Outcome of immediate re-operation or interval debulking after chemotherapy at a gynecologic oncology center after initially incomplete cytoreduction of advanced ovarian cancer.

BACKGROUND: Prognosis in advanced ovarian cancer is largely determined by completeness of tumor resection achieved during primary surgery. Incomplete initial debulking occurs frequently in non-specialized centers and there is an ongoing discussion about the best time for re-surgery after referral to tertiary centers. METHODS: Patients with advanced epithelial ovarian cancer (FIGO IIIB-IV) admitted between 1999 and 2007 who had primary incomplete surgery including those with initiated chemotherapy at an outside institution were included. Surgical results, morbidity and prognosis were evaluated in patients with immediate re-operation before chemotherapy and those with interval debulking. RESULTS: 48 eligible patients were identified in our tumor registry. Self-referral by patient was the most frequent mode of admission (n=21, 43.8%). 22 patients (45.8%) underwent immediate re-surgery and 26 patients (54.2%) had an interval debulking after chemotherapy. In 12 patients (54.5%), macroscopically complete tumor removal could be achieved by immediate re-operation and in 17 patients (65.4%) after chemotherapy. Major complications were observed more frequently in patients with interval debulking (26.9 vs. 9.1%, p=0.324). Median overall survival time was 53 and 34 months (p=0.110) after immediate and delayed re-operation, respectively. CONCLUSIONS: Upfront re-operation before start of chemotherapy is feasible and successful in an expertise referral center in more than half of patients with incomplete primary surgery elsewhere. Complete resection even after initial incomplete debulking could improve outcome. Therefore, referral to expertise centers in those patients should be considered. Progression-free survival and overall survival showed a non-significant trend and complication rate is a remarkable advantage in favor of upfront re-operation.

Requirements to assess feasibility of phase 0 trials during major abdominal surgery: variability of PARP activity.

PURPOSE: The aim of this study was to evaluate the feasibility of phase 0 trials in the setting of a routine surgical procedure. Logistic considerations, tissue sampling and tissue handling, and variability of a biomarker during surgery, in here PARP, were evaluated. EXPERIMENTAL DESIGN: Patients with highly suspicious or proven diagnosis of advanced ovarian cancer, planned for debulking surgery were asked to allow sequential tumor biopsies during surgery. Biopsies were frozen immediately and PARP activity was measured subsequently. RESULTS: Baseline biopsies were obtained from eight patients after a median time of 88 minutes (minimum of 50 to maximum of 123 minutes). Second and third biopsies were obtained after a median of 60 (32-96) and 101 (79-130) minutes, respectively. Mean tumor load was 44% (5%-100%), with a cellular viability of 98% (85%-100%). Median baseline PARP activity was 1035 pg/mL (range, 429-2663 pg/mL). The observed interpatient variability at baseline was large: SD was 0.59 after natural logarithm transformation. CONCLUSIONS: Conducting phase 0 trials during surgery seems to be feasible in terms of logistic considerations. In preparation of a phase 0 trial during surgery, a feasibility study like this should be conducted to rule out major interactions of the surgical intervention with respect to the targeted biomarker.

Impact of a structured quality management program on surgical outcome in primary advanced ovarian cancer.

OBJECTIVE: Surgical outcome in advanced ovarian cancer (AOC) is an important prognostic factor and the only factor amendable to improvement by optimization. Therefore, introduction of quality management programs (QM) regarding the surgical therapy in ovarian cancer may help to improve outcome. METHODS: We introduced a specific ovarian cancer quality management program in 2001 in our gynecologic oncology center. Analysis of 396 consecutive patients with primary surgery for advanced ovarian cancer FIGO stages IIB-IV operated before the introduction of the quality management program 1997-2000, or during the introduction years 2001-2003, or after establishing 2004-2008. RESULTS: Thirty-three percent had complete debulking to no macroscopic residual disease from 1997 to 2000. This rate increased to 47% in 2001-2003 (n = 86) and 62% in 2004-2008 (n = 259). The utilization of extended surgical procedures increased over time. Patients with complete resection had 5-YSR of 55% compared to 16% in patients with residuals 1-10 mm, and 13% in patients with residuals >1 cm (p < 0.001). The median OS increased from 26 months 1997-2000 to 37 months 2001-2003 and 45 months in 2004-2008 (p < 0.003). CONCLUSIONS: Optimizing surgical skills, infrastructure, and introduction of quality management programs may improve both surgical and overall outcome in advanced ovarian cancer.