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C Scarabelli

Publications and source records attributed to C Scarabelli.

At least 19 recordsLinked to original sources
PubMed2003

Doxorubicin versus doxorubicin and cisplatin in endometrial carcinoma: definitive results of a randomised study (55872) by the EORTC Gynaecological Cancer Group.

BACKGROUND: Combination chemotherapy yields better response rates which do not always lead to a survival advantage. The aim of this study was to investigate whether the reported differences in the efficacy and toxicity of monotherapy with doxorubicin (DOX) versus combination therapy with cisplatin (CDDP) in endometrial adenocarcinoma lead to significant advantage in favour of the combination. PATIENTS AND METHODS: Eligible patients had histologically-proven advanced and/or recurrent endometrial adenocarcinoma and were chemo-naïve. Treatment consisted of either DOX 60 mg/m(2) alone or CDDP 50 mg/m2 added to DOX 60 mg/m2, every 4 weeks. RESULTS: A total of 177 patients were entered and median follow-up is 7.1 years. The combination DOX-CDDP was more toxic than DOX alone. Haematological toxicity consisted mainly of white blood cell toxicity grade 3 and 4 (55% versus 30%). Non-haematological toxicity consisted mainly of grade 3 and 4 alopecia (72% versus 65%) and nausea/vomiting (36 % versus 12%). The combination DOX-CDDP provided a significantly higher response rate than single agent DOX (P <0.001). Thirty-nine patients (43%) responded on DOX-CDDP [13 complete responses (CRs) and 26 partial responses (PRs)], versus 15 patients (17%) on DOX alone (8 CR and 7 PR). The median overall survival (OS) was 9 months in the DOX-CDDP arm versus 7 months in the DOX alone arm (Wilcoxon P = 0.0654). Regression analysis showed that WHO performance status was statistically significant as a prognostic factor for survival, and stratifying for this factor, treatment effect reaches significance (hazard ratio = 1.46, 95% confidence interval 1.05-2.03, P = 0.024). CONCLUSIONS: In comparison to single agent DOX, the combination of DOX-CDDP results in higher but acceptable toxicity. The response rate produced is significantly higher, and a modest survival benefit is achieved with this combination regimen, especially in patients with a good performance status.

Adenocarcinoma↗
PubMed2001

Clinical evidence for topotecan-paclitaxel non--cross-resistance in ovarian cancer.

PURPOSE: A large, randomized study comparing the efficacy and safety of topotecan versus paclitaxel in patients with relapsed epithelial ovarian cancer showed that these two compounds have similar activity. In this study, a number of patients crossed over to the alternative drug as third-line therapy, ie, from paclitaxel to topotecan and vice versa. We therefore were able to assess the degree of non-cross-resistance between these two compounds. PATIENTS AND METHODS: Patients who had progressed after one platinum-based regimen were randomized to either topotecan (1.5 mg/m(2)/d) x 5 every 21 days (n = 112) or paclitaxel (175 mg/m(2) over 3 hours) every 21 days (n = 114). A total of 110 patients received cross-over therapy with the alternative drug (61 topotecan, 49 paclitaxel) as third-line therapy. RESULTS: Response rates to third-line cross-over therapy were 13.1% (8 of 61 topotecan) and 10.2% (5 of 49 paclitaxel; P =.638). Seven patients who responded to third-line topotecan and four patients who responded to paclitaxel had failed to respond to their second-line treatment. Median time to progression (from the start of third-line therapy) was 9 weeks in both groups, and median survival was 40 and 48 weeks for patients who were receiving topotecan or paclitaxel, respectively. The principal toxicity was myelosuppression; grade 4 neutropenia was more frequent with topotecan (81.4% of patients) than with paclitaxel (22.9% of patients). CONCLUSION: Topotecan and paclitaxel have similar activity as second-line therapies with regard to response rates and progression-free and overall survival. We demonstrated that the two drugs have a degree of non-cross-resistance. Thus, there is a good rationale for incorporating these drugs into future first-line regimens.

Adult↗
PubMed2001

Secondary cytoreductive surgery for patients with recurrent epithelial ovarian carcinoma.

OBJECTIVE: The aim of this prospective study was to evaluate the influence of secondary cytoreductive surgery on survival of patients with recurrent epithelial ovarian cancer. METHODS: Between June 1993 and June 1999, 149 patients after primary treatment underwent secondary cytoreductive surgery: 69 (46.3%) had recurrence-free interval (RFI) 7-12 months, 59 (39.6%) RFI 13-24 months, and 21 (14.1%) RFI >24 months. Exclusion criteria included secondary cytoreduction during second-look laparotomy, interval cytoreduction, and palliative surgery in patients with intestinal obstruction or progressive disease. RESULTS: The median follow-up was 27 months. According to multivariate analysis, RFI groups, prior chemotherapy combination, and residual tumor after secondary surgery were associated independently with overall survival. Residual tumor after secondary surgery was by far the most strongly predictive factor for patient's survival (hazard ratio (HR) 2.65; 95% confidence interval (CI) 1.43-4.92). The 2-year survival rates were 22.3, 62.9, and 22.7%, respectively, for patients with RFI 7-12, 13-24, and >24 months. The 5-year survival was 29% for patients with RFI 13-24 months. No patients with RFI 7-12 and >24 months outlived the 4-year estimate. Unexpectedly, RFI >24 months was not correlated significantly with overall survival. However, 17 patients (81%) with RFI >24 months were heavily treated with chemotherapy before secondary surgery. CONCLUSIONS: Patients who have documented gross disease preoperatively should be selected for a secondary debulking operation; the entity of surgical effort would be modulated in relation to previous treatment.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2000

Primary cytoreductive surgery with rectosigmoid colon resection for patients with advanced epithelial ovarian carcinoma.

BACKGROUND: The impact of radical bowel resection with multiple organ resection on the survival if patients with advanced ovarian carcinoma has not been well defined. The authors investigated whether primary cytoreductive surgery including rectosigmoid colon resection would affect the recurrence free interval and survival of these patients. METHODS: Between April 1990 and April 1997, 66 previously untreated Stage IIIC-IV ovarian carcinoma patients with macroscopic involvement of the rectosigmoid colon were enrolled. All patients underwent cytoreductive surgery with rectosigmoid colon resection to remove residual tumor less than 2 cm in greatest dimension and received 6 cycles of cisplatin-based postoperative chemotherapy. RESULTS: The median follow-up was 26 months (range, 7-104 months). In multivariate analysis, residual disease and depth of tumor infiltration of the bowel wall were independently associated with overall survival and recurrence free interval. Disease stage was independently associated only with overall survival. Residual tumor was the most strongly predictive factor for recurrence or death. The 2-year estimated survival rates according to the amount of residual tumor were 100% for 24 patients with no macroscopic residual disease and 77.3% for 28 patients with residual disease less than 1 cm. None of the 14 patients with residual disease larger than 1 cm were alive 2-years after operation. Overall, 48 patients (72.7%) developed disease recurrence: 43 (65.1%) in the abdomen, 19 (29.8%) in the liver, and 3 (4.5%) in the pelvis. CONCLUSIONS: The current findings suggest that cytoreductive surgery with rectosigmoid colon resection should be considered for ovarian carcinoma patients with bulky pelvic disease to help ensure that they are left with no residual disease after debulking surgery.

Adult↗
PubMed2000

Clinical value of intraoperative gross examination in endometrial cancer.

We present the largest multicenter study evaluating whether intraoperative visual estimation can accurately assess the depth of myometrial invasion in patients with endometrial cancer. The study population consisted of 403 consecutive women who underwent total hysterectomy for endometrial cancer. After the uterus was removed, a visual estimate of depth of gross myometrial invasion was recorded. The uterus was opened, the endometrial cavity was inspected, and one or more full-thickness incisions were made through the tumor, myometrium, and serosa. An intraoperative estimation of gross myometrial invasion was made and classified as more or less than 50% of the uterine wall. Gross visual estimation accurately identified the microscopic myometrial invasion in 85.3% (344/403) of cases. Sensitivity, specificity, and positive and negative predictive values of gross estimation in determining a microscopic myometrial invasion greater than 50% were 73.0, 92.5, 85.0, and 85.5%, respectively. Among patients in whom the myometrial invasion was underestimated at gross examination the tumoral invasion was limited to the inner two thirds of the myometrium in 45% (18/40) of cases and the distance from the tumor-myometrial junction to the uterine serosa was greater than 3 mm in 65% (26/40) of cases. We conclude that gross estimation of myometrial invasion is a reliable and inexpensive method for evaluating the invasiveness of uterine carcinomas and that deciding to perform an extensive surgical staging upon gross estimation will be in accordance with the final histopathologic report in about 9 of 10 cases.

Aged↗
PubMed2000

Determination of tamoxifen and its metabolites in the endometrial tissue of long-term treated women.

Concentrations of tamoxifen and its metabolites were analysed in the endometrium of 23 post-menopausal asymptomatic breast cancer patients who were on chronic tamoxifen therapy. Small endometrial samples were collected during diagnostic hysteroscopy. Analysis of both serum and tissue for these compounds was performed by mass spectrometry. Tamoxifen and its metabolites were far more concentrated in the endometrium than in serum; tamoxifen was also significantly more concentrated in endometrium with hyperplastic changes than in atrophic endometrium. Endometrial polyps of an additional 9 women showed a trend to a lesser concentration of compounds. Increased concentration of tamoxifen compounds could possibly be explained by the avidity of these compounds for oestrogen receptors (ER).

Antineoplastic Agents, Hormonal↗
PubMed2000

Primary Hodgkin's disease of the vagina.

We describe a patient with primary Hodgkin's disease (HD) of the vagina presenting with stage IEB. To our knowledge, this is the first case reported so far. Based on morphological and immunophenotypic features, the HD was classified as nodular sclerosis subtype, "syncytial" variant. The patient, a 64-year old woman, received chemotherapy followed by radiation therapy. She is still disease-free 14 months after diagnosis.

Female↗
PubMed2000

Different patterns of postoperative bleeding following cytoreductive surgery for gynecological cancer.

PURPOSE OF INVESTIGATION: To study the possible causes of postoperative bleeding following maximal cytoreductive surgery for gynecological cancers. METHOD: We have retrospectively reviewed all our cases of postoperative bleeding following major abdominal and pelvic cytoreductive surgery within a 48-hour period. In the postoperative period, replacement therapy was ineffective in achieving hemodynamic stability. During re-operation, the entire abdominal cavity was evaluated for bleeding sites that were adequately ligated or electrocoagulated. RESULTS: Of 942 women undergoing major cytoreductive surgery 22 women (2.3%) were re-operated for postoperative bleeding after a mean of 14.2 hours. Bleeding was either localized from a vessel in 9 women (40.9%) or diffuse (capillary oozing) in 13 women (59.1). Operative deaths have been as high as 36.8%. CONCLUSION: Postoperative bleeding following cytoreductive surgery can be from a single group of vessels or a capillary oozing from the edges or denuded areas of excised peritoneum.

Female↗
PubMed2000

Feasibility and pain control in outpatient hysteroscopy in postmenopausal women: a randomized trial.

BACKGROUND: Three methods of diagnostic hysteroscopy have been tested for both women's compliance and feasibility of procedures in postmenopause. METHODS: Three hundred and sixty-two postmenopausal women were enrolled in a three-arm study: 5 mm diagnostic sheath (Group 1, 119 women), 5 mm sheath with paracervical block (Group 2, 121 women), and 3.5 mm sheath (Group 3, 121 women). CO2 was the distention medium. Both feasibility of hysteroscopy (procedures failed due to stenosis or incomplete distention of cavity) and discomfort of women have been recorded. Pain perception has been measured on a visual numerical rating scale. Statistical analysis was performed by t-test for unpaired samples and chi-square test. RESULTS: Paracervical block was per se painful in 18.2% and bleeding from injection site occurred in 38.8%. Hysteroscopy failure due to stenosis occurred in 9%, 10% and 0.4% of the three groups respectively (p<0.01). Intolerable pain was reported by 17% of women in Group 1, 6% in Group 2 (p<0.05) and in none of Group 3 (p<0.01). Pain score improved from Group 1 to Group 3 (p<0.01). Hysteroscopy was incomplete because of gas leakage in 1.7% of both Group 1 and 2 and in 13.2% of Group 3 (p<0.01). CONCLUSIONS: Pain perception in postmenopausal women was reduced when paracervical block was used, but discomfort was even less with the narrow sheath hysteroscope. The narrow sheath will expose to a high percentage of inconclusive procedures but it can be overcome by changing to the large sheath hysteroscope without affecting patient pain perception.

Aged↗
PubMed1999

Treatment of vaginal intraepithelial neoplasia (VAIN) with the carbon dioxide laser.

The increasing incidence of VAIN especially in young women, the frequent relapses, and renewed interest in maintaining sexual function have prompted gynecologists to a conservative management of the disease. Over the last decades, surgery, 5-fluorouracil, chemosurgery, electrocautery and cryotherapy were used. Carbon dioxide laser ablation therapy of VAIN has been reported from various authors with different results. From June 1991 through December 1998, 39 patients affected by VAIN were treated with laser surgery (35 vaporizations and 4 excisions). To achieve complete elimination of all lesions, seven patients had two vaporizations and one patient three. One patient was submitted to six combined repeated treatments. Five patients were not evaluable and three presented persistence of VAIN. One patient died because of AIDS. The remaining 30 patients, treated with laser surgery, were lesion free: 7 patients were negative at 12-24 months, 10 at 24-36 months and 13 at 37-90 months. No important complications occurred. Sexual function was not compromised. Carbon dioxide laser is a safe and efficacious tool in the treatment of pre-neoplastic lesions of the vagina.

Adult↗
PubMed1998

Risk factors for endometrial cancer according to familial susceptibility.

Endometrial cancer (EC) shares some environmental or genetic risk factors with colorectal cancer (CRC). It represents a risk factor for CRC. Furthermore, EC is the most frequent extracolonic neoplasm in HNPCC (hereditary nonpolyposis colorectal cancer) and, in this syndrome, it has the same inheritance pattern as CRC. Neoplastic family history and clinical features were evaluated in women with EC in a health care district (Pordenone Province) in Northeastern Italy from 1990 to 1995, to examine the proportion of patients with hereditary cancer and the relation with clinical characteristics of EC. We interviewed 215 patients with EC (average age 61 years, range 35-88) in relation with some risk factors (age, weight, diabetes, menstrual and reproductive pattern, synchronous and metachronous neoplasms) and we obtained their family pedigree. Twenty-nine patients (13.5%) had a CRC family history, 66 (30.7%) showed an aspecific cancer aggregation in their families and more than half (120, 55.8%) had a negative cancer family history. Family pedigrees were consistent with a dominant inherited cancer pattern in 8 patients (3.7%) belonging to the CRC-related family history group. A different pattern of family history distribution emerged in relation with age (< 55 vs. > or = 55, p < 0.001) and body mass index (BMI) (< 26 vs. > or = 26, p = 0.002). Patients with a CRC pedigree were more numerous in the younger group, in the group with lower BMI and in pre-menopausal women.

Adolescent↗
PubMed1998

Maximal cytoreductive surgery as a reasonable therapeutic alternative for recurrent endometrial carcinoma.

OBJECTIVE: The objective was to determine if maximal cytoreductive surgery could carry any benefit in pelvic and abdominal recurrent endometrial carcinoma. METHODS: Twenty women at their first large pelvic or abdominal recurrence from endometrial carcinoma were treated with maximal cytoreductive surgery. Women were classified as R1 (residual tumor) or R0 (no residual tumor) by tumor left at the end of surgery. Adjuvant postoperative therapy was undertaken upon clinical judgement. Progression-free, overall, and cancer-related survivals were analyzed with the product-limit method and compared with the log-rank test. The Cox regression model was used to study the variables involved in progression-free and overall survival. RESULTS: Complete macroscopic resection of tumor was feasible in 13 women (65%). R0 group women had a significant both progression-free (median reached at 9.1 months) and overall survival (median reached at 11.8 months) compared to R1 group women. There were 2 (10%) perioperative deaths. Eight women died of cancer, 5 in the R1 group and 3 in the R0 group. There were four intercurrent deaths in women still free from the disease. Local control of neoplasia was achieved in 84.6% of R0 women and their survival was affected mostly by distant recurrences or intercurrent deaths. Residual tumor at the end of surgery was the only significant variable to affect both progression-free and overall survival. CONCLUSION: Intensive surgery is a valid treatment option in women with large pelvic or abdominal recurrence from endometrial carcinoma. Tumor can be completely resected and local control of the disease can be achieved in most of the patients, although survival could be affected by distant recurrence and intercurrent deaths.

Aged↗
PubMed1998

[Laser surgery in the conservative management of vaginal intraepithelial neoplasms].

BACKGROUND AND AIMS: The increase finding of vaginal intraepithelial neoplasia (VaIN) in young women has led to the need to develop personalized conservative treatment. The authors studied the use of CO2 laser in the treatment of VaIN, evaluating the efficacy, repeatability, complications and the conservation of sexual function. METHODS: A total of 37 consecutive patients with histologically demonstrated VaIN (10 VaIN 1, 14 VaIN 2 and 13 VaIN 3): mean age 45.3 years, 37.8% aged < 35 years, 20/37 in childbearing age; VaIN was isolated in two patients, synchronous in 22 and in 13 cases it was metachronous with other intraepithelial or invasive genital neoplasia. 30/37 patients were treated with laser surgery as outpatients for a total of 41 operations (37 vaporisations and four excisions) using colposcopic guided CO2 laser with a constant emission power of 35 watts or 30 watts in the pulsed mode, under local anaesthesia, following the application of 5% acetic acid. RESULTS: Twenty-one (87.5%) of the 24 patients evaluated at 12 months were negative after one (16 patients) or more treatments (from 2 to 5 in 5 patients). Following the second recidivation, one elderly patient preferred traditional demolitive surgery; 2 patients are still awaiting further laser surgery. Five patients with multifocal lesions associated topical treatment with 5-fluorouracil. None of the sexually active patients complained of dyspareunias after treatment. CONCLUSIONS: Given the lack of other equally effective treatment and with the aim of preserving genital integrity, the authors regard laser surgery as the elective treatment for VaIN 2 and 3.

Adult↗
PubMed1997

Nonclosure of peritoneum at radical abdominal hysterectomy and pelvic node dissection: a randomized study.

OBJECTIVE: To compare closure and nonclosure of the peritoneum at radical abdominal hysterectomy and pelvic node dissection with respect to postoperative morbidity. METHODS: Women with uterine cancer who underwent radical abdominal hysterectomy and node dissection type II or III of Piver-Rutledge were assigned randomly to have a standard closure of pelvic and parietal peritoneum and placement of a T-shaped suction drain or to have the peritoneum left open but the vagina closed and two abdominal drains placed. Adjuvant radiotherapy was given to patients with risk factors. The postoperative incidence of lymphocysts (within 8 weeks from the operation and after 1 year) and infection-related and non-infection-related complications were analyzed. RESULTS: One hundred twenty subjects were enrolled, of whom 59 had peritoneal closure and 61 did not. Both groups were similar with regard to age, weight, nodes removed, nodal metastases, operative time, type of surgery, need for transfusion, and incidence of postoperative radiotherapy. The median follow-up was 36 months (range 11-72). Eleven patients died, four because of treatment-related complications. The amount of drainage was significantly higher in the closed group than in the unclosed group (median 740 mL, range 50-5980 versus median 340 mL, range 40-4000; P < .005). The incidence of asymptomatic lymphocysts was similar in the closed and open groups at 2 weeks (17 of 59 versus 15 of 6, respectively), at 8 weeks (eight of 56 versus ten of 61, respectively), and after 1 year (one of 21 versus four of 22, respectively). No difference was found between closed and open groups in terms of symptomatic lymphocysts (one of 59 versus two of 61, respectively), wound and pelvic infection (seven of 59 versus 11 of 61, respectively), febrile morbidity (two of 59 versus 11 of 61, respectively), and obstruction (zero of 59 versus one of 61, respectively). CONCLUSION: Nonclosure of the peritoneum at radical abdominal hysterectomy and node dissection is not hazardous and is not associated with an increased incidence of infection- or adhesion-related complications.

Adult↗
PubMed1997

Systematic pelvic and para-aortic lymphadenectomy in advanced ovarian cancer patients with no residual intraperitoneal disease.

A comparative non-randomized study was carried out to evaluate the role of systematic pelvic and para-aortic lymphadenectomy (SL) on patients with no residual intraperitoneal disease (NRID) of advanced ovarian cancer (stage IIIC-IV). A total of 142 optimally cytoreduced patients (macroscopic disease absent on peritoneal surface) were divided into two groups: Group A, consisting of 98 patients (53 previously untreated and 45 pretreated at other Institutions), who underwent SL; Group B, consisting of 44 patients (21 previously untreated and 23 pretreated at other Institutions), who did not undergo SL. Each group had statistically equivalent histology, grading, performance status and variety of cytoreductive operations performed. Group A pretreated patients had a greater number of stage III than Group B (P = 0.03). Systematic pelvic and para-aortic lymphadenectomy could be carried out with an acceptable morbidity and no mortality. All 142 patients received post-operative chemotherapy including carboplatin. The number of chemotherapy sessions did not differ between the two groups. Comparison of survival revealed that SL significantly improved the survival of previously untreated patients (P = 0.02). The survival was significantly different with nodal status (P = 0.006). Cox's proportional hazard analysis showed that only systematic lymphadenectomy was a significant covariate. The survival was not significantly different in Group A vs Group B pretreated patients; however, it was significantly different with respect to nodal status (P<0.001). Cox's proportional hazard analysis showed that only the initial stage of disease was a significant covariate. The results of the present study shows that aggressive surgical cytoreduction with SL could be therapeutic in previously untreated patients with NRID. Currently, an international prospective randomized study is ongoing to clarify definitively the clinical role of SL.

Journal Article↗
PubMed1997

Surgical second look in ovarian cancer: a randomized study in patients with laparoscopic complete remission--a Northeastern Oncology Cooperative Group-Ovarian Cancer Cooperative Group Study.

PURPOSE: The usefulness of extensive and repetitive surgery for patients with ovarian cancer still remains unproven (at least for some conditions). We planned an accurate prospective test of the hypothesis that patients with advanced-stage disease, after they had reached a clinical complete remission (CR), may benefit from surgical second look (SSL). PATIENTS AND METHODS: One hundred two patients in CR (as assessed by clinical findings, markers, and visualization by computed tomographic [CT] scan and laparoscopy), after initial debulking and first-line chemotherapy, were randomized to two arms, which were well balanced for predictive criteria such as age, stage at presentation, histology, grading, date of randomization, and residua after first surgery. Forty-eight patients were randomly assigned to receive follow-up evaluation only, while 54 were assigned to receive second surgery (eight of them refused). Of 46 surgical patients, 35 had negative and 11 positive surgical findings (24% clinically false-negative). RESULTS: Despite the microscopic residua found at open surgery, and the fact that the patients were then treated with second-line chemotherapy, SSL did not increase the probability of survival in this setting. In an analysis of the results according to the intention-to-treat criteria, after a 60-month follow-up period, the overall survival rates in the two groups of patients (SSL v no SSL) were 65% and 78%, respectively (P = .14). Multivariate analysis according to predictive criteria confirmed there was no significant difference between the two groups (P = .39). CONCLUSION: Our study shows the following: (1) our second-line treatment is scarcely effective; (2) SSL accurately defines complete responders to first-line chemotherapy; (3) SSL per se does not prolong survival; and (4) if confirmed, a less invasive procedure could replace SSL as a valuable method in new first-line regimens in ovarian cancer patients with clinical CR confirmed by laparoscopy.

Female↗