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This study reviews the experience at the University of Texas M.D. Anderson Cancer Center with elderly patients treated for advanced epithelial ovarian cancer with cisplatin-based combination chemotherapy.From 1978 through 1988, 215 patients with Stage III or IV, Grade 2 or 3 epithelial ovarian cancer were entered onto one of three consecutive trials involving cisplatin-based combination chemotherapy. The treatment plans were as follows: Trial 1: 12 cycles of cisplatin-melphalan (75 patients); Trial 2: 12 cycles of cisplatin-cyclophosphamide (49 patients); and Trial 3: 6 cycles of cisplatin-cyclophosphamide (91 patients). End-points of analysis included the effect of age on other prognostic factors, clinical response rate, surgical response rate, toxicity, progression-free survival, and survival.Of the entire study group, 57 patients (27%) were 65 years of age and older at diagnosis. There was no effect of age on FIGO stage or histologic grade distribution, but 61% of patients younger than 65 years of age had residual tumors less than or equal to 2 cm compared with only 33% of patients 65 years of age and older (P = 0.00027). There were no differences between the two age groups with respect to response rates, recurrence rate after negative second-look surgery, toxicity, or progression-free survival. Patients in the younger than 65 years of age group, however, had a significantly longer median survival time than those 65 years of age and older (30 versus 19 months, respectively) (P = 0.0038).This analysis suggests that elderly patients are more likely to begin chemotherapy with bulky residual disease and to have a significantly shorter survival time than their younger counterparts.

Purpose To evaluate the efficacy and toxicity of intravenous cisplatin and vinorelbine as combination chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the cervix. Patients and Methods Between August 1997 and January 2001, 73 patients with advanced or recurrent squamous cell carcinoma of the cervix were entered onto this study. Eligible patients had received no prior therapeutic chemotherapy, except when administered concurrent with primary radiation therapy. The initial doses administered were cisplatin 75 mg/m2 every 4 weeks and vinorelbine 30 mg/m2 weekly. Subsequent doses were unchanged, reduced, escalated, or omitted according to observed toxicity and protocol guidelines. Patients were evaluated for response and toxicity using standard Gynecologic Oncology Group criteria. Results Of 73 patients, 67 were eligible and assessable. The overall response rate was 30% (five complete and 15 partial responses). The overall median response duration was 5.5+ months. The major toxicity was neutropenia, with 16% grade 3 and 67% grade 4 reported. Gastrointestinal and neurotoxicity were infrequent and mild. Conclusion The combination of cisplatin and vinorelbine has moderate activity in advanced or recurrent squamous cell carcinoma of the cervix. Additional study of this regimen in a phase III setting is justified in this patient population.

This chaptertraces the connections between a prevailing mode of “authenticity” in Cecil B. DeMille’s 1956 film The Ten Commandments and the music Elmer Bernstein wrote for the film. It describes how Bernstein’s musical score for the riot around the Golden Calf created the necessary orgiastic impression and how DeMille’s narration created the distance that freed the scene from any risk of censorly reproach. It also considers the devotional and political elements of the film and its religious and social impact.

The aim of this study was to develop a surveillance program that optimizes clinical outcome following primary treatment of women with cervical cancer.The records of 1096 patients with FIGO stage IB cervical cancer treated from 1983 to 1993 were retrospectively reviewed. Recurrence was analyzed by site, presence or absence of symptoms, method of detection, and survival. Univariate and multivariate analyses using a Cox proportional hazards model were performed.One hundred thirty-three patients (13%) developed recurrent disease. Of these, 114 were symptomatic and 19 were asymptomatic at the time of recurrence. Thirty-seven patients recurred in the central pelvis, 21 each in the lung or pelvic wall, 22 in nodes, and 35 in other sites. The median disease-free interval was 17 months for symptomatic patients and 16 months for asymptomatic patients. The median survival from initial diagnosis was 31 months for symptomatic and 83 months for asymptomatic patients (P = 0.001). The median survival from recurrence was 11 months for symptomatic and 42 months for asymptomatic patients (P0.001). Multivariate analysis revealed that symptom status at time of recurrence was a significant predictor of survival, even when known prognostic factors were considered (P0.001). All asymptomatic pelvic recurrences were diagnosed by pelvic exam; all asymptomatic pulmonary recurrences were detected by chest radiographs. Pap smears did not detect a single asymptomatic recurrence.Posttherapy surveillance programs are directed toward asymptomatic patients in whom early detection of recurrence may impact survival. These data indicate that a subset of women may benefit from surveillance. A model for surveillance is proposed.

Objective: To study reproductive function and disease outcome in women with borderline ovarian tumors who were treated with conservative surgery. Methods: Patients with borderline ovarian tumors were identified from institutional databases. Patients were eligible if they had pathologically confirmed borderline ovarian tumors, no prior sterilization, no history of radiation therapy, retained their uterus and ovarian tissue, and were younger than age 45. Information was acquired by retrospective medical record review and patient interview. Results: Forty-three patients met the eligibility criteria. The median age was 25 years, with a range of 15‐39 years. Twenty-six patients had serous tumors, and 17 had mucinous tumors. Fifteen had stage I disease, three had stage III, and 25 were unstaged. Follow-up was available for all patients (median, 5.7 years). Twenty-nine remained diseasefree, and 14 developed a new primary lesion/recurrence, with a median time to recurrence of 39.3 months. Recurrence was more frequent in patients treated with ovarian cystectomy than in those treated with oophorectomy alone (58% compared with 23%) (P < .04). After treatment, 29 of 36 patients (81%) retained normal menstrual cycles, and 12 of 24 patients attempting pregnancy conceived 25 pregnancies. Most patients were highly satisfied with conservative surgery. Conclusion: Conservative surgery remains a therapeutic option in selected patients with borderline ovarian tumors. Although the rate of new lesion/recurrence is relatively high, especially in those treated with ovarian cystectomy, mortality from cancer remains low. Many patients who desire pregnancy are able to conceive and deliver healthy offspring after conservative surgery. (Obstet Gynecol 2000;95:541‐7. © 2000 by The American College of Obstetricians and Gynecologists.)

mg/m 2 . In the second stage of the study, the doses of cisplatin and melphalan were fixed at 75 mg/m 2 and the MTD level, respectively, and the dose of paclitaxel was escalated. The planned dose escalation levels of paclitaxel were 150 mg/m 2 , 175 mg/m 2 , 200 mg/m 2 , 225 mg/m 2 , and 250 mg/m 2 . G-CSF was administered for 12‐19 days with each cycle, and cycles were repeated every 4 weeks for a total of 6 cycles. Other end points included clinical or surgical response, progression free survival, and survival. RESULTS. Between January 1993 and May 1996, 34 women with untreated advanced stage epithelial ovarian carcinoma or primary peritoneal carcinoma were treated with 192 cycles of therapy. The MTD of melphalan was 10 mg/m 2 , with the dose-limiting toxicity being thrombocytopenia. Paclitaxel was escalated to a dose level of 200 mg/m 2 with a toxicity rate of , 33%. The clinical response rate was 80% in 29 patients with measurable disease. Of 11 patients who underwent second-look surgery, 5 (45%) had a surgical pathologic complete response. The median progression free survival was 16.8 months and the median survival was 32.8 months. CONCLUSIONS. The combination of intravenous melphalan, paclitaxel, and cisplatin was found to have acceptable toxicity and good activity. A Phase II study of this combination appears to be warranted. Cancer 1999;86:2291‐300. © 1999 American Cancer Society.

Purpose: To evaluate the long-term results of continuous infusion intra-arterial 5-fluorouracil (CI IA 5-FU) given with concurrent pelvic radiotherapy (RT) for FIGO stage IIIB–IVA carcinoma of the cervix. Methods and Materials: Between 1965 and 1974, 27 patients with extensive FIGO Stage IIIB (22 patients) or Stage IVA (5 patients) squamous cell carcinoma of the cervix were treated with CI IA 5-FU and RT. Twenty-one patients (78%) had bilateral pelvic wall involvement, 25 (93%) had massive tumors (≥8 cm in diameter), 7 (27%) had involvement of the lower one-third of the vagina, and 15 (56%) presented with hydronephrosis. All patients underwent routine clinical staging, transperitoneal para-aortic lymph node dissection, and bilateral hypogastric artery catheter placement. 5-FU was continuously infused at a dose rate of 10 mg/kg/day on Days 1–15 of RT. The median dose of 5-FU was 376 mg/m 2 /day (range 270–692). All patients received concurrent pelvic RT to a median dose of 50 Gy at 2.0 Gy per fraction. Only 4 patients received intracavitary RT. The median follow-up of surviving patients was 190 months. Results: The overall 5-year survival rate was 37%. For the 22 patients with FIGO Stage IIIB disease, the 5-year survival rate was 41%. The survival rate for 18 patients treated with only external beam radiation and chemotherapy for Stage IIIB disease was 33%. Four of 10 patients treated with only 50 Gy of external beam radiation and CI IA 5-FU were long-term survivors. Acute complications, including hematologic toxicity and skin reactions, were severe, with 1 death from neutropenic sepsis. Severe late complications were only observed in patients treated with ≥ 60 Gy of external beam radiation. Conclusions: While this series is small, the fact that 4 patients with massive Stage IIIB tumors survived after a total radiation dose of only 50 Gy suggests that RT with CI IA 5-FU deserves further study. Modifications in dose, technique, and route of administration should reduce toxicity, and the addition of intracavitary RT should improve the local effectiveness of combined treatment.

PURPOSE To identify characteristics that predict response to chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the cervix. PATIENTS AND METHODS Between January 1986 and May 1996, 190 chemotherapy-naive patients with advanced or recurrent squamous cell carcinoma of the cervix not amenable to curative radiation therapy or surgery were treated on 14 different chemotherapy protocols at M.D. Anderson Cancer Center. Patient's charts were retrospectively reviewed for patient demographics, tumor and treatment characteristics, and patterns of response and survival. RESULTS Of 190 patients, 22 had advanced or persistent disease and 168 had recurrent disease. Patients were treated with platinum-based (n=95) and non-platinum-based (n=95) regimens. The overall response rate was 20.0% (4.2% complete response; 15.8% partial response), with a median response duration of 4.8 months. Race, socioeconomic class, tumor stage and grade, mode of primary treatment, time from primary diagnosis to disease recurrence, initial performance status, and use of platinum-based therapy were not significant predictors of response. Age at time of chemotherapy (P=.001) and site of recurrence (P=.044) were significant determinants by multivariate analysis. Patients who were older were more likely to respond to therapy, and the response rate for patients in whom disease recurred outside the irradiated field was 25.2%, compared with a 5.3% response rate for patients with recurrent disease limited to a previously irradiated field. CONCLUSION The site of disease recurrence and patient age should be taken into account when designing chemotherapy trials and also when considering chemotherapy in the patient with recurrent cervix cancer.

To assess the effect of high-fiber dietary instruction in relieving chronic constipation, a known and accepted complication of radical hysterectomy (RH).Thirty-five women with a diagnosis of cervical cancer who were scheduled for RH were randomized into groups that followed either a high-fiber diet plan or their usual diet. Data were gathered using a validated subjective bowel function questionnaire (SBFQ); a typical day's intake form and food frequency tool; and a diary used to record food, medication, bowel, and exercise information. Patients were evaluated at 1, 4, and 7 months after surgery.Postoperatively, the dietary fiber intake was significantly higher for the treatment (T) group (22.9 g) than the control (C) group (12.4 g) (P = 0.007). With regard to intergroup comparisons, there were few differences at the first follow-up. By the second visit, the T group reported taking medications to achieve regularity less often (P = 0.0269), straining less often (P = 0.0210), having pain with bowel movement (BM) less often (P = 0.0116), and having crampy abdominal pain less often (P = 0.123) than the C group. Four significant positive changes occurred in the T group, whereas only one occurred in the C group. With regard to intragroup comparison, the significant changes in bowel function in the T group were generally positive, whereas all of the C group's significant changes were negative. According to summary questions on the SBFQ, the T group reported a significant change in the frequency of BM (P = 0.0096); however, the C group reported no significant changes. Analysis of bowel function records showed clearer differences. The T group took less time to defecate (P0. 001) but had more BMs accompanied by gas (P0.001). The C group had significantly more BMs with cramps (P0.001), straining (P0. 001), and retention (P0.001) and significantly more BMs, which were hard (P0.001). Two C patients dropped out of the study because of severe bowel dysfunction despite maximum medication.Dietary management seems to be an inexpensive effective therapeutic intervention for addressing bowel dysfunction associated with RH.

To evaluate the effectiveness of an outcomes-management program designed to provide high-quality patient care, generate data for outcomes research, and decrease costs in a managed-care environment.An outcomes-management program was launched in June 1994, based on the elimination of wasteful or ineffective therapies through the systematic development of practice guidelines and collaborative care paths, with concomitant definition of desired outcomes. Over 3 months, care paths were developed for our most common surgical procedures. A matched control outcomes study was undertaken for the most commonly performed gynecologic oncology procedure: total abdominal hysterectomy and oophorectomy with pelvic and para-aortic node sampling for endometrial cancer. Thirty consecutive women treated on the care path were compared with 29 matched controls accrued during the period of care-path planning and with 73 controls from the period preceding care-path planning. Patient satisfaction with care-path treatment was assessed by a survey sent 2 weeks after discharge.Median length of hospital stay decreased significantly, from 6 days before care-path planning to 4 days after care-path implementation (P.001). Median laboratory costs decreased by 74% (P.001), medication costs by 35% (P.001), room costs by 29% (P.001), and total hospital costs by 20% (P.002). Incremental improvements were observed during care-path planning. There were no readmissions for complications in the care-path group. According to the survey results, patient satisfaction with care was very high among care-path patients.A physician-driven outcomes-management program in an academic setting permits the delivery of high-quality care and supports outcomes research while decreasing costs.

Purpose: To evaluate the role of surgical debulking in patients with stage IV ovarian cancer. Methods: We conducted a retrospective review of patients with advanced epithelial ovarian cancer treated at M. D. Anderson Cancer Center. Eligible patients included women with stage IV disease treated with platinum-based chemotherapy. Surgical debulking was considered optimal if the diameter of the largest residual tumor was 2 cm or less. Survival analysis and comparisons were performed using the Kaplan–Meier method and the log-rank test. Results: One hundred eight women with stage IV ovarian cancer were identified. The extraperitoneal metastatic sites were the liver parenchyma in 16 patients, the pleura in 54 patients, a variety of other organs in 22, and two or more sites in the remaining 16. Median age of the patient population was 58 years (range 35–81 years). Surgery to reduce the primary tumor was performed in 100 patients. The procedures included salpingo-oophorectomy with or without hysterectomy in 94 patients, omentectomy in 90, small bowel resection in 4, large bowel resection in 23, and splenectomy in 2. At the completion of surgery, tumor reduction was considered optimal in 31 patients, suboptimal in 61, and undetermined in 8. The overall median survival for optimally debulked patients was 25 months compared to 15 months for suboptimally debulked patients (P< 0.02). The progression-free survival, on the other hand, was not statistically different between the two groups. Conclusion: Residual tumor seems to be an important prognostic factor in patients with stage IV ovarian cancer. Surgical debulking may play a significant role in the treatment of these patients.