Vaginal prolapse surgery with transvaginal mesh: results of the Austrian registry.

INTRODUCTION AND HYPOTHESIS: Several mesh repair systems for pelvic organ prolapse (POP) were introduced into clinical practice with limited data on safety, complications or success rates, and impact on sexual function. The Austrian Urogynecology Working Group initiated a registry to assess the use of transvaginal mesh devices for POP repair. We looked at perioperative data, as well as outcomes at 3 and 12 months. METHODS: Between 2006 and 2010 a total of 20 gynecology departments in Austria participated in the Transvaginal Mesh Registry. Case report forms were completed to gather data on operations, the postoperative course, and results at 3 and 12 months. RESULTS: A total of 726 transvaginal procedures with 10 different transvaginal kits were registered. Intra- and perioperative complications were reported in 6.8%. The most common complication was increased intraoperative bleeding (2.2%). Bladder and bowel perforation occurred in 6 (0.8%) and 2 (0.3%) cases. Mesh exposure was seen in 11% at 3 and in 12% at 12 months. 24 (10%) previously asymptomatic patients developed bowel symptoms by 1 year. De novo bladder symptoms were reported in 39 (10%) at 3 and in 26 (11%) at 12 months. Dyspareunia was reported by 7% and 10% of 265 and 181 sexually active patients at 3 and 12 months postoperatively respectively. CONCLUSIONS: The 6.8% rate of intra- and perioperative complications is in line with previous reports. Visceral injury was rare. The 12% rate of mesh exposure is consistent with previous series.

Low-grade mucosa-associated lymphoma of the breast: radiological-pathological correlation.

Primary breast lymphoma generally is a rare disease. We present a case of a low-grade mucosa-associated (MALT) lymphoma of the breast in a 32-year-old woman, a distinctive type of localized non-Hodgkin's lymphoma (NHL), which is very seldom located in the breast. We performed differential diagnosis and radiological-pathological correlation with regard to typical microscopic criteria and clinical relevance that apply for that special entity.

Lunar phases and survival of breast cancer patients--a statistical analysis of 3,757 cases.

The potential influence of lunar phases on human life has been widely discussed by the lay press. The purpose of this study was to find out whether the timing of surgery during particular lunar phases influences the survival of breast cancer patients. It has been postulated that breast cancer surgery performed during the waxing moon, or particularly at full moon, is associated with a poorer outcome. We tested this hypothesis by evaluating the overall survival for 3,757 consecutive patients with invasive breast cancer. All patients underwent either modified radical mastectomy or breast conserving surgery plus radiotherapy, followed by adjuvant cytotoxic or hormonal therapy. The date of definitive surgery was allocated to the lunar phases. 1,904 (50.7%) patients were operated on during the waxing moon and 1,853 (47.3%) during the waning moon. The median follow-up was 74 months (range 1-372 months). The mean age at primary surgery did not differ significantly in the two groups 58.39 (SD 13.14) versus 58.34 (12.75) (p >0.05, t-test). Breast cancer stages at initial diagnosis were evenly distributed according to the lunar phases (p = 0.325; chi-square). Survival curves were plotted according to the method of Kaplan-Meier. No significant differences were observed when timing of surgery was allocated to the lunar phases (p = 0.4841, log-rank). Subgroup analysis of premenopausal patients revealed similar results (p = 0.2950, log-rank; n = 1072). Using multivariate Cox modelling, we found a significant association between the patient's age, stage of disease and survival, whereas no association with survival was observed for the timing of surgery (RR= 1.062; 95% CI, 0.970-1.163; p = 0.1937). No significant differences in overall survival of breast cancer patients were observed when timing of breast cancer surgery during the lunar cycle was considered. Although this was not a prospective randomized trial, the statistical magnitude of the results do not support any recommendations for scheduling patients for surgery at any particular day of the lunar phase.

Does long-term application of granulocyte colony-stimulating factor adversely influence overall survival in patients with ovarian cancer? A clinical study.

The purpose of this study was to investigate the effect of long-term administration of G-CSF with regard to its impact on overall survival of patients with ovarian cancer. We report the results of a non-randomized trial on 64 patients with advanced ovarian cancer treated with 6 cycles of conventional chemotherapy. Chemotherapy comprised carboplatin 400 mg/m2 and epirubicin 70 mg/m2 on day 1 of each cycle and prednimustine 100 mg/m2 on days 3 to 7, every 28 days. Thirty-three patients received CEP chemotherapy with G-CSF support whereas 31 women received CEP chemotherapy alone. The schedule of G-CSF was 5 mg/kg/day subcutanously on days 8 to 21 of each cycle. The severity of reduction in white cells and neutrophil count was significantly different in the two treatment groups (p<0.05), with more toxicity in the non- G-CSF group. G-CSF users had a non significant 0.88-fold lower risk of dying from ovarian cancer (95% CI, 0.48-1.60, p=0.678). In a survival analysis using a Cox proportional hazards model, residual tumor remained as an independent prognostic factor. The increasing amount of residual tumor resulted in a 1.767-fold higher risk (95% CI, 1.23-2.53, p=0.002) of death secondary to the underlying disease. In conclusion, this trial has failed to demonstrate any negative impact on patients' overall survival for the additional use of G-CSF with platinum-based chemotherapy; our results were consistent with the beneficial effects of G-CSF treatment on cytotoxic chemotherapy-induced myelosuppression.

Quantitative PCR Detection of c-erbB-2 Gene Amplification.

The association of c-erbB-2 oncogene amplification and prognostic factors was intensively studied in human gynecological carcinomas, especially in mammary carcinoma (1). Positive lymph nodes, estrogen and progesterone receptor negative tumors, and short survival time correlate with c-erbB-2 amplification.

Relevance of sonographic B-mode criteria and computer-aided ultrasonic tissue characterization in differential/diagnosis of solid breast masses.

We aimed to evaluate the differential diagnostic value of a method of computer-assisted texture analysis in comparison to established ultrasonographic B-mode characteristics in the examination of solid breast masses. At two centers, 77 patients presenting with a solid mass on B-mode scan were studied at 7.5 MHz. Description of B-mode appearance included assessment of tumor shape, borders, presence of an echogenic rim, tissue architecture, internal echo structure, absorption and elasticity. For statistical pattern recognition, the following parameters were used: form factor, mean grey level, signal-to-noise ratio, mean gradient and correlation from the co-occurrence matrix. At center 1, the most decisive parameter for differential diagnosis was distortion of tissue architecture (sensitivity, SN, 83%; specificity, SP, 92%) and, at center 2, relation to the adjacent tissue (SN 93%, SP 92%). Among texture parameters, best discrimination was achieved for correlation from the co-occurrence matrix at center 1 (SN 58%, SP 73%) and for form factor at center 2 (SN 93%, SP 77%). Among sonographic criteria, the highest contribution to the diagnosis was found for an unsharp border (odds ratio, OR, 12.2), architectural distortion (OR, 8.6), fixation to skin or chest wall (OR, 9.0) and fixation to adjacent breast parenchyma (OR, 8.8), according to texture analysis for parameters form factor (OR 4.0) and correlation from the co-occurrence matrix (OR 4.7). Ultrasonographic texture analysis can be helpful as an additional parameter in differential diagnosis of breast tumors, but did not reach differential diagnostic accuracy of sonomorphologic features.

Ultrasonographic tissue characterization in monitoring tumor response to neoadjuvant chemotherapy in locally advanced breast cancer (work in progress).

A program of computer-assisted texture analysis was applied to evaluate its usefulness for objective description of changes in tumor architecture due to primary medical treatment in patients with locally advanced breast cancer. Changes in values of parameters of the statistical pattern recognition technique were compared to ultrasonographically depictable, subjectively recorded changes in echogenicity and echotexture (brightness, homogeneity) and reviewed with regard to histopathologic evaluation of tumor regression. Characteristic trends of defined quantitative texture parameters (mean gradient, mean gray value, contrast from the co-occurrence matrix) corresponded to visually depictable changes of the B-mode image and underlying histopathologic changes. The results indicate that quantitative texture analysis may aid in noninvasive monitoring of tumor response to neoadjuvant chemotherapy.

Locally advanced breast carcinoma: computer assisted semiquantitative analysis of color Doppler ultrasonography in the evaluation of tumor response to neoadjuvant chemotherapy (work in progress).

We aimed to evaluate objectively the value of color Doppler flow imaging in the assessment of response of locally advanced breast cancer to primary medical treatment by using a computer assisted semiquantitative method. Prior to and after neoadjuvant treatment, 17 patients with locally advanced breast carcinoma were prospectively evaluated by physical examination and computer assisted semiquantitative color Doppler ultrasonography. The results of clinical and color Doppler examination were finally correlated to the histopathologic evaluation of tumor response. The degree of concordance between posttherapeutic histopathologic results, clinical examination, and color Doppler assessment was evaluated by kappa statistics. Concordance was 0.474 (0.135-0.813) between histopathologic results and clinical posttherapeutic assessment and 0.870 (0.627-1.113) between histopathologic results and semiquantitative color Doppler examination. Objective semiquantitative assessment of tumor vascularity as displayed by color Doppler ultrasonography has potential as a functional tool for measuring tumor response to neoadjuvant chemotherapy.

First report of lymphatic mapping with isosulfan blue dye and sentinel node biopsy in cervical cancer.

BACKGROUND: Sentinel lymph node status provides important information about the status of the regional nodes in various malignant tumors. Our report describes a method of identifying the sentinel lymph nodes in cervical cancer. PATIENTS AND METHODS: In three cases of early cervical cancer, isosulfan blue dye was injected paracervically into each lateral fornix immediately before surgery. RESULTS: In all cases we identified two to three blue stained (sentinel) lymph nodes located either at the iliac artery or in the obturatory space. The blue colored nodes were positive for disease, all other pelvic lymph nodes removed were negative. CONCLUSIONS: Our findings demonstrate that preoperative lymphatic mapping with vital blue dye is an easy to perform technique to visualize sentinel lymph nodes in cervical cancer. Sentinel lymph node status may be representative of the pelvic lymph node status in cervical cancer and thus could provide important information for further treatment.

Locally advanced breast carcinoma: evaluation of mammography in the prediction of residual disease after induction chemotherapy.

BACKGROUND: We aimed to assess the mammographic features of locally advanced breast carcinoma treated with neoadjuvant chemotherapy and to evaluate morphological criteria that determine the value of mammography in therapy monitoring. MATERIALS AND METHODS: We reviewed the pre- and post-therapeutic mammograms of 44 patients with stage III-breast carcinoma with regard to tumor characteristics and malignant calcifications and compared to histopathological results. RESULTS: Delineation of the tumor proved to be the most significant criterion. In 34 tumors more than 50% of the lesion was defined; these showed a high correlation between the mammographically determined tumor diameter and that determined on histopathological examination (r = 0.77). Less than 50% of the mass was definable in 14 tumors; here the correlation between mammographically and histopathologically determined tumor diameter was low (r = -0.19). CONCLUSIONS: The diagnostic value of mammography in the evaluation of tumor response to induction chemotherapy depends primarily on the extent to which the tumor can be delineated from the adjacent breast tissue. For tumors whose margins can be defined by more than 50% on the baseline mammogram, the diagnostic reliability of mammography is high. Ill-defined masses should preferably be assessed with other imaging procedures such as ultrasonography or magnetic resonance imaging.

Impact of hysteroscopy on disease-free survival in clinically stage I endometrial cancer patients.

Recent data strongly suggest tumor cell dissemination of endometrial carcinoma cells in the course of fluid hysteroscopy. In patients who had endometrial cancer which was (except for peritoneal cytology) confined to the uterus, the disease-free survival (DFS) of 135 patients who underwent hysteroscopy prior to staging laparotomy was compared with the DFS of 127 patients without hysteroscopy. After a median follow-up of 23 months, 10 patients experienced tumor recurrence. Although there was a trend towards a higher incidence of positive peritoneal cytology at laparotomy in patients who underwent hysteroscopy, this difference did not achieve statistical significance (P = 0.47). For 5 years, the DFS was 92.4% in patients with hysteroscopy and 84.7% in patients without hysteroscopy before laparotomy (log-rank, P = 0.782). Our data therefore suggest a similar short-term DFS in endometrial cancer patients with and without hysteroscopy prior to laparotomy.

CA 125 regression after two completed cycles of chemotherapy: lack of prediction for long-term survival in patients with advanced ovarian cancer.

The prognostic influence of CA 125 regression between the time point before surgery and after two completed courses of chemotherapy was studied in 210 patients with advanced ovarian cancer, and was compared to other well established prognostic factors. CA 125 blood samples were collected preoperatively (CA 125 pre) and 3 months after surgery (CA 125 3 mo) (at the beginning of the 3rd cycle of chemotherapy). The parameter CA 125 regression defined as log10 (CA 125 3 mo/CA 125 pre) was used for statistical analysis. In a survival analysis using a Cox proportional hazards model, CA 125 regression (P = 0.0001), residual tumour (P = 0.0001), age (P = 0.0095) and grading (P = 0.044) were independent variables, whereas stage of disease, histology, ascites and type of surgery failed to retain significance. Using log10 (CA 125 3 mo/CA 125 pre) as simple covariate in a Cox model showed a hazard ratio of 1.70 (95% confidence interval 1.32-2.19, P = 0.0001). However, a detailed analysis of the interaction of time with the prognostic factor CA 125 regression on survival revealed a strong time-dependent effect with a hazard ratio of more than 6 immediately after two courses of chemotherapy, whereas within approximately 1 year the hazard ratio for the surviving patients dropped quickly to the neutral level of 1. In summary, CA 125 regression is an independent prognostic factor for survival of women with advanced ovarian cancer and allows an identification of a high-risk population among patients with advanced ovarian cancer. However, the discriminating power of serial CA 125 for long-term survival seems to be temporary and prediction of individual patients outcome is far less precise.

Association between endometrial cancer and tamoxifen treatment of breast cancer.

A retrospective cohort-study in 4109 breast cancer patients was undertaken to determine how tamoxifen affected the risk of endometrial cancer. Data on 1701 tamoxifen-treated women were analysed. Two thousand four hundred and eight non-tamoxifen users served as control group. The occurrence of new primary uterine cancers was assessed by computerized linkage to the Austrian Cancer Registry. Twenty-five women who subsequently developed endometrial cancer were identified. Eight uterine cancers occurred in the tamoxifen group, whereas 17 uterine cancers were found in the control group. The estimate of the relative risk (RR) showed an increased risk to develop endometrial cancer for the tamoxifen group RR 1.136 (95% CI 0.71; 1.80). Analysis of relevant confounding variables did not show any differences in the two groups. In conclusion, this retrospective study demonstrated a non-significant increased risk of endometrial cancer in women receiving tamoxifen as treatment for breast cancer. However, the magnitude of RR and the absolute number of endometrial cancer cases in this long term observation demonstrate clearly that the clinical benefit of tamoxifen therapy greatly outweighs the risk.

Tumor flow in malignant breast tumors measured by Doppler ultrasound: an independent predictor of survival.

The purpose of this study was to investigate tumor blood flow in breast cancers with regard to its impact on the overall survival of patients. Tumor blood flow was assessed in seventy-four patients with primary breast cancer by the use of color-coded Doppler ultrasound techniques. Preoperatively obtained Doppler frequency spectra were analyzed for peak systolic flow velocity (Vmax). Color Doppler signals were detected in 71 (96%) of the breast tumors. Out of 74 patients, 17 experienced a relapse or distant metastasis, and 15 women had died due to breast cancer at the time of data analysis. The mean Vmax of the patients who had died was 0.27 m s(-1), whereas survivors showed a mean Vmax of 0.16 m s(-1) (p = 0.01). Vmax, nodal status, and progesterone receptor status remained the only significant factors of overall survival in the multivariate model, whereas tumor size, tumor grade, and estrogen receptor status failed to retain prognostic significance. Moreover, Vmax was identified as the most important prognostic marker for survival in our series. The five-year-survival was 82.3% in Vmax < or = 0.25 m s(-1) patients versus 36.6% in women with tumor flow greater than 0.25 m s(-1). Patients with Vmax > 0.25 m s(-1) experienced a 4.33-fold increased risk of death secondary to the underlying disease. In summary, our data showed that tumor blood flow velocity measured by ultrasonography is an independent prognostic factor of survival in breast cancer patients. Furthermore, tumor flow velocity allows identification of patients at very high risk of death due to breast cancer. Large scale clinical trials should evaluate the clinical usefulness and future impact of this procedure for adjuvant treatment decisions.

Endometrial cancer: accuracy of the finding of a well differentiated tumor at dilatation and curettage compared to the findings at subsequent hysterectomy.

The objective of this study was to examine the accuracy of the finding of a histologically well differentiated endometrial carcinoma at dilatation and curettage (D & C) prior to hysterectomy. A retrospective multicentric chart review of 137 endometrial cancer patients was conducted, including all patients in whom a well differentiated endometrial carcinoma had been diagnosed by D & C. Histopathologic grading as determined by D & C was compared with the grading established at the final histologic examination after hysterectomy. Seventy-eight percent of all cases in which a well differentiated tumor was diagnosed with D & C were confirmed as well differentiated endometrial carcinomas, whereas 20.4% had to be upgraded as moderately differentiated tumors after evaluation of the hysterectomy specimen. In one case in which a uterine adenocarcinoma was diagnosed by D & C, a well differentiated adenocarcinoma was found to be combined with a carcinosarcoma in the hysterectomy specimen. In order to avoid false findings of a well differentiated tumor, the histologic grade should be confirmed by intraoperative frozen section examination. This is especially important in cases in which surgical staging was not planned initially.

[Oral contraceptives and endometrial and ovarian carcinomas]. / "Pille" und Endometrium-sowie Ovarialkarzinome.

Combined oral contraceptives reduce the risk of endometrial and ovarian cancer by about 50%. The risk of both carcinomas decreases with an increasing duration of oral contraceptive use. The reduced risk lasts for 10-15 years after cessation. A significantly lower risk of developing an endometrial carcinoma can be observed for contraceptives with a high progestin and a low estrogen concentration. Due to the protective effect, the use of oral contraceptives is a useful means for primary prevention (chemoprevention) in women at high risk of endometrial and ovarian cancers.

PIP: Two studies published in the late 1980s indicated that combined oral contraceptives (OCs) reduced the risk of endometrial cancer by 50% and this reduced risk lasted up to 15 years after discontinuing the use of OCs. Reduced estrogen content decreased the risk (RR = 0.59) and increased progesterone content further decreased the risk (RR = 0.15). The highest protective effect was produced by preparations with the lowest estrogen and the highest progesterone content. A 1993 investigation conducted in Seattle revealed a risk reduction of 52% in postmenopausal women who had ever used OCs. However, if the OC use had started between 20 and 24 years of age, the RR increased to 2.71. A 1992 meta-analysis of 20 large studies involving women who had used combined OCs for more than one year showed a reduction of the risk of ovarian cancer by 36% (RR = 0.64). The risk was reduced by 11% per year of OC use. The use of OCs for more than 5 years reduced the risk by 54%. A linear reduction of the risk was found with the duration of OC use. More than 10 years of OC use provided a protective effect against ovarian cancer. Positive family history and nulliparity significantly increased the risk of ovarian cancer. A 1994 meta- analysis studied these factors on the genesis of ovarian cancer and found that OC use reduced the risk in all groups (risk, age, and duration of use) in about equal proportions. After 10 years of OC use, the risk was reduced to a level (RR = 0.37 and 0.44) that was below that of women not using OCs.

[Systematic classification of milk flow obstruction in cattle using endoscopic findings with special consideration of hidden teat injuries]. / Systematische Einteilung der Milchabflussstörungen des Rindes anhand endoskopischer Befunde unter besonderer Berücksichtigung der gedeckten Zitzenverletzungen.

Evaluation of clinical and endoscopic findings in 224 dairy cows, suffering from milk flow hindrance (MFH), led to a systematic categorization. Dairy cows of different age and race, being patients in the Ambulatorische und Geburtshilfliche Veterinärklinik der Justus-Liebig-Universität, Giessen, and the Tierärztliche Klinik Babenhausen, were used as probands. Just a small amount of animals (8.93%) showed causes for MFH that were inborn or non-traumatic, such as inflammations or foreign bodies. In the majority of cases (91.07%) covered teat lesions (CTL) were diagnosed as causes for MFH. The inner orifice of the papillar duct and the papillar duct itself were found to be the by far most frequent locations of traumatic insult, which was diagnosed as avulsion of the mucosa in 86.16% of cases. Minimal invasive endoscopy proved to be a valuable imaging modality to investigate, document and categorize the diverse alterations of the inner teat cistern lining. Basing on clinical and endoscopic findings, MFH is categorized systematically, paying special attention to CTL as its major cause, and illustrated by comparing endoscopic pictures of typical alterations and physiological findings.

Color-coded and spectral Doppler flow in breast carcinomas--relationship with the tumor microvasculature.

The phenomenon of tumor angiogenesis is an important aspect of understanding tumor biology. Studies in breast carcinoma have shown microvessel density (MVD) assessed by immunohistochemistry to be of prognostic importance in primary breast cancer. On the other hand, recently developed highly sensitive color-coded Doppler techniques offer a noninvasive method to examine neovascularisation in breast tumors. The purpose of this study was to determine the relationship between Doppler flow parameters and microvessel count assessed by immunohistochemistry. Fifty-three patients with primary breast cancer were examined preoperatively with color-coded Doppler ultrasound. The obtained Doppler frequency spectra were analyzed for peak systolic flow velocity (Vmax). Following surgery, paraffin-embedded microsections were immunohistochemically stained for factor VIII-related antigen. Tumor angiogenesis was assessed by microvessel count under light microscopy. Undifferentiated tumors correlated with high MVD (p=0.009) whereas other clinicopathological parameters were not associated with MVD. Color Doppler signals were detected in 50 out of 53 breast tumors. Evaluation of tumor flow velocity with various clinicopathological parameters showed a significant correlation with tumor size (p=0.0001) and lymph node metastasis (p=0.02). However, there was no significant correlation between MVD and intratumoral blood flow velocity assessed by color-coded Doppler. Our findings showed that Doppler flow measurement did not correlate with the extent of tumor angiogenesis of breast cancer. The present data give circumstantial evidence that microvessel count assessed by immunohistochemistry reflects the microvascular network, whereas tumor vasculature documented by Doppler ultrasound supplies information on the macrovasculature.

TATI (tumor associated trypsin inhibitor) and cancer antigen 125 (CA 125) in patients with early-stage endometrial cancer.

BACKGROUND: In patients with gynecologic malignancies, a 6 kD polypeptide known as the tumor-associated trypsin inhibitor (TATI) is present in high concentrations, both in the urine and the serum. This study attempts to evaluate the usefulness of pretreatment serum levels of TATI (cutoff level 21 ng ml-1) and CA 125 (cutoff levels 35 U ml-1 and 65 U ml-1) in the prediction of early endometrial cancer. PATIENTS AND METHODS: One hundred twenty-seven patients with stage I and II endometrial carcinomas, 110 healthy women and 258 women with benign pelvic pathologies were evaluated. The data obtained were correlated with the tumor stage and tumor grade. RESULTS: Overall, TATI showed a sensitivity of 31% and a specificity of 81%. The sensitivity and specificity of CA 125 > 35 U ml-1 was 25% and 86%, respectively. When both serum tumor markers were combined the sensitivity increased to 48% (CA 125 > 35 U ml-1), with a specificity of 71%. A correlation with the depth of myometrial infiltration was found for neither of the tumor markers under investigation. In addition, neither TATI nor CA 125 correlated well with tumor grade. The combination of TATI and CA 125 had a high positive predictive value (84%) when no other gynecologic pathologies were present. Furthermore, if TATI and CA 125 levels are within normal ranges and gynecological examination does not show other abnormalities besides vaginal bleeding, endometrial carcinoma appears to be very unlikely. CONCLUSION: We concluded that, while TATI and CA 125 may not be recommended as a screening method for the detection of endometrial cancer, the combination of TATI and CA 125 is a valuable additional tool for further evaluation of women with suspected uterine cancer.

Erythropoietin treatment under polychemotherapy in patients with gynecologic malignancies: a prospective, randomized, double-blind placebo-controlled multicenter study.

In order to examine the influence of erythropoietin (rHuEPO) on serum hemoglobin levels, transfusion requirements, and quality of life in patients with gynecologic malignancies under polychemotherapy and chronic tumor anemia (hemoglobin <11 g/dl), we performed a prospective, randomized, double-blinded placebo-controlled clinical trial. Between October 1992 and October 1993, 35 patients from 5 gynecologic departments were entered into this trial. Inclusion criteria were hemoglobin level <11 g/dl, ferritin level >29 ng/ml, stool negative for occult blood, and life expectancy for more than 3 months. Patients received either 150 U/kg body wt rHuEPO (Erypo by Cilag-Janssen) sc three times a week for 12 weeks (n = 23) or a placebo (n = 12). If the hemoglobin levels of the 4th, 8th, or 12th week were >2 g/dl above the baseline value and/or >12 g/dl, the patient was classified as a responder. Patients who required blood transfusions (hemoglobin <8 g/dl, erythrocytes <3 x 10(6)/ml, or clinical symptoms of anemia) were classified as nonresponders. A nonvalidated quality of life questionnaire was completed by the patient at the beginning of the treatment and then every fourth week before receiving chemotherapy. In the rHuEPO group 56.6% of the patients responded to the treatment (chi2 = 10.79, P = 0.001) and only 5 patients (21.7%) required blood transfusions, whereas 8 of 12 patients in the placebo group (66.6%) had to be transfused (chi2 = 6.81, P = 0.009). Quality of life did not differ significantly between the rHuEPO group and the placebo group of patients. Within the rHuEPO group those patients that responded showed a significant increase in physical activity after response in comparison to the preresponsive phase (P = 0.02, paired t test). We therefore concluded that rHuEPO significantly increases serum hemoglobin levels and decreases transfusions requirements while maintaining quality of life in patients with gynecological malignancies who are undergoing polychemotherapy.