Carboplatin and paclitaxel in advanced or metastatic endometrial cancer.

OBJECTIVES: The purpose of this study was to evaluate the activity and toxicity of carboplatin and paclitaxel combination in advanced or recurrent endometrial carcinoma. METHODS: Forty-seven eligible patients with measurable advanced or recurrent endometrial carcinoma were treated with carboplatin [area under the curve (AUC) 5] and paclitaxel 175 mg/m(2) every 3 weeks for 6-9 cycles or until disease progression or unacceptable toxicity. RESULTS: There were 10 complete responses (CRs) (21%) and 19 partial responses (PRs) (41%) for an overall response rate (RR) of 62% (29 patients) (95% confidence interval [CI], 47-76%). The median progression-free survival (PFS) was 15 months (95% CI, 7.3-22.7 months) and the median overall survival (OS) was 25 months (95% CI, 19.0-31.0 months). No difference was found in RR and OS in patients with primary advanced disease and those with recurrent tumors. Similarly, no difference was found in PFS and OS for patients with serous/clear tumors and those with endometrioid tumors. Toxicity was generally mild except for myelotoxicity. Neutropenia grade 3/4 was recorded in 36% of patients and 6% experienced febrile neutropenia. One patient each developed grade 4 thrombocytopenia and anemia. Grade 3 sensory neuropathy was recorded in 6% of patients. CONCLUSION: The combination of carboplatin and paclitaxel appears to have activity in advanced or recurrent endometrial carcinoma with an acceptable toxicity profile.

A phase III randomized study comparing paclitaxel and cisplatin versus cyclophosphamide and cisplatin in patients with advanced ovarian cancer.

AIM: To assess progression-free survival (PFS) and overall survival (OS) in patients with advanced epithelial ovarian cancer receiving the combination of cisplatin (75 mg/m(2) i.v.) and cyclophosphamide (700 mg/m(2) i.v.) (CP), or the combination of paclitaxel (175 mg/m2) followed by cisplatin (75 mg/m2) (TP). PATIENTS AND METHODS: One hundred and twenty patients were randomized to receive six cycles of one of the treatments every 3 weeks. If measurable, complete response (CR) or partial response (PR) was determined. RESULTS: There was a significant difference (p<0.05) in the frequency of response (CR +PR) rates between treatment groups, in favor of paclitaxel containing regimen. The median PFS was 9 months for patients in the CP group and 12 months for patients in the TP group (log-rank p=0.215). The median OS were 24 months and 20 months in TP and CP arms, respectively (log-rank p=0.350). Neutropenia and alopecia were more severe with paclitaxel-containing regimen. CONCLUSION: Although OS and PFS were similar in two arms, TP regimen yielded superior response rates relative to CP, with an acceptable toxicity profile. Therefore, the TP regimen remains the preferred initial treatment option.

Pharmacokinetic profile and efficacy of a fentanyl transdermal delivery system for acute postoperative pain after intra-abdominal gynecologic surgery for cancer.

PURPOSE: This prospective, randomized, single-blind study evaluated the efficacy and pharmacokinetic profile of a transdermal delivery system for fentanyl to provide relief of acute postoperative pain in patients undergoing intra-abdominal gynecologic surgery for cancer. METHODS: Forty female patients were randomized to either transdermal fentanyl 50 microg/hour (n = 20) or transdermal placebo (n = 20). Transdermal systems were placed 1 hour preoperatively and removed 25 hours later. Pain control was supplemented with a nonopioid drug, bupivacaine 0.125-0.25%, administered through an epidural catheter via patient-controlled epidural analgesia. Serum fentanyl concentrations, bupivacaine consumption, pain scores [visual analog scale (VAS)], sedation rating score, adverse events, and physiological parameters were recorded for 48 hours postoperatively. RESULTS: The minimum effective concentration of fentanyl in serum (0.63 ng/mL) was achieved at 11.3 +/- 4.9 hours after application, and serum concentrations remained above this level until 13 hours after removal. The TTS-F group had lower VAS pain scores and a significant 66% reduction in utilization of bupivacaine compared with placebo. Pain scores were significantly correlated with serum fentanyl concentration (P = 0.025). All physiological parameters fluctuated within normal range and no differences were observed between treatments. Adverse events were similar between the groups with only the incidence of local erythema significantly higher in the TTS-F group (30% vs. 5%, P < 0.05), and sedation scores were significantly higher in the TTS-F group during the immediate postoperative period. CONCLUSION: The transdermal therapeutic system for administration of fentanyl, combined with epidural administration of a nonopioid analgesic such as bupivacaine is effective in controlling postoperative pain after gynecologic surgery. Additionally, the safety/tolerability of this regimen was similar to placebo plus bupivacaine.

A safe method of gut resection in women with complicated post-radiation enteritis after cervix cancer.

BACKGROUND: Resection of the irradiated gut in women with cervical cancer is complicated by high morbidity and mortality mainly due to accidental injuries to the adjacent intrapelvic structures. To eliminate these injuries a new method is proposed. METHOD: Six patients between 41 and 56 years old who had received radiation therapy for cervical cancer were operated on for post-radiation injury of the terminal ileum. All patients underwent partial resection of the irradiated small bowel plus right colectomy. The surgical technique was undertaken so as to leave parts of the small bowel (20 to 45 cm) adherent to the adjacent organs when complete resection was judged precarious. RESULTS: All patients had an uneventful recovery with 6 to 14 days hospitalization. No complications related to the remaining intrabdominal parts of the gut were observed. All patients died of the primary disease over 1 to 5 years postoperatively. CONCLUSION: The method is safe, simple and eliminates injuries to the adjacent structures.

Prognostic factors for survival in invasive squamous cell vulvar carcinoma: a univariate analysis.

The charts of 50 women with invasive squamous cell vulvar carcinoma were reviewed retrospectively, and pathologic, medical and life style factors were analyzed for their possible influence on survival using the Cox regression univariate model. The median age of the cohort was 73.5 years. The patient distribution according to stage was as follows: stage I: 17; stage II: 16; stage III: 12, and stage IVa: 5 patients. The median follow-up was 61 months. The univariate analysis revealed that the overall survival was decreased by age > or = 73.5 years (p = 0.0185), advanced stage (p = 0.0026), grade III differentiation (p < 0.0001), ulcerative type of the tumor (p = 0.0055), tumor diameter >40 mm (p = 0.0053), obesity (p = 0.011), smoking (p = 0.0177), diabetes (p = 0.0122) and hypertension (p = 0.044), but not with clitoral involvement.

A randomized trial of pulsatile vs continuous oxytocin infusion for labor induction.

In a prospective randomized study, 560 pregnant women were subjected to labor induction with continuous or pulsed intravenous oxytocin infusion. There were no significant differences with respect to maternal history, Bishop score and perinatal morbidity. The mean induction to delivery interval was shorter in the pulsed infusion group than in the continuous infusion group (325 +/- 63 vs 433 +/- 67 min in primiparous, p < 0.001 and 204 +/- 52 vs 236 +/- 87 min in multiparous women, p < 0.01). The mean amount of oxytocin administered in the pulsed infusion group was also significantly lower than in the continuous infusion group (4.7 +/- 0.6 mU/min versus 9.6 +/- 3.4 mU/min in primiparous, p < 0.001 and 2.1 +/- 0.4 mU/min versus 5.2 +/- 2.3 mU/min in multiparous women, p < 0.001). Our study demonstrates that pulsatile administration of oxytocin is as safe as continuous intravenous infusion, requires less oxytocin and is more effective as it reduces labor duration.

Renin-aldosterone system alterations during abdominal gynaecological operations under general or combined general and epidural anaesthesia.

Alterations of plasma renin-activity and aldosterone levels were comparatively studied in 41 premenopausal patients who were subjected to total abdominal hysterectomy. Twenty-one women received general anaesthesia (group A) and 20 received a combination of general and epidural anaesthesia (group B). Five blood specimens were drawn from each patient in order to determine plasma aldosterone levels (PA) and plasma renin activity (PRA) by radioimmunoassay (RIA). The rise of PA levels in group A occurred 30 min after the initiation of surgery and at that time there was a statistically significant difference as compared with the epidural anaesthesia (EA) group (p < 0.001). PRA levels in both groups showed a rise of limited statistical significance at 30 minutes after the initiation of surgery (p < 0.05). During the remaining time intervals, group A did not show any significant changes, whereas group B showed a reduction of limited statistical significance (p < 0.05). General anaesthesia for gynecological abdominal surgery without the use of volatile agents significantly increases plasma aldosterone levels. Combined anaesthesia does not totally inhibit intraoperative hyperaldosteroism but it is much slower and is of great advantage for the patient.

A benign-looking subcutaneous metastasis from squamous cell cervical carcinoma: A case report and review of the literature.

A 30-year-old woman with a stage IIIB grade 3 squamous cell cervical carcinoma and pelvic lymph node metastases was treated with external beam radiotherapy and intracavitary brachytherapy. One month after the completion of the treatment, a rubbery, movable, and painless mass appeared in the lower third and outer aspect of her right thigh. The overlying epidermis was intact. The whole clinical picture and CT scan image indicated a benign tumor. Biopsy revealed a nonkeratinizing, grade 2-3, squamous cell carcinoma similar to the primary cervical tumor. She then received six cycles of chemotherapy (cis-platinum and 5-fluorouracil) with transient partial response. The patient died one year after the diagnosis of the disease. This is the 29th case of cutaneous metastasis from a cervical carcinoma, the seventh localized on the leg, but the first solitary one with a benign-looking appearance reported since 1855. The possible mechanism of this rare metastasis is debated and the literature is reviewed.