Residual tumor and primary debulking surgery vs interval debulking surgery in stage IV epithelial ovarian cancer.

INTRODUCTION: It is debated whether women with FIGO (International Federation of Gynecology and Obstetrics) Stage IV epithelial ovarian cancer should be offered primary debulking surgery (PDS) or interval debulking surgery (IDS). Furthermore, the impact of complete resection of intra-abdominal disease (R0) despite their extra-abdominal metastases is questioned. The objective of this study was to investigate the impact of intra-abdominal residual tumor, Stage IVA vs IVB, the localization and number of metastases defining Stage IV disease on overall survival (OS) comparing PDS and IDS in FIGO Stage IV epithelial ovarian cancer. MATERIAL AND METHODS: We included 2091 women registered with Stage IIIC-IV ovarian cancer in the Danish Gynecological Cancer Database during 2009-2016. The impact of residual tumor was evaluated using univariate and multivariate analyses. RESULTS: In total, 681 patients had stage IV disease, of whom 26% underwent PDS, 38% IDS, and 36% chemotherapy only. Overall survival for PDS and IDS were similar. Patients achieving R0 at PDS showed a tendency towards a higher OS than patients achieving R0 at IDS, though the difference was non-significant. In women with Stage IVA and IVB disease there was a survival benefit in achieving R0 both when treated with PDS and IDS. Women with Stage IVB disease treated with chemotherapy only had a significantly lower OS than patients achieving R0 at both PDS and IDS. Malignant pleural effusion and having five metastatic sites compared with having one was associated with a poorer OS. CONCLUSIONS: Our study shows similar OS in patients with Stage IV disease treated with IDS compared with PDS. Complete intra-abdominal tumor resection improves the prognosis in both PDS and IDS in Stage IV ovarian cancer. Malignant pleural effusion seems to be a negative prognostic factor and should have more focus in future studies.

Danish Gynecological Cancer Database.

AIM OF DATABASE: The Danish Gynecological Cancer Database (DGCD) is a nationwide clinical cancer database and its aim is to monitor the treatment quality of Danish gynecological cancer patients, and to generate data for scientific purposes. DGCD also records detailed data on the diagnostic measures for gynecological cancer. STUDY POPULATION: DGCD was initiated January 1, 2005, and includes all patients treated at Danish hospitals for cancer of the ovaries, peritoneum, fallopian tubes, cervix, vulva, vagina, and uterus, including rare histological types. MAIN VARIABLES: DGCD data are organized within separate data forms as follows: clinical data, surgery, pathology, pre- and postoperative care, complications, follow-up visits, and final quality check. DGCD is linked with additional data from the Danish "Pathology Registry", the "National Patient Registry", and the "Cause of Death Registry" using the unique Danish personal identification number (CPR number). DESCRIPTIVE DATA: Data from DGCD and registers are available online in the Statistical Analysis Software portal. The DGCD forms cover almost all possible clinical variables used to describe gynecological cancer courses. The only limitation is the registration of oncological treatment data, which is incomplete for a large number of patients. CONCLUSION: The very complete collection of available data from more registries form one of the unique strengths of DGCD compared to many other clinical databases, and provides unique possibilities for validation and completeness of data. The success of the DGCD is illustrated through annual reports, high coverage, and several peer-reviewed DGCD-based publications.

Identification of high-risk patients by human epididymis protein 4 levels during follow-up of ovarian cancer.

The majority of ovarian cancer patients with advanced disease at diagnosis will relapse following primary treatment, with a dismal prognosis. Monitoring the levels of serum markers in patients under follow-up may be essential for the early detection of relapse, and for distinguishing high-risk patients from those with less aggressive disease. The aim of the present study was to investigate the possible predictive value of human epididymis protein 4 (HE4) and carbohydrate antigen 125 (CA125) in relation to recurrence of epithelial ovarian cancer by measuring the two markers during follow-up subsequent to surgery and adjuvant first-line carboplatin/paclitaxel chemotherapy. Serum HE4 and CA125 were analyzed in 88 epithelial ovarian cancer patients at the end of treatment and consecutively during follow-up. The patients were divided into a high-risk and a low-risk group based on having an increase in HE4 and CA125 levels above or below 50% during follow-up, relative to the baseline (end-of-treatment) level. Disease recurrence was detected in 55 patients during follow-up. Patients with an increase in HE4 of >50% at 3- and 6-month follow-up compared to the end-of-treatment sample had significantly poorer progression-free survival (PFS) [hazard ratio (HR), 2.82 (95% CI, 0.91-8.79; P=0.0052) and HR, 7.71 (95% CI, 3.03-19.58; P<0.0001), respectively]. The corresponding 3- and 6-month biomarker assessments for increased CA125 levels (>50%) showed HRs of 1.86 (95% CI, 0.90-3.80; P=0.0512) and 2.55 (95% CI, 1.39-4.68; P=0.0011), respectively. Multivariate analysis confirmed HE4 as a predictor of short PFS, with an HR of 8.23 (95% CI, 3.28-20.9; P<0.0001) at 6-month follow-up. The increase of CA125 was not a significant prognostic factor in multivariate analysis for PFS. In conclusion, HE4 appears to be a sensitive marker of recurrence and instrumental in risk assessment during the first 6 months of follow-up.