RESUMEN
BACKGROUND: Before the era of immunotherapies and antibody-drug conjugates, there were limited chemotherapeutic options for patients with recurrent and metastatic cervical cancer. Combination therapies with cisplatin have shown some superiority over monotherapy. This study examined platinum-free treatment regimens, comparing a combination of topotecan and paclitaxel (TP) with topotecan and cisplatin (TC) in patients with recurrent or metastatic cervical cancer, with or without prior platinum-based treatment. METHODS: The AGO-Zervix-1 Study (NCT01405235) is a prospective, randomized phase III study in which patients were randomly assigned at a 1:1 ratio to treatment within the control arm with topotecan (0.75 mg/m2) on days 1-3 and cisplatin (50 mg/m2) on day 1 every 3 weeks and in the study arm topotecan (1.75 mg/m2) and paclitaxel (70 mg/m2) on days 1, 8, and 15 every 4 weeks or treatment. The primary study aim was overall survival; progression-free survival, toxicity, and quality of life were secondary aims. The interim and final analysis is here reported after recruitment of 173 of 312 planned patients. RESULTS: Median overall survival in the TP arm was 9.6 months, compared with 12.0 months in the TC arm (log-rank test, P = 0.33). Median progression-free survival rates were 4.4 months with TP and 4.2 months with TC (log-rank test, P = 0.47). Leukopenia and nausea/vomiting were more frequent in the cisplatin-containing arm. Otherwise, toxicity profiles were comparable. There were no differences in FACT-G-assessed quality of life. CONCLUSION: Platinum-based combination chemotherapy remains the standard of care chemotherapy regimen for patients with recurrent or metastatic cervical cancer.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica , Cisplatino , Recurrencia Local de Neoplasia , Paclitaxel , Topotecan , Neoplasias del Cuello Uterino , Humanos , Neoplasias del Cuello Uterino/tratamiento farmacológico , Neoplasias del Cuello Uterino/patología , Femenino , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Topotecan/administración & dosificación , Cisplatino/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Persona de Mediana Edad , Recurrencia Local de Neoplasia/tratamiento farmacológico , Adulto , Estudios Prospectivos , Anciano , Calidad de Vida , Supervivencia sin ProgresiónRESUMEN
PURPOSE: Postmenopausal hormone therapy (HT) is known to affect the development of hormone-dependent endometrial carcinoma (type I EC). Several studies on breast and ovarian carcinoma have shown that HT influences the molecular profile and prognostic behavior of these tumors. This study aimed to investigate the influence of prior HT and other risk factors on the prognosis in a cohort of patients with invasive endometrial carcinoma (EC). METHODS: Among 525 patients diagnosed with EC between 1987 and 2010, 426 postmenopausal patients were identified. Information regarding HT was available in 287 of these patients, 78 of whom had a history of HT and 209 of whom did not. Both overall survival (OS) and progression-free survival (PFS) were analyzed. In addition to OS and PFS, risk factors such as age at diagnosis, postmenopausal HT, body mass index (BMI), diabetes mellitus, tumor stage, EC type (I or II), and recurrences were analyzed. RESULTS: Relative to HT alone, women with EC and a history of HT had a longer survival than those with no HT. However, the Cox proportional hazards model showed that it was not HT itself, but rather other characteristics in the HT group that were causally associated with longer survival. CONCLUSIONS: Age (the older, the worse) and tumor stage (the higher, the worse) were significant influences on overall survival. Patients with HT also had lower BMIs, less diabetes, more type I EC, and fewer recurrences in comparison with the non-HT group. With regard to the PFS, it made no difference whether the patient was receiving HT.
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Neoplasias Endometriales/tratamiento farmacológico , Terapia de Reemplazo de Estrógeno/efectos adversos , Anciano , Estudios de Cohortes , Neoplasias Endometriales/mortalidad , Neoplasias Endometriales/patología , Femenino , Humanos , Recurrencia Local de Neoplasia , Pronóstico , Factores de Riesgo , Tasa de SupervivenciaRESUMEN
BACKGROUND: Daysy is a fertility monitor that uses the fertility awareness method by tracking and analyzing the individual menstrual cycle. In addition, Daysy can be connected to the application DaysyView to transfer stored personal data from Daysy to a smartphone or tablet (IOS, Android). This combination is interesting because as it is shown in various studies, the use of apps is increasing patients´ focus on their disease or their health behavior. The aim of this study was to investigate if by the additional use of an App and thereby improved usability of the medical device, it is possible to enhance the typical-use related as well as the method-related pregnancy rates. RESULT: In the resultant group of 125 women (2076 cycles in total), 2 women indicated that they had been unintentionally pregnant during the use of the device, giving a typical-use related Pearl-Index of 1.3. Counting only the pregnancies which occurred as a result of unprotected intercourse during the infertile (green) phase, we found 1 pregnancy, giving a method-related Pearl-Index of 0.6. Calculating the pregnancy rate resulting from continuous use and unprotected intercourse exclusively on green days, gives a perfect-use Pearl-Index of 0.8. CONCLUSION: It seems that combining a specific biosensor-embedded device (Daysy), which gives the method a very high repeatable accuracy, and a mobile application (DaysyView) which leads to higher user engagement, results in higher overall usability of the method.
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Fertilidad/fisiología , Aplicaciones Móviles , Detección de la Ovulación/métodos , Índice de Embarazo , Teléfono Inteligente/estadística & datos numéricos , Adulto , Femenino , Humanos , Embarazo , Estudios RetrospectivosRESUMEN
BACKGROUND AND OBJECTIVES: Chylous ascites, an accumulation of milky-white lymph fluid in the peritoneal cavity, is a rare complication following retroperitoneal lymphadenectomy. This study evaluated the appearance and management of chylous ascites following lymphadenectomy for gynecological malignancies. METHODS: A total of 931 patients who underwent lymphadenectomy for gynecological malignancies at Erlangen University Hospital between 2002 and 2013 were reviewed retrospectively. RESULTS: Chylous ascites occurred postoperatively in 28 of the 931 patients (3.0%). All patients with chylous ascites had undergone combined systematic para-aortic and pelvic lymphadenectomy (SAPL). Patients with chylous ascites had a larger mean number of lymph nodes removed (51.9 vs. 40.0, P = 0.002) and the proportion of laparoscopic SAPLs was significantly higher (20/28; 71.4%) in comparison with open surgery (8/28; 28.6%) (P < 0.0001). Additional parameters, such as the number of positive lymph nodes, were not significantly associated with the occurrence of chylous ascites. Conservative management was sufficient to resolve chylous ascites in all observed cases, with a mean time to resolution of 8 days. CONCLUSIONS: Postoperative chylous ascites was more frequently observed in patients with laparoscopic SAPL in comparison with open SAPL and was strongly associated with a larger mean number of removed lymph nodes. J. Surg. Oncol. 2016;114:613-618. © 2016 Wiley Periodicals, Inc.
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Carcinoma/cirugía , Ascitis Quilosa/etiología , Neoplasias de los Genitales Femeninos/cirugía , Laparoscopía/efectos adversos , Escisión del Ganglio Linfático/efectos adversos , Complicaciones Posoperatorias/etiología , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma/patología , Femenino , Neoplasias de los Genitales Femeninos/patología , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Adulto JovenRESUMEN
PURPOSE: There is low evidence regarding the optimal treatment in patients with uterine sarcomas and malignant mixed Mullerian tumors (MMMTs). This study provides an overview of experience at our center with patients diagnosed with uterine sarcoma and MMMT, in relation to the clinical management and outcome. METHODS: The medical records for 143 patients with low-grade endometrial stromal sarcoma (ESS), leiomyosarcoma (LMS), and high-grade (undifferentiated) endometrial sarcoma (UES) and MMMT were reviewed. All available clinical and pathological data were collected and analyzed. Putative prognostic factors were entered into a multivariate analysis using a Cox proportional hazards ratio model, and survival data were calculated. RESULTS: The 5-year overall survival rates were significantly different between patients with ESS, LMS, and UES and MMMT (86 vs. 40 vs. 57 vs. 45 %; P < 0.001). The multivariate analysis showed that the patients' age, higher FIGO stage (III-IV), a history of smoking, prior pelvic radiation, diabetes, and residual tumor after surgery were associated with a poorer overall survival. Histological subtypes of LMS (HR 4.68; 95 % CI 1.35-16.17), UES (HR 1.21; 95 % CI 0.26-5.77) and MMMT (HR 1.63; 95 % CI 0.42-6.43) were also associated with a poorer overall survival than ESS (P = 0.008). Adjuvant therapies showed no associations with overall survival. CONCLUSIONS: Adjuvant therapy has so far not shown any overall survival benefit, and the focus is therefore on primary surgery. In future studies, the entities should be investigated separately in relation to prognostic factors and effective therapeutic management.
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Tumores Estromáticos Endometriales/patología , Leiomiosarcoma/patología , Tumor Mulleriano Mixto/patología , Sarcoma Estromático Endometrial/patología , Neoplasias Uterinas/patología , Adulto , Anciano , Terapia Combinada , Supervivencia sin Enfermedad , Neoplasias Endometriales/mortalidad , Neoplasias Endometriales/patología , Neoplasias Endometriales/terapia , Tumores Estromáticos Endometriales/mortalidad , Tumores Estromáticos Endometriales/terapia , Femenino , Humanos , Estimación de Kaplan-Meier , Leiomiosarcoma/mortalidad , Leiomiosarcoma/terapia , Persona de Mediana Edad , Tumor Mulleriano Mixto/mortalidad , Tumor Mulleriano Mixto/terapia , Análisis Multivariante , Pronóstico , Modelos de Riesgos Proporcionales , Sarcoma/patología , Sarcoma Estromático Endometrial/mortalidad , Sarcoma Estromático Endometrial/terapia , Tasa de Supervivencia , Neoplasias Uterinas/mortalidad , Neoplasias Uterinas/cirugíaRESUMEN
BACKGROUND: Medical research studies are becoming increasingly important for optimizing the prevention, diagnosis and treatment of illnesses. Participation in research studies can have many benefits for patients. In randomized and controlled clinical studies, they can receive the best possible medical care currently available. However, only a small proportion of patients nowadays are treated within the framework of medical research. The primary endpoint of this study was to discover what level of knowledge patients have about clinical studies and how they currently perceive them, in order to identify ways of optimizing the information provided about studies from the patients' point of view. METHODS: The study included 2546 patients (breast cancer 21.6%, gynecological cancer 8.3%, obstetrics 32.7%, endometriosis 7.8%, fertility treatment 3.2%, other benign gynecological illnesses 19.2%, no information for 7.2%) in the outpatient clinic (45.2%) and in the in-patient sector (54.8%) at the Department of Gynecology at Erlangen University Hospital and associated centers. In the single-center study, conducted between January 2011 and January 2012, the patients were asked about their level of knowledge regarding the background to medical research studies and the ways in which they are carried out and used. The patients were also asked how they perceived medical studies and how they thought study conditions might be optimized. The three-page questionnaire was included in the feedback sheet received by patients as part of the hospital's quality management system. RESULTS: As a whole, the group only had moderate knowledge about clinical studies. A majority of the respondents considered that studies were valuable (91.6%), but only a few were also willing to take part in them (58.4%). Knowledge and willingness to participate strongly depended on age (P < 0.001), educational level (P < 0.001) and patient group (P < 0.001). Most patients would prefer to decide about participating in studies through a discussion with their outpatient physicians. CONCLUSIONS: The information that patients have about clinical studies affects whether they participate in them. It is therefore extremely important for patients to be well informed, for their anxieties about participation to be relieved, and for the benefits of participation to be explained to them.
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Neoplasias de la Mama/epidemiología , Neoplasias de la Mama/psicología , Estudios Clínicos como Asunto/psicología , Enfermedades de los Genitales Femeninos/epidemiología , Enfermedades de los Genitales Femeninos/psicología , Conocimientos, Actitudes y Práctica en Salud , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Investigación Biomédica , Estudios Transversales , Femenino , Humanos , Persona de Mediana Edad , Encuestas y Cuestionarios , Adulto JovenRESUMEN
BACKGROUND: No screening programs are available for ovarian or endometrial cancer. One reason for this is the low incidence of the conditions, resulting in low positive predictive values for tests, which are not very specific. One way of addressing this problem might be to use risk factors to define subpopulations with a higher incidence. The aim of this study was to investigate the extent to which a medical history of endometriosis can serve as a risk factor for ovarian or endometrial cancer. METHODS: In a hospital-based case-control analysis, the cases represented patients with endometrial or ovarian cancer who were participating in studies aimed at assessing the risk for these diseases. The controls were women between the age of 40 and 85 who were invited to take part via a newspaper advertisement. A total of 289 cases and 1016 controls were included. Using logistic regression models, it was tested whether self-reported endometriosis is a predictor of case-control status in addition to age, body mass index (BMI), number of pregnancies and previous oral contraceptive (OC) use. RESULTS: Endometriosis was reported in 2.1 % of the controls (n = 21) and 4.8 % of the cases (n = 14). Endometriosis was a relevant predictor for case-control status in addition to other predictive factors (OR 2.63; 95 % CI, 1.28 to 5.41). CONCLUSION: This case-control study found that self-reported endometriosis may be a risk factor for endometrial or ovarian cancer in women between 40 and 85 years. There have been very few studies addressing this issue, and incorporating it into a clinical prediction model would require a more precise characterization of the risk factor of endometriosis.
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Neoplasias Endometriales/epidemiología , Neoplasias Endometriales/etiología , Endometriosis/complicaciones , Neoplasias Ováricas/epidemiología , Neoplasias Ováricas/etiología , Adulto , Anciano , Anciano de 80 o más Años , Índice de Masa Corporal , Estudios de Casos y Controles , Femenino , Humanos , Persona de Mediana Edad , Oportunidad Relativa , Embarazo , Factores de RiesgoRESUMEN
PURPOSE: To analyze reoperation rates and perioperative outcomes after long-term follow-up of two surgical approaches in the treatment of endometrial cancer when the standard of care shifts from open surgery to laparoscopy at a university hospital. METHODS: In this retrospective monocenter study a total of 267 patients with endometrial cancer were included; 107 women underwent laparoscopy and 160 laparotomy. All of the patients received total hysterectomy, bilateral salpingo-oophorectomy, and pelvic and para-aortic lymphadenectomy, depending on individual pathological features (e.g. high risk for positive lymph nodes) and the expertise of the surgeon. RESULTS: Repeat surgery was needed significantly more often in the laparotomy group in comparison with the laparoscopy group (11.9 vs. 0.9 %, respectively; P < 0.001). Hospital stays were longer in the laparotomy group in comparison with laparoscopy (16.2 vs. 9.5 days; P < 0.000001). Postoperative complications were significantly more frequent in the laparotomy group in comparison with laparoscopy (25.0 vs. 10.3 %; P < 0.01). Operating times and preoperative and postoperative hemoglobin differences were similar in the two groups (193.9 vs. 190.6 min, 2.0 vs. 1.8 g/dl). Intraoperative complication rates were similar in the two groups (3.8 vs. 5.6 %). CONCLUSIONS: Laparoscopy is a safe alternative to laparotomy for low risk endometrial cancer patients and offers markedly improved perioperative outcomes with a lower reoperation rate and fewer postoperative complications when the standard of care shifts from open surgery to laparoscopy in a university hospital.
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Neoplasias Endometriales/patología , Neoplasias Endometriales/cirugía , Histerectomía , Laparoscopía/métodos , Reoperación/estadística & datos numéricos , Nivel de Atención , Anciano , Anciano de 80 o más Años , Animales , Femenino , Estudios de Seguimiento , Humanos , Laparotomía/efectos adversos , Tiempo de Internación , Escisión del Ganglio Linfático , Persona de Mediana Edad , Estadificación de Neoplasias , Evaluación de Resultado en la Atención de Salud , Ovariectomía , Periodo Perioperatorio , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Segunda CirugíaRESUMEN
PURPOSE: Ectopic pregnancy is an acute, potentially life-threatening condition. The aim of this study was to compare the results of surgery and methotrexate treatment in women with ectopic pregnancy, along with a review of the literature. METHODS: 164 women with ectopic pregnancy, treated from 2000 to 2008 at the university gynecology department, were examined in a retrospective analysis. Patients with diagnosed ectopic pregnancy underwent one of the following treatments: Salpingotomy, salpingectomy or administration of a single dose of 30 mg methotrexate. The main outcome measures were treatment success rate, rate of patients wishing to have children after the ectopic pregnancy, and rates of pregnancy, live births, recurrent ectopic pregnancy, miscarriage, use of assisted reproduction and side effects. RESULTS: There were no significant differences in success rates between the groups (methotrexate 83.9 %, salpingotomy 88.2 %, salpingectomy 96.8 %). Significantly more patients in the salpingotomy group wished to become pregnant afterward than in the salpingectomy group. No significant differences were observed between the groups in the rates of intrauterine pregnancy, live births, recurrences, miscarriages, or side effects. CONCLUSIONS: With defined inclusion criteria, similar results can be achieved with low-dose single administration of 30 mg methotrexate in comparison with surgical treatment for ectopic pregnancy. On the basis of the data presented here, further research to establish optimal dosages for methotrexate is needed.
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Antagonistas del Ácido Fólico/administración & dosificación , Metotrexato/administración & dosificación , Embarazo Ectópico/tratamiento farmacológico , Adulto , Trompas Uterinas/cirugía , Femenino , Humanos , Embarazo , Embarazo Ectópico/cirugía , Estudios Retrospectivos , Salpingectomía , Resultado del TratamientoRESUMEN
Prediction of the prognosis for metastatic breast cancer patients depends on molecular subtypes similar to those found in patients with primary breast cancer. Several studies have shown that estrogen receptor (ER) and progesterone receptor (PR) status determine the course of the disease and the prognosis. As Ki-67 helps to differentiate molecular subtypes in patients with primary breast cancer, the aim of this study was to assess the prognostic relevance of Ki-67 in the primary tumor in relation to its prognostic relevance for patients with metastatic breast cancer. A total of 467 patients with invasive breast cancer were identified in the database of a single breast cancer center, in whom Ki-67 had been assessed in tumor material from the breast at the time of the primary diagnosis and who had developed a metastasis at any time during the subsequent course. For these patients, tumor and patient characteristics were used to determine prognostic factors relative to overall survival after the diagnosis of distant metastases. Ki-67 was added to this model to investigate whether this might improve the prediction of overall survival. In the multivariate Cox model, age at diagnosis, body mass index, nodal status, tumor size, ER and PR status, and time from diagnosis to metastasis were identified as relevant prognostic factors. Adding Ki-67 to the model improved the prediction of overall survival. There was also a significant and relevant interaction with the PR status. In patients with a low-proliferation primary tumor, a high level of PR expression would indicate an extraordinarily good prognosis (HR 0.39; 95 % CI, 0.23-0.66). In patients with higher-proliferation primary tumors, PR status was not capable of differentiating prognostic groups. Ki-67 is useful in addition to known prognostic factors for breast cancer. It is able to indicate a group of women with a poorer prognosis, specifically in the group of patients with PR-positive breast cancer.
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Neoplasias de la Mama/mortalidad , Neoplasias de la Mama/patología , Antígeno Ki-67/análisis , Anciano , Índice de Masa Corporal , Neoplasias Óseas/metabolismo , Neoplasias Óseas/patología , Neoplasias Óseas/secundario , Neoplasias de la Mama/metabolismo , Femenino , Humanos , Neoplasias Hepáticas/metabolismo , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/secundario , Neoplasias Pulmonares/metabolismo , Neoplasias Pulmonares/patología , Neoplasias Pulmonares/secundario , Metástasis Linfática/patología , Persona de Mediana Edad , Análisis Multivariante , Valor Predictivo de las Pruebas , Pronóstico , Modelos de Riesgos Proporcionales , Receptores de Estrógenos/metabolismo , Receptores de Progesterona/metabolismo , Estudios RetrospectivosRESUMEN
OBJECTIVES: The aim of this study is to evaluate the activity and toxicity of fulvestrant, a pure estrogen receptor antagonist in patients with advanced or recurrent endometrial cancer, expressing estrogen and/or progesterone receptors (ER/PR). METHODS: Eligible patients with advanced or recurrent endometrial cancer not amenable to curative surgery and/or radiotherapy were treated with fulvestrant at a dose of 250 mg by IM injection every 4 weeks for at least 12 weeks. Therapy was continued until disease progression, death, intolerable side effects or end of study. Response was assessed in patients with at least one target lesion according to WHO-criteria. RESULTS: Thirty-five patients were enrolled in this study and received at least one injection of fulvestrant (intention to treat-population, ITT). Twenty six patients received the intended 3 injections of fulvestrant (per protocol population, PP). There was no complete response but 4 partial responses (11.4% ITT) and 8 stable diseases. The median time to progression was 2.3 months (ITT). Overall survival was 13.2 months (ITT). Treatment was well tolerated. CONCLUSIONS: Fulvestrant at a dose of 250 mg IM every 4 weeks has marginal activity and good tolerability in patients with ER and/or PR positive advanced or recurrent endometrial cancer. A loading dose strategy and the use of 500 mg/4 weeks might improve the efficacy of this treatment.
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Antineoplásicos Hormonales/administración & dosificación , Neoplasias Endometriales/tratamiento farmacológico , Estradiol/análogos & derivados , Antagonistas de Estrógenos/administración & dosificación , Recurrencia Local de Neoplasia/tratamiento farmacológico , Anciano , Anciano de 80 o más Años , Antineoplásicos Hormonales/efectos adversos , Esquema de Medicación , Neoplasias Endometriales/metabolismo , Neoplasias Endometriales/patología , Estradiol/administración & dosificación , Estradiol/efectos adversos , Antagonistas de Estrógenos/efectos adversos , Femenino , Fulvestrant , Humanos , Inyecciones Intramusculares , Persona de Mediana Edad , Recurrencia Local de Neoplasia/metabolismo , Recurrencia Local de Neoplasia/patología , Estadificación de Neoplasias , Receptores de Estrógenos/biosíntesis , Receptores de Progesterona/biosíntesisRESUMEN
INTRODUCTION: Although care in certified breast centers is now established throughout Germany, numerous services are still not being reimbursed. This also affects other centers involved in the specialty of gynecology such as gynecological cancer centers, perinatal centers, and endometriosis centers. Although a certified center is entitled to charge additional fees, these are in most cases not reimbursed. Calculation of additional costs is limited by the fact that data from the Institute for the Hospital Reimbursement System (Institut für das Entgeltsystem im Krankenhaus, InEK) do not reflect interdisciplinary services and procedures. For decision-makers, society's willingness to pay is an important factor in guiding decisions on the basis of social priorities. A hypothetical maximum willingness to pay can be calculated using a willingness-to-pay analysis, making it possible to identify deficiencies in the arbitrary setting of health budgets at the macro-level. MATERIALS AND METHODS: In a multicenter study conducted between November 2009 and December 2010, 2,469 patients at a university hospital and at a non-university hospital were asked about the extent of their awareness of certified centers, the influence of centers on hospital presentation, and about personal attitudes toward quality-oriented reimbursement. A subjective assessment of possible additional charges was calculated using a willingness-to-pay analysis. RESULTS: In the overall group, 53.4 % of the patients were aware of what a certified center is and 27.4 % had specific information (obstetrics 40.0/32.3 %; mastology 66.8/23.2 %; gynecological oncology 54.7/27.3 %; P < 0.001). For 43.8 %, a certified center was one reason or the major reason for presentation (obstetrics 26.2 %; mastology 66.8 %; gynecological oncology 46.6 %; P < 0.001). A total of 72.6 % were in favor of quality-oriented reimbursement and 69.7 % were in favor of an additional charge for a certified center amounting to 538.56 (mastology 643.65, obstetrics 474.67, gynecological oncology 532.47). In all, 33.9 % would accept an increase in health-insurance fees (averaging 0.3865 %), and 28.3 % were in favor of reduced remuneration for non-certified centers. CONCLUSIONS: The existence of certified centers is being increasingly recognized by patients. Additional charges for certified centers are generally supported. There is therefore a clear demand for them-from patients as well. This may be useful when negotiations are being conducted.
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Actitud Frente a la Salud , Instituciones Oncológicas/economía , Maternidades/economía , Mecanismo de Reembolso/economía , Certificación/economía , Honorarios y Precios , Femenino , Alemania , Ginecología/economía , Humanos , Reembolso de Incentivo/economía , Encuestas y CuestionariosRESUMEN
Several factors can influence individual perceptions of the expected benefit of recommended adjuvant treatment for breast cancer. This study investigated differences between patients and physicians with regard to the required efficacy of treatment and the factors influencing patients' and physicians' willingness to accept different therapeutic options. A total of 9,000 questionnaires were distributed to patients with breast cancer, and 6,938 questionnaires were distributed to physicians treating breast cancer patients. The patients were asked for personal information and about their medical history and experiences during treatment. The physicians were asked about personal information and their specialty and work environment. The treatment efficacy required by the two groups was assessed using six virtual cases of breast cancer and the treatment regimens proposed, with specific benefits and side effects. A total of 2,155 patients and 527 physicians responded to the questionnaire (return rates of 23.9 and 7.6 %). Significantly different ratings between patients and physicians with regard to the expected benefit of certain treatment options were observed. The differences were noted not only for chemotherapy but also for antihormonal and antibody treatments. Whereas physicians had a quite realistic view of the expected treatment benefits, the patients' expectations were varied. Approximately one-fifth of the patients were willing to accept treatment regimens even with marginal anticipated benefits, whereas one-third required unrealistic treatment benefits. Several influencing factors that were significantly associated with the quality rating of treatment regimens in the groups of breast cancer patients and physicians were also identified. In contrast to physicians, many breast cancer patients required treatment benefits beyond what was realistically possible, although a large group of patients were also satisfied with minimal benefits. Individual factors were also identified in both groups that significantly influence thresholds for accepting adjuvant treatment, independently of risk estimates and therapy guidelines.
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Neoplasias de la Mama/tratamiento farmacológico , Neoplasias de la Mama/psicología , Toma de Decisiones , Aceptación de la Atención de Salud/psicología , Médicos , Resultado del Tratamiento , Antineoplásicos/uso terapéutico , Neoplasias de la Mama/radioterapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Encuestas y CuestionariosRESUMEN
PURPOSE: To evaluate complication rates associated with total laparoscopic hysterectomy (TLH) using the Hohl instrument in women with benign indications for hysterectomy, a prospective cohort study was conducted in a university teaching hospital. METHODS: A total of 567 women with benign indications for hysterectomy underwent the TLH procedure using the Hohl instrument between January 2005 and July 2009. The laparoscopic approach was used when the patient had undergone more than one previous pelvic abdominal operation, when an adnexal finding was present, and/or if the patient had reduced vaginal capacity. RESULTS: One ureteral injury (0.18%), four bladder injuries (0.71%), one small-bowel injury (0.18%), one vaginal injury (0.18%), and one conversion to abdominal hysterectomy (0.18%) occurred. The general complication rate during surgery was 1.42%, whereas in the postoperative period was 3.19%. The mean loss of hemoglobin was 1.47 g/dL (SD 1.06), the mean operating time was 103.87 min (SD 43.89), and the mean uterus weight was 241.41 g (SD 196.73). CONCLUSIONS: Total laparoscopic hysterectomy using the Hohl instrument simplifies the surgical procedure. The technique reported here is safe and effective in preventing ureteral complications during TLH, even in a university training program.
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Histerectomía/instrumentación , Histerectomía/métodos , Laparoscopía/instrumentación , Laparoscopía/métodos , Adulto , Femenino , Hospitales Universitarios , Humanos , Histerectomía/efectos adversos , Incidencia , Laparoscopía/efectos adversos , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiologíaRESUMEN
Common germline genetic variation in the population is associated with susceptibility to epithelial ovarian cancer. Microcell-mediated chromosome transfer and expression microarray analysis identified nine genes associated with functional suppression of tumorogenicity in ovarian cancer cell lines; AIFM2, AKTIP, AXIN2, CASP5, FILIP1L, RBBP8, RGC32, RUVBL1 and STAG3. Sixty-three tagging single nucleotide polymorphisms (tSNPs) in these genes were genotyped in 1,799 invasive ovarian cancer cases and 3,045 controls to look for associations with disease risk. Two SNPs in RUVBL1, rs13063604 and rs7650365, were associated with increased risk of serous ovarian cancer [HetOR = 1.42 (1.15-1.74) and the HomOR = 1.63 (1.10-1.42), p-trend = 0.0002] and [HetOR = 0.97 (0.80-1.17), HomOR = 0.74 (0.58-0.93), p-trend = 0.009], respectively. We genotyped rs13063604 and rs7650365 in an additional 4,590 cases and 6,031 controls from ten sites from the United States, Europe and Australia; however, neither SNP was significant in Stage 2. We also evaluated the potential role of tSNPs in these nine genes in ovarian cancer development by testing for allele-specific loss of heterozygosity (LOH) in 286 primary ovarian tumours. We found frequent LOH for tSNPs in AXIN2, AKTIP and RGC32 (64, 46 and 34%, respectively) and one SNP, rs1637001, in STAG3 showed significant allele-specific LOH with loss of the common allele in 94% of informative tumours (p = 0.015). Array comparative genomic hybridisation indicated that this nonrandom allelic imbalance was due to amplification of the rare allele. In conclusion, we show evidence for the involvement of a common allele of STAG3 in the development of epithelial ovarian cancer.
Asunto(s)
Predisposición Genética a la Enfermedad/genética , Neoplasias Glandulares y Epiteliales/genética , Proteínas Nucleares/genética , Neoplasias Ováricas/genética , Alelos , Proteínas de Ciclo Celular , Femenino , Humanos , Pérdida de Heterocigocidad , Análisis de Secuencia por Matrices de Oligonucleótidos , Polimorfismo de Nucleótido Simple , Factores de RiesgoRESUMEN
Background More and more information about complementary and integrative medicine is becoming available, especially among cancer patients. However, little is known about the use of herbal medicine by patients with gynecologic cancers. This study aimed to assess the use of herbal products by gynecologic cancer patients compared with healthy controls. Methods This cross-sectional study was conducted at the Department for Gynecology and Obstetrics of Erlangen University Hospital and included 201 patients with gynecologic cancer and 212 healthy controls. Use of herbal medicines was evaluated using a standardized questionnaire. Medical information on cancer patients was collected from hospital records. Group comparisons were done using a logistic regression model. Risk ratios were assessed using a Poisson regression model. Results Gynecologic cancer patients used herbal medicine significantly less often than healthy persons. 69% of gynecologic cancer patients and 81% of healthy participants reported using herbal products. 40% of cancer patients and 56% of healthy persons reported using plants for medicinal purposes. Motives of cancer patients for using herbal medicine included treatment of cancer-related symptoms. The major source of information for both groups was family and friends. Conclusions Although herbal medicine was used less by patients with gynecologic cancer, herbal products were used by both cancer patients and healthy individuals. To provide cancer patients with optimal therapy, oncologists should be informed about the herbal products used by their patients as this will allow them to take their patients' self-medication with herbal medicine into account. Counseling by oncologists on the use of herbal medicine should be encouraged.
RESUMEN
BACKGROUND: The ABCSG-12 trial investigated the efficacy of gonadotropin-releasing hormone (GnRH)analogs in combination with tamoxifen or anastrozole + or - zoledronic acid (4 mg, q6m for 3 years) in 1,803 premenopausal women with hormone receptor-positive (HR+) breast cancer. After 48 months of follow-up, there was a 36% improvement in the disease-free survival (DFS) (recurrence-free survival 35%) using zoledronic acid. Based on these data, the costutility of zoledronic acid was calculated for the German healthcare system. MATERIALS AND METHODS: Costs of surveillance, adverse effects, recurrence, contralateral breast cancer, metastasis, and end-of-life care were determined based on the Einheitlicher Bewertungsmabetastab (EBM 2009) and the diagnosis-related groups (DRG) system. Utilities were surveyed with a questionnaire (n = 95). Estimation of the cost-utility was made by calculating the incremental costeffectiveness ratio (ICER) per quality-adjusted life year (QALY), using a Markov model. RESULTS: Including zoledronic acid as adjuvant therapy for 3 years resulted in total costs of euro 2,262. The use of zoledronic acid is dominant when clinical efficacy and quality of life are taken into consideration (- euro 45.83/QALY) (95% confidence interval (CI) - euro 1,838 to E 2,375; 0.02-0.41 QALY). The sensitivity analyses present with a probability of 90% that the cost per QALY gained are Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/economía
, Conservadores de la Densidad Ósea/economía
, Neoplasias de la Mama/tratamiento farmacológico
, Neoplasias de la Mama/economía
, Difosfonatos/economía
, Costos de los Medicamentos/estadística & datos numéricos
, Goserelina/economía
, Imidazoles/economía
, Programas Nacionales de Salud/economía
, Nitrilos/economía
, Tamoxifeno/economía
, Triazoles/economía
, Anastrozol
, Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico
, Conservadores de la Densidad Ósea/efectos adversos
, Conservadores de la Densidad Ósea/uso terapéutico
, Neoplasias de la Mama/mortalidad
, Análisis Costo-Beneficio
, Difosfonatos/efectos adversos
, Difosfonatos/uso terapéutico
, Progresión de la Enfermedad
, Supervivencia sin Enfermedad
, Relación Dosis-Respuesta a Droga
, Femenino
, Alemania
, Goserelina/uso terapéutico
, Humanos
, Imidazoles/efectos adversos
, Imidazoles/uso terapéutico
, Cadenas de Markov
, Método de Montecarlo
, Estudios Multicéntricos como Asunto
, Neoplasias Primarias Múltiples/tratamiento farmacológico
, Neoplasias Primarias Múltiples/economía
, Neoplasias Primarias Múltiples/mortalidad
, Nitrilos/uso terapéutico
, Años de Vida Ajustados por Calidad de Vida
, Ensayos Clínicos Controlados Aleatorios como Asunto
, Tamoxifeno/uso terapéutico
, Triazoles/uso terapéutico
, Ácido Zoledrónico
RESUMEN
Mitomycin C (MMC) is an effective cytostatic agent used in the treatment of patients with gynecological malignancies and breast carcinoma. This review presents and discusses the current treatment options with MMC in patients with breast, cervical, and vulvar carcinomas, as well as rarer gynecological malignancies. New combinations and developments are also presented and their potential clinical relevance is examined. Consequently, also for the next years a MMC-containing chemotherapy continues to be a relevant part of an individualized therapy despite numerous innovative new drugs, especially for the salvage therapy of metastatic breast cancer and the simultaneous radiochemotherapy of other gynecological malignancies.