Association of gynecologic oncology versus medical oncology specialty with survival, utilization, and spending for treatment of gynecologic cancers.

BACKGROUND: We examined the association of gynecologic oncology (GYO) versus medical oncology (MEDONC) based care with survival, health care utilization and spending outcomes in women undergoing chemotherapy for advanced gynecologic cancers. METHODS: Women with newly diagnosed stage III-IV uterine, ovarian, and cervical cancers from 2000 to 2015 were identified in SEER-Medicare. We assessed the association of provider specialty with overall survival, emergency department utilization, admissions, and spending. Outcomes were assessed using unadjusted and Inverse Treatment Probability Weighted propensity-score applied, multi-variable cox modeling, Poisson regression, and generalized models of log-transformed data. RESULTS: We identified 7930 gynecologic cancer patients (4360 ovarian, 2934 uterine, 643 cervix). 37% were treated by GYO and 63% by MEDONC. For ovarian patients, GYO care was associated with improved OS (median OS 3.3 v. 2.9 years; HR 0.85, 95%CI 0.80, 0.91, p < .0001) and similar mean spending per month ($4015 v. $4316, mean ratio 0.97 (95% CI 0.93, 1.02), p = .19), compared to MEDONC in adjusted analyses. For uterine patients, GYO care was associated with similar OS, but decreased spending ($3573 v. $4081, mean ratio 0.87 (95% CI.81, 0.93), p < .0001), and decreased ED utilization (RR 0.76, 95% CI 0.69, 0.85, p < .0001). For cervical patients, GYO care was associated with similar OS, and similar spending. Admissions were more likely in ovarian (RR 1.23, 95%CI 1.11, 1.37, p = .0001) and cervical patients (RR 1.26, 95% CI 1.05, 1.51, p = .015) treated by GYO, in adjusted analyses. CONCLUSIONS: GYO based care was associated with improved OS and equal spending for patients with advanced stage ovarian cancer. Uterine and cervix patients had similar OS, and less or equal spending respectively, when treated by GYO compared to MEDONC.

Clinical assessment of prophylactic chemotherapy in treating with hydatidiform mole: A protocol for systematic review and meta-analysis.

BACKGROUND: Hydatidiform mole (HM) is more common as molar pregnancy. It is a disease classified under the category of gestational trophoblastic diseases, which could metastasize after originating in the placenta. A majority of females suffering from molar pregnancies are curable by evacuating retained products of conception and the patient's fertility is preserved. In some cases, the growth perseveres and leads to gestational trophoblastic neoplasia, which is an extremely malicious condition that needs chemo-based treatment. There is a possibility to lessen the risk of gestational trophoblastic disease in females with HM through the administration of prophylactic chemo. Yet, there is controversy regarding prophylactic chemotherapy administered pre-or-post removal of HM to curtail the malignant sequelae. Therefore, we will conduct this research to assess both the efficacy as well as security of using prophylactic chemotherapy to treat HM. METHODS: In the preliminary review, the authors will search for randomized controlled trials involving prophylactic chemotherapy to treat HM. The literature search is carried out in the following electronic databases from their inception to May 2021: Chinese National Knowledge Infrastructure, Chinese BioMedical Literature, and WanFang database are the three Chinese language databases. Web of Science, PubMed, Cochrane Library, and EMBASE are the four English language databases. The authors will also perform a manual search through the bibliographies in related literature to find extra articles and ongoing studies. Two independent authors will assess the literature according to an inclusion criteria, use a specialized data collection table to extract data, and use the Cochrane 'Risk of bias' tool for evaluating any possible bias risk in the selected articles. Data synthesis and statistical operations are completed with the RevMan software (v. 5.3). RESULTS: The present systematic analysis provides a rationalized synthesis of existing evidence related to the use of prophylactic chemotherapy in the treatment of HM. CONCLUSION: Our findings will summarize the current evidences for prophylactic chemotherapy in the treatment of HM. ETHICS AND DISSEMINATION: An ethics approval is nonrequired because pre published results will be used. REGISTRATION NUMBER: DOI 10.17605/OSF.IO/6QV52 (https://osf.io/6qv52/).

Trastuzumab with carboplatin/paclitaxel for treatment of advanced stage and recurrent uterine papillary serous carcinoma: A cost-effectiveness analysis.

OBJECTIVE: Uterine papillary serous carcinoma (UPSC) is a variant of endometrial cancer that is aggressive and associated with poor outcomes. We sought to evaluate the cost effectiveness of carboplatin/paclitaxel alone versus carboplatin/paclitaxel with trastuzumab among patients with Her2/neu-positive advanced or recurrent UPSC. METHODS: We designed a Markov model in TreeAge Pro 2019 software to simulate management of a theoretical cohort of 4000 patients with Her2/neu-positive advanced or recurrent uterine papillary serous carcinoma (UPSC) followed for four years. In the carboplatin/paclitaxel with trastuzumab strategy, we included the cost of testing for Her2/neu status. We obtained all model inputs from the literature and a societal perspective was assumed. Outcomes included progression-free survival, progression, UPSC-specific mortality, cost, and quality-adjusted life years (QALYs). The intervention was considered cost effective if the incremental cost-effectiveness ratio (ICER) was below the willingness-to-pay threshold of $100,000 per QALY. Sensitivity analyses were used to determine the robustness of the results. RESULTS: In our theoretical cohort of 4000 women, treatment with the addition of trastuzumab resulted in 637 fewer deaths and 627 fewer cases of progression compared with treatment with carboplatin/paclitaxel alone. Treatment with trastuzumab was associated with an additional cost of $144,335,895, but was associated with an increase of 2065 QALYs. The ICER was $69,903 per QALY, which was below our willingness-to-pay threshold. Sensitivity analysis demonstrated that this treatment strategy was cost-effective until the cost of 6 months of treatment surpassed $38,505 (baseline input: $27,562). CONCLUSION: We found that the addition of trastuzumab to carboplatin/paclitaxel was a cost-effective treatment strategy for patients with advanced/recurrent Her2/neu-positive UPSC.

Efficacy assessment of acupuncture in improving symptoms of uterine fibroids: A randomized controlled trial.

INTRODUCTION: Uterine fibroids are a common benign genital tumor disease in gynecological diseases. It is mainly a change in physical function caused by the growth of smooth muscle cells in the factor uterus. Modern medicine's treatment of this disease is based on the dependence of uterine fibroids on sex hormones. Treatment with antiprogestin and estrogen drugs can reduce the volume of fibroids or slow the rate of increase in volume, thereby achieving the goal of alleviating clinical symptoms. In order to meet the needs of the majority of women of childbearing age and to maintain fertility, acupuncture treatment of uterine fibroids has a broad prospect for development. METHODS/DESIGN: This study plans to select 60 cases that meet the corresponding selection criteria. According to the random principle, they will be divided into intervention group and control group, with 30 cases in each group. The general information, fibroid size, and TCM syndrome scores of the two groups of patients will be compared before treatment. In terms of treatment, the intervention group will be given acupuncture combined therapy; the control group will be given Chinese patent medicine. The treatment cycles in both groups will be three menstrual cycles. After the treatment is completed, the data of the relevant curative effect indicators are analyzed by using SPSS software to draw conclusions. DISCUSSION: We aim to provide higher evidence-based medical evidence for acupuncture treatment of uterine fibroids. TRIAL REGISTRATION: ClinicalTrials.gov, ChiCTR2000030438, Registered on March 01, 2020.

Evaluation of goserelin effectiveness based on assessment of inflammatory cytokines and symptoms in uterine leiomyoma.

Background Uterine leiomyoma is a benign tumour of the uterine smooth muscles associated with an elevated level of inflammatory cytokines. Goserelin, a synthetic gonadotropin-releasing hormone analogue, suppresses the production of sex hormones and release of inflammatory cytokines in uterine leiomyoma cells. Objective The primary objective of this study was to find out the effectiveness of subcutaneous goserelin therapy on lowering serum levels of inflammatory cytokines and improving uterine leiomyoma-related symptoms in female patients diagnosed with uterine leiomyoma. The secondary objective was to assess the tolerability to goserelin therapy used in the management of this tumour. Setting Outpatient gynaecological clinic of the medical consultation department of Baghdad Teaching Hospital, Baghdad province, Iraq. Methods A single centre, prospective, longitudinal, cohort study was carried out on female patients diagnosed with uterine leiomyoma. Goserelin 3.6 mg subcutaneous injection was given in a consecutive monthly dose for the total time duration of three months. Serum levels of inflammatory cytokines, tumour necrosis factor-α and monocyte chemotactic protein-1 were detected before and after goserelin therapy in a consecutive monthly assessment. The study also assessed the improvement in uterine leiomyoma-related symptoms, including pelvic pain alongside the incidence of goserelin-related side effects during therapy schedules. Main Outcome Measures Assessment of serum levels of tumour necrosis factor-α and monocyte chemotactic protein-1 alongside uterine leiomyoma-related symptoms, including pelvic pain and goserelin-related side effects. Results There was a significant decrease in serum levels of tumour necrosis factor-α and monocyte chemotactic protein-1 compared to the baseline level over the 3-month duration of goserelin therapy (0.11 ± 0.02 vs. 0.74 ± 0.19) pg/mL; (0.07 ± 0.00 vs. 0.44 ± 0.18) pg/mL respectively. Patients showed a clinical improvement regarding uterine leiomyoma-related symptoms following each of the consecutive monthly doses of goserelin therapy (n = 11, 55%, P < 0.0001; n = 15, 75%, P < 0.0001; n = 18, 90%, P < 0.0001) respectively. This also includes a significant decrease in the intensity of leiomyoma-related pelvic pain before and after goserelin therapy (7.2 ± 1.43 vs. 3.05 ± 1.14, P < 0.0001). The majority of patients reported vaginal dryness (60%) as the main goserelin-related side effect. Conclusion Goserelin therapy reduces serum levels of inflammatory cytokines, tumour necrosis factor- α and monocyte chemotactic protein-1, improving leiomyoma-related symptoms with good tolerability in patients with uterine leiomyoma.

Chance of reimbursement for ADD-ON therapies in Poland and in the world - review of the reimbursement recommendations

INTRODUCTION: Oncology drugs combined with standard therapies (so-called add-on therapies, e.g. bevacizumab, palbociclib) often receive negative recommendations regarding the legitimacy of public financing, issued by government agencies responsible for their assessment, i.e. health technology assessment agencies. The aim of the study was to estimate the scale of the problem related to the reimbursement of add-on therapies used in the treatment of breast and genitourinary cancers in Poland and in the world. MATERIAL AND METHODS: A multimodal approach was used to select add-on therapies. The reimbursement routes were analysed in 8 reference countries (Poland, Canada, England, Wales, France, Scotland, Australia, New Zealand). Based on a systematic search, data for breast and urogenital cancers were included. RESULTS: A total of 68 reimbursement documents for add-on therapies were identified. The analysis showed that in Poland, 20% of innovative schemes including add-on therapies should be reimbursed, while in the world the percentage of positive recommendations reaches 56%. It was observed that globally (including data for Poland) the chance for a favorable reimbursement recommendation for add-on therapies is 53%, with 29% being positive recommendations with limitations. In Poland, the majority of negative recommendations concern genitourinary cancers in comparison to breast cancer (83% vs 75%). CONCLUSIONS: Poland is at the head of the countries in terms of the number of negative reimbursement recommendations. Bearing in mind the world's need of modifying the criteria for the evaluation of oncological therapies in the context of the possibility of their reimbursement, one should expect a change in the approach to the assessment of the legitimacy of financing innovative add-on therapies in Poland.

Ulipristal acetate for pre-operative management of uterine fibroids: Modeling outcomes and costs.

OBJECTIVES: The aim of this study was to evaluate the pharmacoeconomic profile in Italy of preoperative treatment with ulipristal acetate at the dose of 5 mg/day for 13 weeks in comparison with placebo prior to surgical management of symptomatic uterine fibroids. STUDY DESIGN: The pharmacoeconomic analysis was based on the calculation of incremental cost-effectiveness ratio (ICER). Effectiveness data were derived from the randomized-controlled trial PEARL-1, whilst costs data were retrieved from the published literature. A Markov model was employed to simulate the pattern of costs and two univariate sensitivity analyses tested the robustness of the results. RESULTS: In comparison with placebo, ulipristal acetate 5 mg for presurgical therapy was estimated to be associated with an incremental cost of €351 per patient. Costs per patient were €3836 for ulipristal acetate vs €3485 for placebo. The incremental effectiveness was 0.01931 QALYs per patient (around 7 quality-adjusted days per patient). Hence, the cost effectiveness ratio was calculated to be €18,177 per QALY gained. CONCLUSIONS: Preoperative use of ulipristal acetate 5 mg in patients with uterine fibroids has a favourable pharmacoeconomic profile.

Ulipristal en miomatosis uterina / Ulipristal in uterine myomatosis

CONTEXTO CLÍNICO: Los miomas uterinos son los tumores benignos más comunes del tracto reproductivo femenino. Se los conoce también como fibroleiomiomatosis, leiomiomatosis, fibromiomatosis o fibromas uterinos. Se producen por una mutación de los miocitos uterinos ante la estimulación de los receptores de estrógenos que producen factores de crecimiento y de los receptores de progesterona que inducen mitosis e inhiben la apoptosis en miocitos de miomas. Se clasifican en miomas intramurales, submucosos, subserosos y cervicales. TECNOLOGÍA: El acetato de ulipristal es un modulador selectivo de los receptores de progesterona de las células del mioma, inhibiendo la proliferación celular y de la matriz extracelular a través de la inducción de apoptosis. También reduce la expresión de citoquinas proinflamatorias. Produce cambios celulares del endometrio miomatoso sin afectar el resto del endometrio ni los vasos sanguíneos. OBJETIVO: El objetivo del presente informe es evaluar la evidencia disponible acerca de la eficacia, seguridad y aspectos relacionados a las políticas de cobertura del uso de ulipristal en miomatosis uterina. MÉTODOS: Se realizó una búsqueda en las principales bases de datos bibliográficas, en buscadores genéricos de internet, y financiadores de salud. Se priorizó la inclusión de revisiones sistemáticas (RS), ensayos clínicos controlados aleatorizados (ECAs), evaluaciones de tecnologías sanitarias (ETS), evaluaciones económicas, guías de práctica clínica (GPC) y políticas de cobertura de diferentes sistemas de salud. RESULTADOS: Se incluyeron dos revisiones narrativas, cuatro GPC, cuatro evaluaciones económicas, y seis informes de políticas de cobertura para el acetato de ulipristal en miomatosis uterina. No se encontraron estudios que comparen el uso de acetato de ulipristal versus miomectomía o histerectomía. CONCLUSIONES: Evidencia de alta calidad sugiere que el uso de acetato de ulipristal en mujeres de edad fértil con miomatosis uterina sintomática, sería más efectivo y más seguro que los análogos de hormona liberadora de gonadotrofina controlando las metrorragias moderadas y severas, y reduciendo el tamaño tumoral a corto plazo. No se encontraron estudios que evalúen la reducción de tasas de miomectomía o histerectomía. Las guías de práctica clínica de Latinoamérica, Europa y Canadá consideran al ulipristal como uma alternativa válida a los análogos de hormona liberadora de gonadotrofina en mujeres en edad fértil con metrorragias severas, anemia sintomática, miomas mayores a 3 cm y necesidad de preservar el útero. La mayoría de los financiadores de salud europeos dan cobertura a este tratamiento. No es cubierta por financiadores estadounidenses por no tener aprobación por la agencia regulatória estadounidense para esta indicación. No se encontraron políticas de salud en Latinoamérica.

Repeated-intermittent use of ulipristal acetate for the management of uterine fibroids: an Italian pharmacoeconomic evaluation.

BACKGROUND: The aim of this paper was to evaluate an Italian pharmacoeconomic profile of repeated-intermittent (from 4 to 10 cycles) use of ulipristal acetate 5 mg (UPA 5 mg) in comparison with the use of UPA 5 mg before surgery (2 cycles) for the management of symptomatic uterine fibroids. METHODS: The pharmacoeconomic analysis was performed in two steps: 1) estimating an incremental cost-effectiveness ratio (ICER); 2) assuming a nationwide prediction of future expenditure in the Italian scenario. Effectiveness data were derived from the randomized-controlled trial, whilst quality of life and costs data were retrieved from the published literature. RESULTS: In comparison with the use of UPA 5 mg before surgery, the values of ICER per patient were the following: 1) €20,600 euros (UPA 5 mg 4 cycles); 2) €26,884 (UPA 5mg 6 cycles); 3) €30,244 (UPA 5 mg 8 cycles); 4) €31,906 (UPA 5 mg 10 cycles). In comparison with the use of UPA 5 mg before surgery plus subsequent surgery, the saving per patient for the National Healthcare System (NHS) by adding repeated-intermittent use of UPA 5 mg were the following: 1) €26 million (UPA 5 mg 4 cycles); 2) €17.6 million (UPA 5mg 6 cycles); 3) €8.9 million (UPA 5 mg 8 cycles); 4) €0.2 million (UPA 5 mg 10 cycles). CONCLUSIONS: The results showed that repeated-intermittent use of UPA 5 mg for the long-term treatment of uterine fibroids has a favourable pharmacoeconomic profile up to 10 repeated cycles and may be a cost-saving treatment option for the NHS. Although the data are encouraging, more data are needed regarding the benefits and risks of long-term treatment with UPA.

The cost-effectiveness of ulipristal acetate tablets in treating patients with moderate to severe symptoms of uterine fibroids.

OBJECTIVES: Ulipristal acetate is a selective progesterone receptor modulator that has been demonstrated to be an effective 3-month pre-operative treatment for moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The aim of this analysis was to assess the cost-effectiveness of 5mg ulipristal as an add-on therapy to standard pre-surgical observation and treatment in Hungary. STUDY DESIGN: A Markov model was developed using a 10-year time horizon. Ulipristal was compared with pre-surgical observation and immediate hysterectomy. The model comprised the following mutually exclusive health states: mild, moderate, severe, or persistent severe excessive bleeding disorder; myomectomy; post-myomectomy with mildly to moderately excessive bleeding disorder; post-myomectomy with severely excessive bleeding disorder; hysterectomy; post-hysterectomy; post-menopause; and death. Transition probabilities and utility values were obtained from clinical trials and the scientific literature. Resource utilisation and unit costs were derived from a consensus panel of clinical experts, National Health Insurance Fund tariffs, and publications. RESULTS: Adding a 3-month course of ulipristal to pre-operative observation was predicted to achieve an additional 0.021 quality-adjusted life years (QALYs) at an estimated incremental cost of €397, which would result in an incremental cost of €19,200/QALY. When 3 months of ulipristal therapy was compared with immediate hysterectomy, the incremental cost-effectiveness ratio was reduced to €3575/QALY. The results were most sensitive to the utility value of the post-hysterectomy health state but responsive to changes in other model parameters. CONCLUSIONS: The results of this analysis suggest that adding ulipristal treatment to standard pre-surgical therapy represents a good value for money in Hungary. The inclusion of societal benefits may considerably reduce the cost-effectiveness ratio.

Low dose mifepristone in medical management of uterine leiomyoma - an experience from a tertiary care hospital from north India.

BACKGROUND & OBJECTIVES: Uterine myoma is a common indication for hysterectomy in India. An effective medical treatment option may reduce hysterectomy associated morbidity. This study was undertaken to evaluate efficacy and safety of low dose mifepristone in medical management of myoma and to compare two doses - 10 vs. 25 mg/day. METHODS: In this randomized clinical trial, women with symptomatic myoma or myoma>5 cm were included. Uterine size >20 wk, fibroids >15 cm were excluded. Pictorial blood loss assessment chart (PBAC) score was used to assess menstrual-blood-loss and visual analog scale (VAS) for other symptoms. Haemogram, liver function test, ultrasound with doppler and endometrial histology was performed. Patients were randomized and were given oral mifepristone as 25 mg/day in group 1 and 10 mg/day in group 2 for 3 months. Patients were followed at 1, 3 and 6 months. RESULTS: Seventy patients in group 1 and 73 in group 2 completed treatment. Mean PBAC score reduced from 253 to 19.8 and from 289.2 to 10.4 at 1 and 3 months in groups 1 and 2, respectively. At 3 months, 67 of 70 (95.7%) patients of group 1 and 66 of 73 (90.4%) of group 2 developed amenorrhoea which reverted after median 34 (range 4-85) days. Mean myoma volume decreased by 35.7 per cent (from 176.8 to 113.7 cm 3 ) and 22.5 per cent (from 147.6 to 114.4 cm 3 ) at 3 months in groups 1 and 2, respectively. Side effects seen were leg cramps in 7 of 70 (10%) and 5 of 73 (6.8%) and hot-flushes in 5 of 70 (7.1%) and 5 of 73 (6.8%) in groups 1 and 2, respectively. Repeat endometrial-histopathology did not reveal any complex hyperplasia or atypia in either group. INTERPRETATION & CONCLUSIONS: Mifepristone (10 and 25 mg) caused symptomatic relief with more than 90 per cent reduction in menstrual blood. Greater myoma size reduction occured with 25 mg dose. Amenorrhoea was developed in 90-95 per cent patients which was reversible. It can be a reasonable choice for management of uterine leiomyoma as it is administered orally, cost-effective and has mild side effects.

A retrospective assessment of outcomes of chemotherapy-based versus radiation-only adjuvant treatment for completely resected stage I-IV uterine carcinosarcoma.

PURPOSE: To determine the progression-free survival (PFS) and overall survival (OS) in a cohort of patients who received either platinum-based chemotherapy with or without radiation therapy (pelvic or WAI), or RT alone. METHODS: Memorial Sloan-Kettering Cancer Center (MSKCC) electronic medical records from 8/1/1995 to 10/3/2007 were reviewed for patient age, diagnosis date, type of primary surgery, residual disease at the completion of primary surgery, FIGO stage, treatment details, dates of progression and death, and site(s) of first recurrence. PFS and OS by stage (I/II v III/IV) and by treatment type (chemotherapy with or without RT v RT alone) were determined using landmark analyses 8 weeks after surgery. Patients who received chemotherapy with or without RT (pelvic or abdominal) or RT alone (pelvic or abdominal) were included in the analysis. Both groups were allowed to have received intravaginal radiation therapy (IVRT). RESULTS: Forty-nine patients met study criteria. Thirty-eight/49 patients received chemotherapy: 23/38 (60.5%) received paclitaxel-carboplatin; 7/38 (18.4%) received ifosfamide-platinum; 8/38 (21.0%) received other chemotherapy. FIGO stage was: I=15 (31%); II=5 (10%); III=21 (43%); IV=8 (16%). Three-year PFS for the entire cohort was 24%. Three-year OS for the entire cohort was 60%. Three-year median PFS time for the entire cohort was 15 months (95% CI: 11-25 months). Three-year median OS time for the entire cohort was 67 months (95% CI: 23-89 months). Three-year PFS for stages I-II was 43% v 14% for stages III-IV (HR=1.98 [0.9-4.33]); P=0.082. Three-year OS for stages I-II was 68% v 55% for stages III-IV (HR=1.26 [0.47-3.41]); P=0.648. Three-year PFS for chemotherapy with or without RT was 35% v 9% for RT alone (HR=1.74 [0.79-3.85]); P=0.164. Three-year OS for chemotherapy with or without RT was 66% v 34% for RT alone (HR=2.02 [0.77-5.33]); P=0.146. CONCLUSIONS: Our study corroborates GOG 150 results, and shows that paclitaxel-carboplatin appears to be an efficacious adjuvant chemotherapy regimen for completely resected uterine carcinosarcoma. The role of adjuvant RT in addition to chemotherapy warrants further investigation.

Semiquantitative assessment of MR imaging in prediction of efficacy of gonadotropin-releasing hormone agonist for volume reduction of uterine leiomyoma: initial experience.

PURPOSE: To prospectively determine if semiquantitative assessment of R2* images and T1-weighted magnetic resonance (MR) images of leiomyomas correlates with the efficacy of gonadotropin-releasing hormone (GnRH) agonist treatment for volume reduction. MATERIALS AND METHODS: Internal review board approval and informed consent were obtained for this study. Twenty women (mean age, 36.3 years) with intramyometrial leiomyomas were enrolled in this study. Single-section double-echo dynamic MR imaging was performed before GnRH agonist administration. T2-weighted images were obtained before and after two or three GnRH agonist injections (1.88 mg leuprorelin acetate). The steepest signal intensity (SI) upslope on T1-weighted images and the area under the curve (AUC) on R2* images were determined by using a 16 x 16-voxel matrix that was placed in the center of a leiomyoma. Pearson correlation analysis was performed to compare the percentage of volume reduction with SI upslope and AUC. Unpaired t test was performed to evaluate the difference between leiomyomas with AUC and SI upslope values that were less than or greater than the mean. RESULTS: Percentage of volume reduction ranged from 6.2% to 51.1%. The mean AUC and mean SI upslope were 39.2 and 9.83% per second, respectively. There was a significant correlation between the AUC and the percentage of volume reduction (r = 0.81, P < .001), although no significant correlation was observed between the SI upslope and the percentage of volume reduction. A significant difference in percentage of volume reduction was observed in leiomyomas by using mean AUC as a cutoff value (P = .003). CONCLUSION: AUC on R2* images correlates with the efficacy of GnRH agonist before initiation of treatment for volume reduction of leiomyoma.

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in the management of peritoneal carcinomatosis. Preliminary results and cost from two centers in Greece.

PURPOSE: To report our preliminary experience in the combined treatment of peritoneal carcinomatosis (PC) using cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC). PATIENTS AND METHODS: This prospective study included patients with PC from gynaecological, gastric and colon cancer, treated in two centers. Cytoreductive surgery included the peritonectomy procedures described by Jacquet and Sugarbaker as well as multivisceral resections in order to achieve a complete macroscopical cancer eradication. The HIPEC that followed was performed via the open abdomen technique. RESULTS: Twenty-four patients (3 men and 21 women, mean age 60 years) were treated. Twelve patients had PC from ovarian cancer, 7 from colon, 3 from gastric and 2 from uterine cancer. The mean duration of the procedure was 7.83 h (range 5 -12.30). Macroscopically, complete cytoreduction (CC) was achieved in 18 (75%) patients. Two (8.3%) patients died in the first 30 days. The overall morbidity was 42% and 2 patients were reoperated. The mean follow up was 22 months (range 3-36). The overall 1-year survival was 59.1%; concerning the gynaecological cancers it was 53.8% (mean survival 11.7 months) and for gastrointestinal cancers it was 44.4% (mean survival 9.5 months). CONCLUSION: Our preliminary data suggest that the combined treatment of cytoreduction plus HIPEC for PC is associated with acceptable mortality and morbidity and offers an improved survival in these patients. An optimal patient selection and establishment of experienced centres are of paramount importance.

[Assessment of staging and prognostic scoring system for malignant trophoblastic neoplasia].

OBJECTIVE: To assess malignant trophoblastic neoplasia with the standards of the clinical stage and prognostic factor scoring system. METHODS: Through assessing the high-risk factors except clinical stages for 223 patients before treatment according to International Federation of Gynecology and Obstetrics (FIGO) scoring system published in 2000, appropriate treatments were selected for the different patients. RESULTS: Forty-three of 78 cases of choriocarcinomas were with high-risk factors, the other 35 cases were with low-risk factors; 7 of 145 cases of invasive moles were with high-risk factors and the others were with low-risk factors. The primary chemotherapy principle was that one agent was used for those patients with low-risk factors and two or multiple-agents were used for those patients with high-risk factors. Among all patients, the one-year, three-year and five-year survival rates were 98.6%, 98.1% and 97.1% respectively. No patient died of drug toxicity or complication. CONCLUSION: Selection of treatment approaches according to the prognostic assessment of malignant trophoblastic neoplasia could lead to promising survival rate with no uncurable complication and toxic effects.

The role of repeat uterine evacuation in the management of persistent gestational trophoblastic disease.

OBJECTIVE: To evaluate the role of second (and third) uterine evacuation in the management of persistent gestational trophoblastic disease (GTD). METHODS: This was an observational study of all cases registered over a 10-year period at the Trophoblastic Disease Centre at Weston Park Hospital, Sheffield. Five hundred and forty-four of 4050 women registered during 1991-2000 underwent a second uterine evacuation following a presumptive diagnosis of persistent GTD. The reason for evacuation, hCG level prior to the procedure, histological appearances of evacuated products and the clinical outcome (in terms of the need for chemotherapy) were determined. RESULTS: After a second uterine evacuation 368 patients (68%) completed the follow-up programme without further evidence of persistent disease or need for chemotherapy. If the diagnosis of persistent GTD was confirmed solely on the basis of elevated hCG levels then 171 of 282 (60%) patients did not require chemotherapy. Chemotherapy was more likely where there was histological evidence of persistent trophoblastic disease and where the urinary hCG was >1500 IU/L at the time of the repeat evacuation. Twenty-eight of 60 patients (46%) undergoing a third evacuation required chemotherapy. CONCLUSION: Second uterine evacuation can be a useful therapeutic option for patients with presumed persistent trophoblastic disease not mandating immediate chemotherapy, particularly where the hCG level is <1500 IU/L. Patients with documented persistent trophoblastic disease on histological examination of the second evacuation sample are more likely to require chemotherapy. Third evacuation is not now recommended.

Cost effectiveness of pre-operative gonadotrophin releasing analogues for women with uterine fibroids undergoing hysterectomy or myomectomy.

OBJECTIVE: To conduct a cost effectiveness analysis of pre-operative gonadotrophin releasing hormone agonists (GnRHa) in women with uterine fibroids undergoing hysterectomy or myomectomy. DESIGN: A cost effectiveness analysis using the effectiveness data from a systematic review of GnRHa. SETTING: Secondary care. SAMPLE: Women with uterine fibroids undergoing hysterectomy or myomectomy and women volunteers. METHODS: Effectiveness data were used from a systematic review to construct a model and to calculate the cost per surgical outcome avoided. In order to evaluate the value women place on the outcome, a willingness to pay analysis of women volunteers was undertaken. MAIN OUTCOME MEASURES: (a) The cost of avoiding abdominal hysterectomy and the cost of avoiding a vertical incision at either hysterectomy or myomectomy; (b) The value that women place on avoiding abdominal hysterectomy and on avoiding a vertical incision at either hysterectomy or myomectomy. All costs are in NZ dollars. RESULTS: For hysterectomy, the additional cost of treatment with GnRHa was NZ$1190 per case. The cost of avoiding one abdominal procedure was NZ$4577 per case and the cost of avoiding one vertical incision was NZ$6263. For a myomectomy, the additional cost of treatment with GnRHa was NZ$1535 per case. The cost of avoiding one vertical incision was NZ$4651 per case. These costs exceeded the benefit women placed on the outcomes. CONCLUSION: Although the pre-operative use of GnRHa results in benefits which include less frequent abdominal incisions in the case of hysterectomy and less frequent vertical incisions in the case of myomectomy, the benefits do not justify the costs. This study highlights the importance of considering both the benefits and costs in health care decisions.