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Objective: To report our experience of abdominal wall closure using a running mass suture of looped #1 polydioxanone in a high-risk patient group and reviewing the current literature. Methods: Between August 1999 and March 2002, 149 patients undergoing major gynecological surgery by the gynecology oncology service had abdominal wall closure with a single No. 1 looped polydioxanone II suture. Running mass closure with linearly (equally) spaced bites was performed on all patients. A single knot was used to secure the suture. The study population was considered high-risk because most patients had a gynecological cancer or were obese. Results: One fascial dehiscence with evisceration occurred in the study group. This patient coughed uncontrollably after undergoing a postoperative cardiac catheterization. The suture was intact but the tissue was torn along the entire length of the wound. Two incisional hernias were found in the study group with a follow-up of 6-36 months. Conclusion: Our case series reconfirms...

Purpose. A multicenter Phase II trial was conducted to evaluate the activity and toxicity of gemcitabine in patients with previously treated squamous cell carcinoma of the uterine cervix. Patients and methods. Patients were required to have measurable disease with adequate performance status, bone marrow, hepatic, and renal function. Histologic confirmation of the primary diagnosis as squamous cell cancer of the uterine cervix was mandatory. Patients were allowed one prior chemotherapy regimen, usually cisplatin-based. The initial dose of gemcitabine was 800 mg/m 2 weekly times three with 1 week off until progressive disease or adverse effects prohibited further therapy. Doses were escalated or reduced based on previous cycle toxicity. Results. Twenty-seven patients were entered into the trial. One patient never received the drug and 1 patient was inevaluable for response. A median of two cycles were administered to each patient (range: 1–7 cycles). The overall response rate (two partial responses) was 8% with 21% of patients having stable disease. The median progression-free interval was 1.9 months (range: 0.5–9.0) and overall survival was 4.9 months (range: 1.5–16.3). Two patients had grade 4 neutropenia; 1 patient had grade 4 anemia. The median WBC nadir in the 13 patients experiencing any leukopenia was 2300/μl (range: 400–3800). There was only one episode of grade 4 gastrointestinal toxicity. Conclusions. Gemcitabine as a single agent demonstrated minimal antitumor activity in previously treated patients with squamous cell cancer of the uterine cervix. Since gemcitabine in the dose and schedule employed is known to potentiate the cytotoxicity of cisplatin and radiotherapy (the current standard therapies for this disease), further development of gemcitabine would only be indicated in combination with these treatment modalities.

Objective. The aims of this study were to assess the early and late toxicities of multiple-daily-fraction whole pelvic radiation plus concurrent chemotherapy with either hydroxyurea or 5-fluorouracil (5-FU)/cisplatin and to determine the maximum tolerated external radiation dose in conjunction with brachytherapy, when given with either of these drug regimens, as treatment for locally advanced carcinoma of the cervix. Methods. The first study (GOG 8801) of 38 patients utilized hydroxyurea as a single oral dose of 80 mg/kg to a maximum of 6 g at least 2 h prior to a radiation treatment twice every week. In the second study (GOG 8901) of 30 patients, cisplatin and 5-FU were used concomitantly with radiotherapy. Fifty milligrams per square meter of cisplatin was administered on days 1 and 17 of external radiation. 5-FU was given by continuous intravenous infusion at a dose of 1000 mg/m 2 /day for 4 consecutive days on days 2, 3, 4, 5, and 18, 19, 20, and 21 of external radiation therapy. Both studies utilized external radiation given by an accelerated hyperfractionated regimen of 1.2 Gy per fraction, two fractions per day. All patients were treated 5 days per week with a minimum of 4 h between fractions. Results. Acute toxicity was manageable on both protocols but nausea, vomiting, and myelosuppression were more severe with hydroxyurea. Chronic toxicity was primarily enteric and appeared to be dose-related. There was no obvious correlation seen between pelvic failure rates and the radiation dose or between the chemotherapy regimens used. Conclusions. The defined maximal tolerated dose of whole pelvic radiation was 57.6 Gy in 48 fractions which could be delivered in a hyperfractionated setting with concomitant chemotherapy, followed by brachytherapy. Follow-up is now sufficient that further adverse events should be rare.

It was shown that infertility and its treatment constitute a stressful experience for women, reflected particularly in disturbing intrusive ideation about the stress source. Infertility patients reported levels of intrusive ideation significantly higher than routine gynecologic patients and not significantly different from levels of psychiatric outpatients being treated for stress reactions to traumatic events. Intrusive ideation also predicted the degree of self-reported infertility-specific distress and dysfunction, further clarifying the key role of such ideation in the experience. Finally, as hypothesized, the frustration level of the treatment experience (as indexed by the number of infertility treatment methods attempted) predicted avoidant ideation. Implications for managing the psychological distress and disruption associated with the infertility treatment experience were discussed.

We explored the interaction effects of individual attentional style (high versus low monitoring) and the framing of informational messages on the responses of women undergoing diagnostic follow-up (colposcopy) for precancerous cervical lesions. Prior to the colposcopic procedure, patients (N=76) were randomly assigned to one of three preparatory conditions: (a) Loss-framed message, which emphasized the cost of nonadherence to screening recommendations; (b) Gain-framed message, which emphasized the benefit of adherence; and (c) Neutrally-framed message. It was hypothesized that low monitors (who are more positively biased about their health) would show a more adaptive pattern of response to loss-framed information than high monitors (who are more negatively biased about their health). The results of a series of hierarchical multiple regression analyses were consistent with this prediction. Low monitoring was associated with greater knowledge retention (beta=.61, p.05) and less canceling/rescheduling of follow-up appointments in the loss condition than in the neutral condition (beta=.82, p.002). High monitoring, however, was associated with greater intrusive ideation when information was presented in the loss-oriented frame as compared to the neutral frame (beta=.99, p.01). Knowledge retention and screening adherence were not affected by the framing manipulation. The differences between high versus low monitors as a function of loss or neutral frame suggest an interaction effect, wherein both the type of framing message and the individual's attentional style lead to distinctive cognitive-affective and behavioral patterns. The findings may have clinical implications for the tailoring of health messages to the individual's signature style.

This study reviews 148 patients colposcoped in 1986 in the practice of the principal investigator. An attempt was made to biopsy the cervix, vagina, and vulva of all patients. Of the total of 148 patients, 11 had prior hysterectomies and 6 others had no biopsies. Of the remaining 131 patients, 82 patients (62.6%) had biopsies of all three areas, 35 (26.7%) had two areas biopsied, and 14 (10.7%) had only one area biopsied. Of the group that had three biopsies, 48.8% demonstrated HPV infection involving the cervix, vagina, and vulva synchronously, 24.4% had HPV infection in two of three areas, and 20.7% had HPV documented in only one area. Of the 35 patients who had only two biopsies performed, results were similar—62.9% had both areas involved, and 25.7% had only one of two area involvement. The total number of patients with HPV infections involving two or more sites was 82, 62.6% of the total of 131 patients evaluated and 70.1% of the patients with two or more biopsies performed. This study confi...

The purpose of this study was to examine the relationship between avoidant and intrusive ideation about cancer risk and immune responses among women with mild cervical dysplasia. Participants were 54 women undergoing diagnostic follow-up (i.e. colposcopy) for an abnormal Pap smear test result. Baseline assessments, collected prior to the colposcopy appointment, included demographic and medical history, levels of depression, and the intrusion and avoidance subscales of the Revised Impact of Events Scale. In addition, a sample of blood was obtained at baseline and 6-month follow-up for immune assessments. Hierarchical regression analyses revealed that higher levels of cognitive and behavioral avoidance at baseline predicted a significantly lower percentage of circulating cytotoxic/suppressor T cells (CD3+/CD8+) at 6-month follow-up, after controlling for baseline levels of cytotoxic/suppressor T cells and potential confounding variables (e.g. age, smoking status). Baseline intrusive ideation was unrelated to changes in percentage of cytotoxic/suppressor T cells. Avoidant ideation, but not intrusive ideation or depression, appears to be associated with alterations in immunologic measures in women with cervical lesions. The findings suggest that it may be important to evaluate the impact of cognitive and behavioral avoidance on progression of precancerous cervical lesions. Copyright © 2003 John Wiley & Sons, Ltd.

Objective The purpose of this study was to investigate whether subjective sleep quality is more strongly associated with immunocompetence than depression among women at risk for cervical cancer. Methods Participants were 91 women referred for colposcopy because of abnormal results on a Pap smear. On the day of the procedure. participants completed the Center for Epidemiological Studies Depression Scale, two indices of subjective sleep quality (ie, satisfaction with sleep obtained and degree of sleep restfulness), and a health behaviors assessment questionnaire. Levels of peripheral blood lymphocyte subpopulations (helper T, cytotoxic/suppressor T, NK, and B cells) were also assessed at this time. Approximately 10 days later, the presence of depressive disorder was assessed using the Structured Clinical Interview for DSM-III-R. Results Hierarchical regression analyses revealed that satisfaction with the amount of sleep obtained was significantly associated with the circulating number and percentage of helper T cells (T(H)/CD4+) and the percentage of cytotoxic/suppressor T cells (T(C)/CD8+), after controlling for confounder variables (ie, age, smoking status, and drug use). Depression was significantly associated only with the percentage of T(C) cells. Sleep satisfaction remained significantly associated with the number and percentage of T(H) cells and percentage of T(C) cells after controlling for the variance explained by depression. Conclusions Results of this study suggest that subjective sleep quality shares a significant and independent portion of the variance with immunity that is not accounted for by depression. Although the long-term impact of these immune alterations on disease progression needs to be directly explored, it may be important to systematically screen for and manage sleep disturbance in women at high risk for cervical cancer.

We report the case of a 77-year-old white female with adenoid cystic carcinoma of Bartholin's gland. To date only 45 cases of adenoid cystic carcinoma of Bartholin's gland have been reported in the world literature. The longest reported survival is 27 years. This patient was originally diagnosed 33 years ago and presented with her fourth recurrence. She was treated with radical surgery and did well for 6 months, but later died secondary to renal failure. Adenoid cystic carcinoma of the Bartholin's gland is a rare tumor of the vulva. When diagnosed the treatment should be tailored to the patient. When margins are found to be positive, adjuvant radiotherapy may prove to be beneficial.

Dianhydrogalactitol was administered intravenously to patients with advanced or recurrent gynecologic malignancies on a weekly schedule. The initial dosage was 60 mg/m2 with escalation to 75 mg/m2 if there were no adverse effects. Forty-two patients with ovarian epithelial adenocarcinoma (OEA) and forty-one patients with squamous carcinoma of the cervix (SCC) were entered into this study. Of these, 39 patients with OEA and 36 with SCC were evaluable for toxicity and response. Seven patients (19.4%) with SCC had an objective response, while six patients (15.4%) with OEA had an objective response. Adverse effects were frequent but tolerable. There were no drug-related deaths, and only two patients suffered life-threatening hematologic toxicity. Myelosuppression was observed more frequently among the patients with OEA. A higher percentage of OEA patients had received prior chemotherapy. The level of activity and frequency of adverse effects observed at this dose schedule warrant further studies of this drug in these two tumors.

Thirteen patients with a variety of advanced gynecologic malignancies were administered BCG via the dorsal lymphatics of the lower extremity in addition to standard accepted forms of therapy. Prolonged febrile courses, lymphangitis and suppurative adenitis were observed along the lymphatic pathway of the injected lower limbs. There was no correlation between reaction to a standard anergy panel and survival. There was also no correlation between reaction to a standard anergy panel and the inflammatory response to intralymphatic BCG (ILP-BCG). There was, however, a positive correlation between the inflammatory response to ILP-BCG and survival. Intralymphatic administration of immunostimulants may conceivably be of value as ancillary therapy for use in gynecologic malignancy. However, complications of this approach to immunotherapy are significant and the method should not be used until complications are decreased.

Since the route of administration of BCG may have an important function in immunotherapy, we investigated intralymphatic administration to direct BCG to the lymph nodes. Multiple injections of high doses of BCG were administered to 6 rhesus monkeys via the dorsal lymphatics of the lower limb. A suppurative lymphadenitis was observed along the lower limb and in the inguinal area in 5 of the 6 monkeys. However, many of the complications reported with other routes of administration were not observed. Granulomatous reactions and histiocytic responses developed in lymph nodes on the injected sides of the pelvis and distant nodes as well as in the liver. The intralymphatic route is the method by which high doses of nonspecific immunostimulants were delivered to regional lymph nodes. The efficacy of this approach remains to be established in tumor-bearing animals and humans.

One hundred endometrium specimens have been studied with flow cytometry for DNA analysis (FCDA) and a proliferative enzyme marker, 5′-nucleotide phosphodiesterase (5′-NPD). FCDA data showed that aneuploidy was present in only 5 of 40 cancer specimens. However, with corrected histograms, a higher DNA value was observed in the G2/M (6%) of all cancer compared with noncancer specimens (4%). Thus, FCDA can be a useful diagnostic aid for endometrial cancer. The determination of 5′-NPD was done with a quenching method based on the use of 5′-(5-iodo-3-indoxyl)-thymidine phosphodiester as a substrate and 4′,6-diamidino-2-phenylindole for DNA. This method could qualitatively define which population of the cell cycle had a higher enzyme level and also quantitatively gave the enzyme units per cell. It was found that 12.5% of all cancer specimens had 5′-NPD activity in the G0/G1 cells and 87.5% in the S and/ or G2/M cells, whereas in the noncancer specimens 5′-NPD was found in 28.5% of the G0/C1 cells and 71.5% of the specimens had 5′-NPD in the S and/or G2/M cells. Furthermore, the concentration of 5′-NPD was found to be five times higher in the G2/M cells of the cancer specimens than that in the noncancer specimens. However, in the hyperplasia specimens, the activity was only two times higher in the same cell cycle fraction than in the normal specimens. The results of this investigation provided for the first time evidence that this exonuclease activity alters in the cell cycle fractions and that a decrease in the enzyme activity in G0/G1 cells and an increase in G2/M cells may be a useful marker for neoplastic development in human endometrial cancer.

The physician population delivering obstetric care in Philadelphia between 1950 and 1970 was contacted to ascertain their use of diethylstilbesterol (DES) during pregnancy. Of the 31.8% of the physicians who responded to the questionnaire, 71.8% used DES during pregnancy and 12.7% desired assistance in review of their records. During the 6 years from the initial survey, 830 young women exposed to DES in utero were periodically screened for cervicovaginal abnormalities and clear cell adenocarcinoma. Of these 830 patients 61.7% were found to have cervicovaginal abnormalities, and 65.9% of the patients showed either adenosis or evidence of the prior existence of vaginal adenosis. Eight patients were treated for clear cell adenocarcinoma. Two cases were detected while asymptomatic. Seven of the patients are living with no evidence of cancer, and two of these have survived over 5 years.A project, designed to locate the population at risk to diethylstilbestrol (DES) exposure in utero in the greater Philadelphia area from 1950-1970, was implemented by contacting area physicians who might have used the drug in their practices on pregnant women. 216 (31.8%) physicians responded to the questionaire; 155 (71.8%) responded that they had used DES. During the 6 years from initial survey, 830 young women exposed to DES in utero were periodically screened for cervicovaginal abnormalities and clear cell adenocarcinoma. Gross structural cervicovaginal abnormalities were found in 512 (61.7%) of the individuals evaluated. In 38 patients, vaginal adenosis existing alone was documented. In another 279 patients, metaplasia alone was noted in the vagina, and in another 230 patients, both metaplasia and adenosis coexisting in varying degrees were found. Thus, 547 (65.9%) showed either adenosis or evidence of the prior existence of vaginal adenosis. 8 patients with clear cell adenocarcinoma of the vagina or cervix were seen; each individual was born during the decade of the 1950s. 2 cases were detected while asymptomatic; 7 of the patients are living with no evidence of cancer, and 2 of these have survived over 5 years. These results showed a much lower incidence of significant dysplastic squamous changes (1.1%) than that of earlier reports, emphasizing the subjective element of earlier, more alarming reports.

After hysterectomy, 156 evaluable patients with stage I (limited to the corpus) or stage II (limited to the corpus and cervix) uterine sarcomas were randomly assigned to adjuvant chemotherapy with Adriamycin (Adria Laboratories, Columbus, Ohio) for six months or to no further treatment. Pelvic irradiation (external or intracavitary) was optional before randomization. Of 75 patients receiving Adriamycin, 31 have suffered recurrences compared with 43 of 81 receiving no adjuvant chemotherapy. This difference is not statistically significant. Moreover, there is no difference in progression-free interval or survival. The optional radiotherapy did not influence the outcome although there was a suggestion that vaginal recurrence was decreased by pelvic radiotherapy. The recurrence rates in specific cell types (leiomyosarcoma, homologous mixed mesodermal sarcoma, or heterologous mixed mesodermal sarcoma) were not significantly different although the pattern of recurrence differed, with pulmonary metastases being more common in leiomyosarcoma and extrapulmonary recurrence being more common in mixed mesodermal sarcoma. The outcome with respect to chemotherapy was not altered even after adjusting for maldistribution of cases. Thus, we could not show a benefit for this dose schedule of Adriamycin as adjuvant treatment for uterine sarcomas.

Flow cytometric DNA analysis data (FCDA) were obtained from 324 samples provided through the Gynecology-Oncology Clinic. These samples consisted of 294 combined endoectocervical and vaginal smears and 30 peritoneal washings. Using a conventional scheme for G0/G1, S + G2/M and the coefficient of variation with computer correction for the cell-cycle kinetics, it was possible to assign a diagnostic Class I, II, III or V similar to that used by the Cytology Laboratory. These data were then compared with the histopathologic and colposcopic diagnoses. The correlation between FCDA and cytologic results were essentially similar to the previous data obtained from only endocervical sampling. The most interesting finding in this study was the recognition of an FCDA pattern showing a higher DNA content in the G0/G1 and the early S regions in 70 of 94 (74.5%) of samples from patients with condyloma acuminata. All condyloma samples were diagnosed either by cytologic, histopathologic, or colposcopic examination, or a combination of two or three. All biopsy specimens were then reviewed by one pathologist to verify any discrepancies. The relationship of this pattern to the viral etiology of this disease is discussed with the three methods of diagnosis and electron microscopic observations. It is suggested that, based on this study. FCDA analysis of pap smears may also be useful in determining the presence of condyloma in a gynecology clinic. The potential value of FCDA analysis from peritoneal washings for the diagnosis of gynecologic cancer can not be ascertained in this preliminary investigation because of insufficient samples.

A total of 246 endocervical samples were collected for Papanicolaou staining and one-parameter flow cytometric DNA analysis (FCDA) using 4′,6-diamidino-2-phenylindole as a DNA stain. Typical histograms derived from FCDA analysis were designated class I, II, III, and V. Two groups of patients were studied: 135 women referred for colposcopy (COLPO), and 79 women exposed to diethylstilbestrol (DES). The remaining 32 samples were evaluated and found unsatisfactory. In the colposcopy group FCDA assigned 38 patients normal, 62 mild to moderate dysplasia, 33 moderate to severe dysplasia, and 2 carcinoma in situ and invasive carcinoma. Agreement of Pap smear and FCDA occurred in 56, 59, 72, and 100%, respectively. In the diethylstilbestrol group 57 patients were normal and 12 had mild to moderate dysplasia according to Pap diagnosis. Agreement between FCDA and Pap diagnosis were 45 and 58%, respectively. However, FCDA did not falsely assign severe dysplasia or carcinoma in situ to any DES patient. This preliminary study based on FCDA appears to clearly differentiate patients with normal Pap smears from those patients with invasive cancer.

Of 265 patients accessioned to a study of microinvasive carcinoma of the cervix by participating institutions in the Gynecologic Oncology Group, 132 were rejected after preliminary review because of no evidence of invasion (99 patients), invasion in excess of 5 mm. (18 patients), inadequate conization (nine patients), and protocol violations (six patients). The data available for the 133 evaluable patients included clinical patient information, operative reports, narrative pathology reports, and microscopic slides. Tumor penetration was less than 2 mm. in 90 patients (67.5 per cent) and greater than 3 mm. in 21 patients (16 per cent). Lateral tumor extension was less than 4 mm. in 76 patients (57 per cent) and wider than 8 mm. in 29 patients (22 per cent). Extensive lateral spread was observed more frequently than deep penetration. Positive correlation was noted between the depth of penetration and lateral extension. Capillary-like space invasion by tumor was noted in 31 cases (23 per cent) and increased with depth of penetration. Lack of tumor differentiation occurred in patients with less than 1 mm. penetration more frequently than in those with deep penetration. A confluent pattern of tumor was observed more frequently with advanced depth of penetration and greater lateral spread. There was a strong correlation with residual tumor on hysterectomy specimen and capillary-like (CL) space involvement with deep stromal penetration and extensive lateral spread. No positive lymph nodes were observed in the 74 patients treated by radical hysterectomy and recurrence was noted in two patients with extensive CL space involvement. Conization specimens with surgical margins involved with cancer are inadequate for diagnosis of microinvasion and constitute a clear indication for management as a frankly invasive lesion. Simple hysterectomy may be the mode of therapy in patients with questionable invasion, with invasion less than 2 mm. in depth and 4 mm. in width, and without evidence of CL space invasion. Such conservative treatment is unwarranted if the conization margin is inadequate, if the margins are not clear, if invasion is deeper than 2 mm., if lateral spread is greater than 4 mm., or if tumor is present in the CL spaces.

This is a study of 243 radical hysterectomy and pelvic lymphadenectomy procedures performed for gynecologic malignancy. The term “problem” radical hysterectomy was applied to those patients with one of the following conditions: (1) recent cervical conization (within 21 days), (2) previous total or supravaginal hysterectomy, (3) pregnancy, or (4) previous pelvic radiation. There were 88 patients in these categories. One hundred and fifty-five patients had none of these predisposing problems which might influence operative or postoperative complications. There were two deaths (0.82 per cent). There was no statistically significant difference in operative injuries to the bladder, ureters, or rectum or in the mean operative time and mean blood loss across the categories. However, there was a statistically significant difference across the categories in postoperative complications, both major and minor. The greatest incidence of such complications occurred in patients who had previous radiation therapy and the second greatest incidence was in patients who had recent cervical conization. Pregnant patients had the least number of complications.

Eighty-five patients underwent a surgical staging procedure during a 2-year period. Fifty-eight of these patients were evaluated in relation to the histologic grade of their squamous carcinoma of the cervix. An increased incidence of extrapelvic lymph node metastasis is associated with poorly differentiated tumors and with parametrial extension of the primary tumor regardless of histologic grade. Surgical staging is suggested for patients with parametrial extension of their tumor or for patients with poorly differentiated tumors.

Thirty-six patients with primary ovarian carcinoma who had 42 second-look procedures performed are reported. Twenty-three patients had no tumor found at the second-look celiotomy and were given no further treatment. Thirteen patients had tumor at the second-look procedure and were continued on therapy. Six patients have died with disease and all had a positive second-look celiotomy. Two patients have died with leukemia but with no evidence of ovarian cancer, one after a negative second-look and the other a negative third-look. No patient with a negative second-look celiotomy has died with disease. A correlation with respect to the findings at the second-look was found with respect to the stage of disease and the amount of residual tumor at the initial surgery. The use of the second-look celiotomy in patients with disease in the early stages and in patients treated with irradiation is discussed, along with the utilization of the laparoscopy.

Thirty-one patients with advanced squamous cell carcinoma of the cervix were entered onto this phase II study evaluating the efficacy of ICRF-159 (razoxane). Three of these patients were excluded; one had no tumor, one had a second primary, and one received no therapy. ICRF-159 was administered orally at a dose of 2.5 g/m2 weekly until progression, unacceptable toxicity, or death. Adverse effects were primarily hematologic in nature. Twenty-three of the 28 patients exhibited leukopenia which in ten instances was severe (below 2000/mm3). Seven cases had thrombocytopenia (one case below 50,000/mm3). Other toxicity, including fever and anorexia, was mild to moderate. There was tumor response in five (18%) patients (one CR, four PRs) ranging from 1 to 5 months. Fifteen patients with stable disease and eight with progressive disease had a median survival duration of 3.8+ and 3.5+ months, respectively. ICRF-159 showed limited activity in this patient population. However, it might be considered for combination with other low myelosuppressive agents.

The nomenclature of the lymph node groups draining the pelvic organs has been poorly standardized. This has impaired understanding of the natural history of gynecologic malignancies and led to difficulties in communication among specialists treating those diseases. In order to assess the extent of this problem, members of the Society of Gynecologic Oncologists and other physicians treating pelvic malignancy were asked to label a diagram of the pelvic lymph nodes. The lack of uniformity in the answers confirms the need for a simple, clinically relevant system of nomenclature. Such a system is proposed.

Estrogen binding in endometrial tissue of various hormonal conditions was compared by a quantitative dextran-coated charcoal assay. The amount of [ 3 H]E 2 bound to cytosol in vitro was expressed as fmole/ μ g DNA and fmole/mg protein. The highest values were obtained for proliferative endometrium (1.95 ± 0.45; 244.06 ± 38.99). Endometrium from patients on oral contraceptives had low levels of estrogen receptor, which was slightly higher than that of atrophic endometrium. Various endometrial lesions were examined. The most consistent results were found for areas of hyperplastic endometrium (1.51 ± 0.41; 138.88 ± 3.43). Seventeen cases of endometrial adenocarcinoma plus one case of endocervical adenosquamous carcinoma can be divided into three groups. One-third showed no detectable estrogen binding, one group of seven patients showed low values, and a third group of five patients had high concentrations of estrogen receptors.

Because certain proteolytic enzymes are thought to be released by malignant cells, we have measured the activity of cathepsin B in the urine samples of 57 patients with gynecologic malignancies and 60 disease-free controls. A unit (U) of enzyme activity is the release of one n-mol of 7-amino-4-fluoromethylcoumarin (AFC) from BZ-val-lys-lys-arg-MNA min-1 ml-1. Units of activity in the malignant group (10.6 +/- 9.8) differed significantly (p less than 0.0001) from controls (2.8 +/- 3.3). Although enzyme activity in both groups correlated with increasing age, the difference between those subjects with malignancies and those with none remained significant (p = 0.049) by analysis of covariance after adjusting for age. There was no correlation between titers and the race or weight of the subjects in either group. Enzyme activity of subjects with malignant disease correlated (p = 0.003) with the clinical stage of disease. Optimum sensitivity and specificity as determined by Receiver Operator Characteristic Analysis with an upper normal level of 5 U were 84.2% and 86.7%, respectively. Our findings suggest that measurement of urinary cathepsin B might be useful in detecting and managing patients with gynecologic tumors.

From 1960 to 1979 there were a total of 14 patients followed at the University of Pennsylvania with early cervical carcinoma who had histologically documented metastases to the para-aortic nodes and who were treated with extended-field radiotherapy. Thirteen of these patients were stage IB and one was stage IIA. All patients underwent exploratory laparotomy and lymph node dissection, followed by extended-field radiotherapy. Six patients are alive with NED for greater than 5 years; one patient is alive with NED at 3 years. An additional patient is now alive and well almost 3 years from a biopsy documented recurrence treated with chemotherapy, and 6 years from initial diagnosis. Thus 8 of 14 patients have enjoyed a long-term survival. Five patients experienced severe treatment-related morbidity. Two had long-term survival, two died of disease, and one died of radiation complications with NED on autopsy. Each of the six patients that died of disease had recurrences at distant sites. One also had a pelvic recurrence. These patients appear to have a prognosis quite different from that of patients with locally advanced cervical cancer metastatic to the para-aortic nodes and deserve aggressive treatment. The need for adjuvant systemic therapy is stressed.

Activities of selected hydrolytic enzymes were assessed in blind-coded sera of 121 women with invasive cancer of various organs. Acetylglucosaminidase, β-glucuronidase, and alkaline phosphatases were not markedly elevated above controls. In contrast, cathepsin B1-like (CB1) activity in sera before therapy averaged 45-fold greater than that of 56 normal controls ( P P P

This study compares the effectiveness of various routes of administration of Bacillus Calmette-Guerin (BCG) utilizing the New Zealand white (NZW) rabbit V2 carcinoma model. The routes compared were intratumor, intravenous, scarification, subcutaneous, and intralymphatic. Primary tumor regression, disease-free interval, and survival were measured. The disease-free interval and survival for the intralymphatic group were significantly longer (p less than 0.05) than all groups except the scarification group. That group had a prolonged survival as compared with all groups except the intralymphatic group. The intralymphatic route of administration was the most effective method in causing local tumor regression and curtailing metastasis. This study clearly demonstrates that the intralymphatic route requires further mechanistic studies and clinical investigation as a means for delivering biological response modifiers.

The average postoperative stay for 45 patients undergoing radical vulvectomy with femoral and inguinal lymphadenectomy was 37 days. Five patients were treated with oral zinc sulfate for at least 7 days prior to surgery. The incidence of wound infection was decreased, and the average postoperative stay was reduced to 18 days.