Preoperative quality of life and surgical outcomes in gynecologic oncology patients: a new predictor of operative risk?

OBJECTIVE: Quality of life (QoL) for women with gynecologic malignancies is predictive of chemotherapy related toxicity and overall survival but has not been studied in relation to surgical outcomes and hospital readmissions. Our goal was to evaluate the association between baseline, pre-operative QoL measures and 30-day post-operative morbidity and health resource utilization by gynecologic oncology patients. METHODS: We analyzed prospectively collected survey data from an institution-wide cohort study. Patients were enrolled from 8/2012 to 6/2013 and medical record data was abstracted (demographics, comorbid conditions, and operative outcomes). Responses from several validated health-related QoL instruments were collected. Bivariate tests and multivariable linear and logistic regression models were used to evaluate factors associated with QoL scores. RESULTS: Of 182 women with suspected gynecologic malignancies, 152 (84%) were surveyed pre-operatively and 148 (81%) underwent surgery. Uterine (94; 63.5%), ovarian (26; 17.5%), cervical (15; 10%), vulvar/vaginal (8; 5.4%), and other (5; 3.4%) cancers were represented. There were 37 (25%) cases of postoperative morbidity (PM), 18 (12%) unplanned ER visits, 9(6%) unplanned clinic visits, and 17 (11.5%) hospital readmissions (HR) within 30days of surgery. On adjusted analysis, lower functional well-being scores resulted in increased odds of PM (OR 1.07, 95%CI 1.01-.1.21) and HR (OR 1.11, 95%CI 1.03-1.19). A subjective global assessment score was also strongly associated with HR (OR 1.89, 95%CI 1.14, 3.16). CONCLUSION: Lower pre-operative QoL scores are significantly associated with post-operative morbidity and hospital readmission in gynecologic cancer patients. This relationship may be a novel indicator of operative risk.

Dynamic cervical change during real-time ultrasound: prospective characterization and comparison in patients with and without symptoms of preterm labor.

OBJECTIVES: To compare the incidence of dynamic cervical change (spontaneous real-time cervical shortening) in singleton patients with and without symptoms of preterm labor (PTL). METHODS: A total of 109 patients between 23 and 34 weeks' gestation with and without PTL symptoms underwent cervical length ultrasound and contraction monitoring over a 10-min period. Cervical length measurements were taken at 1-min intervals. Exclusion criteria included ruptured membranes, dilation > 3 cm or cerclage. Following the examination, the sonographer made a subjective assessment as to whether noticeable dynamic cervical change had occurred. A measurement was then made during the application of fundal pressure. The initial cervical length, shortest length, maximum change in length and incidence of dynamic change were compared between patients with and without PTL symptoms. The shortest cervical length was compared to the presence and timing of uterine contractions and the measurement during the application of fundal pressure. RESULTS: A total of 43 asymptomatic patients and 66 symptomatic patients were studied. Compared to asymptomatic patients, patients with PTL symptoms had shorter initial lengths, nadir lengths and mean lengths over time as well as a greater amount of maximum change. Dynamic cervical change was more frequently seen in symptomatic patients (48% vs. 9%, P < 0.001) and was associated with uterine contractions (odds ratio 4.6, 95% CI 1.9-10.8). Fundal pressure was not able to reproduce the shortest cervical length that occurred spontaneously during the observation period. CONCLUSIONS: Dynamic cervical change (real-time cervical shortening) is common in patients with PTL symptoms and is associated with uterine contractions. Whether this finding enhances the ability to predict preterm delivery remains to be elucidated.

Recruitment strategies for cervical cancer prevention study.

OBJECTIVE: The aim of this study was to describe recruitment strategies for a single-visit cervical cancer prevention study. METHODS: From January through December 1999, low-income, predominantly Latino women were recruited to participate in a single-visit cervical cancer prevention study. For the first 6 months, all women who had ever visited one of two community-based study clinics were invited to participate (clinic registry recruitment). For the remainder of the year, recruitment was modified to be primarily inclusive of advertisements in English- and Spanish-language community newspapers and fliers left in local businesses and organizations (media campaign recruitment). Eligible volunteers were randomized to one of two study arms, usual-care program or single-visit program. All study subjects completed demographic and medical questionnaires delivered by bilingual staff. Women who declined to participate in this study were asked to provide reasons for this preference. Statistical analyses included the use of chi-square, logistic regression, and Student's t test. RESULTS: The proportion of women who agreed to participate was higher in the media recruitment group than in the clinic registry group [51% (535/1041) compared to 26% (405/1542), P < 0.001]. The no-show rate among participants solicited from the media strategy was significantly less than that from the clinic registry. There were no significant differences in the median age, number of months since the last Papanicolaou smear, incidence of abnormal Papanicolaou smear, education, or income of the subjects based on the recruitment strategy. CONCLUSION: A media-based recruitment strategy was effective for this single-visit cervical prevention study. This approach may be effective for recruitment of other low-income groups to clinical trials.

Racial and ethnic colorectal cancer patterns affect the cost-effectiveness of colorectal cancer screening in the United States.

BACKGROUND & AIMS: Colorectal cancer screening beginning at age 50 is recommended for all Americans considered at "average" risk for the development of colorectal cancer. METHODS: We used 1988-1995 California Cancer Registry data to compare the cost-effectiveness of two 35-year colorectal cancer screening interventions among Asians, blacks, Latinos, and Whites. RESULTS: Average annual age-specific colorectal cancer incidence rates were highest in blacks and lowest in Latinos. Screening beginning at age 50 was most cost-effective in blacks and least cost-effective in Latinos (measured as dollars spent per year of life saved), using annual fecal occult blood testing (FOBT) combined with flexible sigmoidoscopy every 5 years and using colonoscopy every 10 years. A 35-year screening program beginning in blacks at age 42, whites at age 44, or Asians at age 46 was more cost-effective than screening Latinos beginning at age 50. CONCLUSIONS: Colorectal cancer screening programs beginning at age 50, using either FOBT and flexible sigmoidoscopy or colonoscopy in each racial or ethnic group, are within the $40,000-$60,000 per year of life saved upper cost limit considered acceptable for preventive strategies. Screening is most cost-effective in blacks because of high age-specific colorectal cancer incidence rates.

Intent-to-treat analysis of stage Ib and IIa cervical cancer in the United States: radiotherapy or surgery 1988-1995.

OBJECTIVE: To estimate the patterns of care and outcome of women with early cervical cancer in the United States based on surgical or radiation intent-to-treat principles. METHODS: The Surveillance, Epidemiology, and End Results 1995 public-use file was the data source. Subjects between the ages of 15 and 80 years at diagnosis who were treated for stage Ib or IIa cervical cancer were identified. The 1039 women who comprised the study group were stratified according to age at diagnosis (40 years or less, older than 40 years), primary treatment intent (surgery, radiotherapy), tumor size (4 cm or less, over 4 cm), registry site, and ethnicity. Survival analyses included 784 women who had at least 2 years of follow-up. RESULTS: There were 276 cancers (26.5%) over 4 cm, and 586 (56%) women were older than 40 years at diagnosis. There were 741 (71%) subjects in the surgical intent-to-treat group, and the remainder (298) were in the radiation intent-to-treat group. Kaplan-Meier analysis indicated a 5-year survival advantage for women with tumors 4 cm or less who were in the surgical intent-to-treat group compared with the radiation intent-to-treat group (86% and 71%, P <.001). Treatment group was not prognostic for cervical cancers over 4 cm (surgical intent-to-treat compared with radiation intent-to-treat; 72% and 68% survival, respectively). Multivariable analysis confirmed a survival advantage for women with surgical intent-to-treat and tumors of 4 cm or less. CONCLUSION: In the United States there is a survival advantage for surgical intent-to-treat compared with radiation intent-to-treat for women with tumors 4 cm or less, independent of ethnicity, adjuvant therapy, or age.

The topography of colorectal cancer varies by race/ethnicity and affects the utility of flexible sigmoidoscopy.

Colorectal cancer screening beginning at age 50 is recommended for all Americans considered at "average" risk for the development of colorectal cancer either with flexible sigmoidoscopy and fecal occult blood testing (FOBT) or with colonoscopy. Patients who elect flexible sigmoidoscopy and FOBT undergo full colonoscopy only if left-sided neoplasia is detected or if the FOBT is positive. Unfortunately in blacks and whites most right-sided colorectal lesions are unaccompanied by left-sided sentinel lesions, which leads some to prefer colonoscopic screening in these patients. The topography of colorectal cancer in Asians and Latinos is unavailable. We used 1988-1995 California Cancer Registry data to determine the topography of 105,906 consecutive colorectal cancers among Asian, black, Latino, and white patients. We found that the proportion of colorectal cancer distal to the splenic flexure and therefore detectable by flexible sigmoidoscopy varied by ethnicity: Asian (71%) > Latino (63%) > white (57%) > black (55%); P < 0.001. These differences were significant after adjusting for age and sex. The risk of distal disease relative to whites was 1.61 in Asians, 1.15 in Latinos, and 0.82 in blacks (P < 0.001). Flexible sigmoidoscopy detects a higher proportion of colorectal cancers in Asians and Latinos than in whites or blacks. Further study is needed to assess whether the topography of benign colorectal neoplasia parallels that of malignant disease. Colorectal screening recommendations may need to incorporate racial and ethnic differences in colorectal neoplasia topography.

A randomized controlled trial of the effect of increased intravenous hydration on the course of labor in nulliparous women.

OBJECTIVE: One variable that has the potential to affect the course of labor but has not been evaluated previously is the adequacy of maternal hydration. Typical orders provide for 125 mL of intravenous fluids per hour in patients taking limited oral fluids. Many such patients are clinically dehydrated. Physiologists have shown that increased fluids improve skeletal muscle performance in prolonged exercise. This study was designed to determine whether increased intravenous fluids affect the progress of labor. STUDY DESIGN: Nulliparous women with uncomplicated singleton gestations at term, in spontaneous active labor with dilatation between 2 and 5 cm, and with a cephalic presentation were included. Patients who gave consent were randomly selected to receive either 125 mL or 250 mL of intravenous fluids per hour. RESULTS: One hundred ninety-five patients were randomly selected, 94 to the 125-mL group and 101 to the 250-mL group. Prerandomization variables were well matched between the 2 groups. The mean volume of total intravenous fluids was significantly greater in the 250-mL group (2008 mL vs 2487 mL; P =.002), as was the mean hourly rate (152 mL/h in the 125-mL group vs 254 mL/h in the 250-mL group; P =.001). The frequency of labor lasting >12 hours was statistically higher in the 125-mL group (20/78 [26%] vs 12/91 [13%]; P =.047). In addition, there was a trend favoring longer mean duration of the first stage and total duration of labor in patients delivered vaginally in the 125-mL group, by 70 and 68 minutes, respectively (P =.06). There was a trend toward a lower frequency of oxytocin administration for inadequate labor progress in the higher fluid rate group (61 [65%] in the 125-mL group vs 51 [49%] in the 250-mL group; P =.06). Cesarean deliveries were more frequent in the 125-mL group (n = 16) than in the 250-mL group (n = 10) but did not reach statistical significance. CONCLUSION: This study presents the novel finding that increasing fluid administration for nulliparous women in labor above rates commonly used is associated with a lower frequency of prolonged labor and possibly less need for oxytocin. Thus inadequate hydration in labor may be a factor contributing to dysfunctional labor and possibly cesarean delivery. Consideration of this factor in clinical management and in future studies considering variables that affect labor is warranted.

Pathologic variables and adjuvant therapy as predictors of recurrence and survival for patients with surgically evaluated carcinosarcoma of the uterus.

BACKGROUND: The purpose of this study was to determine clinicopathologic variables associated with extrauterine disease, recurrence, and survival in patients with carcinosarcoma (CS) of the uterus. METHODS: Patients believed to have disease confined to the uterine corpus who underwent primary surgical assessment were identified and data retrospectively reviewed. RESULTS: Occult metastases were found in 38 (61%) of 62 patients. At last follow-up, 31 (50%) had had recurrence, with an extrapelvic component in 43%, and 53% had died. Depth of myometrial invasion and lymph-vascular space invasion (LVSI) were associated with extrauterine disease. Five-year survival for patients with disease confined to the corpus (74%) was significantly greater than for those with more advanced disease (24%, P = 0.0013). Factors associated with recurrence and survival included depth of myometrial invasion, LVSI, adnexal and serosal involvement, positive cytology, and lymph node metastases. Of 24 patients with uterine disease only, 11 received no adjuvant therapy, yet 8 (73%) were free of disease at last follow-up. Neither adjuvant radiotherapy nor chemotherapy was identified as an independent prognostic variable for recurrence or survival. CONCLUSIONS: More than half of patients with CS clinically confined to the uterine corpus harbor occult metastases in a pattern similar to that found with endometrial carcinoma. Survival is significantly diminished for this group. Although the benefit of adjuvant therapy cannot be demonstrated by this study, a number of early stage patients survive without adjuvant therapy. This argues for extending the International Federation of Gynecology and Obstetrics endometrial carcinoma surgical staging system to include CS, and also for conducting prospective trials to examine the benefits of adjuvant therapy for patients with early stage disease.

Breast cancer survival and hormone replacement therapy: a cohort analysis.

Controversy exists regarding the safety of hormone replacement therapy (HRT) after a diagnosis of breast cancer. The objective of this study is to perform a matched cohort analysis to evaluate the impact of HRT on mortality in breast cancer survivors. Patients with breast cancer who received HRT after diagnosis of breast cancer were identified. Control subjects were identified from the regional cancer registry. Matching criteria included age at diagnosis, stage of breast cancer, and year of diagnosis. Controls were selected only if they were alive at the time of initiation of HRT of the matched case. Only subjects not included in a previously reported matched analysis were selected. One hundred twenty-five cases were matched with 362 controls. Ninety-eight percent (123/125) of the cases received systemic estrogen; 90/125 (72%) also received a progestational agent. The median interval between diagnosis of breast cancer and initiation of HRT was 46 months (range 0-401 months). The median duration of HRT was 22 months (range 1-357 months). The risk of death was lower among the HRT survivors; odds ratio 0.28 (95% confidence interval 0.11-0.71). This analysis does not suggest that HRT after the treatment of breast cancer is associated with an adverse outcome.

Signet ring cell histology is associated with unique clinical features but does not affect gastric cancer survival.

Signet ring cell histology is found in 3 to 39 per cent of gastric cancer cases and has been reported to be a feature of poor prognosis, although this issue has not been rigorously examined. The objective of this study was to determine those demographic and clinical variables associated with signet ring cell histology and to determine the effect of signet ring cell histology on survival using multivariate analyses. We studied a historical cohort of consecutive cases of gastric cancer reported to the population-based California Cancer Registries of Orange, San Diego, and Imperial Counties from 1984 through 1994. Factors associated with signet ring cell histology were assessed using chi2 and logistic regression. Life tables were constructed to assess unadjusted survival and survival differences in patient subgroups. Multivariate survival was determined using a Cox proportional hazards model. Of 3020 patients, 464 (15%) had signet ring cell histology. Patients with signet ring cell histology were more likely to be younger than 50 years (odds ratio (OR) = 2.4; 95% confidence interval (CI) = 1.6-3.5), less likely to be male (OR = 0.49; 95% CI = 0.37-0.66), and more likely to have tumors of the distal stomach (OR = 2.0; 95% CI = 1.4-3.0). Signet ring cell histology did not adversely affect unadjusted overall survival, race-stratified survival, or stage-stratified survival. Multivariate analysis indicated that patients with signet ring cell histology had an insignificant increased risk of dying (relative risk = 1.027; P>0.10) in comparison with patients without signet ring cell histology. Patients with signet ring cell histology were more likely to be young women and to have tumors of the distal stomach. Signet ring cell histology did not impact survival in our group of largely advanced gastric cancer cases.

Does human papillomavirus have a role in cancers of the uterine corpus?

OBJECTIVE: Thepurpose of this study was to determine the role of the human papillomavirus (HPV) in invasive uterine corpus cancer by characterizing the frequency of HPV DNA in malignant uterine tumors. METHODS: Hysterectomy specimens from 66 women with uterine carcinoma were analyzed. Tumor specimens were frozen at -80 degrees C at the time of surgical resection. DNA was later extracted and examined for HPV DNA using type-specific PCR primers for HPV 6, 16, and 18 and consensus primers MY09/MY11, which detect DNA from 33 other common HPV types. Isolation procedures were undertaken to prevent contamination. RESULTS: The histologic diagnoses of the 66 uterine cancer cases included 58 endometrial adenocarcinomas, 4 adenosquamous carcinomas, 3 malignant mixed mesodermal tumors, and 1 squamous cell carcinoma. HPV was detected by both type-specific and consensus primers in only 2 of the uterine specimens. None of the typical endometrioid adenocarcinoma specimens contained HPV DNA. HPV 16 was detected in 1 of the adenosquamous carcinoma samples and HPV 18 was detected in the squamous carcinoma specimen. CONCLUSION: HPV DNA is not found in malignancies of the uterine corpus without malignant squamous elements when the risk of contamination is minimized. For these tumors, HPV appears to be unrelated to the neoplastic transformation process.

An experience with estrogen replacement therapy in breast cancer survivors.

OBJECTIVE: To evaluate the outcome of breast cancer patients who elected estrogen replacement therapy (ERT). STUDY DESIGN: Breast cancer survivors who elected ERT received the preferred regimen of conjugated estrogen 0.625 mg/day with medroxyprogesterone acetate 2.5 mg/day. RESULTS: 145 patients received ERT for at least 3 months. Thirteen recurrences (9%) were identified; 10 are alive with disease, 3 are dead of disease. The median interval between diagnosis and commencement of ERT was 41 months. Forty-one percent of the study group initiated ERT within 3 years of their breast cancer diagnosis. The median duration of follow-up on ERT was 30 months. CONCLUSION: The concern that ERT might activate growth in occult metastatic sites and promote a rash of recurrences was not confirmed. It is unreasonable to categorically deny all breast cancer survivors ERT.

Interstitial brachytherapy for vaginal recurrences of endometrial carcinoma.

OBJECTIVE: The aim of this study was to evaluate the efficacy of interstitial brachytherapy in the management of vaginal recurrences of endometrial carcinoma. METHODS: Thirty patients received interstitial irradiation, with or without external beam radiotherapy. They were followed for a minimum of 5 years or until death. RESULTS: The median age was 66 years at initial diagnosis of endometrial cancer. FIGO stages included Stage I (n = 18), Stage II (n = 7), and Stage III (n = 5). All patients were treated originally by total abdominal hysterectomy and bilateral salpingo-oophorectomy, with or without lymphadenectomy, and 13 (43%) also received postoperative adjuvant whole pelvis radiotherapy as part of their primary treatment. Vaginal recurrences were diagnosed at a mean interval of 29 months after hysterectomy (range, 3-119 months). No patient had clinical evidence of pelvic sidewall extension or of distant metastatic disease. All patients were treated with interstitial brachytherapy; each implant delivered a mean maximal tumor dose of 25.5 Gy. Eighteen patients (60%) also received external beam radiotherapy (mean dose, 48 Gy) as part of their treatment for vaginal recurrence. Twenty-eight patients (93%) experienced a complete clinical response. Ten patients relapsed in the vagina (n = 5) or at distant sites (n = 5). Eleven patients are dead of disease. From the time of vaginal recurrence, the median overall survival was 60 months and the cause of death adjusted 5-year survival rate was 65%. Major morbidity included radiation proctitis (n = 2), fistula (n = 2), and radiation stricture (n = 1). CONCLUSION: Interstitial irradiation resulted in favorable local control as well as a 5-year survival rate and morbidity comparable to that reported previously for conventional brachytherapy.

Young age as a prognostic factor in cervical cancer: results of a population-based study.

OBJECTIVE: Our goal was to use population-based data to determine the difference in 5-year survival in women diagnosed with cervical cancer between those aged 18-34 years and those aged 40-60 years. STUDY DESIGN: The SEER (Surveillance, Epidemiology, and End Results) public-use database, 1973-1994, was used for this investigation. Only subjects with cervical carcinoma diagnosed between 1988 and 1990 were included. Subjects were stratified on age at diagnosis (<35 years or 40-60 years), clinical stage, histologic type, race-ethnicity, and grade. RESULTS: Two thousand cases of invasive cervical cancer were identified. The younger subgroup of patients was diagnosed with earlier-stage disease more frequently than the older group (P =.0001). When adjustments were made for non-cervical cancer causes of death, there was no difference in 5-year survival between the 2 cohorts. African American women had a poorer 5-year survival (P =.02) CONCLUSION: There was no overall difference in survival between the 2 cohorts when appropriate adjustments were made for cause of death and for stage, histologic type, and grade of disease.