison with intact membranes in nulliparous women with an unfavorable cervix whose labor was induced. METHODS: This retrospective cohort study included all term nulliparous women with an unfavorable cervix requiring labor induction over a 2-year period. Prostaglandin E(2) (dinoprostone) and oxytocin were used for labor induction. Criteria for enrolment included (i) singleton pregnancy; (ii) term nulliparous women; or (iii) Bishop score below 6. Statistics were analyzed with Student's t-test, chi(2)-test, Fisher's exact test, and multiple logistic regression. RESULTS: Our study subjects were 82 women whose labor was induced for PROM and 219 women with intact membranes whose labor was induced for social or fetal reasons. The mean durations of active phase of labor were not significantly different between women with PROM and those with intact membranes. However, the women with PROM had a significantly longer mean duration of second stage and a higher rate of cesarean delivery for failure to progress than those with intact membranes. Multiple logistic regression demonstrated that only PROM and fetal macrosomia were significantly associated with an increased risk of cesarean delivery for failure to progress after other confounding variables were adjusted. CONCLUSIONS: Labor induction for PROM at term in nulliparous women with an unfavorable cervix is associated with longer duration of the second stage and a higher risk of cesarean delivery for failure to progress in comparison to those with intact membranes.

Effect of preeclampsia, magnesium sulfate prophylaxis, and maternal weight on labor induction: a retrospective analysis.

BACKGROUND: Our purposes were to determine the effect of preeclampsia, magnesium sulfate prophylaxis, and maternal weight on labor induction in women with preeclampsia and identify risk factors associated with its failure. METHODS: Fifty-five preeclamptic women and 176 non-preeclamptic women requiring labor induction over an 18-month period were studied retrospectively. Prostaglandin E(2) (dinoprostone) and oxytocin were used for labor induction. Women with rupture of the membranes, spontaneous contraction resulting in cervical change, or an initial cervical examination showing more than 2 cm dilatation and 50% effacement were excluded. Statistics were analyzed with chi(2) test, Fisher's exact test, Student t test, Mann-Whitney U test, and multiple logistic regression. RESULTS: The women with preeclampsia had a significantly higher rate of failed induction than did those without preeclampsia (p = 0.01). However, the women with preeclampsia had a higher mean maternal weight and an increased use of magnesium sulfate, and labor was induced at earlier gestational age than in those without preeclampsia (p < 0.05 for each). Multiple logistic regression showed that the use of magnesium sulfate, higher maternal weight, and unfavorable cervix, but not preeclampsia, were significantly associated with an increased risk of failed induction after correction for known confounding variables. CONCLUSIONS: Although the risk of failed induction is increased in preeclamptic women, preeclampsia is not an independent risk factor for failed induction. The use of magnesium sulfate, higher maternal weight, and unfavorable cervix are independent risk factors for failed induction.