TRAINING-Ovary 01 (connecTed pRehabiliAtIoN pelvIc caNcer surGery): multicenter randomized study comparing neoadjuvant chemotherapy for patients managed for ovarian cancer with or without a connected pre-habilitation program

2020 ◽  
pp. ijgc-2020-002128
Author(s):  
Eric Lambaudie ◽  
Cécile Bannier/Braticevic ◽  
Charlène Villaron/Goetgheluck ◽  
Christophe Zemmour ◽  
Jean-Marie Boher ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Primary Endpoint ◽  
Advanced Ovarian Cancer ◽  
Well Being ◽  
Phase Iii ◽  
Pelvic Surgery ◽  
Control Group ◽  
Gynecology And Obstetrics ◽  
Pelvic Cancer

BackgroundPatients undergoing neoadjuvant chemotherapy before surgery for advanced ovarian cancer may have impaired functional capacity, nutritional status, and emotional well-being.Primary objective(s)TRAINING-01 aims to determine if a connected pre-habilitation program during neoadjuvant chemotherapy for patients treated for an advanced ovarian cancer will improve physical capacity before major abdomino-pelvic surgery.Study hypothesisA pre-habilitation program during neoadjuvant chemotherapy will bring a fitter patient to surgery and will decrease treatment morbidity and improve oncological outcomes.Trial designThis study is a prospective, multi-center, phase III study. The pre-habilitation program consists of providing multi-dimensional support during neoadjuvant chemotherapy using connected devices. The control group will receive usual care.Major inclusion/exclusion criteriaEligible patients will be women with International Federation of Gynecology and Obstetrics stage III–IV advanced ovarian cancer undergoing neoadjuvant chemotherapy. Patients must be able to perform a cardiopulmonary exercise test.Primary endpoint(s)The primary endpoint will be the comparison of the variation in maximum oxygen uptake (VO2 max) between baseline and surgery in the pre-habilitation group and control groups.Sample size136 patients (68 per arm) will be recruited to demonstrate a medium standardized effect d=0.5 in the variations of VO2 max between baseline and surgery.Estimated dates for completing accrual and presenting resultsThe duration of the study includes 24 months of recruitment and 5 years of follow up. We anticipate reporting primary endpoint results in 2024.Trial registrationTRAINING-01-IPC 2018-039 (NCT04451369).

Risk of venous thromboembolism in patients receiving neoadjuvant chemotherapy for ovarian cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6073-6073
Author(s):  
Derman Basaran ◽  
Jessa Suhner ◽  
Dib Sassine ◽  
Thomas Boerner ◽  
Ying L Liu ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Venous Thromboembolism ◽  
Neoadjuvant Chemotherapy ◽  
Phase I ◽  
Thrombotic Event ◽  
Anticoagulation Therapy ◽  
Advanced Ovarian Cancer ◽  
Treatment Phase ◽  
Phase Iii ◽  
Prophylactic Anticoagulation

6073 Background: To identify the incidence of newly occurring venous thromboembolism (VTE) in patients with ovarian cancer receiving neoadjuvant chemotherapy (NACT). Methods: Using our prospectively maintained ovarian cancer database, we identified all ovarian cancer patients who received NACT at our institution from 4/15-9/18. VTE events included clinically diagnosed deep venous thrombosis (DVT) or pulmonary embolism (PE). Patients who presented with VTE prior to induction of NACT or patients on anticoagulation therapy prior to diagnosis were excluded. The incidence of newly occurring thrombotic events were categorized according to treatment phases, defined as 1) NACT prior to interval debulking surgery (IDS); 2) intraoperative and 30-day post-IDS; and 3) adjuvant chemotherapy. Results: 290 patients underwent NACT during the study period. Thirty-eight patients (13%) who presented with VTE, 12 (4%) on anticoagulation at presentation, and 4 (1.4%) seeking only a second opinion were excluded from analysis. Of the 236 evaluable patients, the overall rate of VTE during all treatment phases was 15% (35/236). In treatment phase I, 11% (27/236) of patients experienced VTE during NACT. In phase II, an additional 2.5% (6/236) developed VTE in the intraoperative and 30-day postoperative period. In phase III, an additional 0.8% (2/236) experienced a thrombotic event >30 days postoperatively. Sevety-seven percent (27/35) of VTE events occured during phase I. Conclusions: Patients receiving NACT for advanced ovarian cancer are at high risk for the development of clinically detectable thromboembolic events. The highest rate of new VTE events was seen during induction of NACT, a phase of treatment traditionally without any prophylactic anticoagulation. Further research regarding the timing of thromboprophylaxis for this patient population is warranted. [Table: see text]

Morbidity of Surgery After Neoadjuvant Chemotherapy Including Bevacizumab for Advanced Ovarian Cancer

2013 ◽  
Vol 23 (7) ◽  
pp. 1326-1330 ◽  
Author(s):  
Elisabeth Chéreau ◽  
Eric Lambaudie ◽  
Gilles Houvenaeghel
Keyword(s):  
Ovarian Cancer ◽  
Postoperative Complications ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Ovarian Cancer ◽  
Median Number ◽  
Debulking Surgery ◽  
Surgical Safety ◽  
Computed Tomographic ◽  
Gynecology And Obstetrics ◽  
Grade 3

ObjectiveNeoadjuvant chemotherapy followed by interval debulking surgery is an alternative for the management of advanced ovarian cancer (AOC). Owing to unresectable disease at initial evaluation, some patients received bevacizumab in addition to neoadjuvant chemotherapy. The aim of this study was to evaluate the safety and postoperative course of patients who had received bevacizumab before debulking surgery for AOC.MethodsIn 2012, we identified all patients with AOC who had received neoadjuvant bevacizumab before debulking surgery. We recorded patients’ characteristics, surgical course, and postoperative complications.ResultsFive patients were identified, of whom 80% were International Federation of Gynecology and Obstetrics stage 4 at diagnosis. All patients underwent surgery after 6 courses of neoadjuvant chemotherapy with carboplatin, paclitaxel, and bevacizumab. The median number of bevacizumab injections was 3 (3–4), and the median time between the last injection of bevacizumab and surgery was 54 days (34–110 days). One patient had a grade 3 complication (lymphocyst with puncture under computed tomographic scans).ConclusionIn this preliminary study, debulking surgery after neoadjuvant chemotherapy that included bevacizumab did not increase the rate of postoperative complications when there was a reasonable interval between the last bevacizumab injection and surgery. Larger studies are warranted to assess surgical safety after antiangiogenic treatment in the neoadjuvant setting for advanced ovarian cancer.

The Role of HE4, a Novel Biomarker, in Predicting Optimal Cytoreduction After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

2017 ◽  
Vol 27 (4) ◽  
pp. 696-702 ◽  
Author(s):  
Francesco Plotti ◽  
Giuseppe Scaletta ◽  
Stella Capriglione ◽  
Roberto Montera ◽  
Daniela Luvero ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Positive Predictive Value ◽  
Negative Predictive Value ◽  
Predictive Value ◽  
Advanced Ovarian Cancer ◽  
Debulking Surgery ◽  
Gynecology And Obstetrics ◽  
Group A ◽  
Group B

ObjectivesThis study aimed to evaluate serum human epididymis protein 4 (HE4) changes during neoadjuvant chemotherapy (NACT) to establish HE4 predebulking surgery cutoff values and to demonstrate that CA125, HE4, and computed tomography (CT) taken together are better able to predict complete cytoreduction after NACT in advanced ovarian cancer patients.MethodsFrom January 2006 to November 2015, patients affected by epithelial advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage III–IV), considered not optimally resectable, were included in this prospective study. After 3 cycles of NACT, all patients underwent debulking surgery and were allocated, according to residual tumor (RT), into group A (RT = 0) and group B (RT > 0). Serum CA125, HE4, and CT images were recorded during NACT and compared singularly and with each other in term of accuracy, sensitivity, specificity, and positive and negative predictive value.ResultsA total of 94 and 20 patients were included in group A and group B, respectively. The HE4 values recorded before debulking surgery correlated with RT. The identified HE4 cutoff value of 226 pmol/L after NACT was able to classify patients at high or low risk of suboptimal surgery, with a sensitivity of 75% and a specificity of 85% (positive predictive value, 0.87; negative predictive value, 0.70). The combination of CA125, HE4, and CT imaging resulted in the best combination with a sensitivity of 96% and a specificity of 92% (positive predictive value, 0.96; negative predictive value, 0.94).ConclusionsThe novel biomarker HE4, in addition to CA125 and CT, is better able to predict the RT at debulking surgery and the prognosis of patients.

Long-term follow-up of the first randomized study of cisplatin versus carboplatin for advanced epithelial ovarian cancer.

1994 ◽  
Vol 12 (10) ◽  
pp. 2066-2070 ◽  
Author(s):  
A E Taylor ◽  
E Wiltshaw ◽  
M E Gore ◽  
I Fryatt ◽  
C Fisher
Keyword(s):  
Ovarian Cancer ◽  
Single Agent ◽  
Survival Rates ◽  
Advanced Ovarian Cancer ◽  
Phase Iii ◽  
Term Survival ◽  
Gynecology And Obstetrics ◽  
To Receive

PURPOSE A phase III trial was performed between October 1981 and June 1984 to compare the efficacy of single-agent cisplatin and single-agent carboplatin in previously untreated patients with International Federation of Gynecology and Obstetrics stage III or IV carcinoma of the ovary following surgery. This report describes the survival rates of patients in this study after a minimum follow-up duration of 8 years. PATIENTS AND METHODS Sixty-four patients were randomized to receive cisplatin and 67 patients to receive carboplatin. Cisplatin was administered every 4 weeks for a total of 10 courses, courses 1 to 5 at a dosage of 100 mg/m2 and courses 6 to 10 at 30 mg/m2. Carboplatin was administered at a dosage of 400 mg/m2 every 4 weeks for 10 courses. Patients who had clinical or radiologic evidence of response after five courses of chemotherapy underwent second-look surgery. The study was designed to allow crossover between the two arms. Thirteen patients were excluded from response analyses because they were incorrectly randomized. Patients were crossed over to the other arm of the study because of progressive disease (PD), nonresponse, or toxicity. RESULTS The overall response rate for patients randomized to the cisplatin arm was 53.8% (28 of 52; 95% confidence interval [CI], 39% to 68%) and for those randomized to the carboplatin arm, 38.4% (20 of 52; 95% CI, 25% to 53%). There were 16 (30.8%) and 14 (26.9%) complete remissions (CRs) in the cisplatin and carboplatin arms, respectively. None of these differences were statistically significant. The median duration of response for the cisplatin and carboplatin arms was 21 months and 17 months, and the 5-year relapse-free survival rates were 22% and 25%, respectively. The median survival durations for the cisplatin and carboplatin arms were 19.5 and 13 months, and the 5-year survival rates were 15% (95% CI, 8% to 26%) and 19% (95% CI, 11% to 30%), respectively. None of these differences was statistically significant. The median follow-up duration of patients is 9 years. Crossover due to toxicity was more frequent in the cisplatin than the carboplatin arm, occurring in 50% and 3.3% of patients, respectively. CONCLUSION The mature data from this study of patients with advanced ovarian cancer show that cisplatin and carboplatin have similar long-term survival results.

Multicenter Phase 2 Study of Combined Gemcitabine and Epirubicin as Second-Line Treatment for Patients With Advanced Ovarian Cancer

2010 ◽  
Vol 20 (6) ◽  
pp. 953-957 ◽  
Author(s):  
Viviana Murgia ◽  
Roberto Sorio ◽  
Claudia Griso ◽  
Orazio Caffo ◽  
Carmela Arcuri ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Ovarian Cancer ◽  
Hematological Toxicity ◽  
Line Treatment ◽  
Second Line ◽  
Phase 2 ◽  
Platinum Resistant ◽  
Gynecology And Obstetrics

Objective:The aim of this phase 2 trial was to evaluate the tolerability and efficacy of combined gemcitabine (G) and epirubicin (E) as second-line treatment for patients with advanced ovarian cancer.Methods:Treatment with G 1000 mg/m2 (days 1 and 8) and E 60 mg/m2 (day 1) every 3 weeks for 3 or, in the absence of progression, 6 courses.Results:Fifty patients with advanced ovarian cancer (31 serous, 2 endometrioid, 10 unclassified adenocarcinoma, and 7 other) and a median age of 60 years (range, 38-74 years) were enrolled after giving their informed consent. Performance status according to the Eastern Cooperative Oncology Group was 0 in 29 patients (58%), 1 in 17 patients (34%), and 2 in 4 patients (8%), and the initial stages according to the International Federation of Gynecology and Obstetrics were I to II in 4 patients (8%), III in 31 patients (62%), and IV in 15 patients (30%). They had previously received a median of 1.5 lines of treatment (range, 1-4). The median platinum-free interval was 5 months (range, 0-12 months): 32 patients had relapse within 6 months and 18 patients had relapse after 6 months.The response rate was 42% (2% complete response and 40% partial response), with a median duration of 7.2 months: the corresponding figures were 37.5% and 5.2 months in the platinum-resistant patients and 50% and 8.8 months in the platinum-sensitive patients. The main grade 3 to 4 hematological toxicity was neutropenia (56% of cases). After a median follow-up of 13.5 months, median progression-free survival was 5 months, and median overall survival was 23.5 months.Conclusions:This E + G combination seems to be active and safe in platinum-resistant/refractory patients.

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