Does adjuvant chemotherapy improve the prognosis of cervical carcinoma with lymph-node metastasis? A long-term follow-up.

OBJECTIVE: to verify the efficacy of adjuvant therapy in the prevention of neoplastic recurrence in patients at high risk for lymph-node involvement on surgical examination. METHODS: 72 patients, suffering from squamous cell cervical carcinoma Stage IB-IIB (FIGO) who underwent radical hysterectomy with lymph-node involvement confirmed at the final histological examination, were enrolled. All the patients were treated with adjuvant chemotherapy (AC), which included cisplatin, bleomycin and vinblastine, and were followed for a minimum period of six years. The results were compared with those obtained with a historical group of 78 patients, with comparable age, stage and lymph-node involvement, on whom only radical surgery (RS) was performed. RESULTS: the average total survival rate of the two groups (RS + AC vs RS) at five years was 63.9% and 55.1%, respectively (chi2 = 1.191; p = NS). The disease-free interval was 55.6% vs 46.2% (chi2 = 1.324; p = NS). The best results were obtained in cases where the common iliac lymph-nodes were affected, with the highest survival rate of 16.9% in the RS+AC group, out of a total of 25 cases. CONCLUSIONS: adoption of adjuvant chemotherapy in patients at high risk for lymph-node positivity did not produce statistically significant results in terms of overall and disease-free survival; however, a small number of these patients, approximately 9%, could receive benefit from the treatment.

The role of neoadjuvant chemotherapy for squamous cell cervical cancer (Ib-IIIb): a long-term randomized trial.

OBJECTIVE: to verify whether a regimen of preventive chemotherapy in the treatment of cervical carcinoma allows surgical treatment in a larger number of patients and whether cases treated with this combined neoadjuvant polychemotherapy/surgery regimen improves overall and disease-free survival rates. DESIGN: prospective randomized clinical study. SETTING: Department of Gynaecology and Obstetrics, University of Rome "La Sapienza". METHODS: 192 patients suffering from squamous cell carcinoma of the uterine cervix in Stages Ib-IIb were randomized to one of the following treatments: three courses of neoadjuvant chemotherapy with cisplatin, vincristine, bleomycin (NACT arm; n = 106); conventional surgery or radiotherapy alone (CO arm; n = 86). One hundred and fifty-six patients in Stage Ib-IIb (n = 86, NACT arm and n = 70, CO arm) and 16 patients in Stage III (NACT arm) who proved to be sensitive to the neoadjuvant chemotherapy, underwent radical hysterectomy. Four Stage III patients not sensitive to chemotherapy and 16 patients, Stage III, of the CO arm underwent radiotherapy. RESULTS: the 5-year overall survival rates for the NACT and CO arm, respectively, were 78.6% and 73.2% in Stages Ib-IIa (p = NS), 68.7% and 64.3% in Stage IIb (p = NS). A 5-year disease-free survival rate for the NACT arm and CO arm, respectively, of 77.1% and 64.3% in Stages Ib-IIa (p < .05), 56.2% and 57.1% in Stage IIb (p = NS) was found. CONCLUSIONS: the responsiveness of cervical cancer to neoadjuvant chemotherapy allows surgical treatment in a larger number of patients and results in longer overall and disease-free survival.

Laparoscopic surgery in treatment of stage IIb cervical cancer after neoadjuvant chemotherapy. A case report and review of the literature.

BACKGROUND: A detailed operative procedure of laparoscopic radical hysterectomy (type III) with pelvic and aortic lymphadenectomy after neoadjuvant chemoterapy in treatment of Stage IIb cervical cancer is described. CASE REPORT: A 50-year-old patient with Stage IIb squamous cell carcinoma of the uterine cervix, who initially was not surgically resectable, received three courses of neoadjuvant chemotherapy that included ifosfamide 5 g/m2, cisplatin 50 mg/m2 and paclitaxel 175 mg/m2 (TIP). Following a partial clinical response to chemotherapy, the patient underwent laparoscopic type III radical hysterectomy with bilateral salpingo-oophorectomy and pelvic and paraaortic lymphadenectomy. The surgical procedure lasted 250 minutes. Blood loss was 310 ml. The patient was discharged on postoperative day 4. The mean length of the resected parametria and paracolpia was 4.1 cm and 2.0 cm, respectively. The number of dissected lymph nodes was 48:29 pelvic and 19 paraaortic nodes. No major intraoperative or postoperative complications occurred. The patient also underwent adjuvant radiation therapy. Follow-up was performed at six months so far. CONCLUSIONS: This experience suggests that such a surgical procedure is safe. Laparoscopic radical hysterectomy potentially allows for decreased perioperative morbidity and blood loss, faster recovery and better cosmetic results. Large studies with long term follow-up are needed to confirm that this approach may be proposed as an alternative to conventional surgery.

Hormonal replacement therapy and evaluation of intrauterine pathology in postmenopausal women: a ten-year study.

BACKGROUND: To evaluate the role of hormonal replacement therapy (HRT) in determining: a) abnormal uterine bleeding (AUB); b) increased endometrial thickness at transvaginal sonography (TVS); c) the correct indication for outpatient hysteroscopy (HS) and biopsy in diagnosing intrauterine pathology. METHODS: Between April 1991 and April 2001 a group of 3,400 postmenopausal women was referred to the Department of Obstetrics and Gynecology of Rome University "La Sapienza"; 16.7% of them had received HRT. 587 out of the 3,400 women were recruited for a comparative study, including four groups. To assess statistical significance of HRT in determining AUB, and/or endometrial thickness related to malignant disease the chi-square test was used; p < 0.05 was considered significant. Histology was considered the true result (control). RESULTS: An increase in the endometrial thickness occurred significantly more often in women on HRT (p < 0.03); as well as the percentage of AUB (p < 0.0001). No difference in the incidence of endometrial adenocarcinoma was reported between the HRT and the non HRT groups. CONCLUSIONS: In postmenopausal women using HRT we can confirm that a higher incidence of signs (AUB, endometrial thickness > or = 5 mm) does not coincide with a higher incidence of malignant pathology. The data obtained from the recruited patients was arranged and evaluated by the most suitable methods for screening endometrial adenocarcinoma. According to our experience, we believe a cut-off point of 8 mm to be significant (p < 0.001) to perform an hysteroscopy and biopsy except for asymptomatic patients on HRT.

[Effects of tamoxifen and estrogen replacement therapy on lipid metabolism and some other cardiovascular risk factors. A prospective study in hysterectomised women]. / Effetti del tamoxifene e della terapia estrogenica sostitutiva sul metabolismo lipidico e su altri fattori di rischio cardiovascolare. Studio prospettico in donne isterectomizzate.

BACKGROUND: The aim of this clinical study was to evaluate the relationship of tamoxifen and the risk factors of cardiovascular disease in hysterectomised women. METHODS: Between 1992 and 1998, 93 women were recruited for a prospective study with follow-up at 0, 12 and 24 months. All women had an increased risk of breast cancer and they were hysterectomised and ovariectomised for a benign pathology. They were divided according to the following categories: Group A was constituted of 26 (28%) symptomatic patients (hot flushes, depression) who had received tamoxifen and oral conjugated estrogens. Group B was constituted of 27 (29%) symptomatic patients who had received tamoxifen and transdermal 17B-estradiol. Group C was constitued of 19 (21%) asymptomatic patients who had received only tamoxifen. Group D (control) was constitued of 21 (22%) asymptomatic patients who had not received any therapy. A venous blood sample for total cholesterol levels (T-C), high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), triglycerides (TRG), fibrinogen (FBR), platelets (PLT) and antithrombin III (AT III) was taken during follow-up. ANOVA (repeated measures) was used to assess statistical significance: p<0.05 was considered significant (95% CI). RESULTS: The patients who received tamoxifen with or without estrogen replacement therapy showed after 24 months, a reduction of T-C, LDL-C and FBR (p<0.01); the HDL-C levels did not vary significantly compared to the control group (p=NS); the 26 patients of group A showed an increase of HDL-C (p<0.02). We reported an increase of TRG in the patients of group A and C (p<0.05); on the contrary, we obtained a significant reduction of TRG (p<0.01) in the patients who received tamoxifen and transdermal 17B-estradiol (group B). There was no interaction on plateled count (p=NS). CONCLUSIONS: These results suggest the administration of tamoxifen in hysterectomised women with a high risk of breast cancer and without climateric symptoms. In these patients, tamoxifen could reduce coronary heart disease and incidence of breast cancer. The symptomatic patients are suggested to receive tamoxifen and transdermal 17B-estradiol because of the better effects on lipid metabolism.

[The role of copper-releasing intrauterine device or levonorgestrel-releasing intrauterine system on uterine bleeding and iron status (prospective study of 8 years)]. / Modificazioni del flusso mestruale e dei parametri della crasi ematica in donne portatrici del dispositivo intrauterino medicato al rame o del sistema intrauterino liberante levonorgestrel. Studio prospettico di otto anni.

BACKGROUND: The aims of this study were the effects of copper intrauterine device (Cu-IUD) compared to progesterone (PRG-IUS) or levonorgestrel releasing intrauterine system (LNg-IUS) on menstrual bleeding, menorrhagia and dysfunctional uterine bleeding. The authors evaluated the effect of copper surface area on uterine bleeding. METHODS: Between March 1992 and November 1999, 223 women, referred to I Institute of Obstetrics and Gynaecology University of Rome, were recruited in a prospective study with follow up at 3, 6 and 12 months to evaluate the incidence of endometrial pathology. The study includes 38 fertile women with regular menstruations and without intrauterine devices, as control group, and 185 patients with intrauterine devices, divides as follows: - 117 copper-releasing intrauterine devices: 30 with a copper (Cu) surface area =200 mm2, releasing 45 microgram Cu/24h (Nova T (R)); 27 with a copper surface area =250 mm2, releasing 50 microgram Cu/24h (Multiload 250 (R)); 25 with a copper surface area =375 mm2, releasing 65 microgram Cu/24h (Multiload 375 (R)); 20 with a copper surface area =384 mm2, releasing 100 microgram Cu/24h (No Gravid M (R)); 15 with a copper surface area =440 mm2, releasing 120 microgram Cu/24h (No Gravid 0,5 (R)). - 68 progesterone/levonorgestrel-releasing intrauterine devices: 40 progesterone-releasing intrauterine systems (Progestasert(R)); 28 levonorgestrel-releasing intrauterine systems 20 mg/24h (Mirena (R)). A total of 211 subjects had data that were valid for analysis: 12 women out of 223 (5,4%) were excluded from the prospective study lost to follow-up. A venous blood sample for serum ferritin (mg/l), iron (mg/dl), hemoglobin (g/dl), hematocrit (%), blood cell count, MCHC and MCV was taken during follow-up. RESULTS: PRG or LNg-IUSs determined a significant reduction in menstrual blood loss and in irregular bleeding by gradually reducing endometrial fitness and vascularisation. Serum ferritin significantly increased in women inserted with LNg- IUSs already after 6 months (26+/-22 e 28+/-14 microgram/l versus 32.5+/-19 e 34.5+/-25 microgram/l). Hemoglobin significantly increased (p>0.05) 6 months after insertion. On the contrary this did not occur with the insertion of Cu-IUDs. We observed that the increased amount of copper, released by IUD, causes increasing of bleeding. CONCLUSIONS: The LNg-IUS is a new contraceptive method combining the advantages of both hormonal and intrauterine contraception. In addition, it can be considered an alternative method in the treatment of menorrhagia and dysfunctional uterine bleeding. On the contrary, in women inserted with Cu-IUDs, the main reason of menorrhagia probably is due both to the shape of device and to copper surface area.

[Hyperemesis gravidarum--etiology and treatment]. / Eziologia e trattamento dell'iperemesi gravidica.

Hyperemesis gravidarum is a common pathology encountered by the obstetrician in 0.1-2% of all pregnancies. The purpose of our review, along with other literature, is to report general outline of the syndrome, with etiology, complications and some guidelines about conventional and newer therapy.

[Recovery of cervical portio epithelial integrity using radiofrequency: preliminary results]. / Il recupero dell'integrità epiteliale della portio mediante radiofrequenza: risultati preliminari.

PURPOSE: The aim of this study was to evaluate the efficacy of the radiosurgical procedure (high frequency, filtered wave-form energy) in the management of benign lesions of uterine cervix. MATERIALS AND METHODS: In a prospective study a radiothermal cautery treatment by micro-needle was performed to 168 women, attending a gynecology office, with an abnormal cervical cytology, istology and with a colposcopic diagnosis of benign cervical lesions with a total visibility of squamous columnar junction and no extended lesion of cervical canal. Cytology and colposcopy were used to follow up after treatment 3-4 months and 10-12 months after the procedure. RESULTS: 130 women (77.6%) obtained a complete recovery at the first follow-up. Partial treatment failure, defined as the persistence or recurrence of a small cervical lesion after three months, was observed in 19 women (18.2%) but after a second treatment in the 100% we obtained a complete recovery with a well visible squamous columnar junction. Radiothermal cautery procedure was advantageous with a shorter duration of surgery, lower cost, reduced operation bleeding, no need for pain-relieving medication and shorter duration of postoperative disability. CONCLUSIONS: This surgical procedure resulted an excellent technique to obtain a complete epithelial recovery of uterine cervix, easy and cheap to be executed in a outpatient office.

[Laparoscopically assisted vaginal hysterectomy Gasless. Retrospective study in patients with uterine fibroids]. / Colpoisterectomia con assistenza laparoscopica Gasless. Studio retrospettivo per uteri voluminosi.

PURPOSE: To evaluate the feasibility to perform laparoscopically assisted vaginal hysterectomy in patients who were not suitable for vaginal hysterectomy. PATIENTS AND METHODS: LAVH Gasless was carried out on 31 patients with uterine fibroids. Uterine weight ranged of 420-800 gr. RESULTS: There were 2 laparotomy conversion (6%) for uterus 800 gr; median operating time was 79 +/- 18 minutes (range 75-89); the average haemoglobin drop was 1.7 +/- 0.9 g/dl; the mean in postoperative stay was 3.7 +/- 0.7 days (range 3-5). Febrile morbidity > 38 degrees C were found in 3 cases. CONCLUSIONS: Laparoscopic assistance has advantages in performing transection of round and infundibolo-pelvic ligaments in vaginal steps and in controlling post-operative blood loss.

A new flavone glycoside from the fern Pteris cretica.

A new flavone glycoside isolated from the fern Pteris cretica has been shown to be luteolin 7-O-robinobioside (1) by chemical and spectral methods. In addition luteolin 7-O-rutinoside (2) and luteolin 7-O-glucoside (3) have been isolated from this plant. Flavonoid 2 is reported for the first time in ferns.