Intra- and postoperative catumaxomab in patients with epithelial ovarian cancer: safety and two-year efficacy results from a multicentre, single-arm, phase II study.

BACKGROUND: This is the first study investigating the safety and efficacy of the trifunctional antibody catumaxomab administered i.p. at the end of cytoreductive surgery and postoperatively prior to standard chemotherapy in patients with primary epithelial ovarian cancer (EOC). METHODS: Patients received i.p. catumaxomab 10 µg intraoperatively and 10, 20, 50 and 150 µg on days 7, 10, 13 and 16, respectively, postoperatively. After the study, patients received standard chemotherapy and were followed for 23 months. The primary endpoint was the rate of postoperative complications. RESULTS: Forty-one patients entered the study and were evaluable for safety and 34 were alive at 24 months. Complete tumour resection rate was 68%. Postoperative complications were observed in 51%, the most common anastomotic leakage (7%) and wound infections (5%). The most common catumaxomab-related adverse events were abdominal pain, nausea, vomiting and pyrexia. Thirty-nine percent discontinued catumaxomab therapy, and 98% received chemotherapy post study. Kaplan-Meier estimates of disease-free and overall survival after 24 months were 56% and 85%, respectively. CONCLUSIONS: Intra- and close postoperative catumaxomab seems feasible, but efficacy and safety were limited by postsurgical complications. In the future prospective trials are needed to investigate the best schedule of integration of catumaxomab into current treatment strategies for EOC.

Indications and Route of Hysterectomy for Benign Diseases. Guideline of the DGGG, OEGGG and SGGG (S3 Level, AWMF Registry No. 015/070, April 2015)

Background: Official guideline "indications and methods of hysterectomy" to assign indications for the different methods published and coordinated by the German Society of Gynecology and Obstetrics (DGGG), the Austrian Society of Gynecology and Obstetrics (OEGGG) and the Swiss Society of Gynecology and Obstetrics (SGGG). Besides vaginal and abdominal hysterectomy, three additional techniques have been implemented due to the introduction of laparoscopy. Organ-sparing alternatives were also integrated. Methods: The guideline group consisted of 26 experts from Germany, Austria and Switzerland. Recommendations were developed using a structured consensus process and independent moderation. A systematic literature search and quality appraisal of benefits and harms of the therapeutic alternatives for symptomatic fibroids, dysfunctional bleeding and adenomyosis was done through MEDLINE up to 6/2014 focusing on systematic reviews and meta-analysis. Results: All types of hysterectomy led in studies to high rates of patient satisfaction. If possible, vaginal instead of abdominal hysterectomy should preferably be done. If a vaginal hysterectomy is not feasible, the possibility of a laparoscopic hysterectomy should be considered. An abdominal hysterectomy should only be done with a special indication. Organ-sparing interventions also led to high patient satisfaction rates, but contain the risk of symptom recurrence. Conclusion: As an aim, patients should be enabled to choose that therapeutic intervention for their benign disease of the uterus that convenes best to them and their personal life situation.

Combined external and high dose rate intracavitary radiotherapy in the primary treatment of cancer of the uterine cervix.

From August 1980 to December 1985, 153 patients with stage I, II and III carcinomas of the uterine cervix were treated with external beam irradiation and high dose rate (HDR) Cs-137 and Ir-192 Curietherapy at the Barmherzige Schwestern Hospital in Linz, Austria. Complete remission was achieved in 146 patients (95.4%). The 5-year overall survival probabilities (Kaplan-Meier) in stages I, II and III were 79.3%, 62.6% and 40.8%, respectively. The 5-year recurrence-free survival rates were 91.5%, 59.6% and 52.9%. These results are equivalent to those achieved by treatments incorporating low dose rate (LDR) Ra-226 applications in regard to the limitations of historical comparisons. Use of the high dose rate afterloading methods lead to similar rates of local failures and complications.

Significance of pretreatment serum hemoglobin and survival in epithelial ovarian cancer.

Tumor anemia is common in patients with malignant tumors and it was repeatedly demonstrated to be associated with impaired prognosis in patients with malignant tumors. We conducted a retrospective analysis based on 553 patients with histologically proven epithelial ovarian cancer. Blood hemoglobin levels were determined before surgery and patients with values <12 g/dl were considered anemic. Data analysis included univariate and multiple Cox models. Tumor anemia was present in 143 (25.9%) patients before surgery. Tumor anemia was present in 143 (25.9%) patients before surgery. In a multivariate Cox model, pretreatment hemoglobin values proved to be an independent prognostic factor for patients with stage I-II epithelial ovarian cancer (n=203), but failed to attain significance in patients with stage III-IV disease (n=350). Tumor anemia defined as pretreatment hemoglobin values <12 g/dl may indicate patients with stage I and II epithelial ovarian cancer, who are at increased risk of relapse.

[Interdisciplinary significance of a basically equipped urodynamic measuring unit (author's transl)]. / Die interdisziplinäre Bedeutung eines einfachen urodynamischen Messplatzes. Erfahrungen und Ergebnisse von über 1000 Untersuchungen.

The present work deals with the indication and results of 1102 urodynamic examinations on 776 patients, grouped according to the various medical departments from which they were assigned. The interdisciplinary importance of these examinations was emphasized by the fact that urodynamic examinations turned out to be necessary in patients from gynaecological, urological, neurological, pediatric, surgical and medical departments. After the usual gynaecological, urological, radiological and neurological examinations, a detailed case history was obtained with the help of a questionnaire and cystometry, uroflowmetry, and/or simultaneous vesico-urethrotonometry was carried out on each patient, depending on the medical evidence. The results, which were listed according to assignment from the various medical departments, show that urinary disturbances occur in all the medical fields mentioned above and that they cannot be treated successfully without a previous urodynamic examination. We were able to differentiate the various forms of female urinary incontinence of gynaecological patients, as well as various forms of neurogenic bladder disturbances of the patients from all the other medical departments. A broad discussion deals with the complexity of the subject and shows the possibilities of a small, but easily and quickly usable urodynamic examination programme at a general hospital.

[Effectiveness and tolerance of a gonadotropin releasing hormone (goserelin) in treatment of symptomatic endometriosis]. / Wirksamkeit und Verträglichkeit eines Gonadotropin Releasing Hormones (Goserelin) zur Behandlung der symptomatischen Endometriose.

Endometriosis is one of the most common benign gynecological diseases, affecting an estimated 10-15% of all premenopausal women. In this open multicentric prospective study, we investigated the effectiveness and tolerance of a gonadotropin releasing hormone agonist (goserelin) for the treatment of symptomatic endometriosis. One hundred and thirteen patients were included in the study. During the treatment, we documented a relevant reduction in the rAFS score and in the additive diameter of the implants. In addition, we noted a reduction in pelvic pain and an improvement of symptoms on pelvic examination. These effects were also reported during the follow up visits (24 weeks). Only 12 patients had intolerable side effects (hot flushes, sweating during the night, vaginal dryness, depression), which could be managed with transdermal 17 beta estradiol, without reducing therapeutic effectiveness. In conclusion, gonadotropin releasing hormone analogs proved to be an excellent treatment for symptomatic endometriosis and are generally well tolerated.

[Color doppler ultrasonography of uterine vessels during radiotherapy of advanced cervix cancers]. / Colordopplersonographische Untersuchungen uteriner Gefässe während der Radiotherapie fortgeschrittener Zervixkarzinome.

In tumor vessels of 14 patients with an advanced squamous cell carcinoma of the cervix uteri, an increase of the resistant index (RI) and the pulsatility index (PI) of tumor vessels was found later than the decrease of the volume of the tumor. For the uterine arteries these indices remained unchanged for patients with a complete remission, while for patients with incomplete remission there was a decrease of RI and PI.

National German Guideline (S2k): Guideline for the Diagnosis and Treatment of Endometriosis: Long Version - AWMF Registry No. 015-045.

In this guideline, recommendations and standards for optimum diagnosis and treatment of endometriosis are presented. They are based on the analysis of the available scientific evidence as published in prospective randomized and retrospective studies as well as in systematic reviews. The guideline working group consisted of experts from Austria, Germany, Switzerland, and the Czech Republic.

[Experience with the use of cystometry and simultaneous cystometry and urethrometry to clarify urinary incontinence in women (author's transl)]. / Erfahrungen mit der Zystometrie und simultanen Blasen-Harnröhrentonometrie zur Abklärung der weiblichen Harninkontinenz

Cystometry and simultaneous cystometry and urethrometry were conducted in 81 incontinent female patients (46 Grade I, 35 Grade II, according to the Ingelman-Sundberg Scale). The tonometric criteria for stress incontinence were presented and discussed by statistically comparing the pressure parameters for continent and incontinent patients. The results of both examinations indicated that, in almost all cases, the cause of incontinence (bladder, bladder obstruction or combination of both) can be determined with certainty. This method is well suited as a routine procedure to clarify urinary incontinence in women.

[Clinical aspects of endometriosis]. / Klinik der Endometriose.

Endometriosis is defined as the presence of endometrial tissue outside the uterine cavity. Its pathogenesis ist still not definitely clear. The incidence today is stated very differently, most studies report an incidence of 10-15% for women in their reproductive age. The leading symptoms are as dysmenorrhoea and chronic pelvic pain, which do not have to occur synchronously with the menstrual cycle. Endometriosis is a chronic, progressive disease and may lead to severe destructions of reproductive organs and infertility in advanced stages. Clinical symptoms are often uncharacteristic, and imaging techniques may not be able to give the correct diagnosis; furthermore, there is often no direct relationship between the extent of the disease and the severity of the symptoms. Differential diagnosis other inflammatory diseases as far as malignant tumors. Therefore early indication of surgical affirmation and therapy of endometriosis by laparoscopic techniques is recommended as soon as symptoms occur, even in adolescent girls. Endometriosis genitalis externa is presenting as peritoneal or ovarian implants of different shape, as endometriotic cyst of the ovaries or as deep nodal implants in the spatium rectovaginale, which possibly represent different entities.

[10 years' obstetric medicine at a district hospital. Methods and results]. / 10 Jahre Geburtsmedizin an einem Bezirkskrankenhaus. Methodik und Ergebnisse.

Between July 1st, 1975 and June 30th, 1985 9669 deliveries seen were evaluated according to parameters of obstetric efficiency, particular risk factors, perinatological proceedings including a trend analysis. A significant diminuation of perinatal mortality and morbidity could be registered. Since there has been an obvious augmentation of cases with higher obstetrical risks in the time mentioned, these results may be underlined positively. After all, the high taint of the results by preterm deliveries still remains an unsolved problem.

[Remarks on sonography in obstetrics]. / Bemerkungen zur Sonographie in der Geburtsmedizin.

For the near future two routine examinations by sonar for every pregnancy in Austria were announced by government. Therefore an analysis of 3076 ultrasonographic examinations of 1217 pregnancies seen in 1984 may lead to an estimation of the frequency of pathological factors to be expected. More than 90% of all pregnant women seen in our department for delivery or other indications had had sonographic examinations during pregnancy, 74% of them as outpatients. The most common pathological factors diagnosed were discrepancies between sonographic estimated and anamnestic gestational age (14.1% of cases), pathological fetal growth (11.0%), pathologics of placenta and umbilical cord (8.6%), pathological presentation (5.9%). Accompanying pathological factors as a cervical length less than 30 mm, an uterus myomatosus, uterine malformations, cystic adnexal masses were found in 1-2% of cases each. Fetal malformations and anomalies were seen in 0.8%. Problems arising from low frequencies of certain rare pathological findings, especially for their detection by office sonographiers or small departments, are discussed. For solution of such problems the multiple step programs as well as an intensive interdisciplinary local or countrywide collaboration is proposed. In Upper-Austria, such collaboration takes place organized by the collaboration group for antenatal detection of fetal malformations, which was founded in 1985 by the Upper-Austrian part of the Osterreichische Gesellschaft für Ultraschall in der Medizin (OGUM).

Chemotherapy versus radiotherapy versus observation for high-risk cervical carcinoma after radical hysterectomy: A randomized, prospective, multicenter trial.

BACKGROUND: Adjuvant treatment modalities after radical hysterectomy have long been used in an attempt to eradicate microscopic tumor residuals in patients at high risk for recurrence. However, it has not been clearly demonstrated that adjuvant radiation, adjuvant chemotherapy, or both improve the outcome. To evaluate the effect of adjuvant treatment in patients with high-risk cervical cancer after radical hysterectomy, the Austrian Gynecologic Oncology Group conducted a prospective, randomized, multicenter clinical trial between 1989 and 1995. MATERIAL AND METHODS: Seventy-six patients with stage IB-IIB cervical cancer treated with radical hysterectomy with pelvic lymph node metastases and/or vascular invasion randomly received adjuvant chemotherapy (400 mg/m2 carboplatin, and 30 mg bleomycin), standardized external pelvic radiation therapy, or no further treatment. RESULTS: After a median follow-up of 4.1 years (range, 2-7) there were no statistically significant differences (P = 0.9530) in disease-free survival among the three treatment arms. CONCLUSION: The data suggest that adjuvant chemotherapy or radiation do not improve survival or recurrence rates in high-risk cervical cancer patients after radical hysterectomy. The most important treatment for these patients seems to be radical abdominal hysterectomy with systematic pelvic lymphadenectomy.

Interferon-gamma in the first-line therapy of ovarian cancer: a randomized phase III trial.

Intraperitoneal treatment with interferon-gamma (IFN-gamma) has been shown to achieve surgically documented responses in the second-line therapy of ovarian cancer. To assess its efficacy in the first-line therapy, we conducted a randomized controlled trial with 148 patients who had undergone primary surgery for FIGO stage Ic-Illc ovarian cancer. In the control arm women received 100 mg/m(-2) cisplatin and 600 mg/m(-2) cyclophosphamide, the experimental arm included the above regimen with IFN-gamma 0.1 mg subcutaneously on days 1, 3, 5, 15, 17 and 19 of each 28-day cycle. Progression-free survival at 3 years was improved from 38% in controls to 51% in the treatment group corresponding to median times to progression of 17 and 48 months (P= 0.031, relative risk of progression 0.48, confidence interval 0.28-0.82). Three-year overall survival was 58% and 74% accordingly (n.s., median not yet reached). Complete clinical responses were observed in 68% with IFN-gamma versus 56% in controls (n.s.). Toxicity was comparable in both groups except for a mild flu-like syndrome, experienced by most patients after administration of IFN-gamma. Thus, with acceptable toxicity, the inclusion of IFN-gamm in the first-line chemotherapy of ovarian cancer yielded a benefit in prolonging progression-free survival.