Complete Secondary Cytoreductive Surgery Research Articles

Surgery in Recurrent Ovarian Cancer: A Meta-Analysis.

Background: The second cytoreductive surgery performed for a patient who has recurrent ovarian cancer remains controversial. Our study analyzes overall survival (OS) and disease-free survival (DFS) for cytoreductive surgery in addition to chemotherapy in recurrent ovarian cancer instead of chemotherapy alone. Methods: A meta-analysis was conducted using PubMed and the Cochrane database of systematic reviews to select randomized controlled studies. In total, three randomized studies were used, employing a total of 1249 patients. Results: The results of our meta-analysis of these randomized controlled trials identified significant differences in OS (HR = 0.83, IC 95% 0.70-0.99, p < 0.04) and DFS (HR = 0.63, IC 95% 0.55-0.72, p < 0.000001). A subgroup analysis comparing complete cytoreductive surgery and surgery with residual tumor achieved better results for both OS (HR = 0.65, IC 95% 0.49-0.86, p = 0.002) and DFS (HR = 0.67, IC 95% 0.53-0.82, p = 0.0008), with statistical significance. Conclusions: A complete secondary cytoreductive surgery (SCS) in recurrent ovarian cancer (ROC) demonstrates an improvement in the OS and DFS, and this benefit is most evident in cases where complete cytoreductive surgery is achieved. The challenge is the correct patient selection for secondary cytoreductive surgery to improve the results of this approach.

The value of PET/CT for cytoreductive surgery selection in recurrent ovarian carcinoma.

To evaluate the value of positron emission tomography/computed tomography (PET/CT) in predicting no residual disease (NRD) after secondary cytoreductive surgery (SCS) compared with MSK criteria, the iMODEL, and the AGO score. We analyzed 112 patients with platinum-sensitive ovarian carcinoma who underwent SCS. We excluded patients for whom PET/CT was not performed, those without sufficient data, and who received chemotherapy before SCS. Ultimately, 69 patients were included. Variables that correlated with NRD were peritoneal carcinomatosis index (odds ratio [OR]=0.91; 95% confidence interval [CI]=0.83-0.99; p=0.044), European Cooperative Oncology Group Performance Status (ECOG) 0 (OR=8.0; 95% CI=1.34-47.5; p=0.022), and ≤2 lesions by PET/CT (OR=4.36; 95% CI=1.07-17.7; p=0.039). Of the patients with ≤2 lesions by PET/CT, 48 (92.3%) underwent complete SCS. The sensitivity, positive predictive value, negative predictive value, and accuracy of PET/CT for NRD were 85.7%, 92.3%, 33.3%, and 81.2%, respectively. NRD was achieved after fulfilling the MSK criteria, iMODEL and AGO Score in 89.1%, 88.1% and 85.9%, respectively. The accuracy of the MSK criteria, iMODEL, and AGO score in predicting NRD was 87%, 83.3%, and 77.3%, respectively. The PET/CT findings agreed well with the AGO score and iMODEL. The addition of PET/CT to these models increased the NRD rates (92.2%, 91.8%, and 89.4% for MSK+PET/CT, iMODEL+PET/CT, and AGO+PET/CT, respectively), but lowered their accuracy. We observed NRD in 92.3% of patients with ≤2 lesions by PET/CT, with an accuracy of 81.2%. PET/CT did not increase the accuracy of the MSK criteria, iMODEL, or AGO score models.

A randomized phase II trial of secondary cytoreductive surgery (SCS) +/- carboplatin hyperthermic intraperitoneal chemotherapy (HIPEC) in patients (pts) with recurrent platinum-sensitive ovarian cancer (EOC).

6016 Background: The role of HIPEC for recurrent EOC is not well defined. The aim of this phase II study was to determine the proportion of pts without evidence of disease progression at 24 months post SCS +/- intraoperative carboplatin HIPEC. Methods: After SCS to ≤ 0.5 cm residual visible disease pts were intraoperatively randomized to carboplatin HIPEC (800mg/m2 for 90 minutes) or no HIPEC. The HIPEC arm received 5 additional and the standard arm received 6 postoperative cycles of IV platinum-based chemotherapy without maintenance treatment. Based on an exact binomial single stage “pick the winner” design, each arm is considered “winner” if ≥ 17/49 pts are without evidence of disease progression at 24 months post SCS. Secondary objectives include postoperative grade ≥ 3 toxicity and complications within 4 weeks post SCS, and pharmacokinetics of carboplatin HIPEC. Results: Of 98 pts, 49 (50%) were randomized to the HIPEC arm. The arms were well balanced for age, stage, histology, BRCA mutation status, prior chemotherapy, and disease-free interval. Complete gross SCS was achieved in 94% of the standard and 82% of the HIPEC arm (p = 0.12). Bowel resection was performed more frequently in the standard (65%) compared to the HIPEC arm (37%; p = 0.008). Median operative time was shorter in the standard (296 minutes) compared to the HIPEC arm (475 minutes; p &lt; 0.001). There was no perioperative mortality and no difference in use of ostomies, length of stay or postoperative toxicity. At a median follow-up of 27.7 months (range: 8.8-81.8 months) 70 of 98 pts progressed and 26 died with a median progression free survival (PFS) of 14.3 months (12.1-16 months) and a median overall survival (OS) of 55.2 months (47.7-not reached). At 24 months post SCS 32 pts progressed within 24 months in the standard versus 35 in the HIPEC arm. There was no statistically significant difference in median PFS (15.4 vs 12.3 months, p = 0.173) or median OS (69.2 vs 53.1 months, p = 0.317) between arms. These are preliminary efficacy estimates as 83/98 pts have a minimum of 24 months follow-up. Conclusions: The HIPEC arm did not reach the predefined “winner” endpoint; the standard arm is still undetermined as 6 pts did not reach 24 months follow-up. No perioperative mortality, and no increased perioperative morbidity or toxicity was seen with HIPEC. SCS with carboplatin HIPEC followed by 5 cycles of platinum-based chemotherapy was not superior to SCS without HIPEC followed by 6 cycles of platinum-based chemotherapy. Clinical trial information: NCT01767675.

BRCA Mutation Status to Personalize Management of Recurrent Ovarian Cancer: A Multicenter Study.

The aim of this study was to assess the correlation between BRCA mutation status and disease presentation, treatment strategy, and survival in a multicenter series of recurrent high-grade serous ovarian cancer (HGSOC) women. A consecutive series of recurrent HGSOC patients with partially or fully platinum-sensitive disease admitted to the Gynecologic Oncology Units of the Catholic University of the Sacred Heart and Sapienza University of Rome. Main eligibility criteria were known BRCA 1/2 germline mutation status and a minimum follow-up period from recurrence of at least 6months. Overall, 126 patients met the eligibility criteria, of whom 76 (60%) were BRCA wild-type (BRCAwt) and 50 (40%) were BRCA 1/2 germline mutation carriers (BRCAmut). Among the latter, 37 (74%) patients presented with BRCA1 mutation, and 13 (26%) presented with BRCA2. No differences were found regarding patterns of disease presentation between BRCAwt and BRCAmut women. BRCAmut patients had the best post-recurrence survival (PRS) regardless of having received secondary cytoreductive surgery (SCS) or not, with a 5-year PRS of 73% in non-resected women versus 78% in resected women (p = 0.558). Conversely, BRCAwt patients who underwent complete SCS had a significantly longer PRS compared with BRCAwt patients who did not receive surgery (5-year PRS of 54% vs. 42%; p = 0.048). Recurrent ovarian cancer BRCAmut patients have the best prognosis regardless of SCS, whereas PRS in BRCAwt women can improve when complete SCS is performed. The identification and incorporation of predictive biomarkers such as BRCA status to tailor the medical and surgical approach is paramount to the success of recurrent HGSOC treatments.

Preoperative predictors that impact the survival and outcome of patients undergoing secondary cytoreduction for ovarian cancer

This study aimed to examine the factors affecting feasibility of optimal and complete secondary cytoreductive surgery (SCRS) and to characterise the prognostic factors that correlate with improved survival in patients who underwent SCRS. This is a retrospective single-institutional cohort study of patients who underwent SCRS for recurrent epithelial ovarian cancer (EOC). One hundred and forty-eight patients met inclusion criteria. Platinum sensitivity was associated with complete cytoreduction at SCRS. Factors associated with suboptimal cytoreduction (SOC) were age >55 years, serous histology, largest tumour implant size >4 cm, and SOC at primary surgery. Overall survival analysis showed significantly longer survival with complete cytoreduction compared to optimal and SOC. Surgical outcome of SCRS was an independent predictor of survival regardless of the outcome of primary cytoreduction. Location of the largest implant, DFI and timing of chemotherapy also impact on survival.

Impact of bevacizumab containing first line chemotherapy on recurrent disease in epithelial ovarian cancer: A case-control study

ObjectiveTo evaluate the timing and pattern of relapse, and duration of response to second line chemotherapy in advanced ovarian cancer (AOC) patients treated with first line carboplatin-paclitaxel chemotherapy with or without bevacizumab. Patients and methodsThis is a case-control study including 222 AOC patients. Seventy-four women treated with first line carboplatin-paclitaxel-bevacizumab chemotherapy (Cases) were matched based on laparoscopic predictive index value, and residual tumor at first surgery with 148 AOC patients treated with carboplatin-paclitaxel. Distribution of pattern of relapse, and response to second line chemotherapy was compared between the two groups. Time to Progression (TTP) for second line chemotherapy was also analyzed for study purpose. ResultsMedian platinum-free interval (PFI) was 16months (range 2–65) in Cases, compared with 9months (1–83) in Controls (p-value=0.001). Twenty patients (51.3%) among Cases showed recurrence in multiple anatomic sites, compared with 31 (31.9%) in the Control group (p-value=0.035). Peritoneal recurrence occurred as diffuse in 30 Cases (96.8%), and 60 Controls (82.2%; p-value=0.046). Secondary cytoreductive surgery (SCS) was successfully completed in 53.5% of Controls compared to 10.0% of Cases (p-value=0.016). In women with fully platinum-sensitive relapse, response rate to second line chemotherapy was 85.2% in Controls, compared to 38.4% in Cases (p-value=0.002). Finally, Cases showed a shorter TTP, compared to Controls (5months vs 8months; p-value=0.041). ConclusionsIncorporation of bevacizumab into upfront regimens prolongs PFI in AOC patients, but is associated with wider presentation of relapse, lower rate of complete SCS, and shorter TTP to second line chemotherapy in women with platinum-sensitive disease.

Surgery for Recurrent Epithelial Ovarian Cancer in the Netherlands: A Population-Based Cohort Study.

The value of secondary cytoreductive surgery (SCS) in patients with recurrent epithelial ovarian cancer is controversial. The aim of this population-based study was to investigate the role of SCS in the Netherlands. Data of 408 patients who underwent SCS between 2000 and 2013 were retrospectively collected from 38 Dutch hospitals. Survival after complete and incomplete SCS was estimated by Kaplan-Meier curves. Factors associated with overall survival (OS) were explored with Cox regression. Median OS after SCS was 51 months (95% confidence interval [95% CI], 44.8-57.2). Complete SCS was achieved in 295 (72.3%) patients, with an OS of 57 months (95% CI, 49.0-65.0) compared with 28 months (95% CI, 20.8-35.2) in patients with incomplete SCS (log-rank test; P < 0.001). Nonserous histology (HR 0.65; 95% CI 0.45-0.95), a long progression free interval (hazard ratio [HR], 0.29; 95% CI, 0.07-1.18), a good performance status (HR, 0.68; 95% CI, 0.49-0.94), SCS without preoperative chemotherapy (HR, 0.72; 95% CI, 0.51-1.01), and complete SCS (HR, 0.46; 95% CI, 0.33-0.64) were prognostic factors for survival. This population-based retrospective study showed that there might be a role for SCS in recurrent epithelial ovarian cancer especially when complete SCS can be accomplished. However, before adopting SCS as a standard treatment modality for recurrent epithelial ovarian cancer, results of 3 ongoing prospectively randomized trials are needed.

Survival Impact of Secondary Cytoreductive Surgery for Recurrent Ovarian Cancer in an Asian Population.

The aim of this study was to evaluate the role of secondary cytoreductive surgery in Asian patients with recurrent ovarian cancer and to assess prognostic variables on overall post-recurrence survival time. We conducted a retrospective review of patients with recurrent ovarian cancer who underwent secondary cytoreduction at the Gynaecological Cancer Center at the KK Women's and Children's Hospital, Singapore, between 1999 and 2009. Eligible patients included those who had been firstly treated by primary cytoreductive surgery and followed by adjuvant chemotherapy and had a period of clinical remission of at least six months and subsequently underwent secondary cytoreductive surgery for recurrence. Univariate analysis was performed to evaluate various variables influencing the overall survival. Twenty-five patients met our eligibility criteria. The median age was 52 years (range=31-78 years). The median time from completion of primary treatment to recurrence was 25.1 months (range=6.4-83.4). Secondary cytoreduction was optimal in 20 of 25 patients (80%). The median follow-up duration was 38.9 months (range=17.8-72.4) and median overall survival time was 33.1 months (95% confidence interval, 15.3-undefined.). Ten (40.0%) patients required bowel resection, but no end colostomy was performed. One (4.0%) patient had wedge resection of the liver, one (4.0%) had a distal pancreatectomy, one (4.0%) had a unilateral nephrectomy, and one (4.0%) had adrenalectomy. There were no operative deaths. The overall survival of patients who responded to secondary cytoreductive surgery and adjuvant chemotherapy was significantly longer than those patients who did not respond to the treatment. Of those patients who responded to the surgical management, patients with clear cell carcinoma fared well compared to those with the endometrioid, mucinous adenocarcinoma, and papillary serous type (p<0.001). Complete secondary cytoreductive surgery appeared to have some relationship to overall survival but was not statistically significant. In carefully selected patients with recurrent ovarian cancer, optimal cytoreductive surgery is possible and in a subgroup of patients who respond to surgery and chemotherapy survival is significantly longer.

A Predictive Score for Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer (SeC-Score): A Single-Centre, Controlled Study for Preoperative Patient Selection

The standard treatments of patients with platinum-sensitive recurrent ovarian cancer (ROC) remains poorly defined. Chemotherapy (CT) and secondary cytoreductive surgery (SCS) represent both valid options, even if several studies demonstrated a greater survival benefit, with survival rates up to 62 months, for platinum-sensitive patients undergoing complete SCS. The purpose of the present study was to develop a predictive model, named SeC-Score (SeC-s), to assess the risk of optimal SCS, including, for the first time in literature, HE4. All patients affected by suspicious ROC at radiologic imaging, referred to the Department of Gynecology of Campus Bio-medico of Rome, were prospectively included in the study. The preoperative variables considered in our predictive model were: age, residual tumour (RT) at primary cytoreduction (0 vs. >0 cm), preoperative CA125 and HE4, and ascites at recurrence. After exploratory laparotomy, patients were submitted to secondary SCS (Group A) or addressed to CT (Group B). A total of 135 patients with ROC were considered for the analysis. Preoperative CA125, HE4, ascites, and RT at first surgery were found statistically significant and included into a multivariate logistic regression model to determine the risk to not optimal SCS. In the overall cohort of patients, SeC-s reported sensitivity and specificity of 82 and 83 %, respectively (PPV = 0.79, NPV = 0.81). Our data support the use of SeC-s to preoperative triage patients suitable of optimal SCS, even if external validation is needed.

External validation of two prediction models of complete secondary cytoreductive surgery in patients with recurrent epithelial ovarian cancer

ObjectiveThe purpose of this study was to validate the performance of two prediction models, the AGO score and the Tian model, of complete secondary cytoreductive surgery (SCS) in patients with recurrent epithelial ovarian cancer. The predictive value of both models for survival controlled for the outcome of SCS was analyzed and known predictive factors for complete SCS were tested. MethodsA population-based database with 408 patients, who underwent SCS between 2000 and 2013 in 38 Dutch hospitals, was used. The validation cohorts for the AGO score and the model of Tian contained 273 (66.9%) and 257 (63.0%) patients, respectively. ResultsThe AGO score and Tian model showed a positive predictive value for complete SCS of 82.0% and 80.3% respectively, and a false negative rate of 68.5% and 55.6% respectively. A positive AGO score had no significant association with overall survival (HR 0.73; 95% CI 0.51–1.06) whereas the low risk score of the Tian model did (HR 0.62; 95% CI 0.41–0.93). A good performance status (OR 0.60; 95% CI 0.33–1.10) and the absence of ascites (OR 0.18; 95% CI 0.08–0.41) were prognostic factors for complete SCS. ConclusionsBoth the AGO score and the model of Tian showed a high positive predictive value for complete SCS but also relatively high false negative rates. However, before the two prediction models can be applied in daily clinical practice the usefulness of SCS itself has to be proven first by the three ongoing randomized controlled trials: DESKTOP III trial, the GOG 213 trial and the Dutch SOCceR trial.

Secondary cytoreductive surgery in patients with isolated platinum-resistant recurrent ovarian cancer: A retrospective analysis

ObjectiveTo analyze the impact of secondary cytoreductive surgery (SCS) on survival outcome in a retrospective series of isolated platinum-resistant recurrent ovarian cancer. MethodsWe evaluate a consecutive series of 268 ovarian cancer patients with platinum-resistant relapse. Isolated recurrence was defined as the presence of a single nodule, in a single anatomic site, and was observed in 27 cases (10.1%). In all women the presence of isolated relapse was assessed at radiological evaluation, and surgically confirmed in the SCS group. ResultsAmong the 27 patients with isolated recurrence, 16 (59.3%) received chemotherapy alone, and 11 (40.7%) complete SCS followed by non-platinum based chemotherapy. No significant differences were observed in the distribution of baseline clinico-pathological characteristics, pattern of recurrent disease, duration of PFI, and type of salvage chemotherapy between the two groups. In the SCS group, 6 patients (54.5%) showed isolated peritoneal relapse and 5 women (45.4%) showed isolated lymph nodal recurrence, and were treated with peritonectomy and lymphadenectomy, according with site of relapse. Two post-operative complications (18.2%) occurred: asymptomatic lymphocele and groin wound dehiscence. SCS significantly prolonged median time to first progression (12months vs 3months; p-value=0.016), median time to second progression (8months vs 3months; p-value=0.037), and post-relapse survival (PRS) (32months vs 8months; p-value=0.002). Residual tumor at 1st surgery (X2=5.690; p-value=0.017), duration of PFI (X2=5.401; p-value=0.020), and complete SCS (X2=4.250; p-value=0.039) retains independent prognostic role for PRS in multivariate analysis. ConclusionsSCS prolongs PRS compared to chemotherapy alone in isolated platinum-resistant recurrent ovarian cancer.

Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum-sensitive epithelial ovarian cancer (SOCceR trial): a multicenter randomised controlled study

BackgroundImprovement in treatment for patients with recurrent ovarian cancer is needed. Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy. Median overall survival is reported between 18 and 35 months. Currently, the role of surgery in recurrent ovarian cancer is not clear. In selective patients a survival benefit up to 62 months is reported for patients undergoing complete secondary cytoreductive surgery. Whether cytoreductive surgery in recurrent platinum-sensitive ovarian cancer is beneficial remains questionable due to the lack of level I-II evidence.Methods/DesignMulticentre randomized controlled trial, including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals. Eligible patients are women, with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who meet the inclusion criteria. Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy. Primary outcome measure is progression free survival. In total 230 patients will be randomized. Data will be analysed according to intention to treat.DiscussionWhere the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far. A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained. Therefore the 4th ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed. We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer.Trial registrationNetherlands Trial Register number: NTR3337.

Ovarian cancer patients with localized relapse: Clinical outcome and prognostic factors

ObjectiveWe evaluated the clinical outcome and prognostic factors for post-relapse survival (PRS) in a large retrospective series of ovarian cancer patients with localized relapse. Patients and methodsThe following radiological inclusion criteria were adopted: relapse in single anatomic site and ≤3 nodules. All cases were followed for at least 24months after recurrent disease. ResultsTwo hundred twenty ovarian cancer patients met the inclusion criteria. Serous histotype and G3 tumors were observed in 173 (78.6%) and 151 (77.4%) cases, respectively. All women received platinum-based first-line chemotherapy. Overall, the median follow-up was 46 (8–249) months, and platinum-resistant relapse was documented in 51 women (23.2%). Eighty-one patients (36.8%) recurred in the peritoneum (LPeR), 76 patients (34.5%) in the abdominal lymph nodes (LLNR), and 63 patients (28.7%) in parenchymal organs (LPaR); 142 patients (64.5%) recurred with a single nodule; and 78 patients (35.5%) recurred with 2–3 nodules. Secondary cytoreductive surgery (SCS) was attempted in 73 cases (33.2%), and complete debulking was achieved in all patients. On multivariate analysis, platinum-free interval (PFI, χ2=13.457, p value=0.001), complete SCS (median PRS, 69months vs 25months, p=0.001), anatomic site of relapse (median PRS, 41months in LPeRs, 63months in LLNRs and 24months in LPaRs, p=0.001), and number of nodules (median PRS, 58months in patients with one nodule, 24months in patients with 2–3 nodules, p=0.001) were identified as predictors of PRS. ConclusionsBeside the duration of PFI, the complete SCS, the anatomic site of relapse, and the number of nodules were independent prognostic factor for duration of PRS.

Prognostic factors for patients treated for a recurrent FIGO stage III ovarian cancer: A retrospective study of 108 cases

Aims To determine overall survival of patients treated for a first relapse of FIGO stage III ovarian cancer, outside of randomized trial, with a long term follow-up and to identify prognostic factors. Materials and methods A consecutive series of 108 patients treated for a first relapse of a FIGO stage III ovarian cancer was retrospectively included from December 1999 to November 2004. Each patient was treated with platinum-based chemotherapy in case of late (>6 months) relapse and with salvage chemotherapy without platinum in case of <6 months relapse. For statistical analysis the studied parameters were age, histological subtype, the completeness of initial surgery, disease-free period, localization of the relapse, clinical response to second-line chemotherapy, the completeness of secondary cytoreductive surgery (SCS) when it was performed. Results Median follow-up from the first relapse was 40 months. From the 108 patients, 35 underwent SCS. Median overall survival from the first relapse was 13 months in case of no SCS or non-optimal SCS and 35 months for patient with an optimal SCS ( p = 0.006). In a multivariate analysis age, disease-free period, the clinical presentation of the relapse, completeness of SCS and response to second line chemotherapy appeared to be independent prognostic factors. Conclusions Prognostic factors of ovarian cancer relapse are directly or indirectly linked with the feasibility of a complete SCS. Thus in the case of an ovarian cancer relapse, the feasibility of SCS must be considered in order to give the patient the best chance to experience its complete removal.

A Risk Model for Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer: An Evidence-Based Proposal for Patient Selection

To develop a risk model for predicting complete secondary cytoreductive surgery (SCR) in patients with recurrent ovarian cancer. Individual data of 1075 patients with recurrent ovarian cancer undergoing SCR from 7 worldwide centers were pooled and analyzed. The risk model was developed based on the factors impacting on SCR surgical outcome. Additional data on 117 patients who were not included in the development of the model were used for external validation and to assess the discrimination of the model. Of the 1075 patients, 434 (40.4%) underwent complete resection. Complete secondary cytoreduction was associated with six variables: FIGO stage (odds ratio [OR] = 1.32, 95% confidence interval [95% CI]: 0.97-1.80), residual disease after primary cytoreduction (OR = 1.69, 95% CI: 1.26-2.27), progression-free interval (OR = 2.27, 95% CI: 1.71-3.01), Eastern Cooperative Oncology Group (ECOG) performance status (OR = 2.23, 95% CI: 1.45-3.44), CA125 (OR = 1.85, 95% CI: 1.41-2.44), and ascites at recurrence (OR = 2.79, 95% CI: 1.88-4.13). These variables were entered into the risk model and assigned scores ranging from 0 to 11.9. Patients with total scores of 0-4.7 were categorized as the low-risk group, in which the proportion of complete cytoreduction was 53.4% compared with 20.1% in the high-risk group (OR = 4.55, 95% CI: 3.43-6.04). In external validation, the sensitivity and specificity was 83.3% and 57.6%, respectively. Area under the curve of the receiver-operating characteristics for predicting complete SCR was 0.68 (95% CI: 0.60-0.79). This model and scoring system may well predict the outcome of SCR and could potentially be useful in future clinical trials to determine which patients with recurrent ovarian cancer should have SCR as part of their management.

A risk model for secondary cytoreductive surgery in recurrent ovarian cancer: An evidence-based proposal for patient selection.

5053 Background: This study aims to redefine the role of secondary cytoreductive surgery (SCR) and develop a risk model for predicting outcomes of SCR in patients with recurrent ovarian cancer. Methods: Individual data of patients with recurrent ovarian cancer undergoing SCR from seven world-wide centers were pooled analyzed. The risk model was developed based on the factors impacting on SCR outcome. Additional data of 117 patients were used for external validation and to assess the discrimination of the model. Results: Complete SCR was strongly associated with the improvement of survival, with a median survival of 57.7 months, when compared to 27.0 months and 15.6 months in those with residual disease of 0.1-1cm and >1cm, respectively (P< 0.0001). Of the 1075 patients, 434 (40.4%) underwent complete resection. Complete SCR was associated with six variables: FIGO stage (OR=1.32), residual disease after primary cytoreduction (OR=1.69), progression-free interval (OR=2.27), ECOG performance status (OR=2.23), CA125 (OR=1.85) and ascites at recurrence (OR=2.79). These variables were entered into the risk model and assigned scores ranging from 0 to 11.9. Patients with total scores of 0-4.7 were categorized as the low risk group, in which the proportion of complete cytoreduction was 53.4% compared to 20.1% in the high risk group (OR=4.55). In external validation, the sensitivity and specificity of the model was 83.3% and 57.6%, respectively. Conclusions: SCR may be recommended for selected patients with recurrent ovarian cancer. This model may well predict the outcome of SCR and determine who benefit from SCR.

Secondary cytoreductive surgery for recurrent ovarian cancer. A prospective study

The prognosis for patients with recurrent epithelial ovarian cancer is poor. Most are treated with salvage chemotherapy. The role of secondary cytoreductive surgery is controversial. Hence, this prospective study was undertaken to determine the feasibility and benefit of secondary cytoreductive surgery before the administration of salvage chemotherapy. Between 1990 and 1994, 36 patients with recurrent epithelial ovarian cancer underwent secondary surgical cytoreduction. All had prior primary cytoreductive surgery, platin-based chemotherapy, and had relapsed at least 6 months after completion of primary treatment. The goal was the excision of all macroscopic disease before initiation of chemotherapy or radiation therapy. Statistical analysis was undertaken to determine which clinical and pathologic variables influenced the feasibility of complete excision as well as morbidity, mortality, survival benefit, and quality of life resulting from secondary cytoreductive surgery. Thirty (83.0%) patients had complete surgical excisions. The probability of a complete excision was influenced by Gynecologic Oncology Group (GOG) performance status (0-2 vs. 3, P = 0.05) and size of largest tumor deposit (< 10 cm vs. > 10 cm, P = 0.03). Eleven (30.1%) patients experienced morbidity and 1 (2.8%) died postoperatively. Of 27 symptomatic patients with at least 3 months of follow-up, 26 (96.2%) had resolution or improvement of their symptoms. Of 25 followed for at least 6 months postoperatively, 23 (92.0%) had a GOG performance status of 0 or 1. Survival was adversely influenced by the administration of salvage chemotherapy before surgery (P = 0.02), a preoperative GOG performance status of 3 (P = 0.01), and a brief disease free interval after completion of primary treatment (P = 0.01). The median survival was extended for patients completely resected before salvage chemotherapy or radiation, compared with those with macroscopic residual disease remaining (43 vs. 5 months, P = 0.03). Complete secondary cytoreductive surgery for recurrent epithelial ovarian cancer is technically feasible and has an acceptable operative complication rate. Survival is significantly improved for patients having complete resection. Subsequent relief of symptoms and performance status are excellent.