Larry E. Puls

Transition from benign to malignant epithelium in mucinous and serous ovarian cystadenocarcinoma

The slides of all patients with ovarian cystadenocarcinoma treated at the University of Kentucky Medical Center from 1966-1990 were reviewed. Fifty-four serous tumors and 42 mucinous neoplasms were identified for further study. Benign epithelium adjacent to an area of borderline or malignant epithelium was observed in 74 tumors (79%) and a site of epithelial transition was noted in 38 cases (40%). The presence of associated benign epithelium was more common in borderline or well-differentiated lesions and in patients with early-stage disease. These findings are consistent with epidemiologic and molecular genetic data and suggest that certain benign serous or mucinous ovarian tumors have the potential for malignant transformation. Removal of these tumors, particularly in postmenopausal women, should result in a subsequent reduction in the frequency of ovarian cancer.

Ovarian cancer screening in asymptomatic postmenopausal women by transvaginal sonography

From November 1987 to January 1991, 1300 postmenopausal women underwent screening with transvaginal sonography (TVS). Women eligible for screening were all asymptomatic with no known ovarian tumors. Ovarian volume was calculated using the prolate ellipsoid formula, and a value in excess of 8.0 cm3 was considered abnormal. Ovarian abnormalities were detected in 33 women (2.5%), and 27 underwent exploratory laparotomy. Ovarian tumors were noted in all 27 patients, including 2 primary carcinomas and 14 serous cystadenomas. The two women with ovarian carcinomas had normal results of pelvic examinations and normal serum CA‐125 levels. Both women had Stage I disease, and are alive and well after conventional therapy. TVS was time efficient, easy to perform, and well‐accepted by patients. Currently, there are more than 3000 patient years of follow‐up in the screened population, and there have been no deaths due to ovarian cancer. A multi‐institutional trial to determine the efficacy of TVS as a screening method for ovarian cancer is indicated.

Endometrioid carcinoma of the ovary and endometriosis: The association in postmenopausal women☆

Histologic material from 42 patients with endometrioid carcinomas of the ovary was reviewed. Ovarian endometriosis was present in 11 cases (26%) and 8 of these patients were postmenopausal. The exact site of transition from benign to malignant epithelium was observed in 4 cases. The clinical characteristics of patients with associated endometriosis were not significantly different from those without this finding except that endometriosis was present only in patients with Grade 1 or Grade 2 carcinomas. These data suggest that ovarian endometriosis in the postmenopausal patient has the potential to undergo malignant transformation and, when detected, should be removed surgically.

Confirmatory chest radiographs after central line placement: Are they warranted?

Objectives This study was designed to determine the ability of physicians to predict complications associated with the placement of central venous access devices and to decide whether a confirmatory chest radiograph is warranted after placement. Methods Patients receiving central venous access on an inpatient and outpatient gynecologic oncology service were studied. Data were collected regarding patient demographics, patient history, procedural details of the placement, and the type of catheter used. The physician then predicted which patients had a reasonable potential for placement complications. All of the patients then underwent radiography, which was then compared with the original prediction. Results Ninety-eight patients who had central venous access devices placed were included in the study. Eighty of the 81 central lines thought by the practitioner to have been placed without incident caused no significant complications; one individual in this group had a minor pneumothorax. Two of 17 patients predicted to have complications were noted to have a pneumothorax that required hospitalization. No patients in the low-risk group were hospitalized for a placement complication, whereas two hospitalizations occurred in the high-risk group. Conclusion Confirmatory chest radiographs may potentially be omitted in certain cases after line placement when experienced clinicians use good technique, good clinical judgment, and discrimination.

Cognitive function during and six months following chemotherapy for front-line treatment of ovarian, primary peritoneal or fallopian tube cancer: An NRG oncology/gynecologic oncology group study.

OBJECTIVES Changes in cognitive function have been identified in and reported by many cancer survivors. These changes have the potential to impact patient quality of life and functional ability. This prospective longitudinal study was designed to quantify the incidence of change in cognitive function in newly diagnosed ovarian cancer patients throughout and following primary chemotherapy. METHODS Eligible patients had newly diagnosed, untreated ovarian cancer and had planned to receive chemotherapy. Web-based and patient reported cognitive assessments and quality of life questionnaires were conducted prior to chemotherapy, prior to cycle four, after cycle six, and six months after completion of primary therapy. RESULTS Two-hundred-thirty-one evaluable patients entered this study between May 2010 and October 2011. At the cycle 4 time point, 25.2% (55/218) of patients exhibited cognitive impairment in at least one domain. At the post-cycle 6 and 6-month follow up time points, 21.1% (44/208) and 17.8% (30/169) of patients, respectively, demonstrated impairment in at least one domain of cognitive function. There were statistically significant, but clinically small, improvements in processing speed (p<0.001) and attention (p<0.001) but not in motor response time (p=0.066), from baseline through the six-month follow up time period. CONCLUSIONS This was a large, prospective study designed to measure cognitive function in ovarian cancer. A subset of patients had evidence of cognitive decline from baseline during chemotherapy treatment in this study as measured by the web-based assessment; however, changes were generally limited to no more than one domain.

A multicenter, randomized, phase 2 clinical trial to evaluate the efficacy and safety of combination docetaxel and carboplatin and sequential therapy with docetaxel then carboplatin in patients with recurrent platinum-sensitive ovarian cancer†

The aim of this randomized clinical trial was to evaluate the efficacy and safety of combination (cDC) and sequential (sDC) weekly docetaxel and carboplatin in women with recurrent platinum‐sensitive epithelial ovarian cancer (EOC).

Health-related quality of life outcomes of docetaxel/carboplatin combination therapy vs. sequential therapy with docetaxel then carboplatin in patients with relapsed, platinum-sensitive ovarian cancer: results from a randomized clinical trial.

OBJECTIVES A phase II clinical trial compared docetaxel in combination with carboplatin to sequential single agent docetaxel followed by carboplatin for treatment of recurrent platinum-sensitive ovarian, peritoneal, or tubal cancer. This manuscript reports prospectively collected health-related quality of life (HRQL). METHODS Participants were randomized to either weekly docetaxel 30 mg/m(2)/days 1 and 8 and carboplatin AUC 6/day 1 every 3 weeks (cDC) or docetaxel 30 mg/m(2)/days 1 and 8, repeated every 3 weeks for 6 cycles followed by carboplatin AUC 6/day 1 every 3 weeks for 6 cycles or until disease progression (sDC). The primary HRQL endpoint was the trial outcome index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, and was assessed as an intent-to-treat analysis. The secondary HRQL endpoints included the FACT-O total score, the FACT-General, and several domain scores of the FACT-O instrument (physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and the ovarian cancer specific (OCS) module). The FACT-O was administered at randomization, prior to each of 6 cycles of treatment, and at study endpoint. RESULTS One hundred forty-eight participants were randomized to each group. Sequential docetaxel followed by carboplatin (sDC) was associated with significant improvements in the FACT-O TOI (p=0.013), FACT-O total score (p=0.033), and OCS (p=0.029) compared to the combination docetaxel and carboplatin group (cDC). CONCLUSIONS Sequential single agent docetaxel followed by carboplatin is associated with improved HRQL when compared to cDC. The improved progression-free survival observed with cDC should be weighed against lower quality of life during treatment.

New-onset congestive heart failure with gemcitabine in ovarian and other solid cancers.

Objective:To assess clinical features that may predispose individuals taking gemcitabine to new-onset congestive heart failure. Methods:A retrospective chart review was conducted with 156 female patients, 51 with ovarian cancer and 105 with breast, lung, pancreas, and bladder cancer, all of whom had received gemcitabine. Patients with new-onset congestive heart failure were compared with patients without new-onset congestive heart failure with the use of Wilcoxon rank-sum test for continuously distributed data and the Fisher exact test for proportions. Results:Seven patients developed new-onset congestive heart failure (4.5%) during their treatment, which was significantly greater than that reported previously (0.76%). Patients with new-onset congestive heart failure did not differ from other patients in the study for age, weight, gravidity, parity, body mass index, and type of cancer. They also did not differ in history of myocardial infarction, hypertension, prior episodes of congestive heart failure, prior treatment with adriamycin, or use of tobacco. However, diabetes mellitus and coronary artery disease were more common, and all patients who developed new-onset congestive heart failure received >17,000 mg/m2 of gemcitabine. The incidence of new-onset congestive heart failure in this study is significantly higher than previously reported with the use of gemcitabine. Conclusions:The single-most predictive risk factor for new-onset congestive heart failure in this cohort of patients is the receipt of a minimum dose of 17,000 mg/m2. Therefore, additional follow-up may be necessary for all patients receiving >15,000 mg/m2 of gemcitabine to screen for potential new-onset congestive heart failure.

Stage I Ovarian Carcinoma: Specialty-Related Differences in Survival and Management

Background. In patients with FIGO (International Federation of Gynecology and Obstetrics) stage I ovarian carcinoma given care with or without subspecialists, we compared completeness of initial staging and disease-free survival. Methods. Two groups of patients with stage I ovarian carcinoma were compared. Patients were managed by either gynecologic oncologists or community-based physicians. The two groups were compared for similarities in demographic, tumor, and substage characteristics and survival differences. Results. Fifty-four patients with stage I ovarian cancer were included. The two groups were comparable in age, gravidity, parity, grade, and substage. Substaging was determined to be adequate in 100% of the gynecologic oncologist group and 28% of the community-based group. Postoperative chemotherapy was given to 79% and 36% of the two groups, respectively. Six-year survival was 90% in the gynecologic oncologist group and 68% in the communitybased group. Conclusions. Of these two groups of patients with stage I ovarian cancer, the group managed without gynecologic oncology involvement had significantly less adequate staging, decreased administration of chemotherapy, and lower survival rates.

91341916 Ovarian cancer screening in asymptomatic postmenopausal women by transviginal sonography

naire about their menstrual and menopausal history. By logistic analysis the age at the menopause of patients with ulcerative colitis was 49 f 0.6 (SE.) years compared to 50 * 0.5 years in those with an ileostomy and 49 & 0.1 years in the heahhy controls. No difference between ages at the menopause between ulcerative colitis patients, those with an ileostomy and controls were found with the r-test. This is in sharp contrast to Crohn’s disease, where chronic disease is associated with a premature menopause.