Progression-free and overall survival in ovarian cancer patients treated with CVac, a mucin 1 dendritic cell therapy in a randomized phase 2 trial.

BACKGROUND: CAN-003 was a randomized, open-label, Phase 2 trial evaluating the safety, efficacy and immune outcomes of CVac, a mucin 1 targeted-dendritic cell (DC) treatment as a maintenance therapy to patients with epithelial ovarian cancer (EOC). METHODS: Patients (n = 56) in first (CR1) or second clinical remission (CR2) were randomized (1:1) to standard of care (SOC) observation or CVac maintenance treatment. Ten doses were administered over 56 weeks. Both groups were followed for progression-free survival (PFS) and overall survival (OS). RESULTS: Fifty-six patients were randomized: 27 to SOC and 29 to CVac. Therapy was safe with only seven patients with Grade 3-4 treatment-emergent adverse events. A variable but measurable mucin 1 T cell-specific response was induced in all CVac-treated and some standard of care (SOC) patients. Progression free survival (PFS) was not significantly longer in the treated group compared to SOC group (13 vs. 9 months, p = 0.36, hazard ratio [HR] = 0.73). Analysis by remission status showed in the CR1 subgroup a median PFS of 18 months (SOC) vs. 13 months (CVac); p = 0.69 (HR = 1.18; CI 0.52-2.71). However CR2 patients showed a longer median PFS in the CVac-treated group (median PFS not yet reached, >13 vs. 5 months; p = 0.04, HR = 0.32 CI). OS for CR2 patients at 42 months of follow-up showed a difference of 26 months for SOC vs. > 42 months for CVac-treated (as median OS had not been reached; HR = 0.17 (CI 0.02-1.4) with a p = 0.07). CONCLUSIONS: CVac, a mucin 1-dendritic cell maintenance treatment was safe and well tolerated in ovarian cancer patients. A variable but observed CVac-derived, mucin 1-specific T cell response was measured. Notably, CR2 patients showed an improved PFS and lengthened OS. Further studies in CR2 ovarian cancer patients are warranted (NCT01068509). TRIAL REGISTRATION: NCT01068509. Study Initiation Date (first patient screened): 20 July 2010. Study Completion Date (last patient observation): 20 August 2013, the last patient observation for progression-free survival; 29 April 2015, the last patient was documented regarding overall survival.

Laparoscopic-assisted application of interstitial brachytherapy for locally advanced cervical carcinoma: results of a pilot study.

PURPOSE: To assess the efficacy of diagnostic laparoscopy at the time of interstitial brachytherapy in patients with FIGO Stages IIB-IVA cervical carcinoma, who were not candidates for conventional brachytherapy after completion of whole pelvic radiation. MATERIALS AND METHODS: Six patients with FIGO Stages IIB-IVA cervical carcinoma completed whole pelvic radiation (WPR) and were assessed for the placement of conventional intracavitary brachytherapy. Three patients (Stage IIB) received 50.40 Gy WPR and three (Stage IIIA-VA) received 61.20 Gy WPR. Because distorted vaginal anatomy precluded the placement of standard intracavitary brachytherapy equipment, interstitial therapy was selected. To minimize the risk of source misplacement, needles were placed with laparoscopic guidance. 192Iridium was utilized as a source of radiation. RESULTS: A total of 98 needles were placed under direct laparoscopic guidance. The median interstitial brachytherapy tumor dose was 20.00 Gy (range 19.00-41.20 Gy). Eleven perforations in the pelvic peritoneum and/or bladder were identified intraoperatively in 5 of the 6 patients, leading to immediate repositioning of needles. No acute or short-term morbidity related to the procedure was appreciated. CONCLUSION: Interstitial brachytherapy offers an alternative for intracavitary radiation therapy for selected patients, in whom adequate placement of intracavitary afterloading equipment is precluded by abnormal pelvic geometry. Historically, the placement of interstitial sources has been a procedure that was performed without visualization of the pelvic cavity. A major concern is direct injury to pelvic viscera and intestine. The use of diagnostic laparoscopy at the time of placement of interstitial brachytherapy may avert potential complications from misapplication of interstitial sources. Longer follow-up is required to substantiate these results.

Remarkable response of primary squamous cell carcinoma of the ovary to paclitaxel and cisplatin.

BACKGROUND: The survival rate of patients with advanced stage primary squamous cell carcinoma of the ovary is dismal and the best treatment is unknown. We describe the response of this tumor to systemic chemotherapy employing paclitaxel and cisplatin. CASE: A 31-year-old white woman diagnosed with International Federation of Gynecology and Obstetrics stage IV primary squamous cell carcinoma of the ovary associated with ovarian endometriosis underwent cytoreductive surgery followed by paclitaxel and cisplatin every 4 weeks for 12 courses. The patient tolerated chemotherapy well, demonstrated a dramatic response with disappearance of hepatic metastases, and remains without evidence of disease 2 years after diagnosis. CONCLUSION: Paclitaxel and cisplatin may be effective in treating primary squamous cell carcinoma of the ovary.

Laparoscopic surgery in obese women.

OBJECTIVE: To assess the feasibility and complications of operative laparoscopy in women with high body mass indices (BMIs). METHODS: Forty-seven consecutive patients with BMIs exceeding 30 who underwent operative laparoscopy were compared with 160 consecutive patients with BMIs of 30 or less who underwent the same procedure. Patient characteristics, ultrasound features of adnexal masses, and details of operative procedures were compared. Operative and postoperative complications, the percentage of failed laparoscopies, and length of hospital stay were compared between groups. RESULTS: There were no significant differences between groups in terms of age, parity, menopausal status, history of laparotomy, ultrasound features of adnexal masses, complexity of laparoscopic procedures, and the presence and degree of adhesions at the time of laparoscopy. Estimated blood loss, operative times, operative and major postoperative complications, and lengths of hospital stay also did not differ significantly between women with high BMIs and those with low BMIs (180.3 versus 151.4 mL, P = .41; 150.5 versus 146.5 minutes, P = .78; 2.1 versus 1.9%, P = .90; 2.1 versus 1.9%, P = .91; and 2.3 versus 1.9 days, P = .51, respectively). However, women with BMIs exceeding 30 had a significantly higher incidence of procedure conversion to laparotomy (14.9 versus 5.6%, P = .04). CONCLUSION: Operative laparoscopy is safe and feasible in women with high BMIs. Although there is an increased chance of procedure conversion to laparotomy in these women, the morbidity and length of hospitalization associated with the procedure are similar to those among women with low BMIs.

The addition of bleomycin and dose-escalated ifosfamide to the combination of cisplatin plus ifosfamide does not improve survival in advanced or recurrent cervical carcinoma.

Twenty patients with advanced or recurrent cervical cancer were treated with bleomycin 30 U, ifosfamide 5 g/m2, and cisplatin 50 mg/m2 (BIP) every 28 days in a phase II trial. The primary purpose of this study was to compare response rate, survival, and toxicity of this regimen with results obtained in a similar group of patients treated with cisplatin 1 mg/kg per week for six courses followed by cisplatin, 20 mg/m2, plus ifosfamide 1.2 g/m2 daily for 3 days every 28 days. Four of 17 evaluable patients (23.5%) treated with BIP demonstrated a response to therapy (complete response 11.7%; partial response 11.7%). The median duration of response was 8.5+ months (range, 6+ to 24 months). These data do not differ significantly (P = 0.76) from a response rate of 27.5% among patients treated with cisplatin plus ifosfamide (PI). A significant (P = 0.003) increase in myelotoxicity was observed among patients treated with BIP versus those treated with PI. The median survival of patients treated with BIP of 13.5+ months (range, 8+ to 24 months) does not differ significantly from the median survival of 9+ months (3 to 26+ months) among patients treated with PI. The addition of bleomycin and dose-escalated ifosfamide did not significantly improve response rate or survival among patients with advanced or recurrent cervical cancer and resulted in a significant increase in myelotoxicity.

Stage I adenocarcinoma of the cervix: does lesion size affect treatment options and prognosis?

A retrospective analysis of 93 patients with International Federation of Gynecology and Obstetrics stage I adenocarcinoma of the cervix was performed to determine the significance of tumor size, patient age, tumor grade, lymph node status, and primary treatment modality as prognostic variables of 5-year survival and 5-year progression-free survival (PFS). Multivariate analysis demonstrated that patient age and tumor grade were significant variables prognostic of survival (p < 0.01 and p = 0.01, respectively). Tumor size was a significant (p < 0.01) prognostic variable of PFS in a multivariate model that included tumor size and patient age. An important advantage in survival and PFS for patients with lesions smaller than 3 cm compared with those patients with lesions 3 cm or more was observed (92% vs. 76% and 89% vs. 67%, respectively). Among surgically treated patients, survival and PFS among patients with lesions smaller than 3 cm were significantly improved compared with patients with tumors 3 cm or more (97% vs. 77% [p = 0.03] and 90% vs. 69% [p = 0.03], respectively). Significant improvement in survival and PFS was observed among patients with lesions smaller than 3 cm who were treated with surgery compared with those who received radiation therapy (97% vs. 77% [p = 0.03] and 90% vs. 77% [p = 0.048], respectively).

Progesterone receptor status is a significant prognostic variable of progression-free survival in advanced epithelial ovarian cancer.

The purpose of this study was to determine if tumor estrogen receptor (ER) or progesterone receptor (PR) status were significant prognostic variables of survival and progression-free survival among patients with International Federation of Gynecology and Obstetrics (FIGO) stage III and IV epithelial ovarian cancer. Tumor steroid receptor status was evaluated among 67 consecutive patients who underwent primary surgery from June 1983 through September 1990. Characteristics of receptor-negative and receptor-positive populations were compared by chi-square analysis. Univariate and multivariate analyses were used to identify variables prognostic of survival and progression-free survival. Fifty-one of 67 patients (76.1%) had ER-positive tumors and 31 (46.3%) patients had PR-positive tumors. Significant differences between receptor-positive and receptor-negative populations were not observed. Neither univariate nor multivariate analysis identified ER or PR status as significant prognostic variables of survival (p = 0.93 and p = 0.06, respectively). Progesterone receptor-positive status was a significant prognostic variable of progression-free survival in both univariate (p = 0.03) and multivariate (p = 0.04) analyses even after adjustment for residual disease and patient age. Estrogen receptor status was not a significant prognostic indicator of progression-free survival in either univariate or multivariate analyses. Progesterone receptor-positive tumor status is shown to be an independent prognostic variable of improved progression-free survival among patients with advanced epithelial ovarian cancer.

Prospective sequential trials of induction weekly cisplatin followed by monthly cisplatin, doxorubicin, cyclophosphamide and paclitaxel and cisplatin in optimal (< or = 1 cm) stage III and IV ovarian cancer.

PURPOSE OF INVESTIGATION: This study was conduced to assess the results of paclitaxel plus cisplatin given over six months as firstline therapy in women with stage III and IV epithelial ovarian cancer with residual disease < 1 cm and compare it to our previous standard of cisplatin, adriamycin, and cyclophosphamide given over ten months in two sequential trials totaling 100 patients. METHODS: We compared induction weekly cisplatin (1 mg/kg x 4) followed by monthly cisplatin (50 mg/m2), doxorubicin (50 mg/m2) and cyclophosphamide (750 mg/m2) x 10 (n = 56) versus induction cisplatin (1 mg/kg x 4) followed by cisplatin (75 mg/m2) and paclitaxel (135 mg/m2) monthly over six months (n = 44). RESULTS: The two groups were similar in age, histologic subtypes, grade, performance status, and substage. The mean dose of cisplatin in the PAC patients was 617.1 (+/-92.7) mg/m2 as compared to 567.1 (+/-89.2) mg/m2 in the TP patients (p < 0.0001). Surgical response was assessed in 83.9% of the PAC and 86.4% of the TP patients. The incidence of nausea and vomiting, myelotoxicity and renal toxicity were similar in the two groups. Peripheral neuropathy occurred more frequently following TP (57% vs 16%; p = 0.001). Cardiac toxicity (grade 1) occurred in 39% of the PAC patients and in 4.5% of the TP patients (p < 0.001). The overall response rate (75% vs 88.7%), surgical response rate (67.9% vs 79.5%), complete surgical responses (37.5% vs 40.9%), estimated two-year survival (80.2% vs 79.6%), progression-free median survival (36 months vs 30.4 months) and two-year progression/recurrence rates (32.3% vs 46.9%), respectively, of PAC and TP patients were not statistically significant (p = NS). CONCLUSIONS: Given the discussed limitations of the study, compared with PAC, TP did not improve overall and surgical response rates, two-year survival, two year disease-free survival, or median time of recurrence in patients with optimal (< 1 cm) stage III and IV ovarian cancer and resulted in higher peripheral neuropathy rates.

The clinical value of digene hybrid capture HPV DNA testing in a referral-based population with abnormal pap smears.

PURPOSE OF INVESTIGATION: The hybrid capture human papillomavirus (HPV) DNA assay is offered by the manufacturer to assist clinicians with patients with ASCUS pap smear results to assess the risk factor and to potentially direct follow-up of these patients. In our practice, a gynecologic oncology practice that has a referral based population with abnormal pap smears, our purpose was to evaluate the patients referred with all grades of abnormal cervical cytology. METHODS: One hundred consecutive patients who were referred for evaluation of abnormal cervical cytology: atypical squamous cells of undetermined significance (ASCUS); low-grade squamous intraepithelial lesion (LGSIL); high-grade squamous intraepithelial lesion (HGSIL); or squamous cell carcinoma (SCC) were evaluated by repeat pap smear, hybrid capture HPV DNA analysis and colposcopy. Colposcopic findings were recorded, and if appropriate, cervical biopsies were performed. Hybrid capture results were correlated with histologic and cytologic findings. Using histopathologic diagnosis as the reference standard, the sensitivity and positive predictive value of pap smear and high risk HPV were calculated. The Kappa test was used to correlate colposcopic and histopathologic findings. RESULTS: Repeat pap smears at the time of initial consultation demonstrated 25 patients with normal results, 39 with LGSIL, 30 with HGSIL, 1 SCC and 5 ASCUS. Seventy-eight patients underwent cervical biopsy. Colposcopic findings correlated significantly with histopathologic findings (p<0.0001). Forty-four percent of patients tested positive for HPV DNA: 40 patients with high risk HPV, three patients with low risk HPV, and one patient with both high risk and low risk HPV. Sixteen of 39 patients (41%) with LGSIL on pap smear tested positive for high risk HPV; 37% of patients in this group required cervical conization because cervical biopsies demonstrated moderate/severe dysplasia. The diagnosis of moderate/severe dysplasia significantly correlated with the presence of high risk HPV [OR 78.9 (8.31-389.30)]. There was no significant correlation between the HPV DNA signal strengths and the histologic grade of dysplasia. The sensitivity and the positive predictive value of pap smear alone in identifying moderate/severe dysplasia was 62% and 96%, respectively. The combination of HGSIL pap smears and high risk HPV increased the sensitivity but not the positive predictive value for the detection of moderate/severe dysplasia to 77.7% and 95%, respectively (P=NS). CONCLUSIONS: Although in this setting, the use of hybrid capture DNA testing did not significantly improve the sensitivity or positive predictive value of the diagnosis of HGSIL cytology when compared to cytologically indicated plus colposcopically directed cervical biopsies in this population of women at high risk for the presence of disease, the combination of HGSIL pap smears and high-risk HPV did result in a clinically important increase in the diagnosis of moderate/severe dysplasia.

Effective management of pelvic lymphocysts by laparoscopic marsupialization.

BACKGROUND AND OBJECTIVES: To evaluate laparoscopic transperitoneal marsupialization of pelvic lymphocysts at the time of laparoscopically directed assessment of response to first-line therapy in a population of patients treated for International Federation of Gynecologists and Obstetricians (FIGO) stage IC-IIC epithelial ovarian cancer. METHODS: Between March 1995 and March 1998, eight patients with FIGO stage IC-IIC serous epithelial ovarian tumors who developed pelvic lymphocysts after primary surgical staging underwent transperitoneal laparoscopically directed marsupialization of lymphocysts at the time of second-look laparoscopy. RESULTS: The mean age of the patient population was 50 years (range 23-65 years). The mean length of time required for marsupialization was 30 minutes (range 25-35 minutes). No patient required inpatient postoperative care. No intraoperative complications were observed. Computerized axial tomography (CT) scan of the abdomen and pelvis obtained 12 weeks following surgery failed to demonstrate re-accumulation of lymphocysts among any patient in the study population. With a median follow-up of 20 months (range 3-39 months), no patients have demonstrated pelvic lymphocyst recurrence. CONCLUSIONS AND DISCUSSION: Laparoscopically directed marsupialization of pelvic lymphocysts is technically feasible, safe and effective. Further study of this technique appears to be warranted.

The new International Federation of Gynecology and Obstetrics surgical staging and survival rates in early endometrial carcinoma.

The medical records of patients with clinical Stage I endometrial adenocarcinoma who were treated at the Maimonides Medical Center between October 1979 and October 1987 were reviewed. There was sufficient surgical-pathologic information to allow a reclassification based on the new International Federation of Gynecology and Obstetrics (FIGO) surgical staging in 93 patients. These are the subjects of analysis. Twenty-one patients (23%) were found surgically to have more than Stage I disease. The 5-year survival rate for the whole group (N = 93) was 90%. However, it was significantly better for patients with surgical Stage I disease (98%) than for patients with surgical Stage III disease (60%) (P less than 0.001). There was no significant statistical difference in survival among patients with different substages within surgical Stage I (i.e., IA, 100%; IB, 100%; and IC, 88%), whereas the distribution of adjuvant therapy among these substages was not statistically different (P = 0.17). Thus, survival was not significantly affected by depth of myometrial invasion in patients who had negative peritoneal washing and no involvement of lymph nodes or the peritoneal cavity.

Pretreatment transperitoneal laparoscopic staging pelvic and paraaortic lymphadenectomy in large (> or = 5 cm) stage IB2 cervical carcinoma: report of a pilot study.

Twelve patients with large stage IB2 (5-8 cm) cervical carcinoma underwent transperitoneal laparoscopically directed pelvic and paraaortic lymph node dissection prior to the initiation of radiation therapy. The mean length of operation was 176 min and the mean estimated blood loss was 60 cc. An average of 25 lymph nodes were retrieved from each patient: 18 pelvic lymph nodes and 7 paraaortic lymph nodes. No patients were hospitalized for more than 24 hr. No operative complications were observed. Pelvic nodal metastases were diagnosed in three patients, all of whom had negative computerized tomography (CT) scans prior to surgery. All patients began radiation therapy within 1 week of surgery. Laparoscopically directed lymphadenectomy for patients with stage IB2 cervical carcinoma is technically feasible, is associated with minimal morbidity, short hospital stay, and minimal delay prior to radiation therapy, and can add valuable information to radiation treatment planning.

Lack of improved survival plus increase in thromboembolic complications in patients with clear cell carcinoma of the ovary treated with platinum versus nonplatinum-based chemotherapy.

BACKGROUND: This study was conducted to evaluate survival rates for patients with clear cell ovarian carcinoma who had platinum-based chemotherapy versus nonplatinum-based chemotherapy and the risk of thromboembolic complications. METHODS: One hundred and eleven evaluable patients with clear cell ovarian carcinoma who underwent primary surgery and postoperative therapy were retrospectively evaluated. Median follow-up was 21.3 months (range, 3-280 months). Patients treated with platinum-based chemotherapy and nonplatinum-based chemotherapy were evaluated according to stage, age, grade, extent of surgery, and development of thromboembolic complications. Patient populations were compared using the chi-square test. Estimated 5- and 10-year survivals for each group were calculated using the method of Kaplan and Meier. Differences in survival rates were calculated using the log rank test. The frequency of thromboembolic complications in the clear cell ovarian carcinoma group was compared with its frequency in a matched-control group of 109 patients with epithelial nonclear cell ovarian carcinoma. RESULTS: Seventy-one patients were treated with nonplatinum-based chemotherapy and 40 patients were treated with platinum-based chemotherapy. There was no statistically significant difference in the characteristics of patient populations treated with platinum-based chemotherapy or nonplatinum-based chemotherapy. The estimated 5-year survival for clear cell ovarian carcinoma patients treated with platinum-based chemotherapy did not differ significantly from the estimated 5-year survival for patients with clear cell ovarian carcinoma treated with nonplatinum-based chemotherapy (36% vs. 32%; P = 0.23). Twelve patients with clear cell ovarian carcinoma developed thromboembolic complications remote from primary surgery, whereas in a matched-control group of patients with nonclear cell ovarian carcinoma treated with platinum-based chemotherapy, no patients developed a thromboembolic complications (P = 0.0004). Eight of 40 patients (20%) with clear cell ovarian carcinoma treated with platinum-based chemotherapy developed thromboembolic complications, whereas 4 of 71 patients (6%) treated with nonplatinum-based chemotherapy developed thromboembolic complications (P = 0.03). Multivariate logistic regression analysis demonstrated that the development of a thromboembolic complication was significantly related to clear cell ovarian carcinoma and platinum-based chemotherapy and had a significant (P = 0.009) negative impact on survival. CONCLUSIONS: Platinum-based chemotherapy did not appear to improve survival compared with nonplatinum-based chemotherapy of patients with clear cell ovarian carcinoma. The combination of platinum-based chemotherapy and clear cell ovarian carcinoma significantly increases the risk for thromboembolic complications and has a significant negative impact on survival.

Paclitaxel and cisplatin combination chemotherapy in recurrent epithelial ovarian cancer.

The objective of this study was to assess the efficacy of chemotherapy in recurrent epithelial ovarian cancer using the sequential combination of 24-hr paclitaxel followed by cisplatin. All patients presenting to the Department of Gynecologic Oncology at Roswell Park Cancer Institute between April 1993 and May 1995 with recurrent epithelial ovarian cancer were offered enrollment in a prospective trial utilizing paclitaxel 135 mg/m2 administered in a continuous 24-hr intravenous infusion, followed by intravenous cisplatin 50 mg/m2. Forty-nine patients were entered into the study. Of 38 patients evaluable for response, there were 14 complete responders and 6 partial responders for an overall response rate of 53%. Median survival was >23 months for responders and 12 months for the entire study group. All complete responders were still alive with a median follow-up of 23 months. Of 12 evaluable patients whose tumors had progressed on single-agent paclitaxel, 4 achieved an objective response with the addition of cisplatin. Response rates and survival were similar in patients with platinum-resistant tumors compared to patients with platinum-sensitive tumors, and in patients who had received one, two, or multiple prior chemotherapy regimens. The combination of paclitaxel administered in a 24-hr infusion followed by cisplatin is highly active in recurrent epithelial ovarian cancer, even in patients who have previously failed single-agent paclitaxel or cisplatin-based chemotherapy.

Lymphvascular space involvement--a prognostic indicator in endometrial adenocarcinoma.

The present study evaluates the effects of various prognostic indicators on survival of patients with clinical Stage I endometrial carcinoma. Ninety-three patients who were treated for clinical Stage I endometrial adenocarcinoma at Maimonides Medical Center from October 1979 to October 1987 had sufficient surgical-pathological information for retrospective surgical staging according to the new FIGO classification. Histology was reviewed. A new grade and surgical stage was assigned to each patient in accordance with the recent FIGO guidelines for surgical staging of corpus cancer. Poor prognostic indicators, namely, tumor grade, depth of myometrial invasion, peritoneal cytology, lymph node metastases, and lymphvascular space (LVS) involvement, were correlated with 5-year survival rates. Survival rates were calculated by the life table method. Depth of myometrial invasion, lymph node involvement, and peritoneal cytology had significant statistical correlation with poor survival. Positive finding of each of the prognostic indicators, including LVS involvement, was significantly associated with poor survival (all P less than 0.001). The value of these prognostic indicators in early endometrial carcinoma is discussed.

A prospective trial of progesterone therapy for malignant peritoneal cytology in patients with endometrial carcinoma.

From February 1982 to February 1991, 45 patients with endometrial carcinoma confined to the uterus except for malignant peritoneal cytology were treated with 1 year of progesterone therapy. Thirty-six patients have undergone planned second-look laparoscopy with repeat peritoneal washings and the remaining 9 patients either refused second-look laparoscopy or the procedure was medically contraindicated. Of the 36 who underwent second-look laparoscopy, 34 (94.5%) were NED (no evidence of disease) and had negative repeat peritoneal cytology and 2 (5.5%) had persistent malignant cytology. The latter two patients, after an additional year of progesterone therapy, were found to be NED and had negative peritoneal cytology at third-look laparoscopy. Of the 45 women enrolled in this protocol, no patient has developed recurrent endometrial cancer, and the expected 5-year disease-free survival was 88.6%.

Estrogen replacement therapy following oophorectomy in women with a family history of ovarian cancer.

Compliance with estrogen replacement therapy (ERT) following surgical menopause is poor. In women who have a family history of ovarian cancer, fear of the oncogenic potential of estrogen might affect compliance with ERT following oophorectomy. Compliance with ERT in such a select group of women has not been previously reported. The aim of the present study was to report on compliance with and side effects of ERT in women with a family history of ovarian cancer who underwent oophorectomy either prophylactically or for benign disease. Eighty women with a family history of ovarian cancer who underwent oophorectomy at Roswell Park Cancer Institute were followed for a median duration of 4.2 years (range, 5 months to 14 years). Of the 76 women who were given prescriptions for ERT, the rates of commencement and maintenance of ERT at 1, 2, and 5 years were calculated. Side effects related to the different modalities of ERT were recorded. Seventy-one of 76 women (93.4%) who were given prescriptions for ERT initiated treatment. The rate of commencement of ERT was higher in premenopausal than in postmenopausal women (98.3% versus 75%, respectively, P = 0.003). Except for one patient who developed breast cancer after the oophorectomy and was advised to stop estrogen, all patients said they continued to use ERT. The maintenance rates at 1, 2, and 5 years were 100% as per patients' history. The pharmacy records for ERT prescription refills were reviewed for 52 patients who were on ERT for more than 1 year. ERT compliance was confirmed in 42 patients (80.7%). Seven of 30 patients (23.3%) who retained their uterus developed irregular uterine bleeding and 4 underwent endometrial biopsies. The incidence of irregular uterine bleeding was significantly higher after continuous compared to cyclic estrogen and progestogen (37.6 and 7% respectively, P = 0.049). Four patients (5.6%) complained of hot flashes and were managed by changing the dose or formula of estrogen. Compliance with ERT among patients with a family history of ovarian cancer who underwent oophorectomy either prophylactically or for benign disease was excellent. The presence of the uterus and the incidence of irregular uterine bleeding did not affect patients' compliance with ERT.

Analysis of failed and complicated laparoscopy on a gynecologic oncology service.

OBJECTIVE: To assess the incidence of and factors that predict failed or complicated operative laparoscopy on a gynecologic oncology service. METHODS: Two hundred four consecutive operative laparoscopies were reviewed. Procedures converted to laparotomy or associated with major operative or postoperative complications were compared with uncomplicated laparoscopies with respect to patient characteristics, details of operative procedure, and length of hospitalization. The influence of patient characteristics, operative findings, and specific procedures on the risk of failed or complicated laparoscopies was estimated. RESULTS: Twenty-five (12. 3%) procedures were either converted to laparotomy or associated with major operative or postoperative complications. Women with failed or complicated laparoscopies had significantly more previous laparotomies and adhesions, greater blood loss, and longer hospital stay than those with uncomplicated laparoscopies (60.0% vs 35.7%, P = 0.03, 68.0% vs 37.4%, P<0.001, 275 ml vs. 132 ml, P = 0.03; and 5. 9 days vs 0.98 days, P< 0.001, respectively). Age, body mass index, parity, menopausal status, preoperative CA-125, appearance of adnexal masses, and complexity of the procedure had no significant influence on failed or complicated laparoscopies. In univariate analysis, history of laparotomy and presence of adhesions and in multivariate analysis only presence of adhesions were predictive of failed or complicated laparoscopies (P = 0.03, <0.001, and 0.006, respectively). CONCLUSIONS: The incidence of failed and complicated laparoscopy is low on a gynecologic oncology service. Presence of adhesions is the only significant independent risk factor predictive of failed or complicated laparoscopy.

Evaluation of survival after second-line intraperitoneal cisplatin-based chemotherapy for advanced ovarian cancer.

BACKGROUND: The authors sought to evaluate survival of patients with ovarian cancer treated with second-line intraperitoneal cisplatin-based chemotherapy. METHODS: From August 1985 to September 1991, 63 patients with recurrent or persistent ovarian cancer after first-line cisplatin-based chemotherapy were on a protocol and treated with cisplatin, cytarabine, with or without bleomycin. Eligibility included Stage III/IV invasive adenocarcinoma of the ovary, documentation of the size of residual disease at reoperation, and prior treatment with first-line intravenous cisplatin-based chemotherapy. RESULTS: The median survival from intraperitoneal chemotherapy was 29 months. For patients who responded to first-line chemotherapy and second-line intraperitoneal chemotherapy, the 5-year survival was 60%, but for patients with response to first-line chemotherapy but no response to intraperitoneal chemotherapy the 5-year survival was only 17%, and no patient survived 5 years who did not have a response to first- or second-line therapy (P < 0.0001). There was significant improvement in the 2-year survival from initiation of intraperitoneal chemotherapy for patients with < or = 5 mm residual tumor in greatest dimension (74%), compared with patients with residual tumor larger than 5 mm and smaller than or equal to 2 cm (38%), and patients with residual tumor larger than 2 cm (0%) (P < 0.0001). CONCLUSION: Survival was increased for patients who (1) had a response to first-line intravenous chemotherapy and second-line intraperitoneal chemotherapy and (2) who had residual tumor 5 mm or smaller at the initiation of intraperitoneal therapy. The conclusion that the prolonged survival is secondary to cisplatin-based chemotherapy administered intraperitoneally must be made with caution because survival may have been secondary to the small residual disease at initiation of second-line chemotherapy or the systemic effect of cisplatin.

Five-year survival after second-line cisplatin-based intraperitoneal chemotherapy for advanced ovarian cancer.

BACKGROUND: To evaluate the 5-year survival rates of second-line intraperitoneal chemotherapy in advanced-staged ovarian cancer. MATERIALS AND METHODS: Between August 1985 and September 1991, 63 patients with advanced epithelial ovarian cancer received intraperitoneal cisplatin and cytarabine chemotherapy as second-line treatment. RESULTS: The median survival from the time of initiation of intraperitoneal chemotherapy (IPC) was 29.1 months. A significant advantage in 5-year survival (40%) and 5-year progression-free survival (37%) was observed among 21 patients who demonstrated a response to first-line and second-line treatment compared to those who demonstrated a response to first-line treatment only (6 and 0%, respectively) (P < 0.0001). No patient (n = 13) who failed to respond to either first-line or second-line treatment survived for 5 years. Among 42 patients with < or = 5 mm residual disease at the time of initiation of IPC, 5-year survival was 36% and 5-year progression-free survival was 31%, while no patient (n = 21) with residual disease measuring > 5 mm at the initiation of IPC survived 5 years (P < 0.0001). CONCLUSION: Given the limitation that this is not a randomized trial, the data appear to indicate that salvage platinum-based intraperitoneal chemotherapy results in significant 5-year survival and progression-free survival in selected patients who initiated therapy with small (< or = 5 mm) tumor burden. These survival rates as second-line therapy approach those achieved by first-line platinum-based intravenous chemotherapy in patients with advanced-stage ovarian cancer with similar small residual disease at the initiation of therapy.