Carmine Conte

HPV vaccine cross-protection: Highlights on additional clinical benefit

Prophylactic human papillomavirus (HPV) vaccines are administered in vaccination programs, targeted at young adolescent girls before sexual exposure, and in catch-up programs for young women in some countries. All the data indicate that HPV-virus-like particles (VLPs) effectively prevent papillomavirus infections with a high level of antibodies and safety. Since non-vaccine HPV types are responsible for about 30% of cervical cancers, cross-protection would potentially enhance primary cervical cancer prevention efforts. High levels of specific neutralizing antibodies can be generated after immunization with HPV VLPs. Immunity to HPV is type-specific. However, if we consider the phylogenetic tree including the different HPV types, we realize that a certain degree of cross-protection is possible, due to the high homology of some viral types with vaccine ones. The assessment of cross-protective properties of HPV vaccines is an extremely important matter, which has also increased public health implications and could add further value to their preventive potential. The impact of cross-protection is mostly represented by a reduction of cervical intraepithelial neoplasia CIN2-3 more than what expected. In this article we review the mechanisms and the effectiveness of Bivalent (HPV-16/-18) and Quadrivalent (HPV-6/-11/-16/-18) HPV vaccine cross-protection, focusing on the critical aspects and the potential biases in clinical trials, in order to understand how cross-protection could impact on clinical outcomes and on the new perspectives in post-vaccine era.

Laparoscopic Versus Laparotomic Surgical Staging for Early-Stage Ovarian Cancer: A Case-Control Study

STUDY OBJECTIVE To evaluate the oncologic outcomes of patients with early-stage ovarian cancer (eOC) managed by laparoscopy or laparotomy in a single high-volume gynecologic cancer center. DESIGN Retrospective case-control study (Canadian Task Force classification II-2). SETTING Catholic University of the Sacred Hearth, Rome, Italy. PATIENTS Data of consecutive women with eOC undergoing comprehensive laparoscopic staging between 2007 and 2013 were matched with a cohort of patients undergoing open surgery between 2000 and 2011. Four-year survival outcomes were analyzed using the Kaplan-Meier method. MEASUREMENTS AND RESULTS Sixty women undergoing staging via laparoscopy were compared with a cohort of 120 patients undergoing open surgery. Baseline characteristics were similar between groups. Seventy percent of patients underwent adjuvant platinum based chemotherapy without differences between the 2 groups. Operative time (p = .01), estimated blood loss (p = .032), and median hospital stay (p = .001) were higher in patients submitted to laparotomic versus laparoscopic staging. As of October 2015, median duration of follow-up was 38 months (range, 24 -48), recurrent disease was documented in 16 patients (13.3%) in the laparotomic group and in 5 patients (8.3%) in the laparoscopic group (p = .651), without differences in the pattern of recurrence presentation. Four-year progression-free survival (PFS) and overall survival (OS) rates were 89% and 92% in the laparoscopic group, respectively, and 81% and 91% in the laparotomic group, without any statistical significant difference between the groups (4-year PFS p = .651; 4-year OS p = .719). CONCLUSION The findings of the present study suggests that in the surgical treatment of FIGO stage I ovarian cancer, laparoscopy is associated with equivalent oncologic outcome compared with a conventional abdominal approach.

Secondary Laparoscopic Cytoreduction in Recurrent Ovarian Cancer: A Large, Single-Institution Experience

STUDY OBJECTIVE To analyze the feasibility and safety of laparoscopic secondary cytoreductive surgery in a retrospective series of patients with platinum-sensitive recurrent ovarian cancer. DESIGN Retrospective cohort study (Canadian Task Force classification II-2). SETTING Catholic University of the Sacred Heart, Rome, Italy. PATIENTS Between October 2010 and October 2016, 58 patients with recurrent ovarian cancer were selected for a retrospective analysis of data. INTERVENTIONS All patients underwent a laparoscopic secondary cytoreduction with single or multiple procedures. RESULTS The most frequent pattern of recurrence was peritoneal (48.3%); 6 patients (10.3%) experienced parenchymal disease (spleen, n = 5; liver, n = 1), and 24 patients (41.4%) had lymph node recurrence. Complete debulking was achieved in all patients. The median operative time was 204 minutes (range, 55-448 minutes), median estimated blood loss was 70 mL (range, 20-300 mL), and the median length of hospital stay was 4 days (range, 1-21 days). Four patients (6.8%) experienced intraoperative complications. Early postoperative complications were documented in 6 patients (10.3%), but only 1 G3 complication was noted. The median duration of follow-up since secondary cytoreduction was 24 months (range, 9-71 months). Twenty-one patients (36.2%) experienced a second disease relapse. The median progression-free survival (PFS) was 28 months, and the 2-year PFS was 58.7%. Five patients died (8.6%); the 2-year overall survival was 90.7%. CONCLUSIONS For selected patients, laparoscopy is a feasible and safe approach to optimal cytoreduction for patients with recurrent ovarian cancer.

Beyond sentinel node algorithm. Toward a more tailored surgery for cervical cancer patients

Nowadays cervical cancer is frequently diagnosed at early stage. For these patients lymph node metastasis (LNM) is considered the most important prognostic factor. During the last decade many efforts have been made to reduce rate of complications associated with lymphadenectomy (LND). A great interest has arisen in sentinel lymph node (SLN) biopsy as a technique able to decrease number of LND performed and, at the same time, to assess lymph nodal status. High diagnostic performances have been reached thanks to SLN surgical algorithm. However, despite the efforts, about 25% of these patients undergo at least unilateral LND to meet NCCN recommendations. Data of women with International Federation of Gynecology and Obstetrics stage IA1‐IB1/IIA1 cervical carcinoma were retrospectively collected by six Italian institutions. All patients underwent complete preoperative staging workup and were primarily treated by radical hysterectomy and pelvic bilateral LND. A total of 368 patients with early‐stage cervical cancer were identified. Among them 333 (90.5%) showed no suspicious enlarged nodes at the preoperative magnetic resonance imaging (MRI). In this subset, tumor diameter ≥20 mm was the only independent predictor of LN status (P = 0.003). None of the 106 patients with negative MRI nodal assessment, with squamous and adenosquamous histotype and a tumor diameter less than 2 cm had LNM. Based on these results we propose a new modified SLN surgical algorithm that could safely reduce LND performed in patients with very low‐risk early‐stage cervical cancer.

Robotic Splenectomy for Isolated Splenic Recurrence of Endometrial Adenocarcinoma

STUDY OBJECTIVE To demonstrate management of a rare case of an isolated intraparenchymal splenic metastasis of endometrial cancer with robotic-assisted surgery. DESIGN Case report (Canadian Task Force Classification III). SETTING A 55-year-old patient with a history of endometrial cancer was found to have a splenic lesion on a follow-up examination. She underwent surgical staging, involving total hysterectomy, bilateral salpingo-oopherectomy, pelvic lymphadenectomy, and peritoneal washing, in 2014, and the final pathological findings showed an endometrioid endometrial adenocarcinoma, International Federation of Gynecology and Obstetrics stage IB G2. Multidisciplinary counseling was provided, and the patient opted for strict medical surveillance. At 20 months after the primary treatment, the patient experienced a vaginal cuff recurrence and refused radiation therapy. She instead underwent robotic surgery, followed by 6 cycles of carboplatin 6 AUC and paclitaxel 175 mg/m2. Seventeen months later, a positron emission tomography/computed tomography scan revealed a 3-cm intraparenchymal lesion of the spleen, and robotic splenectomy was scheduled. The Institutional Review Board approved this study. INTERVENTION The operative time was 90 minutes, and blood loss was <50 mL. The operation was performed successfully, with no intraoperative and postoperative complications. Histopathological analysis showed a 3-cm intraparenchymal splenic lesion. The patient was discharged on day +2, and 46 days later started adjuvant chemotherapy based on carboplatin 6 AUC and doxorubicin (Caelyx) 30 mg/m2. At a 2-month follow-up, the patient was disease-free and in good general condition. CONCLUSION This case demonstrates the successful robotic management of recurrent endometrial cancer.

Laparoscopic Management of Ovarian Cancer Patients With Localized Carcinomatosis and Lymph Node Metastases: Results of a Retrospective Multi-institutional Series.

STUDY OBJECTIVE To investigate the feasibility and safety of laparoscopic cytoreduction in ovarian cancer patients with localized carcinomatosis or lymph node involvement. DESIGN Retrospective cohort study (Canadian Task Force classification II-2). SETTING Multi-institutional study performed in 6 referral gynecologic oncology units. PATIENTS Between June 2005 and December 2014, preoperatively presumed early-stage ovarian cancer patients, who accidentally revealed localized carcinomatosis or lymph node involvement at laparoscopic evaluation or at postoperative pathological examination managed by the laparoscopic approach. INTERVENTIONS All patients with limited carcinomatosis and/or lymph node metastases underwent complete laparoscopic cytoreduction. MEASUREMENTS AND RESULTS Sixty-nine patients were included in the analysis. Twenty-eight (40.6%) patients were staged III C because they had lymph node metastases. Pelvic lymphadenectomy was performed in 75.4% of cases, whereas aortic lymphadenectomy was performed in 79.7% of cases. Lymph node metastases were found in pelvic and aortic regions in 11 and 13 patients, respectively, whereas 4 patients had lymph node metastases in both regions. Twelve (17.4%) patients underwent complete pelvic peritonectomy because of the presence of nodules localized in several pelvic region sites. As of May 2015, the median follow-up was 35 months, and the median disease-free survival was 29 months. The 2-year disease-free survival rate was 77.1%, whereas the 2-year overall survival rate was 90.6%. The median time to recurrence was 26 months (range, 6 -55 months); 15 (21.7%) patients developed recurrence. CONCLUSION The present study shows the technical and clinical feasibility of laparoscopic cytoreduction in ovarian cancer patients with limited carcinomatosis or lymph node involvement.

Robotic Surgery in Elderly and Very Elderly Gynecologic Cancer Patients

STUDY OBJECTIVE To investigate the feasibility, safety, and short-term outcomes of robotic surgery (RS) for gynecologic oncologic indications (cervical, endometrial, and ovarian cancer) in elderly patients, especially women age 65 to 74 years (elderly group [EG]) compared with women age ≥75 years (very elderly group [VEG]). DESIGN Retrospective cohort study (Canadian Task Force classification II-2). SETTING Catholic University of the Sacred Heart, Rome, Italy. PATIENTS Between May 2013 and April 2017, 204 elderly and very elderly patients underwent RS procedures for gynecologic malignancies. RESULTS The median age was 71 years (range, 65-74 years) in the EG and 77 years (range, 75-87 years) in the VEG. The incidence of cardiovascular disease was higher in the VEG (p = .038). The EG and VEG were comparable in terms of operative time, blood loss, and need for blood transfusion. Almost all (98.5%) of the patients underwent total/radical hysterectomy, 109 patients (55.6% of the EG vs 48.3% of the VEG) underwent pelvic lymphadenectomy, and 19 patients (10.5% of the EG vs 6.7% of the VEG) underwent aortic lymphadenectomy. A total of 7 (3.4%) conversions to open surgery were registered. Only 3 patients required postoperative intensive care unit admission. The median length of hospital stay was 2 days in each group. A total of 11 patients (5.6%) had early postoperative complications. Four patients (2.8%) in the EG and 2 patients (3.3%) in the VEG experienced grade ≥2 complications. At the time of analysis, median follow-up was 18 months (range, 6-55 months). Eleven patients (5.6%) experienced disease relapse, 2 (1%) died of disease, and 3 (1.5%) died of cardiovascular disease. CONCLUSIONS This study demonstrates the feasibility, safety, and good short-term outcomes of RS in elderly and very elderly gynecologic cancer patients. No patient can be considered too old for a minimally invasive robotic approach, but a multidisciplinary approach is the best management pathway; efforts to reduce associated morbidity are essential.

M373 PROSPECTIVE STUDY EVALUATING THE ROLE OF mRNA-TEST IN THE MANAGEMENT AND FOLLOW-UP OF HR-HPV CERVICAL LESIONS: PRELIMINARY RESULTS

M373 PROSPECTIVE STUDY EVALUATING THE ROLE OF mRNA-TEST IN THE MANAGEMENT AND FOLLOW-UP OF HR-HPV CERVICAL LESIONS: PRELIMINARY RESULTS C. Ricci, C. Conte, I.N. Trivellizzi, R. Santangelo, M.L. Scarciglia, G. Scambia, R. De Vincenzo. Dipertimento per la tutela della salute della donna e della vita nascente, Università Cattolica del Sacro Cuore-Policlinico A. Gemelli, Rome, Italy; Università Cattolica del Sacro Cuore-Policlinico A. Gemelli – Istituto di Microbiologia, Rome, Italy