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The article describes the case of a 29-year-old woman at 40 weeks of pregnancy, who was brought to the emergency department in spontaneous labor with ruptured membranes. She complained rectal pain two hours after the vaginal delivery. A computed tomography scan of her pelvis revealed a 10-centimeter supralevator hematoma and extrauterine arterial bleeding. She was successfully treated by selective embolization. She was discharged home three days after delivery.

Abstract: Objective: The aim of the study was to analyze the Quality of life (QoL) scores in a single institution series of locally advanced cervical cancer patients (LACC) administered preoperative chemoradiation, compared to early stage disease (ECC) patients undergoing radical surgery. Methods: The following criteria were required in order to enroll patients: age between 18 and 65years at initial diagnosis, at least 12months from the end of treatment, no evidence of recurrence/second malignancy. The SF-36 questionnaire on general health, and the HADS questionnaire on mental distress were utilized. Results: 93 subjects were available for the analysis. At time of analysis, median follow-up was 30months (range 12–120). LACC patients showed QoL scores comparable to ECC patients with the exception of physical functioning (mean±SD=69.0±13.1 versus mean± SD=85.4±16.2, p value=0.0007). In the group of LACC patients, the presence of co-morbidities was significantly associated with the impairment of almost all subscales of QoL. A low education level and the status of unemployment were documented to negatively impact on the vast majority of SF-36 subscale scores. In the multivariate analysis, the presence of co-morbidities, low educational level, age> 50years, and unemployment maintained their independent negative association with poor QoL scores. The percentage of cases with high levels HADS-anxiety was higher in LACC than ECC patients (27.6% versus 8.6%, p value=0.034). Conclusions: LACC patients administered preoperative chemoradiation showed QoL scores comparable to EEC patients, and a higher proportion of anxiety disorders; low educational level and unemployment status were mainly associated with poor QoL scores. [Copyright &y& Elsevier]

Abstract: Objective. : The aim of this study was to investigate the role of anemia at presentation (basal HB) and during treatment (nadir HB) as predictor of pathological response, as well as disease-free (DFS) and overall survival (OS) in LACC patients undergoing chemoradiation followed by radical surgery. Methods. : 114 consecutive LACC patients were accrued at the Gynecologic Oncology Unit, Catholic University, Rome and at the Department of Oncology, Catholic University of Campobasso, Italy. Neoadjuvant treatment included chemotherapy with cisplatin (20 mg/m2) and 5-fluorouracil (1000 mg/m2, 24-h infusion) (both on days 1–4 and 27–30) and external radiotherapy to the whole pelvic region (22 fractions, 1.8 Gy/day, totaling 39.6 Gy). Clinical responders underwent radical surgery. Hemoglobin levels were recorded and expressed in gram per liter×10−2 (g/dl). The value of 10 g/dl was arbitrarily chosen as cut-off value. Results. : In cases showing high basal HB status, the percentage of pathological response was significantly higher than in patients showing low HB status (76.3% versus 46.7%) (P value=0.027). When logistic regression was applied, only advanced stage remained associated with a poor chance of response to treatment. Cases with low basal HB status had a shorter DFS and OS than cases with a high HB status (P value=0.0001 and 0.0022, respectively). Similar results were obtained when analyzing nadir HB status. In multivariate analysis, high basal HB status, and advanced stage, retained an independent negative prognostic role for DFS and OS. Conclusions. : Anemia identifies LACC patients administered preoperative radiochemotherapy, who are at higher risk of recurrence and death of disease. [Copyright &y& Elsevier]

Abstract: Background : To report a case of advanced ovarian carcinoma diagnosed during gestation, which was managed with conservative surgery and chemotherapy until delivery. Case : The patient underwent bilateral salpingo-oophorectomy, omentectomy, and appendectomy at 15 weeks of gestation. Six courses of chemotherapy with cisplatin were administered. Cesarean section followed by total hysterectomy were performed at 36 weeks of gestation. The male infant was 3000 g, Apgar score 9/9. Twenty-four months after delivery, the patient experienced pelvic recurrence and underwent surgery and six cycles of carboplatin and paclitaxel. The patient is alive with no evidence of disease. After 42 months of follow-up, the baby boy showed no evidence of sequelae. Conclusion : Medical and surgical management of ovarian cancer during pregnancy can be an option, although the risks and benefits have to be discussed with caution. [Copyright &y& Elsevier]

The aims of the present study were to assess the oncological outcomes of platinum-sensitive recurrent ovarian cancer patients undergoing secondary cytoreduction (SCS) after treatment with neoadjuvant chemotherapy (NACT) and interval debulking surgery (IDS) at diagnosis and to compare the performance of different selection models in these patients. Retrospective, observational, single-center cohort study including patients with platinum-sensitive recurrent epithelial ovarian cancer with abdominal/inguinal/cardiophrenic disease between November 2012 and November 2020. Patients were selected as surgical candidates with PET/CT-scan and with diagnostic laparoscopy. 272 patients were included in the study. Of these, 165 (60.7%) patients were treated with PDS at diagnosis and 107 (39.3%) with IDS. SCS was performed in 178 (65.4%) cases, with complete gross resection achieved in 155/178 (87.1%). No progression-free survival (PFS) difference was demonstrated when patients treated with PDS were compared with those treated with NACT+IDS at first diagnosis (median 21 versus 21 months; p = 0.684); no post-recurrence survival (PRS) difference was evident between the two groups (median 81 versus 77 months, respectively; p = 0.574). Current selection models to candidate patients to SCS adequately performed in patients treated with IDS at diagnosis, as well as in the PDS group, with combination of PET/CT-scan and laparoscopy being an accurate tool in prediction of no gross residual disease at SCS in this pre-selected population. Patients with platinum-sensitive recurrent epithelial ovarian cancer treated with NACT/IDS as primary treatment have similar post-recurrence survival outcomes of those treated with PDS. Current models to select patients for SCS can be safely applied to IDS patients. • Recurrent ovarian cancer patients with positive AGO-score show a survival benefit from secondary cytoreduction (SCS). • Recurrent ovarian cancer patients receiving NACT and interval debulking surgery are not included in the DESKTOP-III trial. • Primary treatment with interval debulking showed similar post-SCS survival compared with primary debulking surgery. • Current models to select patients for secondary cytoreduction can be safely applied to interval debulking surgery patients. [ABSTRACT FROM AUTHOR]

Objective: Bevacizumab maintenance following platinum-based chemotherapy is an effective treatment for epithelial ovarian cancer (EOC), both in primary and recurrent disease. Our aim was to identify criteria to select elderly patients who can safely benefit from bevacizumab addition. Methods: This is a case-control study on patients with primary or recurrent EOC who received platinum-based chemotherapy plus bevacizumab, between January 2015 and December 2016. Patient characteristics, treatment details and adverse events were reviewed and analyzed in 2 settings: younger (<65 years, group 1) and elderly (≥65 years, group 2). A binary logistic model was applied to correlate clinical variables and severe (grade ≥3) toxicity risk. Results: Overall, 283 patients with EOC were included, with 72 (25.4%) older patients compared with 211 (74.6%) younger women. Bevacizumab had been administered to 234 patients (82.7%) as first-line treatment and in 49 (17.3%) with recurrent disease. At diagnosis, elderly patients presented with at least one comorbidity and were taking at least 1 medication in 84.7% and 80.6% of the cases respectively, compared with correspondingly 47.4% and 37.4% in group 1 (p<0.001). Nonetheless, the occurrence of serious (grade ≥3) adverse events did not increase among the older group. Creatinine serum levels >1.1 g/dL, estimated glomerular filtration rate (eGFR) =60 mL/min, ≥3 comorbidities were independently associated with a higher severe toxicity. Conclusions: Elderly patients with EOC can safely be treated with bevacizumab; factors other than age, as higher creatinine serum levels, eGFR and number of comorbidities should be considered to better estimate bevacizumab-related toxicity risk. [ABSTRACT FROM AUTHOR]

Purpose: The role of dose-dense schedules in the neo-adjuvant treatment (NACT) of locally advanced cervical cancer (LACC) has been reported. This phase II study investigated activity of dose-dense paclitaxel/platinum before radical surgery (RS) in LACC patients.Methods: The primary end-point was the rate of optimal pathological response (OPR: pathological complete/microscopic response). NACT (paclitaxel: 80 mg/m2) and carboplatin (AUC 2) were administered for 6 weeks. Overall response rate (ORR) to NACT was assessed by the RECIST criteria. Patients amenable to surgery were triaged to RS. The null hypothesis was that the OPR rate would improve from 30.0 to 45.0% (α error: 0.05, β error: 0.2). The regimen would be considered active if > 25 OPRs were found.Results: 36 patients were enrolled; 19 patients were stage IIB (52.8%) and 16 (44.4%) patients had pelvic lymph-node involvement at imaging. All patients completed neo-adjuvant chemotherapy; ORR was of 75.0%. RS was performed in 29 (93.5%) patients. Since the OPR was 16.1%, we evaluated the real chances to achieve the number of OPR required by the Simon design and decided to close the study. Grade 3/4 hematological toxicity occurred in 5 patients; surgical morbidity occurred in 14 patients. The 2-year PFS rate was 69.0%.Conclusion: Dose-dense neo-adjuvant paclitaxel/carboplatin is feasible and safe in LACC patients; however, failure to achieve the primary end-point has to be recognized. Given the heterogeneity of the available studies, robust data from an adequately sized prospective study focused on more homogeneous series are required. [ABSTRACT FROM AUTHOR]

Background The aim of this multicenter, retrospective study was to evaluate the efficacy and safety of metronomic oral cyclophosphamide (MOC) in heavily treated, relapsed ovarian cancer (ROC) patients. Methods oral cyclophosphamide (Endoxan®, Baxter, Italy) was administered at the dose of 50 mg daily, continuously. Treatment-related toxicity and response to treatment were assessed by the NCI-CTC criteria, and RECIST criteria, respectively. Progression-free (PFS), and overall survival (OS) were also assessed. Results 54 patients were analyzed: 20 patients (37.0%) were considered primarily platinum refractory/resistant, while 34 patients (63.0%) were defined as platinum sensitive; 79.6% of patients had received ≥2 previous lines before starting MOC. The objective response rate (ORR) was 20.4%. Eleven patients (20.4%) experienced stable disease and 8 of them had a response duration ≥6 months. A total of 32 patients (59.2.%) progressed during treatment. Median PFS was 4 months, and the 12-month PFS rate was 19.6%; median OS was 13 months, and the 12-month OS rate was 51.5% . Patients responding to MOC showed a more favorable PFS (median = 17 months) compared to patients with stabilization (median = 6 months) or progression of disease (median = 3 months) (p value = 0.0001). Median OS of responding patients was 30 months compared to 11 months in cases achieving stabilization, or progression of disease (median = 8 months) (p value = 0.0001). Only 1 patient experienced grade 3 anemia. Non-hematological grade 3 toxicity was registered in 2 patients. Conclusions MOC could provide a valid alternative in terms of risk/benefit ratio in the palliative treatment of heavily treated ROC patients. [ABSTRACT FROM AUTHOR]

Background: Postpartum hematomas are a potentially serious obstetric complication for which management options are not standardized. We report successful treatment of a large postpartum hematoma using arterial embolization as primary approach.Case: A 29-year-old woman at term gestation underwent vacuum-assisted vaginal delivery. Two hours later, marked rectal pain developed. Examination revealed a large left vaginal hematoma and no obvious bleeding sites. Computed tomography demonstrated a 10-cm supralevator hematoma and extrauterine arterial bleeding. Angiography revealed contrast extravasation from a branch of the left internal pudendal artery. Selective embolization of this branch stopped the bleeding. The patient was discharged on the third postpartum day. Eight weeks after delivery, there was no evidence of the hematoma.Conclusion: Arterial embolization can be used as a first-line treatment for large postpartum hematomas. [ABSTRACT FROM AUTHOR]

Abstract: Objectives. : Alterations of the β subunit of tubulin have been reported to be predictive of resistance to radiation and antitubulin agents in several solid tumors. The aim of the study was to investigate the clinical role of β III tubulin expression as prognostic factor for survival and as a predictive parameter of response to preoperative radiochemotherapy in a single institutional series of locally advanced cervical cancer (LACC) patients. Methods. : The study included 98 LACC patients admitted to the Gynecologic Oncology Unit, Catholic University of Rome and Campobasso between January 1998 and January 2005. Immunohistochemistry was performed by using the polyclonal rabbit anti-β III tubulin antibody (Covance, Princeton, NJ, USA). The value of 10% immunostained tumor cells was arbitrarily chosen as cut-off value to distinguish cases with high versus low β III tubulin content. Results. : In the whole series, β III tubulin immunoreaction was detectable in 66/98 cases (67.3%), and the percentage of positively stained cells ranged from 0 to 100% (median=10%). The percentages of cases with high β III tubulin expression were shown not to be differently distributed according to clinico-pathological characteristics. There was no statistically significant difference in the distribution of cases with high β III tubulin expression according to clinical and pathological response to treatment. During the follow-up period, recurrence and death of disease occurred in 15 and 13 cases, respectively. There was no difference in disease-free and overall survival in cases with high versus low β III tubulin expression. Conclusions. : The assessment of class III β tubulin status seems of little usefulness in order to identify LACC patients with poor chance of response to concomitant radiochemotherapy and unfavorable prognosis. [Copyright &y& Elsevier]

The aim of the study was to analyze the accuracy, the positive and negative predictive values, the specificity, and the sensitivity of the pelvic node frozen section examination in endometrial (EC) and cervical cancer (CC) patients. An accurate evaluation of the results of the frozen section examination in patients submitted to neoadjuvant treatments (chemotherapy and radiochemotherapy), and a comparison between specialist and general pathologist results were performed.A total of 186 consecutive patients with endometrial [52 cases (27.9%)] and cervical [134 cases (72.1%)] cancer underwent surgery at our Department between January 2000 and September 2003. All patients underwent a systematic pelvic lymphadenectomy. While all definitive diagnosis were primarily performed or secondarily revised by the specialist pathologist, the frozen section examination was performed in 65 (35%) cases by the specialist pathologist and in 121 (65%) cases by a general pathologist.Two thousand seven hundred eighteen out of a total of 6710 pelvic lymph nodes, which underwent a definitive histological analysis, were also analyzed at intraoperative frozen section examination. In our series, we observed 10 false negative and five false positive cases. Six out of the 10 (60%) false negative cases and two out of the five (40%) false positive were found in the neoadjuvant treated cervical cancer patients. In this subgroup, five out the six (83.3%) false negative and the two false positive diagnoses were made by the general pathologist, while the specialist pathologist registered only one false negative diagnosis.Intraoperative examination of pelvic lymph nodes during surgery for endometrial and cervical cancer can be considered a safe procedure in the presence of an expert gynecologic oncological team, and can be safely performed in patients submitted to neoadjuvant treatments. [Copyright &y& Elsevier]

In this study we investigated whether the flavonoid silybin and its bioavailable derivative IdB 1016 (silipide) could enhance the antitumour activity of cisplatin (CDDP), the most commonly used drug in the treatment of gynaecological malignancies. Silybin alone up to 10 (M was unable to produce a relevant in vitro growth inhibition of A2780 cells, whereas CDDP was effective, giving an IC50 value of 0.5±0.14 μM. When silybin was combined with CDDP, a dose-dependent and statistically significant (p<0.05) increase of the CDDP activity was noticed, yielding IC50 values of 0.35±0.07 and 0.263±0.004 μM at silybin concentrations of 1 and 10 μM, respectively. The same trend was observed for in vivo experiments. IdB 1016 alone (1350 mg/kg) did not significantly affect tumour growth, whereas CDDP at the Maximum Tolerated Dose (12 mg/kg) produced a tumour weight inhibition (TWI%) of 80% and a log10 cell kill (LCK) of 0.7. Administration of both drugs resulted in a potentiation of the antitumour activity and TWI% and LCK increased to 90% and 1, respectively. Interestingly, mice receiving the combination recovered earlier in terms of body weight loss as compared to CDDP-treated mice. CDDP at 6 mg/kg yielded TWI of 44% and LCK of 0. The concomitant administration of IdB 1016 (1800 mg/kg) enhanced CDDP anti-tumour activity, with 68% TWI and 0.6 LCK. Finally, an antiangiogenic effect of IdB 1016 in an in vivo experimental model was demonstrated. Median haemoglobin value for the Matrigel from the vehicle-treated controls was 2.43 versus a value of 0.321 for the IdB 1016-treated animals. [Copyright &y& Elsevier]

SB-T-1213 and IDN5109 are semisynthetic, orally available taxanes that are up to 400-fold more active than paclitaxel against drug-resistant cells. IDN5109 is in clinical trials. We investigated the primary target for SB-T-1213 and IDN5109 and whether the compounds interact with microtubules differently than paclitaxel. Unlike paclitaxel, at 1–10 μM both novel taxanes initiate microtubule polymerization in vitro with no lag. They enhance polymerization equally or more potently than paclitaxel. SB-T-1213 induces unusual microtubules with attached extra protofilaments or open sheets, and IDN5109 induces large protofilamentous sheets. Both inhibit HeLa cell proliferation, block mitosis at the metaphase/anaphase transition, bundle microtubules at high drug concentrations, and induce abnormal metaphase spindles and apoptosis. They target microtubules but alter their polymerization and structure differently than paclitaxel. These differences may play a role in their enhanced cytotoxicity and efficacy. [Copyright &y& Elsevier]

Purpose: The role of dose-dense schedules in the neo-adjuvant treatment (NACT) of locally advanced cervical cancer (LACC) has been reported. This phase II study investigated activity of dose-dense paclitaxel/platinum before radical surgery (RS) in LACC patients.Methods: The primary end-point was the rate of optimal pathological response (OPR: pathological complete/microscopic response). NACT (paclitaxel: 80 mg/m2) and carboplatin (AUC 2) were administered for 6 weeks. Overall response rate (ORR) to NACT was assessed by the RECIST criteria. Patients amenable to surgery were triaged to RS. The null hypothesis was that the OPR rate would improve from 30.0 to 45.0% (α error: 0.05, β error: 0.2). The regimen would be considered active if > 25 OPRs were found.Results: 36 patients were enrolled; 19 patients were stage IIB (52.8%) and 16 (44.4%) patients had pelvic lymph-node involvement at imaging. All patients completed neo-adjuvant chemotherapy; ORR was of 75.0%. RS was performed in 29 (93.5%) patients. Since the OPR was 16.1%, we evaluated the real chances to achieve the number of OPR required by the Simon design and decided to close the study. Grade 3/4 hematological toxicity occurred in 5 patients; surgical morbidity occurred in 14 patients. The 2-year PFS rate was 69.0%.Conclusion: Dose-dense neo-adjuvant paclitaxel/carboplatin is feasible and safe in LACC patients; however, failure to achieve the primary end-point has to be recognized. Given the heterogeneity of the available studies, robust data from an adequately sized prospective study focused on more homogeneous series are required. [ABSTRACT FROM AUTHOR]

Background: The aim of this multicenter, retrospective study was to evaluate the efficacy and safety of metronomic oral cyclophosphamide (MOC) in heavily treated, relapsed ovarian cancer (ROC) patients.Methods: oral cyclophosphamide (Endoxan®, Baxter, Italy) was administered at the dose of 50 mg daily, continuously. Treatment-related toxicity and response to treatment were assessed by the NCI-CTC criteria, and RECIST criteria, respectively. Progression-free (PFS), and overall survival (OS) were also assessed.Results: 54 patients were analyzed: 20 patients (37.0%) were considered primarily platinum refractory/resistant, while 34 patients (63.0%) were defined as platinum sensitive; 79.6% of patients had received ≥2 previous lines before starting MOC. The objective response rate (ORR) was 20.4%. Eleven patients (20.4%) experienced stable disease and 8 of them had a response duration ≥6 months. A total of 32 patients (59.2.%) progressed during treatment. Median PFS was 4 months, and the 12-month PFS rate was 19.6%; median OS was 13 months, and the 12-month OS rate was 51.5% . Patients responding to MOC showed a more favorable PFS (median = 17 months) compared to patients with stabilization (median = 6 months) or progression of disease (median = 3 months) (p value = 0.0001). Median OS of responding patients was 30 months compared to 11 months in cases achieving stabilization, or progression of disease (median = 8 months) (p value = 0.0001). Only 1 patient experienced grade 3 anemia. Non-hematological grade 3 toxicity was registered in 2 patients.Conclusions: MOC could provide a valid alternative in terms of risk/benefit ratio in the palliative treatment of heavily treated ROC patients. [ABSTRACT FROM AUTHOR]