The shift toward neo-adjuvant chemotherapy and interval debulking surgery for management of advanced ovarian and related cancers in a population-based setting: Impact on clinical outcomes.

OBJECTIVES: The aim of this study was to determine the proportion of patients with advanced ovarian and related cancers (EOC+RC), treated with neoadjuvant chemotherapy and interval debulking surgery (NACT - IDS), and to determine if there was any relationship with optimal cytoreduction rates and overall survival (OS) in a state-wide gynaecologic oncology service over time. METHODS: A retrospective review was undertaken using a population-based database of patients with stages 3 and 4 EOC+RC treated from 1982 till 2013 at the Queensland Centre for Gynaecological Cancer (QCGC). The proportion of patients treated with NACT - IDS compared with primary debulking surgery (PDS) was determined and compared with debulking rates and with the moving five-year OS probability. RESULTS: From 1982-2013, 2601 patients with advanced EOC+RC were managed at QCGC. No patients received NACT - IDS till 1995 when the first two patients received this treatment, rising to 55% of patients in 2013. Surgical cytoreduction rates to no macroscopic residual (R0) were achieved 32% of the time by 2006, rising to 48% in 2009, and 62% in 2013. Despite the increase in utilisation of NACT - IDS, our unit has noted a continued rise in the OS probability at five years to 45%. CONCLUSIONS: The increasing utilisation of NACT - IDS in the setting of a large centralised clinical service has been associated with increasing rates of optimal cytoreduction and survival rates have continued to rise in excess of those achieved in the trials reported to date.

Quality of life after early enteral feeding versus standard care for proven or suspected advanced epithelial ovarian cancer: Results from a randomised trial.

BACKGROUND: Malnutrition is common in patients with advanced epithelial ovarian cancer (EOC), and is associated with impaired quality of life (QoL), longer hospital stay and higher risk of treatment-related adverse events. This phase III multi-centre randomised clinical trial tested early enteral feeding versus standard care on postoperative QoL. METHODS: From 2009 to 2013, 109 patients requiring surgery for suspected advanced EOC, moderately to severely malnourished were enrolled at five sites across Queensland and randomised to intervention (n=53) or control (n=56) groups. Intervention involved intraoperative nasojejunal tube placement and enteral feeding until adequate oral intake could be maintained. Despite being randomised to intervention, 20 patients did not receive feeds (13 did not receive the feeding tube; 7 had it removed early). Control involved postoperative diet as tolerated. QoL was measured at baseline, 6weeks postoperatively and 30days after the third cycle of chemotherapy. The primary outcome measure was the difference in QoL between the intervention and the control group. Secondary endpoints included treatment-related adverse event occurrence, length of stay, postoperative services use, and nutritional status. RESULTS: Baseline characteristics were comparable between treatment groups. No significant difference in QoL was found between the groups at any time point. There was a trend towards better nutritional status in patients who received the intervention but the differences did not reach statistical significance except for the intention-to-treat analysis at 7days postoperatively (11.8 intervention vs. 13.8 control, p 0.04). CONCLUSION: Early enteral feeding did not significantly improve patients' QoL compared to standard of care but may improve nutritional status.

Surgical management of abnormally invasive placenta: a retrospective cohort study demonstrating the benefits of a standardized operative approach.

INTRODUCTION: Abnormally invasive placenta is a major cause of maternal morbidity and mortality. The aim of this study was to assess the effectiveness of a standardized operative approach performed by gynecological oncologists in the surgical management of abnormally invasive placenta. MATERIALS AND METHODS: We performed a retrospective analysis of all cases of morbid placental adherence managed at the Mater Mothers' Hospitals, Brisbane, Australia between January 2000 and June 2013. A standard operative approach involving extensive retro-peritoneal and bladder dissection before delivery of the fetus, was undertaken when a gynecological oncologist was present at the start of the procedure. Main outcome measures were estimated blood loss, transfusion requirements, and maternal and neonatal morbidity. RESULTS: The study includes 98 cases of histologically confirmed abnormally invasive placenta. Median estimated blood loss for the entire cohort was 2150 mL (range 300-11 500 mL). Women were divided into three groups, (1) those who had a gynecological oncologist present at the start of the procedure (group 1; n = 43), (2) those who had a gynecological oncologist called in during the procedure (group 2; n = 23), and (3) those who had no gynecological oncologist involved (group 3; n = 32). Group 2 had a significantly higher blood loss than the other groups (p = 0.001) (median 4400 mL). Transfusion requirements were higher in groups 2 and 3 compared with group 1 (p = 0.004). Other maternal and neonatal morbidity was similar across all three groups. CONCLUSION: This study supports the early presence of a gynecological oncologist at delivery when abnormally invasive placenta is suspected and demonstrates that a "call if needed" approach is not acceptable for these complex cases.

Squamous cell carcinoma of the vulva: a comparison between women 35 years or younger and 90 years or older.

OBJECTIVE: This study aimed to compare clinical features, diagnosis, management, and outcomes between women 35 years or younger and 90 years or older with vulvar squamous cell carcinoma referred to Queensland Centre for Gynaecological Cancer between 1983 and 2010. MATERIALS AND METHODS: Fifty-seven case records, including pathology reports for these 2 groups were reviewed and analyzed using the computer software SPSS 11.0. RESULTS: Of the cases, 34 were 35 years or younger (mean = 31.6 years), and 23 90 years or older (mean = 92.6 years). International Federation of Gynecology and Obstetrics classification showed grade 1 for 74% in the younger group and 55% for the older group. Patient status showed 22 alive (65%) in the younger group and 4 alive (17%) in the older group. Three younger patients (9%) were dead of disease and 8 (35%) in the older group. Three patients (9%) died of another disease in the younger group and 10 patients (43%) in the older group. Initial treatment was surgical in 30 younger cases (88%) and 18 older cases (78%). CONCLUSIONS: We demonstrated a trend toward younger women presenting with vulvar squamous cell carcinoma and a history of human papillomavirus and vulvar intraepithelial neoplasia. Immune deficiency diseases occurred in 23% of the younger group, but none occurred in the older group, where Alzheimer disease, heart disease, and renal failure (57%) were present. Poorly differentiated tumors and an International Federation of Gynecology and Obstetrics classification of 2 or more resulted in a worse outcome than did better differentiated lesions, irrespective of additional medical conditions.

Nomograms to predict isolated loco-regional or distant recurrence among women with uterine cancer.

OBJECTIVE: While there is ample literature on prognostic factors for uterine cancer, currently there are nomeans to estimate an individual's risk for recurrence or to differentiate the risk of loco-regional recurrence from distant recurrence. We addressed this gap by developing nomograms to individualize the risk of recurrence. METHODS: A total of 2097 consecutive patients who underwent primary surgery between 1997 and 2007 were included. Sixteen covariates were evaluated for their prognostic significance and modeled using multivariable competing risks regression to predict three-year outcomes as part of a nomogram. Each covariate in the nomogram is assigned a value, and a sum of these values form the overall risk score from which three-year incidence probabilities can be predicted for each individual. Predictive accuracy was assessed with concordance index and then corrected for optimism. RESULTS: The median follow-up time (inter-quartile range, IQR) was 50.0 (28.3-77.5) months and 221 patients developed a recurrence (127 patients with isolated loco-regional recurrence, 94 patients with distant recurrence). The nomograms included the following covariates: age at diagnosis, FIGO stage (2009), grade, lymphovascular invasion, histological type, depth of myometrial invasion, and peritoneal cytology. Concordance indices for isolated loco-regional and distant recurrences were 0.73 and 0.86, respectively. CONCLUSIONS: Our nomograms quantify an individual patient's risk of isolated loco-regional and distant recurrence, using factors that are routinely collected. They may assist clinicians to assess an individual's prognosis, individualize treatment and also assist in the risk stratification in prospective randomized clinical trials evaluating the effectiveness of treatments for uterine cancer.

Validation of the FIGO 2009 staging system for carcinoma of the vulva.

BACKGROUND: The previous (1988) International Federation of Gynecology and Obstetrics (FIGO) vulval cancer staging system failed in 3 important areas: (1) stage 1 and 2 disease showed similar survival; (2) stage 3 represented a most heterogeneous group of patients with a wide survival range; and (3) the number and morphology of positive nodes were not taken into account. OBJECTIVE: To compare the 1988 FIGO vulval carcinoma staging system with that of 2009 with regard to stage migration and prognostication. METHODS: Information on all patients treated for vulval cancer at the Queensland Centre for Gynecological Cancers, Australia, between 1988 to the present was obtained. Data included patients' characteristics as well as details on histopathology, treatments, and follow-up. We recorded the original 1988 FIGO stage, reviewed all patients' histopathology information, and restaged all patients to the 2009 FIGO staging system. Data were analyzed using the Kaplan-Meier method to compare relapse-free survival and overall survival. RESULTS: Data from 394 patients with primary vulval carcinoma were eligible for analysis. Patients with stage IA disease remained unchanged. Tumors formerly classified as stage II are now classified as stage IB. Therefore, FIGO 2009 stage II has become rare, with only 6 of 394 patients allocated to stage II. Stage III has been broken down into 3 substages, thus creating distinct differences in relapse-free survival and overall survival. Prognosis of patients with stage IIIC disease is remarkably poor. CONCLUSION: The FIGO 2009 staging system for vulval carcinoma successfully addresses some concerns of the 1988 system. Especially, it identifies high-risk patients within the heterogeneous group of lymph node-positive patients.

Paget's disease of the vulva: Diagnosis and follow-up key to management; a retrospective study of 50 cases from Queensland.

OBJECTIVE: To review the clinical features, diagnosis, management, and outcomes for the 50 cases of Paget's disease (PD) of the vulva referred to Queensland Centre for Gynaecological Cancer between 1986 and 2009. METHODS: Vulvar PD cases from QCGC were reviewed and analyzed using the computer software Statistical Package for the Social Sciences (SPSS) 11.0. RESULTS: Paget's disease (PD) of the vulva is uncommon. Of the 50 patients, 2 have died of their PD, 1 patient that had coexisting PD died of squamous cell vulva cancer, and 11 died of unrelated causes. The mean age at diagnosis was 67.6 years (range, 31 to 91). All cases were Caucasian. Time from onset of symptoms to diagnosis averaged 21 months. Not until a biopsy was performed was the diagnosis made. The most common presenting complaint was pruritis (27 cases, 54%). There was no identifiable "favored" site on the vulva for PD. Positive groin lymph nodes were found in 4 of the 10 cases who underwent node biopsy. Two who had poorly differentiated carcinoma in the nodes and PD died of disease within a year of diagnosis, one is alive three years later. The fourth case had coincidental PD and vulvar squamous cell carcinoma with squamous carcinoma groin nodes. Initial treatment was surgical. CONCLUSIONS: The prognosis for primary extra-mammary PD of the vulva confined to the epidermis (IEP) is excellent. Early diagnosis and long term follow-up are the keys to successful management. The status of disease at the margins of surgical specimens does not reliably equate to patient long term outcomes.

Evaluation of tumor-free distance and depth of myometrial invasion as prognostic factors for lymph node metastases in endometrial cancer.

INTRODUCTION: Concurrent uterine lesions or an irregular endomyometrial junction can make accurate assessment of depth of myometrial invasion (DOI) and percentage of myometrial invasion (%MI) difficult, leading to patients being staged and or treated suboptimally. An alternative measurement, known as the tumor-free distance (TFD), which measures the distance between maximal myometrial invasion and the uterine serosa, has been proposed. Previous studies comparing the predictive abilities of DOI and TFD were underpowered and inconclusive. Our objective was to compare TFD, DOI, and %MI as predictors for lymph node involvement in surgically staged endometrial cancer patients. METHODS: Patients with endometrioid adenocarcinoma of the endometrium treated between January 1997 and December 2007 were included. Tumor-free distance, DOI, and %MI were evaluated along with other pathological variables to determine their predictive ability for nodal involvement. Depth of myometrial invasion was measured between the endomyometrial junction and the maximal myometrial invasion. Tumor-free distance was calculated by subtracting the DOI from myometrial thickness (MT). Percentage MI was derived by dividing DOI by MT and expressed as a percentage of MT invaded. These 3 variables were transformed to z scores, and their ability to predict nodal involvement was compared. RESULTS: A total of 338 patients were eligible for analysis. Mean (SD) MT was 18.7 (5.9) mm. Median DOI was 6 mm, and median TFD was 10.3 mm. On univariate analysis, all 3 variables showed significant associations with nodal involvement. On multivariate analysis, after adjusting for lymphovascular space invasion, cervical involvement, serosal/adnexal involvement, grade, %MI, and TFD, DOI retained its statistical significance along with lymphovascular space invasion and cervical involvement. CONCLUSIONS: Depth of myometrial invasion predicts nodal involvement independently when compared with TFD.

Disease-free survival after vaginal vault brachytherapy versus observation for patients with node-negative intermediate-risk endometrial adenocarcinoma.

PURPOSE: To compare the disease-free survival (DFS) of patients with surgical stage 1, intermediate-risk endometrial adenocarcinoma (EAC) treated with primary surgery with or without adjuvant vaginal vault brachytherapy (VVBT). PATIENTS AND METHODS: A retrospective chart review identified 575 patients with stage 1B, 1C or 2A endometrial cancer who had surgery between 1990 and 2004. All patients were surgically staged and 259 patients received postoperative VVBT. The date and site of first recurrence were considered the primary statistical endpoints and were analysed by univariate and multivariate Cox models. Subgroups of patients stratified by substage and grade were created and Log-rank tests using vaginal recurrence as the endpoint were calculated within these groups. RESULTS: After a mean follow-up period of 72 months (95%-confidence interval (CI): 68 to 75 months) a total of 43 (7.5%) patients developed recurrence. Multivariate analysis demonstrated that increasing patient's age at diagnosis and stage 1C or 2A disease were independent risk factors for recurrence whereas the grade of differentiation and the type of treatment (surgery alone vs. surgery followed by postoperative VVBT) were not associated with a change in DFS. Analysis within the subgroups stratified by substage and grade did not even reveal a trend towards improved local control with VVBT. CONCLUSION: Postoperative VVBT was not associated with a measurable reduction in the risk of recurrence in surgical stage 1, intermediate-risk endometrial cancer.

Randomized trial of skin closure after laparotomy for gynaecological surgery.

BACKGROUND: New suture materials may provide patients with a better cosmetic outcome at similar pain and wound complication rate. METHODS: To assess pain and cosmetic outcome among patients randomized to receive wound closure after laparotomy for gynaecological surgery using staples, polyglecaprone 25 or polyglecaprone 6211 subcuticular sutures. RESULTS: Overall, 90 patients (87.4% consent rate) were randomized. There was no difference in wound complications and pain between the three groups. Patients randomized to polyglecaprone 6211 subcuticular sutures rated the cosmetic result at 1 and 6 weeks after surgery somewhat lower than patients randomized to the two alternative groups; however, at 3 months after surgery, all three groups rated the cosmetic result as similar. CONCLUSIONS: This study suggests that the three wound closure methods have similar short-term pain and cosmetic outcomes, as well as a similar rate of wound complications, leaving the decision of the most appropriate closure method to individual surgeons.

Prognostic importance of preoperative CA-125 in International Federation of Gynecology and Obstetrics stage I epithelial ovarian cancer: an Australian multicenter study.

PURPOSE: To evaluate the prognostic significance of preoperative CA-125 levels on overall survival of patients with International Federation of Gynecology and Obstetrics (FIGO) stage I epithelial ovarian cancer (EOC). PATIENTS AND METHODS: Data from 518 patients with FIGO stage I EOC treated in seven gynecologic oncology centers throughout Australia between 1990 and 2002 were analyzed. Patients with borderline tumors and nonepithelial ovarian carcinomas were excluded, as were women in whom CA-125 had not been determined preoperatively. Preoperative CA-125 levels were studied in surgically staged and incompletely staged patients and compared with prognostic factors, such as substage, grade, and histologic type. Multivariate Cox models were calculated. RESULTS: CA-125 levels more than 30 U/mL were associated with higher grade, substage 1B and 1C, nonmucinous histologic type, and older age. In univariate analysis, higher histologic grade, the absence of surgical staging, and preoperative CA-125 levels more than 30 U/mL were associated with impaired survival. Multivariate analysis identified histologic grade, preoperative CA-125, and surgical staging as independent predictors for survival. In the subgroup of completely surgically staged patients, the 5-year overall survival rate was 82% (95% CI, 76% to 88%) for patients with CA-125 levels more than 30 U/mL and 95% (95% CI, 90% to 99%) for patients with CA-125 levels of 30 U/mL or less (P = .028). In the group of incompletely staged patients, the 5-year survival rates were similar for patients with elevated and normal serum CA-125 levels. CONCLUSION: Complete surgical staging, histologic grade, and preoperative serum CA-125 levels are independent prognostic factors and should be included in the decision making for chemotherapy.

Incidence of microsatellite instability in synchronous tumors of the ovary and endometrium.

PURPOSE: Families with hereditary nonpolyposis colorectal cancer (HNPCC) have an increased lifetime risk of endometrial (40%) and ovarian (10%) carcinomas. Endometrial and ovarian carcinomas from members of these families frequently display a mutator phenotype as manifest by high levels of microsatellite instability (MSI-H). Microsatellite instability (MSI) occurs in 17-32% of sporadic endometrial carcinomas and 3-17% of sporadic ovarian carcinomas. We hypothesized that there might be a higher rate of MSI in tumors from women with synchronous primary carcinomas of the ovary and endometrium. EXPERIMENTAL DESIGN: We identified 52 cases of synchronous tumors of the ovary and endometrium from the databases of four gynecological oncology units. Archival material and clinical data were available on 45 of these patients. We examined DNA extracted from ovarian and endometrial tumor tissue for MSI using DNA extracted from normal tissue of that patient as a germ-line DNA control. MSI was assessed using a panel of five standard microsatellite markers: D2S123, D5S346, D17S250, BAT25, and BAT26. MSI-H was defined by more than two markers being positive. Low-level MSI (MSI-L) was defined as one or two markers positive and microsatellite stable (MSS) was defined as no markers positive. RESULTS: The 45 patients had a median age at diagnosis of 53 years. Of a total of 134 samples analyzed, only three samples (3.3%) were MSI-H. No patient had high levels of MSI in both ovarian and endometrial tumors. One ovarian carcinoma had five of five markers positive with the corresponding endometrial carcinoma being MSI-L. Two endometrial carcinomas were MSI-H, and the corresponding ovarian carcinomas were MSI-L and MSS, respectively. Seven ovarian tumors and seven endometrial tumors were MSI-L. The majority of patients had early-stage ovarian carcinoma [International Federation of Gynecology and Obstetrics (FIGO) stage I, 44.4%; stage II, 26.7%; and stage III, 26.6%]. Eighty-two % of the endometrial primaries were FIGO stage I. Progression-free survival was significantly better for patients with synchronous primaries than those presenting with ovarian carcinoma alone [adjusted hazards ratio, 1.94; P = 0.023; 95% confidence interval, 1.096-3.44]. CONCLUSION: Synchronous primary carcinomas of the ovary and endometrium are unlikely to be part of the HNPCC syndrome unless the family history is in keeping with the modified Amsterdam criteria.

The management of pre-invasive stage of cervical disease in a low-resource setting.

Cervical cancer is one of the commonest cancers in women. It is also the most preventable cancer. Numerous population based studies have shown that the development of a population based screening program can significantly reduce the incidence of and death rate from cervical cancer. However, it is expensive and requires a large and complex infrastructure to run such a program. As the disease goes through a prolonged pre-invasive phase (cervical intraepithelial neoplasia, CIN) there is ample time in which to treat this phase. Furthermore, this treatment only involves the destruction of the surface epithelium of the cervix. There is ample evidence that those women who have undergone cervical diathermy, for whatever reason, have a lower subsequent incidence of cervical cancer.

Management of borderline ovarian tumours.

Borderline ovarian tumours are known to occur in younger women than invasive cancers and to also have a better prognosis. However, there is also much disagreement about the best approaches to management. At the Queensland Centre for Gynaecological Cancer we have had a particular interest in this disease for some years. Regular reviews of our management have indicated many important guides to management. In our most recent review of 606 cases we have concluded that. Early stage disease can and should be treated conservatively if the patient desires to retain her reproductive function, Treatment should be aimed at leaving no visible disease, Adjuvant therapy does not improve survival, Re-staging laparotomy in clinical Stage 1A patients is not justified as the pick-up is too small, The best prognosis is to be expected in the youngest patients. We will continue to track the progress of these patients in the hope that better management can be offered in the future.

Efficacy of routine follow-up in patients with recurrent uterine cancer.

OBJECTIVE: To evaluate the efficacy of routine follow-up in patients with recurrent uterine cancer. METHODS: In a single institution study, a total of 2637 patients were treated curatively for uterine cancer from 1990 to 2006. A total of 438 patients experienced disease recurrence. Data for detailed analysis were available from 280 of the 438 patients. Prior to the diagnosis of recurrence, all patients had regular follow-up and were investigated through internal examination, vaginal vault cytology and imaging. Overall survival (OS) was the main study endpoint and was calculated from recurrence diagnosis to death or date censored. RESULTS: Clinical and histopathological features as well as patterns of recurrence were similar in symptomatic and asymptomatic patients. Eighty-one patients (28.9%) were diagnosed with asymptomatic recurrence while 199 patients (71.1%) presented with symptomatic recurrence. The overall survival probability at 5 years was 41.0% and 28.9% respectively for asymptomatic and symptomatic patients (log-rank p=0.013). Those patients with stage 1 or 2 tumors of endometrioid type were found to have an overall survival probability at 5 years of 38.0% and 25.7% respectively for asymptomatic and symptomatic recurrence (log-rank p=0.05). The absence of symptoms did not impact on the outcome of patients with stage 3 tumors or tumors of non-endometrioid type. CONCLUSIONS: While patients at low/intermediate risk of recurrence may benefit from intensive follow-up including internal examinations, routine vaginal vault cytology and imaging, high-risk patients might gain more from an alternate follow-up strategy with emphasis on imaging in conjunction with symptom education.

Pap smear screening history of women with squamous cell carcinoma and adenocarcinoma of the cervix.

BACKGROUND: Since the introduction of the Pap smear screening, the incidence of squamous cell carcinoma (SCC) has decreased significantly, but the incidence of adenocarcinoma (AC) relative to SCC has increased. AIM: To compare the Pap smear history of patients with AC and SCC of the cervix. METHODS: Patients for the study were identified from the database of Queensland Centre for Gynaecological Cancer. Patients with AC and SCC were matched for age at diagnosis and International Federation of Gynecology and Obstetrics stage. The final population included 188 matched pairs, being 376 patients in total. Data were collected upon the histological type of cancer, result of the most recent Pap smear, date and result of the Pap smear prior to the most recent Pap smear and symptoms. Chi-squared tests and Fisher's exact test were used to compare the two patient groups for several variables. RESULTS: Patients with AC had significantly more false-negative results on their most recent Pap smear (P<0.0001) than patients with SCC. The incidence of symptoms such as bleeding and/or vaginal discharge was comparable in patients with AC and SCC. The time between the most recent Pap smear and the diagnosis of cervical cancer was significantly shorter for patients with AC (P=0.01). CONCLUSIONS: Patients with AC had Pap smears more regularly than those with SCC, and their most recent Pap smear was significantly more likely to be normal. Thus, Pap smear prior to a diagnosis of AC is more likely than SCC false-negative and therefore not indicative of cervical cancer.

The functional assessment of cancer-vulvar: reliability and validity.

OBJECTIVES: To assess the reliability and validity of the Functional Assessment of Cancer Therapy-Vulvar (FACT-V). METHODS: Seventy-seven patients treated between January 1996 and January 2001 for cancer of the vulva completed the FACT-V, the Eastern Cooperative Oncology Group Performance Status Rating (ECOG-PSR) and the Hospital Anxiety and Depression Scale (HADS) once, 20 consecutive patients treated between February 2001 and October 2001 completed the questionnaires twice, once before surgery and at 2 months follow-up. The FACT-V scores were compared by patients' performance status, FIGO stage, recurrence, and age, and correlated to the HADS scores. Changes in the FACT-V from baseline to 2 months follow-up were evaluated to establish FACT-V's responsiveness to change. RESULTS: The FACT-V's internal consistency was adequate (Chronbach's alpha range, 0.75 to 0.92). Patients with lower performance status, higher FIGO-stage or recurrent disease received lower FACT-V scores, indicating discriminant validity. The correlation between the FACT-V and the HADS were in the expected direction, indicating convergent and divergent validity. From pre- to post-surgery, scores in nine out of fifteen items of the vulvar cancer-specific subscale improved, while those of five items declined, indicating sensitivity of the vulvar cancer specific items to changes in patients' well-being. CONCLUSIONS: The newly developed FACT-V provides a reliable and valid assessment of the quality of life of women with vulvar cancer. It can be used as a short measure of quality of life within research studies, and to facilitate communication about quality of life issues in clinical practice.

Patterns of recurrence and disease-free survival in advanced squamous cell carcinoma of the vulva.

OBJECTIVE: To compare patterns of recurrence and disease-free survival (DFS) of node-positive and node-negative patients with advanced vulval squamous cell carcinoma (SCC). METHODS: Fifty-five patients with FIGO stage III/IVA vulval SCC who had surgery at the Queensland Centre for Gynaecological Cancer from 1989 to 1999 were included. Patients were grouped as follows: Group A, pT3 N0; Group B, pT3 N1; Group C, pT4 N2. Treatment included surgery +/- postoperative radiotherapy. Multivariate Cox models were calculated to identify independent prognostic factors. RESULTS: After a median follow-up of 96 months, 25 patients (45.5%) experienced recurrence at the vulva (n = 2), pelvis (n = 8), or distant sites (n = 15). Recurrence in the pelvis and at distant sites was more likely for patients in groups B and C (P 0.003). At 5 years the probability of DFS was 66.6%, 35.3%, and 39.8% for patients in groups A, B, and C, respectively (P 0.085). Patients with negative nodes (n = 15), one microscopic positive node (n = 11), and two or more positive nodes (n = 29) had a probability of DFS of 66.6%, 67.3%, and 26.1% at 5 years, respectively (P 0.005). CONCLUSION: Patients with > or =2 positive groin nodes are at risk for distant failure. The DFS of patients with negative groin nodes and those with only one microscopic positive node is very similar. The prognosis of patients with > or =2 positive unilateral or bilateral groin nodes is similar. The current FIGO staging system inaccurately reflects prognosis for patients with advanced vulval cancer. Clinical trials are warranted to investigate the benefit of systemic treatment.