Morbidity and survival of 32 recurrent ovarian cancer patients treated with aggressive cytoreductive surgery followed by intraperitoneal hyperthermic chemoperfusion

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 16078-16078
Author(s):  
S. D. Richard ◽  
N. Gusani ◽  
H. J. Zeh ◽  
C. Colovos ◽  
S. W. Cho ◽  
...  

16078 Background: Cytoreductive surgery followed by intraperitoneal hyperthermic chemoperfusion (CS/IPHC) has shown increased survival for patients with recurrent and persistent GI malignancies with peritoneal dissemination. We present our preliminary experience with CS/IPHC as palliative therapy for recurrent ovarian cancer treated at a single institution. Methods: A retrospective review of CS/IPHC for women with recurrent or persistent epithelial ovarian carcinoma previously treated with platinum/taxane chemotherapy at a single institution from 2002–2006 was performed. Each patient had an attempted optimal surgical debulking (volume of residual disease <1 cm) prior to chemoperfusion. IPHC was performed on all patients for 100 minutes at temperatures between 40–42°C with either mitomycin C (40 mg/m2) or cisplatin (100 mg/m2). Post-surgical complications were evaluated. End points analyzed included morbidity, progression free survival, and over all survival. Results: Thirty-two patients were identified, with optimal cytoreductive surgery obtained in 26 (81.3%). Procedures required for cytoreduction included omentectomy (n=16), splenectomy (n=14), colonic resection (n=14), small bowel resection (n=13), ileostomy (n=9), hepatic resection (n=5), partial gastrectomy (n=5), and diaphragmatic stripping (n=3). Over-all morbidity was 65.6%, with major morbidity of 9.4%. There were three mortalities within sixty days of operation. Common morbidities included neutropenia (n=5), ileus (n=5), pleural effusions (n=4), and sepsis (n=4). Median length of stay was 11 days (6 to 47). Nineteen patients had a documented recurrence with a median progression free survival of 8 months (1 to 22). Median survival was 13 months (1 to 54) for these patients with recurrent end stage ovarian cancer. Conclusions: CS/IPHC is associated with high morbidity, but acceptable mortality. In a subset of patients, survival is improved compared to historical controls for recurrent ovarian cancer. A randomized phase II study is planned based on this data. No significant financial relationships to disclose.

2021 ◽  
pp. ijgc-2020-002343
Author(s):  
Sabrina Chiara Cecere ◽  
Lucia Musacchio ◽  
Michele Bartoletti ◽  
Vanda Salutari ◽  
Laura Arenare ◽  
...  

IntroductionThe role of cytoreductive surgery in the poly-ADP ribose polymerase inhibitors era is not fully investigated. We evaluated the impact of surgery performed prior to platinum-based chemotherapy followed by olaparib maintenance in platinum-sensitive BRCA-mutated recurrent ovarian cancer.MethodsThis retrospective study included platinum-sensitive recurrent ovarian cancer BRCA-mutated patients from 13 Multicenter Italian Trials in Ovarian cancer and gynecological malignancies centers treated between September 2015 and May 2019. The primary outcomes were progression-free survival and overall survival. Data on post-progression treatment was also assessed.ResultsAmong 209 patients, 72 patients (34.5%) underwent cytoreductive surgery followed by platinum-based chemotherapy and olaparib maintenance, while 137 patients (65.5%) underwent chemotherapy treatment alone. After a median follow-up of 37.3 months (95% CI: 33.4 to 40.8), median progression-free survival in the surgery group was not reached, compared with 11 months in patients receiving chemotherapy alone (P<0.001). Median overall survival was nearly double in patients undergoing surgery before chemotherapy (55 vs 28 months, P<0.001). Post-progression therapy was assessed in 127 patients: response rate to chemotherapy was 29.2%, 8.8%, and 9.0% in patients with platinum-free interval >12 months, between 6 and 12 months, and <6 months, respectively.ConclusionCytoreductive surgery performed before platinum therapy and olaparib maintenance was associated with longer progression-free survival and overall survival in BRCA-mutated platinum-sensitive relapsed ovarian cancer patients. In accordance with our preliminary results, the response rate to chemotherapy given after progression during olaparib was associated with platinum-free interval.


2019 ◽  
Vol 37 (32) ◽  
pp. 2968-2973 ◽  
Author(s):  
Josep M. del Campo ◽  
Ursula A. Matulonis ◽  
Susanne Malander ◽  
Diane Provencher ◽  
Sven Mahner ◽  
...  

PURPOSE In the ENGOT-OV16/NOVA trial (ClinicalTrials.gov identifier: NCT01847274 ), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy. PATIENTS AND METHODS A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (g BRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed g BRCAmut (non–g BRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to g BRCAmut status and response to their last platinum-based therapy. Ovarian cancer–specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy–Ovarian Symptom Index. RESULTS Progression-free survival was improved in patients treated with niraparib compared with placebo in both the g BRCAmut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non–g BRCAmut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes. CONCLUSION Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.


1986 ◽  
Vol 4 (6) ◽  
pp. 965-971 ◽  
Author(s):  
P F Conte ◽  
M Bruzzone ◽  
S Chiara ◽  
M R Sertoli ◽  
M G Daga ◽  
...  

After primary surgery, 125 patients with epithelial ovarian cancer (International Federation of Gynaecology and Obstetrics [FIGO] 1c + IIb + IIc = 22 patients, FIGO III = 82 patients, FIGO IV = 21 patients) were randomly allocated to receive PC (cisplatin 50 mg/m2 + cyclophosphamide 600 mg/m2 on day 1 every 28 days) (corrected) or PAC (PC + doxorubicin 45 mg/m2). After six cycles, patients clinically disease-free or with resectable residual disease were submitted to second-look surgery. After restaging, patients in surgical complete response (CR) stopped treatment while those responding partially (PR) received six more courses; patients whose disease progressed were excluded from the study. Among patients with measurable disease, the following clinical response rates were observed: PC = 20% CR, 34.3% PR, 14.3% stable disease, and 31.4% progression; PAC = 40.6% CR, 15.6% PR, 12.5% stable disease, and 31.3% progression. In the 75 patients submitted to second look, the results have been the following: PC = 39.5% CR, 36.8% PR, 7.9% stable disease, and 15.8% progression; PAC = 62.2% CR, 18.9% PR, 10.8% stable disease, and 8.1% progression. The difference in surgical complete response in favor of the PAC regimen is significant (P less than .05). Median survival and progression-free survival were 800 and 400 days, respectively, for PAC arm; median survival and progression-free survival were 680 and 380 days, respectively, for PC. These differences are not significant. Probability of survival was affected by FIGO stage, amount of residual disease, histology, performance status, and response at second look, while no influence was observed according to grade of tumor differentiation and age. Our results demonstrate the usefulness of doxorubicin in terms of surgical CR.


2016 ◽  
Vol 12 (7) ◽  
pp. e775-e783 ◽  
Author(s):  
Nicole P. Chappell ◽  
Caela R. Miller ◽  
Aaron D. Fielden ◽  
Jason C. Barnett

Purpose: Although the Food and Drug Administration has approved incorporation of bevacizumab (BEV) into the treatment of platinum-resistant ovarian cancer (PROC), cost-value measures are an essential consideration, as evidenced by the recent ASCO Value Framework initiative. We assessed the cost-effectiveness and reviewed the net health benefit (NHB) of this expensive treatment. Methods: A cost-effectiveness decision model was constructed using results from a phase III trial comparing BEV plus cytotoxic chemotherapy with chemotherapy alone in patients with PROC. The Avastin Use in Platinum-Resistant Epithelial Ovarian Cancer (AURELIA) trial demonstrated improvement in progression-free survival and quality of life in patients receiving BEV. Costs, paracentesis rates, and adverse events were incorporated, including subgroup analysis of different partner chemotherapy agents. Results: Inclusion of BEV in the treatment of platinum-resistant recurrent ovarian cancer meets the common willingness-to-pay incremental cost-effectiveness ratio (ICER) threshold of $100,000 per progression-free life-year saved (LYS) for 15-mg/kg dosing and approaches this threshold for 10-mg/kg dosing, with an ICER of $160,000. In sensitivity analysis, reducing the cost of BEV by 13% (from $9,338 to $8,100 per cycle) allows 10-mg/kg dosing to reach a $100,000 ICER. Exploratory analysis of different BEV chemotherapy partners showed an ICER of $76,000 per progression-free LYS (6.5-month progression-free survival improvement) and $54,000 per LYS (9.1-month overall survival improvement) for the addition of BEV to paclitaxel once per week. Using the ASCO framework for value assessment, the NHB score for BEV plus paclitaxel once per week is 48. Conclusion: Using a willingness-to-pay threshold of $100,000 ICER, the addition of BEV to chemotherapy either demonstrates or approaches cost-effectiveness and NHB when added to the treatment of patients with PROC.


2003 ◽  
Vol 13 (5) ◽  
pp. 683-686
Author(s):  
S. Komiyama ◽  
Y. Mizusawa ◽  
M. Onouchi ◽  
K. Takehara ◽  
A. Suzuki ◽  
...  

We experienced a case of recurrent ovarian cancer that responded to weekly docetaxel. The patient had stage IIIC ovarian cancer (poorly differentiated serous adenocarcinoma). After initial remission was achieved by chemotherapy with paclitaxel and carboplatin plus cytoreductive surgery, the disease recurred and irinotecan therapy achieved temporary remission. During maintenance therapy with oral etoposide, the disease recurred again. We then tried five courses of weekly docetaxel therapy and it successfully controlled the disease. The progression-free survival time on weekly docetaxel treatment is now 7 months and the toxicity was extremely low. This patient demonstrates the effectiveness of weekly docetaxel as salvage chemotherapy for recurrent ovarian cancer.


2020 ◽  
Vol 16 (10) ◽  
pp. 585-596 ◽  
Author(s):  
Ezzeldin M Ibrahim ◽  
Ahmed A Refae ◽  
Ali M Bayer ◽  
Emad R Sagr

Aim: Poly(ADP-ribose) polymerase inhibitors (PARPIs) improved progression-free survival among patients with recurrent ovarian cancer. This meta-analysis examined the effectiveness of PARPIs as maintenance strategy for newly diagnosed patients with advanced high-grade ovarian cancer with or without mutations. Materials & methods: Using defined selection criteria, a literature search identified four eligible randomized clinical trials involving 2386 patients. Results: Compared with placebo maintenance, PARPIs achieved a 46% reduction in the risk of progression or death as compared with placebo (hazard ratio: 0.54; 95% CI: 0.39–0.73; p < 0.0001). That benefit was shown in all clinical subgroups: among those with BRCA mutation, with negative/unknown BRCA mutation, and in those with homologous recombination deficient tumors. Data about the effect on overall survival are still premature. Conclusion: In patients with newly diagnosed advanced ovarian cancer, PARPIs maintenance after standard therapy achieved a significant improvement in progression-free survival as compared with placebo, overall and in all subgroups.


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