RESUMEN
BACKGROUND: Two strategies to interrogate the insulin growth factor 1 receptor (IGF-1R) pathway were investigated: vertical inhibition with dalotuzumab and MK-2206 or ridaforolimus to potentiate PI3K pathway targeting and horizontal cross-talk inhibition with dalotuzumab and MK-0752 to exert effects against cellular proliferation, angiogenesis, and stem cell propagation. METHODS: A phase I, multi-cohort dose escalation study was conducted in patients with advanced solid tumours. Patients received dalotuzumab (10 mg kg(-1)) and escalating doses of MK-2206 (90-200 mg) or escalating doses of dalotuzumab (7.5-10 mg kg(-1)) and MK-0752 (1800 mg) weekly. Upon maximum tolerated dose determination, patients with low-RAS signature, high-IGF1 expression ovarian cancer were randomised to dalotuzumab/MK-2206 versus dalotuzumab/ridaforolimus, whereas patients with high IGF1/low IGF2 expression colorectal cancer received dalotuzumab/MK-0752. RESULTS: A total of 47 patients were enrolled: 29 in part A (18 in the dalotuzumab/MK-2206 arm and 11 in the dalotuzumab/MK-0752 arm) and 18 in part B (6 in each arm). Dose-limiting toxicities (DLTs) for dalotuzumab/MK-2206 included grade 4 neutropenia and grade 3 serum sickness-like reaction, maculopapular rash, and gastrointestinal inflammation. For dalotuzumab/MK-0752, DLTs included grade 3 dehydration, rash, and diarrhoea. Seven patients remained on study for >4 cycles. CONCLUSIONS: Dalotuzumab/MK-2206 and dalotuzumab/MK-0752 combinations were tolerable. Further developments of prospectively validated predictive biomarkers to aid in patient selection for anti-IGF-1R therapies are needed.
Asunto(s)
Anticuerpos Monoclonales/uso terapéutico , Derivados del Benceno/uso terapéutico , Compuestos Heterocíclicos con 3 Anillos/uso terapéutico , Neoplasias/tratamiento farmacológico , Propionatos/uso terapéutico , Sirolimus/análogos & derivados , Sulfonas/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Anticuerpos Monoclonales/farmacocinética , Anticuerpos Monoclonales Humanizados , Protocolos de Quimioterapia Combinada Antineoplásica , Derivados del Benceno/farmacocinética , Biomarcadores de Tumor/metabolismo , Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Compuestos Heterocíclicos con 3 Anillos/farmacocinética , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias/metabolismo , Neoplasias/patología , Pronóstico , Propionatos/farmacocinética , Proteínas Proto-Oncogénicas c-akt/antagonistas & inhibidores , Ensayos Clínicos Controlados Aleatorios como Asunto , Receptor IGF Tipo 1/antagonistas & inhibidores , Receptores Notch/antagonistas & inhibidores , Sirolimus/farmacocinética , Sirolimus/uso terapéutico , Sulfonas/farmacocinética , Serina-Treonina Quinasas TOR/antagonistas & inhibidores , Distribución TisularRESUMEN
The objective of this review is to summarize recent scientific and medical literature regarding chemoresponse assays or chemotherapy sensitivity and resistance assays (CSRAs), specifically as applied to epithelial ovarian cancer. A total of sixty-seven articles, identified through PubMed using the key words "in vitro chemoresponse assay," "chemo sensitivity resistance assay," "ATP," "HDRA," "EDR," "MiCK," and "ChemoFx," were reviewed. Recent publications on marker validation, including relevant clinical trial designs, were also included. Recent CSRA research and clinical studies are outlined in this review. Published findings demonstrate benefits regarding patient outcome with respect to recent CSRAs. Specifically, analytical and clinical validations, as well as clinical utility and economic benefit, of the most common clinically used CSRA in the United States support its use to aid in making effective, individualized clinical treatment selections for patients with ovarian cancer.
Asunto(s)
Bioensayo/métodos , Bioensayo/normas , Resistencia a Antineoplásicos , Neoplasias Glandulares y Epiteliales/tratamiento farmacológico , Neoplasias Ováricas/tratamiento farmacológico , Biomarcadores de Tumor/análisis , Carcinoma Epitelial de Ovario , Femenino , Humanos , Proyectos de InvestigaciónRESUMEN
This study was undertaken to estimate the antitumor activity of tamoxifen in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix. Furthermore, the nature and degree of adverse effects from tamoxifen in this cohort of individuals was examined. Tamoxifen citrate was to be administered at a dose of 10 mg per orally twice a day until disease progression or unacceptable side effects prevented further therapy. A total of 34 patients (median age: 49 years) were registered to this trial; two were declared ineligible. Thirty-two patients were evaluable for adverse effects and 27 were evaluable for response. There were only six grades 3 and 4 adverse effects reported: leukopenia (in one patient), anemia (in two), emesis (in one), gastrointestinal distress (in one), and neuropathy (in one). The objective response rate was 11.1%, with one complete and two partial responses. In conclusion, tamoxifen appears to have minimal activity in nonsquamous cell carcinoma of the cervix.
Asunto(s)
Antineoplásicos Hormonales/uso terapéutico , Carcinoma/tratamiento farmacológico , Carcinoma/patología , Recurrencia Local de Neoplasia/tratamiento farmacológico , Tamoxifeno/uso terapéutico , Neoplasias del Cuello Uterino/tratamiento farmacológico , Neoplasias del Cuello Uterino/patología , Adulto , Anciano , Anciano de 80 o más Años , Antineoplásicos Hormonales/efectos adversos , Antineoplásicos Hormonales/farmacología , Resistencia a Antineoplásicos , Femenino , Humanos , Persona de Mediana Edad , Tamoxifeno/efectos adversos , Tamoxifeno/farmacología , Resultado del TratamientoRESUMEN
UNLABELLED: Clinical usefulness of sentinel lymph node (SLN) biopsy has been demonstrated in the management of early vulvar cancer. However, what constitutes a negative SLN has not been well defined. Furthermore, to what extent the SLNs should be sectioned for the greatest likelihood of detection of micrometastases and whether multilevel sectioning will further increase this detection rate in this setting have not been well studied. We analyzed 280 groin lymph nodes (SLNs=45, non-sentinel [NSLNs]=235) in 14 patients with invasive squamous cell carcinoma (ISCC) of the vulva treated with vulvectomy and inguinal SLN and NSLN dissection at the H. Lee Moffitt Cancer Center (HLMCC) between 1996 and 2001. Each SNL was evaluated for micrometastases by H&E and pancytokeratin AE1/3 (CKAE1/3) immunohistochemical staining. All negative SNLs (N=40) were sectioned times 3 (x3) at 50-micron intervals and independently reviewed by two pathologists in order to assess the utility of this inexpensive and logical approach to identifying additional micrometastases. Also, the Wilcoxon Rank Sum Test was used to determine if there was an association between tumor size, depth of invasion and SNL status. The patient age ranged from 35 to 81 years (mean 59 yrs); size of invasive tumor from 1.0 to 7.0 cm (mean 3.4 cm); depth of invasion from 3 to 25 mm (mean 10.8 mm). Of 45 SLNs examined from 14 patients, 11% (5/45) SNLs were positive for micrometastases on initial H&E and/or CKAE1/3 stains. Eighty-nine per cent (40/45) SNLs were negative in the remaining 9 patients. None of the latter 40 SNLs showed micrometastases on additional multilevel sectioning. Instead 3 of 135 NSLNs examined in these 9 patients revealed micrometastases on H&E (skip-micrometastases). Mean tumor size (cm) and depth of invasion (cm) were 4.06 (s.d. 1.89) and 1.20 (s.d. 0.35) for SLN (+) and 3.02 (s.d. 2.12) and 1.01 (s.d. 0.86) for SLN (-) tumor subsets (p values 0.385 and 0.348, respectively). CONCLUSION: Following routine H&E and CK AE1/3 stains, multilevel sectioning does not appear to detect additional micrometastases in sentinel lymph nodes in squamous cell carcinoma of the vulva. Even though mean tumor size and depth of invasion were greater in SNL (+) as compared to SLN (-) tumor subsets in our series, this difference did not reach statistical significance.
Asunto(s)
Carcinoma de Células Escamosas/patología , Ganglios Linfáticos/patología , Biopsia del Ganglio Linfático Centinela/métodos , Neoplasias de la Vulva/patología , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Células Escamosas/cirugía , Femenino , Humanos , Metástasis Linfática , Persona de Mediana Edad , Invasividad Neoplásica , Neoplasias de la Vulva/cirugíaRESUMEN
OBJECTIVE: Cisplatin is a standard treatment in advanced, recurrent cervical cancer. Because topotecan is an established treatment in gynecologic malignancies such as ovarian cancer and exhibits nonoverlapping toxicity with cisplatin, a phase II trial was conducted to evaluate the tolerability and antitumor activity of a cisplatin/topotecan doublet in persistent or recurrent cervical cancer patients. METHODS: Patients with bidimensionally measurable persistent or recurrent squamous cell and non squamous cell cervical cancer and adequate bone marrow were enrolled. Patients received 50 mg/m(2) of cisplatin intravenously over 1 h on Day 1 and 0.75 mg/m(2) of topotecan intravenously over 30 min on Days 1, 2, and 3 of 21-day cycles for six cycles or until disease progression. Tumor response and regimen toxicity were assessed using established Gynecologic Oncology Group criteria. RESULTS: Thirty-two of 35 enrolled patients were evaluable for toxicity and tumor response. All but 2 evaluable patients had received previous radiotherapy. No patient received prior chemotherapy. The cisplatin/topotecan doublet was well tolerated, with 77 and 78% of courses given without interruption or delay and at full doses, respectively. As anticipated, the most common toxicity was hematologic, with grade 3/4 neutropenia and thrombocytopenia reported in 30 and 10% of cycles, respectively. The overall response rate was 28% (9/32), with 3 complete and 6 partial responses. The antitumor response in nonirradiated fields (30%) was similar to the response observed in previously irradiated fields (33%), suggesting good drug penetration. Median duration of response was 5 months (range, 2 to 15+ months). An additional 9 (28%) patients achieved stable disease. Median survival was 10 months, with 3 patients in lasting remission. CONCLUSIONS: These results demonstrate that the cisplatin/topotecan combination is safe, well tolerated, and active in persistent or recurrent cervical cancer patients. A phase III, multicenter trial is under way (cisplatin/topotecan versus cisplatin) based on these favorable results to confirm the safety and efficacy profile in this patient population.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Células Escamosas/tratamiento farmacológico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Neoplasias del Cuello Uterino/tratamiento farmacológico , Adulto , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Cisplatino/administración & dosificación , Cisplatino/efectos adversos , Esquema de Medicación , Femenino , Enfermedades Hematológicas/inducido químicamente , Humanos , Persona de Mediana Edad , Topotecan/administración & dosificación , Topotecan/efectos adversosRESUMEN
PURPOSE: To determine the safety of omitting routine interval laboratory assessments, dietary restrictions, and isolation precautions between cycles of chemotherapy for gynecologic malignancies. METHODS: Data were retrospectively obtained from the records of women receiving chemotherapy for gynecologic cancer from July 1999-June 2000. Routine nadir determinations were not performed between treatment cycles; social interaction was encouraged, and pathogen-free diet recommendations were not provided. RESULTS: Eighty women received 449 cycles of chemotherapy. Four (5%) patients developed neutropenic fevers, and one of these women succumbed to sepsis. Eighteen (22.5%) women had 29 cycles delayed due to persistent myelosuppression when the ensuing chemotherapy infusion was to be administered. Hematopoietic growth factors overcame these delays during subsequent cycles in all but two patients. CONCLUSION: Omitting scheduled interval laboratory monitoring, dietary restrictions, and isolation precautions between chemotherapy cycles is convenient for patients, likely cost-effective, and does not increase morbidity in the gynecologic oncology population.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Neoplasias de los Genitales Femeninos/sangre , Monitorización Inmunológica/estadística & datos numéricos , Neutropenia/diagnóstico , Evaluación de Resultado en la Atención de Salud , Femenino , Fiebre/inducido químicamente , Fiebre/diagnóstico , Florida , Neoplasias de los Genitales Femeninos/tratamiento farmacológico , Humanos , Recuento de Leucocitos/estadística & datos numéricos , Registros Médicos , Neutropenia/inducido químicamente , Estudios Prospectivos , Estudios Retrospectivos , Factores de TiempoRESUMEN
OBJECTIVE: Our objective was to review our experience with carcinoma of Bartholin's gland relative to treatment and oncologic outcome. METHODS: Patient names were collected from our vulvar cancer database for the period September 1985 to September 2000. The medical records were retrospectively reviewed, and data were abstracted relative to demographics, presenting symptoms, treatment, and oncologic outcome. RESULTS: We treated 12 women with Bartholin's gland carcinoma, and 11 patients are reported. Seven women presented with a painless vulvar mass, and 8 of 11 had initially been treated for an infectious process before referral to our institution. Squamous histology was most common, and the right gland was more frequently involved. Ten patients were treated with primary surgery, followed by adjuvant radiation in 7 for inadequate resection margins or lymphatic metastases. One patient was treated with primary chemoradiation. Stage I, II, III, IVA, and IVB disease was present in 3, 1, 4, 2, and 1 patient, respectively. Recurrence was suffered by 54.5% during a mean follow-up time of 73.5 months (median, 60; range, 8-180 months). Overall survival is 58.3% to date. CONCLUSIONS: Conventional therapy for Bartholin's gland carcinoma yielded a 67% 5-year survival. Seventy-one percent of women receiving adjuvant radiotherapy recurred despite this precaution. Work is needed to identify an effective systemic therapy and to better determine which patients may benefit from pelvic radiotherapy.
Asunto(s)
Glándulas Vestibulares Mayores/patología , Neoplasias de la Vulva/patología , Neoplasias de la Vulva/terapia , Adenocarcinoma/patología , Adenocarcinoma/terapia , Adulto , Anciano , Carcinoma de Células Escamosas/patología , Carcinoma de Células Escamosas/terapia , Terapia Combinada , Femenino , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Radioterapia Adyuvante , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Breast cancer is the most common female malignancy in the USA and second only to lung malignancy in cancer mortality. The only screening modality that effectively detects early breast cancer and decreases mortality is mammography. Because many females turn to obstetrician gynecologists for breast cancer screening, an understanding of the benefits and limitations of mammography and the breast imaging reporting and data system is imperative. Mammography remains the most cost effective and sensitive tool for early detection.
Asunto(s)
Neoplasias de la Mama/prevención & control , Mamografía , Femenino , Ginecología , Humanos , ObstetriciaRESUMEN
In the new millennium, practitioners who provide primary care for women of all ages must be well educated in the diagnosis and treatment modalities for breast carcinoma. This disease strikes one of eight women. That statistic alone should encourage diligent and persistent efforts to detect this disease early enough to prevent the large number of deaths annually Early detection will reduce the morbidity associated with breast cancer. Strong efforts are ongoing in the fields of genetics and breast cancer research to achieve earlier detection of breast cancer and a reduction in morbidity regardless of the stage of the breast carcinoma. As results of ongoing studies materialize and new studies are funded, it is hoped that more answers will emerge to combat the devastating effects of breast cancer.
Asunto(s)
Neoplasias de la Mama/prevención & control , Carcinoma Ductal de Mama/prevención & control , Biopsia , Neoplasias de la Mama/cirugía , Neoplasias de la Mama/terapia , Carcinoma Ductal de Mama/terapia , Carcinoma Lobular/prevención & control , Carcinoma Lobular/terapia , Femenino , Pruebas Genéticas/métodos , Humanos , Mamografía/métodos , Tamizaje Masivo , Terapia Neoadyuvante/métodos , PalpaciónRESUMEN
OBJECTIVE: To assess the accuracy of intraoperative lymph node palpation for identifying lymph node metastasis in gynecologic malignancies. METHODS: We prospectively evaluated 126 women who had lymphadenectomies for staging of various gynecologic malignancies from August 1995 to June 1997. Surgeries were done by obstetrician-gynecologists with subspecialty certification in gynecologic oncology from the American Board of Obstetrics and Gynecology, who had practiced gynecologic oncology for at least 5 years. Data were collected on gynecologic oncologists' opinions of lymph node status by palpation. Nodes believed to be positive were sent separately. We recorded operating time for lymphadenectomies, and intraoperative and postoperative complications. RESULTS: Mean (range) patient age was 55 (18-83) years. Mean (range) operating time was 188 (85-435) minutes. The mean (range) lymphadenectomy time was 46 (5-150) minutes. The total number of lymph nodes dissected was 2138. One hundred seven of 2138 (5%) nodes were positive for malignancy. Thirty-eight of 107 (36%) positive lymph nodes were missed by palpation. Fifty-six of 2031 (3%) negative lymph nodes were selected as positive. Sixty-nine of 107 (64%) positive lymph nodes were identified correctly. Sensitivity and specificity of palpation were 72% and 81%, respectively. The positive and negative predictive values of lymph node palpation were 56% and 89%, respectively. CONCLUSION: Intraoperative lymph node palpation has low sensitivity and positive predictive value even when done by experienced board-certified gynecologic oncologists.
Asunto(s)
Neoplasias de los Genitales Femeninos/patología , Neoplasias de los Genitales Femeninos/cirugía , Escisión del Ganglio Linfático , Palpación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Competencia Clínica , Femenino , Humanos , Periodo Intraoperatorio , Metástasis Linfática , Persona de Mediana Edad , Estudios Prospectivos , Reproducibilidad de los ResultadosAsunto(s)
Terapia de Reemplazo de Estrógeno , Menopausia/efectos de los fármacos , Enfermedad de Alzheimer/prevención & control , Neoplasias de la Mama/etiología , Enfermedades Cardiovasculares/prevención & control , Sistema Nervioso Central/efectos de los fármacos , Diabetes Mellitus/prevención & control , Estudios de Evaluación como Asunto , Femenino , Humanos , Degeneración Macular/prevención & control , Programas Controlados de Atención en Salud , Persona de Mediana Edad , Osteoporosis/prevención & control , Factores de Riesgo , Resultado del TratamientoRESUMEN
Radical surgery has resulted in impressive cure rates in women with locally advanced vulvar carcinoma. Unfortunately, morbidity mostly related to inguinofemoral lymphadenectomy, is common. The present review discusses innovations in the management of vulvar disease with attempts to reduce attendant morbidity.
Asunto(s)
Neoplasias de la Vulva/cirugía , Femenino , Ingle , Humanos , Escisión del Ganglio Linfático/efectos adversos , Ganglios Linfáticos/diagnóstico por imagen , Estadificación de Neoplasias , Complicaciones Posoperatorias , Cintigrafía , Neoplasias de la Vulva/diagnóstico , Neoplasias de la Vulva/epidemiología , Neoplasias de la Vulva/patologíaRESUMEN
There is much debate about the risks and benefits of tamoxifen, most specifically about the incidence of associated endometrial cancer. Nearly all of the published trials on the subject have been criticized for methodological flaws and various forms of bias, making resolution of this controversy difficult. There is a consensus, however, that tamoxifen results in an increased incidence of both premalignant and malignant lesions of the endometrium. As the indications for tamoxifen continue to broaden, a larger number of women will be subjected to the potential adverse effects of tamoxifen. Many techniques for screening patients on tamoxifen for the development of endometrial abnormalities have been suggested. None of these methods appears to be consistently clinically or cost effective. We have reviewed the literature on endometrial surveillance in tamoxifen treated women with a focus on the larger publications reported within the past year. From this, we have provided what we hope to be safe and cost-effective recommendations for the management of these patients.
Asunto(s)
Neoplasias Endometriales/inducido químicamente , Neoplasias Endometriales/prevención & control , Antagonistas de Estrógenos/efectos adversos , Tamoxifeno/efectos adversos , Biopsia , Análisis Costo-Beneficio , Neoplasias Endometriales/diagnóstico , Endometrio/diagnóstico por imagen , Endometrio/patología , Femenino , Humanos , Factores de Riesgo , UltrasonografíaRESUMEN
Gynecologic malignancies account for 15% of all cancer diagnosis in women. Primary lymphatic spread is well recognized in vulvar, cervical, uterine, and ovarian carcinomas. Vulvar carcinoma spreads locally to the inguinofemoral lymph nodes in a relatively predictable fashion similar to the local spread of breast carcinoma. Lymphatic mapping using radioactive colloid should provide adequate means to sample these nodal basins while attempting to reduce postoperative morbidity. Methods of vulvar lymphoscintigraphy are described.
Asunto(s)
Metástasis Linfática , Neoplasias de la Vulva/patología , Femenino , Humanos , Ganglios Linfáticos/patología , Metástasis Linfática/diagnóstico por imagen , Metástasis Linfática/patología , Estadificación de Neoplasias , Cintigrafía , Vulva/diagnóstico por imagenRESUMEN
PURPOSE: The aim of this study was to measure the radial occult microscopic spread of tumor in patients with invasive squamous cell carcinoma of the vulva. MATERIALS AND METHODS: In the operating room the gross tumor border was marked. The pathologist took a radial section in each quadrant and measured the distance of occult lateral spread of the tumor. RESULTS: From 7/01/93 to 6/30/96, 24 tumors from 21 patients were studied. The mean maximum tumor diameter was 3. 2 cm (0.5-7.0) and the mean depth of invasion was 9.1 mm (1.1-28.0). The gross and microscopic extent correlated in 20 tumors. Maximum lateral microscopic extent of the other 4 tumors was 3.5, 5 (to the margin), 10, and 16 mm. These 4 tumors were ulcerative and infiltrative and arose from or involved mucosa. CONCLUSION: The gross and microscopic periphery of most invasive squamous vulvar cancers are approximately the same. Ulcerative tumors with an infiltrative pattern of invasion which involve mucosal epithelium may be more likely to extend beyond what is grossly apparent. Measurement of the tumor-free margin should be included in future studies.
Asunto(s)
Carcinoma de Células Escamosas/patología , Neoplasias de la Vulva/patología , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Persona de Mediana Edad , Invasividad NeoplásicaRESUMEN
BACKGROUND: Identification of sentinel lymph nodes may allow prediction of metastatic disease in cancer patients. We did a prospective study to determine whether lymphazurin dye could identify sentinel lymph nodes in patients with cervical, uterine, and vulvar cancer. METHODS: In 33 patients having surgery for either uterine, cervical, or vulvar carcinoma, lymphazurin dye was injected into the respective organs before the tumor and node dissection began. Sentinel lymph nodes were identified and dissected in situ. RESULTS: The identification rate of sentinel lymph nodes was 0/8 (0%) for uterine cancer patients, 2/13 (15.4%) for cervical cancer patients, and 9/12 for vulvar cancer patients (75%). CONCLUSIONS: In a limited number of patients, lymphazurin day may be useful in identifying or assessing the sentinel nodes draining vulvar and cervical cancers. The role of this procedure in treatment planning for patients with gynecologic malignancies is yet to be determined.
Asunto(s)
Ganglios Linfáticos/patología , Colorantes de Rosanilina , Neoplasias del Cuello Uterino/patología , Neoplasias Uterinas/patología , Neoplasias de la Vulva/patología , Adenocarcinoma/patología , Adenocarcinoma/cirugía , Adulto , Anciano , Carcinoma de Células Escamosas/patología , Carcinoma de Células Escamosas/cirugía , Carcinosarcoma/patología , Carcinosarcoma/cirugía , Neoplasias Endometriales/patología , Neoplasias Endometriales/cirugía , Femenino , Humanos , Escisión del Ganglio Linfático , Metástasis Linfática , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Sensibilidad y Especificidad , Neoplasias del Cuello Uterino/cirugía , Neoplasias Uterinas/cirugía , Neoplasias de la Vulva/cirugíaAsunto(s)
Anticoagulantes/uso terapéutico , Complicaciones Hematológicas del Embarazo/tratamiento farmacológico , Embolia Pulmonar/tratamiento farmacológico , Embolia Pulmonar/prevención & control , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/prevención & control , Femenino , Humanos , Embarazo , Embolia Pulmonar/diagnóstico , Trombosis de la Vena/diagnósticoRESUMEN
A prospective, randomized study of patients undergoing radical hysterectomy for gynecologic malignancies was undertaken from 10/95 to 11/96 to determine if ligation of the hypogastric arteries at the time of radical hysterectomy decreases blood loss. Patients were randomized to either ligation of the hypogastric artery (Group 1) or no ligation (Group 2) prior to a standard Piver type III radical hysterectomy. Surgeries were performed by Board certified gynecologic oncologists with gynecologic oncology fellows and/or OB/GYN residents. Patients were analyzed for demographic characteristics and intraoperative and postoperative parameters. Statistical analysis was performed with independent samples t-test, Mann-Whitney rank sum test, Chi square and Fisher exact test. Twenty-one patients were randomized to group 1 and 22 to group 2. Groups were similar with respect to demographics and preoperative parameters except for age. There were no differences among the groups with respect to intraoperative and postoperative parameters. The mean estimated blood loss for group 1 was 600 ml and 550 ml for group 2 (P = NS). Hypogastric artery ligation (HAL) at the time of radical hysterectomy for gynecologic malignancy does not reduce blood loss.