Marco Calcagno

Randomised study of systematic lymphadenectomy in patients with epithelial ovarian cancer macroscopically confined to the pelvis

No randomised trials have addressed the value of systematic aortic and pelvic lymphadenectomy (SL) in ovarian cancer macroscopically confined to the pelvis. This study was conducted to investigate the role of SL compared with lymph nodes sampling (CONTROL) in the management of early stage ovarian cancer. A total of 268 eligible patients with macroscopically intrapelvic ovarian carcinoma were randomised to SL (N=138) or CONTROL (N=130). The primary objective was to compare the proportion of patients with retroperitoneal nodal involvement between the two groups. Median operating time was longer and more patients required blood transfusions in the SL arm than the CONTROL arm (240 vs 150 min, P<0.001, and 36 vs 22%, P=0.012, respectively). More patients in the SL group had positive nodes at histologic examination than patients on CONTROL (9 vs 22%, P=0.007). Postoperative chemotherapy was delivered in 66% and 51% of patients with negative nodes on CONTROL and SL, respectively (P=0.03). At a median follow-up of 87.8 months, the adjusted risks for progression (hazard ratio [HR]=0.72, 95%CI=0.46–1.21, P=0.16) and death (HR=0.85, 95%CI=0.49–1.47, P=0.56) were lower, but not statistically significant, in the SL than the CONTROL arm. Five-year progression-free survival was 71.3 and 78.3% (difference=7.0%, 95% CI=–3.4–14.3%) and 5-year overall survival was 81.3 and 84.2% (difference=2.9%, 95% CI=−7.0–9.2%) respectively for CONTROL and SL. SL detects a higher proportion of patients with metastatic lymph nodes. This trial may have lacked power to exclude clinically important effects of SL on progression free and overall survival.

Vaginal estrogen therapy and overactive bladder symptoms in postmenopausal patients after a tension-free vaginal tape procedure: a randomized clinical trial.

Objective:To evaluate whether the frequency of overactive bladder (OAB) symptoms increases in menopause patients after a tension-free vaginal tape (TVT) procedure, and to determine if topical estrogen therapy can help prevent these symptoms. Design:After undergoing a preoperative assessment, enrolled patients were randomly allocated to receive TVT plus postoperative vaginal estrogen therapy (ET group) or TVT without adjunctive medical treatment (No ET group). The pre- and postoperative assessments included: acquisition of a urogynecologic history with standardized questions regarding urinary function (including a 10-grade visual analogue scale score), urogynecologic clinical examination, and urodynamic assessment. Follow-up assessments were performed at 1, 3, and 6 months after surgery. Results:Fifty-six of 59 patients were evaluable; 28 received topic vaginal estrogen after surgery (ET group) and 28 did not receive adjunctive medical treatment (No ET group). The overall OAB syndrome rate in menopause patients (No ET group) was 7% (2 of 28 patients) at baseline and 32% (9 of 28 patients) 6 months after surgery (P = 0.04). At the 6-month follow-up assessment, the incidence of urinary urgency was 4% (1 of 28 patients) and 29% (8 of 28 patients) in the ET and No ET groups, respectively (P = 0.01). Differences in frequency and nocturia were not statistically significant. Analysis of the visual analogue scale scores revealed that at the 6-month follow-up assessment, urgency significantly improved in the ET group compared with the No ET group (0.23 ± 1.0 vs 2.30 ± 3.7, respectively; P = 0.02). Conclusions:The TVT procedure seems to increase the frequency of OAB syndrome in menopause patients. Vaginal estriol therapy significantly reduces symptoms of urinary urgency, has a high rate of patient satisfaction, and can be used to treat postmenopausal women for at least 6 months after a TVT procedure.

Update on lymphadenectomy in early and advanced ovarian cancer

Purpose of review Pelvic and para-aortic lymphnode sampling is an integral part of the staging system of ovarian cancer. The issue concerning lymphadenectomy in the management of the disease is still debated, however. The purpose of this paper is to review the role of systematic lymphadenectomy in patients affected by early and advanced-stage ovarian cancer. Recent findings Some retrospective studies have revealed an increased survival rate in early-stage ovarian cancer patients after lymphadenectomy. Recently, the first randomized prospective trial, on lymphadenectomy in advanced-stage disease, was published. It evidenced an improvement in progression-free survival in patients who had undergone lymphadenectomy. Summary Systematic lymphadenectomy has a diagnostic value in early-stage ovarian cancer, thanks to the possibility of accurate clinical staging. As up to 22% of women, who were presumed to have early-stage ovarian cancers, are upstaged during the lymphadenectomy procedure, accurate staging can help to avoid unnecessary postoperative chemotherapy. In patients affected by advanced ovarian cancer, systematic lymphadenectomy statistically significantly improves progression-free survival and reduces recurrence rates despite a higher incidence of postoperative complications. As improvement of overall survival is not statistically significant, further studies are needed to balance risks and benefits of systematic lymphadenectomy in advanced-stage disease.

Early prolapse of a neovagina created with self-dilatation and treated with sacrospinous ligament suspension in a patient with Mayer-Rokitansky-Küster-Hauser syndrome: a case report

OBJECTIVE To report a case of a patient who had an early prolapse of the neovagina, while using Franks dilators method, that was successfully treated with sacrospinous ligament suspension. DESIGN Case report. SETTING Tertiary-care university hospital. PATIENT(S) A 22-year-old woman with Mayer-Rokitansky-Küster-Hauser syndrome. INTERVENTION(S) Franks vaginal dilators method. MAIN OUTCOME MEASURE(S) Vaginal elongation by self-dilatation. Early prolapse of the neovagina. Surgical repair with vaginal sacrospinous ligament suspension. RESULT(S) A few months after the beginning of the treatment the patient had a prolapse of the neovagina. On pelvic examination, the total vaginal length was 5 cm with eversion of the vaginal apex 3 cm beyond the hymen with strain. Vaginal length was not satisfactory for the patient yet; therefore, the vaginal dilation program was continued to reach the prefixed vaginal length. Two months later the total vaginal length was 8 cm with eversion of the vaginal apex 6 cm beyond the hymen with strain. The patient underwent a sacrospinous ligament suspension. Twenty months after surgery, the patient had no symptoms and was highly satisfied with the result. CONCLUSION(S) Prolapse of a neovagina may occur early after conservative treatment. If the initial prefixed goal of vaginal length has not been reached when prolapse develops, the vaginal dilatation program may be continued. In our case vaginal sacrospinous ligament fixation was successful, with good anatomic and functional results.

Post radical hysterectomy urinary incontinence: A prospective study of transurethral bulking agents injection

OBJECTIVE(S) The aim of the present study is to prospectively investigate the efficacy and complications of macroplastique transurethral implantation in cervical cancer patients affected by stress urinary incontinence (SUI) after radical hysterectomy (RH). METHODS Patients affected by de novo SUI post type 3 RH were considered for eligibility in this study. Preoperative and postoperative assessment included a standardized urogynecological history, urogynecological and neurological physical examination, evaluation of severity of SUI symptoms, a 3-day voiding diary, urine culture and urodynamic assessment. All patients underwent transurethral implantation using Macroplastique Implantation System (MIS). Patient follow-up was performed 6 and 12 months after surgery. RESULTS A total of 24 consecutive patients were enrolled. At the 12 month follow up SUI cure rate was 42% (10 of 24 patients), the improvement rate was 42% (10 of 24) and the failure rate was 16% (4 of 24). The overall success rate was 84% (10 patients cured and 10 improved). No intraoperative or postoperative early complications were found. The 4 patients in whom treatment was not a success had preoperative urethral hypermobility. Subjective patient perception of SUI symptom severity showed significant improvement (mean severity of urinary loss perception 6.6+/-1.8 vs 2.3+/-3.3, p<0.05). The frequency of incontinence on the 3-day voiding diary was significantly reduced at the follow up (14.5+/-5.8 vs 4.3+/-7.9 episodes per 3 days, p<0.05). CONCLUSION(S) Bulking agents urethral injection could be a valid option having no surgical complications. This therapeutic strategy is able to treat SUI and improve well being of cervical cancer patients after radical surgery.

Splenectomy during secondary cytoreduction for ovarian cancer disease recurrence: surgical and survival data.

BackgroundOvarian cancer disease recurs predominantly in the abdomen, with the spleen usually involved as part of a vast spread of upper-abdominal disease or, less frequently, as an isolated site of disease recurrence. Very few reports are available in the literature on the outcome of patients subjected to splenectomy during secondary cytoreduction. The aim of this study was to identify prognostic factors and to review surgical and clinical data in order to identify those patients who would benefit the most from splenectomy during secondary cytoreduction.MethodsThis was a retrospective review of platinum-sensitive recurrent epithelial ovarian cancer patients who underwent splenectomy as part of secondary cytoreduction. Surgical and survival data were recorded.ResultsTwenty-four patients were identified. Multiple site disease recurrence was observed in 15 patients. The spleen was involved at the hilus in 12 patients; surface and intraparenchymal metastases were equally present. Optimal cytoreduction was achieved in all patients. At a median follow-up of 30 months, median progression-free and overall survival from the time of secondary surgery were 34 and 56 months, respectively. Overall survival was significantly correlated to residual disease at secondary surgery, disease-free survival, consolidation chemotherapy, and type of adjuvant therapy.ConclusionsSplenectomy as part of secondary cytoreduction is a feasible and safe procedure. Secondary cytoreduction in selected groups of patients is confirmed to be associated with high long-term survival rates even when aggressive surgery of the upper abdomen is required.

Neoadjuvant Chemotherapy Followed by Radical Surgery in Patients Affected by FIGO Stage IVA Cervical Cancer

BackgroundConcomitant chemoradiotherapy represents the standard treatment for patients affected by locally advanced cervical cancer. Survival rates in patients affected by FIGO stage IVA disease remain poor. Some authors have suggested that neoadjuvant chemotherapy followed by radical surgery might be a valid alternative to standard treatment. The objective of this study was to analyze the feasibility and results obtained by neoadjuvant chemotherapy in patients affected by stage IVA disease.MethodsEighteen patients affected by FIGO stage IVA cervical cancer were treated with 175 mg/m2 paclitaxel and 75 mg/m2 cisplatin every 21 days for three courses followed by radical surgery when feasible.ResultsAll patients were subjected to the three planned chemotherapy courses. Two patients achieved a complete clinical response, and 10 patients achieved a partial clinical response. Ten patients were subjected to anterior pelvic exenteration, whereas the remaining eight patients were treated with chemotherapy, radiotherapy, and concomitant chemoradiotherapy. The estimated 3-year and 5-year overall survival rates were 47.4% and 31.6%, respectively. Patients eligible for surgery benefited from significantly longer survival rates.ConclusionsNeoadjuvant chemotherapy followed by radical surgery is feasible in approximately half of patients affected by FIGO stage IVA cervical cancer. Overall survival rates appear similar to those reported with concomitant chemoradiotherapy. Patients who are amenable to radical surgery after chemotherapy may benefit from long-term survival rates.

Laparoscopic fertility-sparing staging in unexpected early stage ovarian malignancies

OBJECTIVE To assess feasibility and safety of fertility-sparing laparoscopic staging in women affected by unexpected ovarian cancer desiring to preserve their fertility. DESIGN Prospective study. SETTING University clinic. PATIENT(S) Twenty-seven patients already operated on elsewhere for a presumably benign ovarian cyst. INTERVENTION(S) Laparoscopic fertility-sparing staging operations. MAIN OUTCOME MEASURE(S) Perioperative and survival data, reproductive outcome. RESULT(S) Histologic findings after first surgery: 12 low malignant potential neoplasms, 11 invasive epithelial ovarian carcinomas,1 sex-cord stromal, and 3 germ cell neoplasms. Fertility-sparing staging consisted of exploration of the peritoneal cavity, peritoneal washing cytology, multiple peritoneal biopsies, omolateral adnexectomy (except in borderline tumors), omentectomy, omolateral or bilateral pelvic and aortic lymph node sampling (except in borderline tumors, well differentiated, mucinous, and granulosa cell (GC) neoplasms), endometrial biopsy, appendectomy in mucinous type. Overall, seven patients (26%) were upstaged. Six patients received adjuvant platinum-based chemotherapy. Two term pregnancies occurred. After a median follow-up of 20 months all patients are alive; one patient has FIGO stage Ic clear cell carcinoma, which recurred 8 months after surgery. CONCLUSION(S) Laparoscopic fertility-sparing staging in early ovarian malignancies is feasible and safe in selected and counseled patients and should be performed in experienced gynecological oncology centers trained in endoscopic procedures.

Invasive vulvar carcinoma and the question of the surgical margin

To assess the discrepancy between width of surgical margin measured with the naked eye/ruler by a surgeon before removing an invasive vulvar carcinoma, and width of margin measured under microscope by pathologist after fixation of the resected lesion with formalin. Potential relationships between discrepancy and disease recurrence were also investigated.

Liposome-encapsulated doxorubicin citrate in previously treated recurrent/metastatic gynecological malignancies.

The aim of this study was to evaluate the safety and efficacy of liposome-encapsulated doxorubicin citrate (LEDC) in patients affected by recurrent/metastatic gynecological malignancies scheduled for palliative chemotherapy. Inclusion criteria were proven recurrent/advanced gynecological neoplasms, measurable/assessable disease, adequate organ function, left ventricular ejection fraction >50% as determined by echocardiography, informed consent. LEDC was administered intravenously over 1 h at the dose of either 75 mg/m2 or 60 mg/m2 (every 3 weeks until disease progression or toxicity prohibiting further therapy). From May 2003 to September 2005, 36 patients were enrolled. Primary disease was ovarian, endometrial, and cervical cancers in 15 (42%), 11 (30%), and 10 (28%) patients, respectively. LEDC was employed as third- or fourth-line chemotherapy in 25 (70%) and 11 (30%) patients, respectively. The median number of courses of LEDC received was 3 (range 2–9). Six patients (17%) achieved a partial response to treatment lasting 27 weeks and 10 patients (28%) experienced stable disease lasting 18 weeks. The predominant toxicity was hematological, especially neutropenia. Among patients receiving a dose of 75 mg/m2, two (11%) suspended therapy for febrile neutropenia, and nine (50%) required a dose reduction of 25%. As a result, the next 18 patients were treated at a reduced dose (60 mg/m2) of LEDC. Severe neutropenia (G3–G4) was significantly less common in this group (61% versus 22%; P= 0.04). LEDC has shown antineoplastic activity in previously treated recurrent/metastatic gynecological cancer patients and the toxicity profile could be considered acceptable at a 60 mg/m2 dosage.