Quality of Life with Vulvar Carcinoma Treated with Palliative Electrochemotherapy: The ELECHTRA (ELEctroCHemoTherapy vulvaR cAncer) Study.

The ELECHTRA (ELEctroChemoTherapy vulvaR cAncer) project was conceived to collect data on palliative electrochemotherapy (ECT) in vulvar cancer (VC) assessing patients' outcomes (response and survival) and impact on quality of life (QoL). After reporting outcome data in 2019, here, we present the results on QoL. A multicenter prospective observational study was conducted on patients with VC refractory or not amenable to standard therapies undergoing palliative ECT as per clinical practice. The following questionnaires were administered before and after ECT (two and four months later, early and late follow-up): visual analog pain scale (VAS), EuroQol 5-Dimension 5-Level (EQ-5D-L5) and Functional Assessment of Cancer Therapy-Vulva cancer (FACT-V). Analyses were conducted on both the whole study population and by subgroups (clinical response after ECT and site, number and size of lesions). Questionnaires from 55 patients were evaluated. Compared to the baseline (6.1 ± 2.1), the VAS was significantly reduced at early (4.3 ± 2.5) and late follow-up (4.6 ± 2.8) (p < 0.0001). The FACT-V score improved significantly at early (9.6 ± 4.0) (p < 0.0001) and late follow-up (8.9 ± 4.1) (p < 0.0054) as compared to the baseline (7.1 ± 3.6). No EQ-5D-5L statistically significant changes were observed. Subgroup analyses showed worse QoL in patients with stable or progressive disease, posterior site and multiple or larger than 3 cm nodules. This is the first study reporting improved QoL in VC patients after palliative ECT. Based on these results, ECT in VC should be considered an effective option based on the favorable outcomes both in terms of response and QoL.

Palliative Electrochemotherapy in Vulvar Carcinoma: Preliminary Results of the ELECHTRA (Electrochemotherapy Vulvar Cancer) Multicenter Study.

Vulvar cancer (VC) is a rare disease of which recurrence poses management problems due to patients' advanced age and comorbidities, and to the localization of the disease. Palliative treatments, allowing local disease control in patients previously treated with multimodal therapies or with comorbidities, are lacking. In this study we tested electrochemotherapy (ECT) on recurrent VC refractory to standard therapies to assess the tumor response and to define the selection criteria for patient's candidate to ECT. This is a multicenter observational study carried out in five Italian centers. Data about patients and tumor characteristics, treatment, toxicity, and clinical response were recorded. In all procedures, intravenous bleomycin was administered according to European Standard Operative Procedure ECT (ESOPE) guidelines. Sixty-one patients, with a median age 79 years (range: 39-85) and mainly affected by squamous cellular carcinoma (91.8%), were treated with ECT. No serious adverse events were reported. Patients were discharged after three days (median, range: 0-8 days). Two months after ECT, the clinical response rate was 83.6% and was not related to age, body mass index, International Federation of Gynecology and Obstetrics (FIGO) stage, number of treated nodules, or previous treatments. ECT is a safe procedure with a favorable cost-effectiveness ratio and should be considered as a treatment option for local disease control in patients unsuitable for standard therapies.

Unilateral twin tubal pregnancy: a case report and review of the literature.

BACKGROUND: Unilateral twin tubal pregnancy is an extremely rare condition, occurring in 1/20.000-250.000 pregnancies and represents a major health risk for reproductive-aged women, leading to even life-threatening complications. AIM: We present a case of a 31-year-old woman with unilateral twin tubal pregnancy, treated with methotrexate and then surgically because of failure, followed by review of the literature. METHODS: Researches for relevant data were conducted utilizing multiple databases, including PubMed and Ovid. RESULTS: The most common type of twin ectopic pregnancy is the heterotopic (1/7000 pregnancies) in which in which both ectopic and intrauterine pregnancy occur simultaneously. Expectant, medical and surgical therapy have similar success rates in correctly selected patients. Two prospective randomized trials did not identify any statistically significant differences between groups receiving MTX as a single dose or in multiple doses. Among the 106 cases reported in literature, methotrexate was tried just in 4 patients (3 unilateral and 1 bilateral) before ours. Details are reported in the table 1. CONCLUSION: The recent shift in the treatment of singleton ectopic pregnancies to the less invasive medical therapy might apply even in the case of twin implants.

Comparison of Robotic and laparoscopic Radical type-B and C hysterectomy for cervical cancer: Long term-outcomes.

STUDY OBJECTIVE: To compare the clinical and oncologic outcomes of Robotic radical hysterectomy (RRH) vs Laparoscopic radical hysterectomy (TLRH) in patients with cervical carcinoma. DESIGN: Long term follow-up in a prospective study between March 2010 to March 2016. SETTING: Oncological referral center, department of gynecology and obstetrics of Alessandro Manzoni Hospital, department of gynecology, University of San Gerardo Monza, Milan. PATIENTS: 52 patients with cervical carcinoma, matched by age, body mass index, tumor size, International Federation of Gynecology and Obstetrics (FIGO) stage, comorbidity, previous neoadjuvant chemotherapy, histology type, and tumor grade to obtain homogeneous samples. INTERVENTIONS: Patients with FIGO stage IA2 or IB1 with a tumor size less than or equal to 2 cm underwent RR type B. RR-Type C1 was performed in stage IB1, with a tumor size larger than 2 cm, or in patients previously treated with NACT (IB2). In all cases Pelvic lymphadenectomy was performed for the treatment of cervical cancer. MEASUREMENTS AND MAIN RESULTS: Surgical time was similar for both the 2 groups. RRH was associated with significantly less (EBL) estimated blood loss (P=0,000). Median number pelvic lymph nodes was similar, but a major number of nodes was observed in RRH group (35.58 vs 24.23; P=0,050). The overall median length of follow-up was 59 months (range: 9-92) and 30 months (range: 90-6) for RRH and TLRH group respectively. Overall survival rate (OSR) was 100% for RRH group and 83.4% for LTRH group. The DFS (disease free survival rate) was of 97% and 89% in RRH and LTRH group respectively. No significant difference was reported in HS (hospital stay). CONCLUSIONS: RRH is safe and feasible and is associated with an improved intraoperative results and clinical oncological outcomes. The present study showed that robotic surgery, in comparison to laparoscopic approach, was associated with better perioperative outcomes because of a decrease of EBL, and similar operative time, HS and complication rate, without neglecting the long-term optimal oncologic outcomes.

Cost analysis of minimally invasive radical hysterectomy for cervical cancer performed by a single surgeon in an Italian center: an update in gynecologic oncological field.

The objective of this study is to perform an economic analysis and examine the influence of procedural volume of our hospital, evaluating the accounting systems of Robotic radical hysterectomy (RRH) vs Laparoscopic radical hysterectomy (TLRH) in patients with cervical carcinoma, due to the costs widely variable and lack in literature. Costs were collected prospectively, from March 2010 to March 2016. Direct costs were determined by examining the overall medical pathway for each type of intervention. 52 patients with cervical carcinoma, which were matched by age, body mass index, tumor size, International Federation of Gynecology and Obstetrics (FIGO) stage, comorbidity, previous neoadjuvant chemotherapy, histology type, and tumor grade to obtain homogeneous samples. Surgical time was similar for both the groups. RRH was associated with a significantly less (EBL) estimated blood loss (P = 0.000). The overall median length of follow-up was of 59 months. The cost of the robot-specific supplies was €2705 per intervention. When considering overall medical surgical care, the patient treatment average cost of an RRH was €5650,31 with an hospital stay (HS) of 3.58 days (SD ± 1) vs €3750.86 for TRLH, with an HS of 4.27 days (SD ± 1.79). Our results are similar to Finnish data; the costs of robot-assisted hysterectomies were 1.5 times higher than TLRH. The main drivers of additional costs are robotic disposable instruments, which are not compensated by the hospital room costs and by an experienced team staff. Implementation of strategies to reduce the cost of robotic instrumentation is due. RRH resulted less expensive than robotic simple hysterectomy for benign conditions.

Cost analysis of minimally invasive hysterectomy vs open approach performed by a single surgeon in an Italian center.

Despite the rapid uptake of robotic surgery, the effectiveness of robotically assisted hysterectomy (RAH) remains uncertain, due to the costs widely variable. Observed the different related costs of robotic procedures, in different countries, we performed a detailed economic analysis of the cost of RAH compared with total laparoscopic (TLH) and open hysterectomy (OH). The three surgical routes were matched according to age, BMI, and comorbidities. Hysterectomy costs were collected prospectively from September 2014 to September 2015. Direct costs were determined by examining the overall medical pathway for each type of intervention. Surgical procedure cost for RAH was €3598 compared with €912 for TLH and €1094 for OH. The cost of the robot-specific supplies was €2705 per intervention. When considering overall medical surgical care, the patient treatment average cost of a RAH was €4695 with a hospital stay (HS) of 2 days (range 2-4) compared with €2053 for TLH and €2846 for OH. The main driver of additional costs is disposable instruments of the robot, which is not compensated by the hospital room costs and by an experienced team staff. Implementation of strategies to reduce the cost of robotic instrumentation is due. No significant cost difference among the three procedures was observed; however, despite the optimal operative time, the experienced, surgeon and the lower HS, RAH resulted 2, 3 times and 1, 6 times more expensive in our institution than TLH and OH, respectively.

Detection of nodal metastases by 18F-FDG PET/CT in apparent early stage ovarian cancer: a prospective study.

BACKGROUND: The rate of nodal metastases in ovarian cancer macroscopically confined to the pelvis is about 15%-20%. Systematic pelvic and aortic lymphadenectomy improves staging but it is associated with increased morbidity and costs. The purpose of this study was to evaluate the role of 18F-FDG PET/CT in the pre-operative nodal metastases detection in ovarian cancer grossly confined to the pelvis. METHODS: From 2006 to 2012, 68 consecutive women with epithelial ovarian cancer confined to the pelvis underwent 18F-FDG PET/CT followed by surgery inclusive of systematic pelvic and aortic lymphadenectomy (SAPL). 18F-FDG PET/CT images were analyzed and correlated to histological examination. RESULTS: Twenty-six women underwent bilateral and 42 unilateral SAPL with 3165 nodes removed and analyzed. Median number of dissected nodes was 42 (range 16-91). Twelve women (17.6%) had nodal metastases. 18F-FDG PET/CT correctly identified 10 patients with nodal involvement. Sensitivity, specificity, accuracy, positive and negative-predictive value of 18F-FDG PET/CT in detecting nodal metastases were 83.3%, 98.2%, 95.6%, 90.9% and 96.5%, respectively, on overall patient-based, and 75.5%, 99.4%, 98.1%, 87.5% and 98.6%, respectively, on nodal lesion site-based analysis. CONCLUSION: 18F-FDG PET/CT is an accurate tool for the detection of nodal metastases. Metabolic imaging could be used to select women who could benefit from systematic lymphadenectomy. The high negative predictive value allows avoidance of SAPL in the vast majority of women, minimizing operative and post surgical complications. Further larger prospective investigation is required to confirm our data.

Tailoring systematic lymphadenectomy in high-risk clinical early stage endometrial cancer: the role of 18F-FDG PET/CT.

OBJECTIVES: To evaluate the role of FDG PET/CT in the preoperative N-staging of high-risk clinical stage I endometrial cancer. The correlation between the metabolic characteristics of endometrial tumor uptake as predictors of a) lymph-node (LN) metastases and b) recurrence, was also evaluated. METHODS: Seventy-six high-risk (G2 with deep myometrial invasion, G3, serous/clear-cell carcinoma) clinical stage I endometrial cancer patients underwent preoperative PET/CT scan followed by total hysterectomy, bilateral salpingo-oophorectomy and lymphadenectomy. PET/CT images were analyzed and correlated to histological findings. Maximal and mean standardized uptake value (SUVmax, SUVmean), metabolic tumor volume (MTV), total lesion glycolysis (TLG, defined as the product between SUVmean and MTV) of endometrial lesions were calculated and correlated to: a) presence of LN metastases, b) recurrences. RESULTS: PET/CT resulted positive at LNs in 12/76 patients: 11/12 truly positive, 1/12 falsely positive. Conversely PET/CT was negative in 64/76 patients: 61/64 truly negative and 3/64 falsely negative. On pt-based analysis, sensitivity, specificity, accuracy, positive and negative predictive value of PET/CT in detecting LN metastases were 78.6%, 98.4%, 94.7%, 91.7%, 95.3%, respectively. A significant association was found between the presence of LN metastases and SUVmax (p=0.038), MTV (p=0.007), TLG (p=0.003) of the primary tumor. No correlations were found between the metabolic parameters and relapse (median follow-up 25.4months). CONCLUSIONS: In high-risk clinical stage I endometrial cancer FDG PET/CT demonstrated moderate sensitivity, high specificity and accuracy for the nodal status assessment. SUVmax, MTV and TLG of the primary tumor are significantly correlated to LN metastases, while none of these parameters is predictor of recurrence.

18F-FDG PET/CT can predict nodal metastases but not recurrence in early stage uterine cervical cancer.

OBJECTIVES: To evaluate the role of the metabolic characteristics of cervical tumor uptake as predictors of a) lymph node (LN) metastases, b) recurrence, in the preoperative staging of early-stage cervical cancer. METHODS: 89 patients with FIGO stage IB1 and IIA<4 cm cervical cancer were imaged with FDG-PET/CT before radical hysterectomy and pelvic lymphadenectomy. PET/CT images were analyzed and correlated to histological findings. Maximum and mean standardized uptake value (SUVmax, SUVmean), metabolic tumor volume (MTV), total lesion glycolysis (TLG) of cervical lesions were calculated by an iterative adaptive algorithm. These parameters were correlated to the presence of: a) LN metastases, b) relapse after primary treatment. RESULTS: Out of the 89 patients who underwent preoperative PET/CT scan for staging purpose, 16 were negative at cervical level: they were all pN0 and without recurrence during follow-up (mean 34.1±14.5 months). In 69 patients MTV and TLG were significantly higher (p=0.0006 and p=0.03) in pN1 patients in comparison to pN0 patients, while SUV values did not show significant differences between the two groups. No significant correlations were found between SUVmax, SUVmean, MTV, TLG and the evidence of relapse (mean follow-up 29.2±15.5 months). CONCLUSIONS: In early-stage cervical cancer MTV and TLG correlate with the presence of nodal metastases, but their clinical impact on patients management has to be clarified. The absence of pathological cervical uptake could be a good prognostic factor, while SUVmax, SUVmean, MTV, TLG of the cervical uptake have not been found predictors of recurrence.

The use of TachoSil for the prevention of postoperative complications after groin dissection in cases of gynecologic malignancy.

OBJECTIVE: To evaluate the effect of TachoSil in preventing postoperative complications after groin dissection performed for primary or recurrent gynecologic malignancy. METHODS: In a case-control analysis, the incidence of postoperative complications-including lymphocyst formation, wound breakdown and/or infection, and chronic lymphedema-was examined among 8 patients who received TachoSil and 16 controls (standard technique) treated for vulvar cancer or recurrent ovarian/breast cancer at San Gerardo Hospital, Monza, Italy, from 2008 to 2011. RESULTS: Thirty-eight inguinal dissections were performed in the 24 patients. Bilateral groin dissection was performed in 14 patients (n=4 in the study group; n=10 in the control group). Patients in the study group had a lower mean daily drainage volume than those in the control group (133 mL [range, 50-356 mL] vs 320 mL [range, 67-472 mL]; P<0.001) and a lower incidence of lymphocyst requiring drainage (25.0% vs 62.5%), cellulitis (12.0% vs 25.0%), and wound infection (0.0% vs 25.0%). CONCLUSION: The use of TachoSil seems to be effective in reducing the rate of postoperative complications after inguinofemoral lymphadenectomy in cases of gynecologic malignancy.

Better anatomical and cosmetic results using tunneled lotus petal flap for plastic reconstruction after demolitive surgery for vulvar malignancy.

OBJECTIVE: To evaluate the efficacy of tunneled lotus petal flap in terms of anatomical and cosmetic results in patients who underwent vulvoperineal reconstruction for vulvar malignancy. METHODS: Between March 2010 and July 2011, 22 women underwent vulvoperineal reconstruction using tunneled lotus petal flap for primary or recurrent disease at San Gerardo Hospital, Monza. In 16 cases, lotus flaps were bilateral, whereas in 6 cases, they were monolateral. RESULTS: The median age was 72 years (range, 53-87 years). The mean operating time was 85 minutes. The mean length of follow-up was 10 months (range, 2-16 months). Postoperative complications occurred in 2 patients, including one case of partial flap necrosis and one case of donor site breakdown. CONCLUSIONS: Tunneled lotus petal flap is safe, easy and fast to perform, has a low rate of complications, and good functional and cosmetic results. This technique represents an optimal solution for plastic reconstruction in case of primary or recurrent vulvar disease, or in case of introital stenosis after primary inadequate closure.

Synchronous early-stage endometrial and ovarian cancer.

OBJECTIVE: To explore the clinicopathologic findings and oncological outcome of early-stage synchronous endometrial and ovarian malignancies. METHODS: A retrospective study of 93 women with synchronous stage I ovarian and stage I-II endometrial cancer treated between December 1981 and August 2005 in the gynecologic oncology department of San Gerardo Hospital, Italy. RESULTS: Fifty-one percent of the ovarian tumors were stage Ia and 71% of the endometrial cancers had minimal myometrial invasion. Endometrioid histology and grade 2 disease were prevalent in both sites. Hyperplasia and endometriosis coexisted in 71% and 22% of endometrial and ovarian cancers, respectively. The actuarial 5-year disease-free and overall survival rates were 83% and 96%, respectively. CONCLUSION: The incidence of synchronous endometrial and ovarian cancer is not negligible, especially among young women. Synchronous cancers show very favorable pathologic features and have an excellent oncologic outcome. Adjuvant therapy should be tailored according to surgical staging and histology.