Alessia Aloisi

Neoadjuvant chemotherapy plus radical surgery followed by chemotherapy in locally advanced cervical cancer

OBJECTIVES To evaluate the efficacy, in terms of safety, overall survival and progression free survival of neoadjuvant chemotherapy followed by radical surgery plus adjuvant chemotherapy in patients affected by locally advanced cervical cancer (stage IB2-IIB) with or without node metastases. METHODS Between June 2000 and February 2007, all patients with diagnosis of locally advanced cervical cancer referred to the Division of Gynecologic Oncology of the University Campus Bio-Medico of Rome were eligible for this protocol. All enrolled patients received 3 cycles of platinum-based chemotherapy every 3 weeks according to the scheme Cisplatin 100mg/mq and Paclitaxel 175 mg/mq. After neoadjuvant chemotherapy all patients with stable or progressive disease were excluded from the protocol, the others were submitted to classical radical hysterectomy, bilateral salpingo-oophorectomy and bilateral systematic pelvic lymphadenectomy and 4 cycles of adjuvant treatment with platinum based chemotherapy were executed. RESULTS Concerning intention to treat basis analysis, 5 year overall survival (OS) and disease-free survival (DFS) are 77% and 61%, respectively. The 5-year OS of patients with positive pelvic nodes and those with negative nodes metastases was respectively 60% and 87%. Concerning the according to protocol analysis, the 5-year OS and DFS are 81% and 70% respectively. The 5-year OS in patient with positive and negative lymph nodes is 75% and 88% respectively. CONCLUSIONS The adjuvant chemotherapy regimen after neoadjuvant chemotherapy and radical surgery represents a valid treatment for patients with locally advanced cervical cancer.

Can the preoperative HE4 level predict optimal cytoreduction in patients with advanced ovarian carcinoma

OBJECTIVE Optimal surgical outcome has been proved to be one of the most powerful survival determinants in the management of ovarian cancer patients. Actually, for ovarian cancer patients there is no general consensus on the preoperatively establishment of cytoreducibility. METHODS Between January 2011 and June 2012 patients affected by suspicious advanced ovarian cancer, referred to the Department of Gynecology of Campus Biomedico of Rome were enrolled in the study. All patients had serum CA125 and HE4 measured preoperatively. After a complete laparoscopy to assess the possibility of optimal debulking surgery defined as no visible residual tumor after cytoreduction (RT=0), patients were submitted to primary cytoreductive surgery (Group A) or addressed to neoadjuvant chemotherapy (Group B). RESULTS After diagnostic open laparoscopy, 36 patients underwent optimal primary cytoreductive surgery (Group A) and 21 patients were addressed to neoadjuvant chemotherapy (Group B). In our population, based on ROC curve, the HE4 value of 262pmol/L is the best cut-off to identify patients candidates to optimal cytoreduction with a sensitivity of 86.1% and a specificity of 89.5% (PPV=93.9% and NPV=77%). In addition, CA125 has a sensitivity of 58.3% and a specificity of 84% at cut-off of 414 UI/mL (AUC is 0.68, 95% C.I.=0.620 to 0.861). CONCLUSION Our data indicate that preoperative HE4 is a better predictor for optimal cytoreduction compared to CA125. The best combination in predicting cytoreduction is HE4≤262 pmol/L and ascites <500mL with a sensitivity of 100% and a specificity of 89.5% (PPV=94% and NPV=100%).

Ten years of HPV vaccines: State of art and controversies

The human papillomavirus (HPV) represents one of the most common sexually transmitted infections and it has been related to cervical cancer. The HPV vaccines prevent infection with certain species of HPV associated with the development of cervical cancer or genital warts. We carried out a PubMed search up to 2015 evaluating all randomized studies published in literature. This review discusses the current status of HPVs vaccines on the global market, efficacy, safety profiles, controversies and future vaccine developments. Three HPVs vaccines are currently on the global market: bivalent, quadrivalent and ninevalent. Bivalent and quadrivalent vaccines can protect against almost 70% of cervical HPV-related cancerous and precancerous conditions and the ninevalent vaccine, instead, provides a protection against almost 90%. The use of vaccinations raised several controversies in the last years and, currently, is not possible to establish which type of vaccine is most effective, however all of them are safe.

REM (RISK OF ENDOMETRIAL MALIGNANCY): A PROPOSAL FOR A NEW SCORING SYSTEM TO EVALUATE RISK OF ENDOMETRIAL MALIGNANCY .

Purpose: It is often difficult to distinguish a benign endometrial disease from a malignancy and tools to help the physician are needed to triage patients into high and low risk of endometrial cancer. The purpose of this study was to obtain a predictive model to assess the risk of endometrial malignancy (REM) in women with ultrasound endometrial abnormalities. Experimental Design: Women, between ages 45 to 80 years, diagnosed through ultrasound with endometrial abnormalities and scheduled to have surgery were enrolled on a prospective study at the Department of Gynaecologic Oncology of Campus Bio-Medico, University of Rome. Preoperative clinical, ultrasound and laboratory characteristics were taken into account. Logistic regression algorithm was used to categorize patients into low- and high-risk groups for endometrial cancer. Results: A total of 675 patients were considered for the analysis: 88 with endometrial cancer and 587 with benign endometrial disease. We divided the patients into two groups: training set (TS) and verification set (VS). Preoperative age, symptom, HE4 levels, and ultrasound endometrial thickness were found statistically significant, and were included into a multivariate logistic regression model to determine the probability to have endometrial cancer. In the TS, REM reported 93.3% sensitivity and 97.1% specificity [positive predictive value (PPV), 0.83; negative predictive value (NPV), 0.98; AUC, 0.957; 95% confidence interval (CI), 0.908–0.984]. In the VS, REM reported 89.3% sensitivity and 95.4% specificity (PPV, 0.73; NPV, 0.98; AUC, 0.919; 95% CI, 0.829–0.970). Conclusions: Our data support the use of REM to triage patients into low- and high-risk groups for endometrial cancer, even if an external validation of the model is needed. Clin Cancer Res; 19(20); 5733–9. ©2013 AACR.

The effects of giving patients verbal or written pre-operative information in gynecologic oncology surgery: a randomized study and the medical-legal point of view

OBJECTIVES To evaluate the verbal and written preoperative information in patients undergoing surgery for malignant gynaecologic disease, in terms of satisfaction about preoperative received informations, hospitalization days, postoperative pain experienced using visual analogue scale (VAS) and number of pain drugs used daily. STUDY DESIGN From January 2008 to December 2012, consecutive patients with diagnosis of endometrial cancer, referred to the Division of Gynecology of University Campus Bio-Medico of Rome, were enrolled. Eligible subjects were randomized into two groups: Group V (Verbal information ward) consisted of patients who had verbal preoperative information about surgical procedure and postoperative management and Group W (Written Information ward) consisted of patients who had written preoperative information. All preoperative and postoperative data were recorded. Concerning satisfaction about preoperative received informations, patients were asked to complete the QLQ-C30 and the EORTC INFO25. RESULTS 190 patients were considered in this study. Group W (n=92) has a better info satisfaction (p=0.0008, statistically significant), a mean VAS value lower (p=0.02, statistically significant) and also a lower number of hospitalization days (p=0.0265, statistically significant) and pain medications used daily, (p=0.0120, statistically significant), comparing with group V (n=98). CONCLUSIONS We support the use of preoperative information leaflet to better prepare patients for a surgical procedure, showing a faster recovery, low medications use and a better quality of life outcome.

Economic Impact Among Family Caregivers of Patients With Advanced Ovarian Cancer.

Objectives The life of a family caregiver changes in many ways when cancer is diagnosed. Changes regard also financial costs. To the authors’ knowledge, little work has been done to estimate the costs associated with caregiving for cancer patients. The aim of the present study is to evaluate for the first time in literature the economic changes among family caregivers of advanced ovarian cancer during the first-line treatment in an Italian survey. Methods Between January 2009 and June 2014, the primary family caregivers of patients with advanced ovarian cancer (N = 172) were recruited from to the Division of Gynecologic Oncology of the University Campus Bio-Medico of Rome within 4 weeks of the patient’s new diagnosis. Caregivers reported demographic, medical information, and economic cost, such as traveling to and from medical appointments, waiting with patients for appointments, missing work, and attending to patients who are hospitalized. Results Between January 2009 and June 2014, 172 primary family caregivers of patients with advanced ovarian cancer were enrolled in the study. The mean age of the study cohort was 54.01 years. They reported 3% of missing workdays. The mean cost for all caregivers was &OV0556;1,888,732 per year. Therefore, the mean cost for each caregiver was &OV0556;10,981 annually. Conclusions This economic analysis of caregiving in patients with advanced ovarian cancer reports the significant burden that cancer treatment places on both families and society. These findings underscore the importance, when appropriate, of including valid estimates of the cost of informal caregiving when evaluating the cost-effectiveness of cancer treatments.

A randomized controlled trial comparing four versus six courses of adjuvant platinum-based chemotherapy in locally advanced cervical cancer patients previously treated with neo-adjuvant chemotherapy plus radical surgery

OBJECTIVES. The aim of this study was to compare 4 versus 6 courses of adjuvant chemotherapy after neoadjuvant chemotherapy plus radical surgery in terms of overall survival (OS), disease-free survival (DFS), recurrence rate and toxicity profile. METHODS. We randomly assigned 200 patients with IB2-IIB cervical cancer to receive 4 (Group A) or 6 (Group B) courses of cisplatin 100 mg/mq and paclitaxel 175 mg/mq every 21 days. RESULTS. At 4-years follow-up, the comparison of recurrence rate (p = 1; RR = 1.005; 95% CI = 0.87 to 1.161), OS (p = 0.906) and DFS (p = 0.825) did not show statistically significant differences between the two groups. Data analysis showed statistically significant differences between the two groups in term of episodes of leukopenia (p = 0.0072; RR = 1.513; 95% CI = 1.127-2.03), anemia (p = 0.048; RR = 1.188; CI = 1.012-1.395) and febrile neutropenia (p = 0.042; RR = 1.119; 95% CI = 1.014-1.235), in favor of Group A. As regards non-hematological toxicities, there were no statistically significant differences in terms of gastrointestinal symptoms (p = 0.49; RR = 1.046; CI = 0.948-1.153. On the contrary, there was a statistically significant difference regarding neurological symptoms (p=0.014; RR=1.208; CI=1.046-1.395), that were less frequent in Group A (13%) than in Group B (28%). CONCLUSIONS. Adjuvant treatment with 4 or 6 courses of platinum-based chemotherapy showed similar results in terms of OS and DSF, with a favorable toxicity profile in favor of the first regimen.

Reference charts for fetal corpus callosum length: A prospective cross-sectional study of 2950 fetuses

The purpose of this study was to establish reference charts for fetal corpus callosum length in a convenience sample.

Adjuvant chemotherapy after primary treatments for cervical cancer: a critical point of view and review of the literature

Cervical cancer is the second most frequent female malignancy worldwide. Concurrent chemoradiotherapy represents the standard of care for patients with advanced stage cervical cancer, while radical surgery (RS) and radiotherapy is widely used for treating early stage cervical cancer. However, the poor control of micrometastasis, declining operability, the lack of radiotherapy departments and the high incidence of long-term complications due to radiotherapy have brought about the development of different therapeutic approaches such as neoadjuvant chemotherapy followed by RS. Unfortunately, treatment results are still unsatisfactory due to a high recurrence rate and several authors have studied the possibility to add an adjuvant treatment to primary therapy. We reviewed the literature concerning the role of adjuvant chemotherapy in advanced cervical cancer after neoadjuvant chemotherapy followed by RS and after chemoradiotherapy.

Does extensive upper abdomen surgery during primary cytoreduction impact on long-term quality of life?

Objectives The objective of this study was to evaluate the feasibility in terms of safety and quality of life in a sample of Italian patients affected by advanced ovarian cancer and submitted to either extensive upper abdomen or standard surgery, through validated questionnaires. Methods From January 2006 to November 2011, a prospective, observational study was conducted to compare quality of life in patients affected by advanced ovarian cancer and submitted to primary cytoreduction in the Division of Gynecology of the University Campus Bio-Medico of Rome. After surgery patients were stratified into 2 groups (group A: standard surgery or group B: extensive upper abdomen surgery). All patients were submitted to standard chemotherapy. At completion of treatment, during the first follow-up visit, all eligible patients were asked to fill in Quality of Life Questionnaire-C30 (QLQ-C30) (version 3.0) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-OV28 (QLQ-OV28) questionnaires. Results Eighty-nine patients were enrolled into our study. Nine were excluded, so finally 80 patients were considered in this study. Group A included 40 patients and underwent standard surgery (pelvic surgery); group B, included 40 patients and underwent extensive upper abdomen surgery. There were no statistical differences in terms of major surgical complication rates (15% vs 10%). We registered same times of beginning of chemotherapy (median, 19 vs 21 days) and no severe related toxicities. Quality-of-life scores of both questionnaires were comparable between groups, with the exception of Global Health Status in QLC-30. Conclusions Upper abdomen surgery is a feasible and safe therapeutic option. Patients present same times of beginning of chemotherapy without an increase in chemorelated toxicities and experience the same general quality of life.