EP888 The impact of levels of biomarkers on overall survival in FIGO stage III–IV ovarian cancer

2019 ◽  
Author(s):  
A Karlsson ◽  
E Lundin ◽  
P Lukas ◽  
G Lindahl ◽  
P Kjølhede
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Figo Stage ◽  
Stage Iii ◽  
The Impact

scholarly journals Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial

2020 ◽  
Vol 30 (6) ◽  
pp. 888-892 ◽  
Author(s):  
Simone Koole ◽  
Ruby van Stein ◽  
Karolina Sikorska ◽  
Desmond Barton ◽  
Lewis Perrin ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Epithelial Ovarian Cancer ◽  
Cytoreductive Surgery ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Residual Disease ◽  
Figo Stage ◽  
Primary Objective ◽  
Phase Iii ◽  
Stage Iii

BackgroundThe addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery. The effect of HIPEC remains undetermined in patients who are candidates for primary cytoreductive surgery.Primary objectiveThe primary objective is to evaluate the effect of HIPEC on overall survival in patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm in maximum dimension.Study hypothesisWe hypothesize that the addition of HIPEC to primary cytoreductive surgery improves overall survival in patients with primary FIGO stage III epithelial ovarian cancer.Trial designThis international, randomized, open-label, phase III trial will enroll 538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer. Following complete or near-complete (residual disease ≤2.5 mm) primary cytoreduction, patients are randomly allocated (1:1) to receive HIPEC or no HIPEC. All patients will receive six courses of platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab according to current guidelines.Major eligibility criteriaPatients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery. Patients with resectable umbilical, spleen, or local bowel lesions may be included. Enlarged extra-abdominal lymph nodes should be negative on FDG-PET or fine-needle aspiration/biopsy.Primary endpointThe primary endpoint is overall survival.Sample sizeTo detect a HR of 0.67 in favor of HIPEC, 200 overall survival events are required. With an expected accrual period of 60 months and 12 months additional follow-up, 538 patients need to be randomized.Estimated dates for completing accrual and presenting resultsThe OVHIPEC-2 trial started in January 2020 and primary analyses are anticipated in 2026.Trial registrationClinicalTrials.gov:NCT03772028

Primary cytoreductive surgery with or without Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: The OVHIPEC-2 trial in progress.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS6100-TPS6100
Author(s):  
Ruby M. van Stein ◽  
Simone N. Koole ◽  
Karolina Sikorska ◽  
Desmond P. Barton ◽  
Lewis Perrin ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Intraperitoneal Chemotherapy ◽  
Cytoreductive Surgery ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Figo Stage ◽  
Phase Iii ◽  
Stage Iii ◽  
Peritoneal Cancer ◽  
Anticancer Treatment

TPS6100 Background: The addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery due to extensive intraperitoneal disease. The effect of HIPEC remains undetermined in patients who are eligible for primary cytoreductive surgery. We hypothesize that the addition of HIPEC to a complete or near-complete (residual disease ≤2.5 mm) primary cytoreductive surgery improves overall survival in patients with FIGO stage III ovarian cancer. Methods: This international, randomized, open-label, phase III trial enrolls patients with newly diagnosed, histological proven FIGO stage III epithelial ovarian, fallopian tube, or primary peritoneal cancer. Patients with resectable umbilical, spleen or local bowel lesions may be included. Following complete or near-complete primary cytoreduction, patients are intra-operatively randomized (1:1) to receive HIPEC or no HIPEC. Patients in both study arms will receive six courses of adjuvant carboplatin-paclitaxel and maintenance PARP-inhibitor or bevacizumab according to current guidelines. The primary endpoint is overall survival. To detect a Hazard Ratio of 0.67 in favor of HIPEC, 200 overall survival events are required. Assuming that accrual will be completed in 60 months, and 12 months additional follow-up, 538 patients need to be randomized. All randomized patients will be included in the analysis for overall survival according to the intention to treat principle. Pre-specified subgroup analyses will be performed based on stratification factors (peritoneal cancer index at start of surgery, completeness of surgery), histologic subtype (high-grade serous versus other), and BRCA mutation (BRCA1/2 mutation versus wildtype). Secondary endpoints are recurrence-free survival, time to first subsequent anticancer treatment, and treatment related complications and toxicity. Exploratory endpoints are time to second subsequent anticancer treatment, health-related quality of life, and cost-effectiveness. The Institutional Review Board of the Netherlands Cancer Institute approved the trial, which is actively enrolling patients since January 2020. Clinical trial information: NCT03772028.

scholarly journals The FIGO Stage IVA Versus IVB of Ovarian Cancer: Prognostic Value and Predictive Value for Neoadjuvant Chemotherapy

2018 ◽  
Vol 28 (3) ◽  
pp. 453-458 ◽  
Author(s):  
Parvin Tajik ◽  
Roelien van de Vrie ◽  
Mohammad H. Zafarmand ◽  
Corneel Coens ◽  
Marrije R. Buist ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Epithelial Ovarian Cancer ◽  
Prognostic Value ◽  
Median Overall Survival ◽  
Stage Iv ◽  
Figo Stage ◽  
Figo Staging ◽  
Stage Ivb

ObjectiveThe revised version of the International Federation of Gynaecology and Obstetrics (FIGO) staging system (2014) for epithelial ovarian cancer includes a number of changes. One of these is the division of stage IV into 2 subgroups. Data on the prognostic and predictive significance of this classification are scarce. The effect of neoadjuvant chemotherapy (NACT) versus primary debulking surgery (PDS) in relation to the subclassification of FIGO stage IV is also unknown.MethodsWe used data of the EORTC 55971 trial, in which 670 patients with previous stage IIIC or IV epithelial ovarian cancer were randomly assigned to PDS or NACT; 160 patients had previous stage IV. Information on previous FIGO staging and presence of pleural effusion with positive cytology were used to classify tumors as either stage IVA or IVB. We tested the association between stage IVA/IVB and survival to evaluate the prognostic value and interactions between stage, treatment, and survival to evaluate the predictive performance.ResultsAmong the 160 participants with previous stage IV disease, 103 (64%) were categorized as stage IVA and 57 (36%) as stage IVB tumors. Median overall survival was 24 months in FIGO stage IVA and 31 months in stage IVB patients (P = 0.044). Stage IVB patients treated with NACT had 9 months longer median overall survival compared with IVB patients undergoing PDS (P = 0.025), whereas in IVA patients, no significant difference was observed (24 vs 26 months, P = 0.48).ConclusionsThe reclassification of FIGO stage IV into stage IVA or IVB was not prognostic as expected. Compared with stage IVA patients, stage IVB patients have a better overall survival and may benefit more from NACT.

TRUST: Trial of Radical Upfront Surgical Therapy in advanced ovarian cancer (ENGOT ov33/AGO‐OVAR OP7)

2019 ◽  
Vol 29 (8) ◽  
pp. 1327-1331 ◽  
Author(s):  
Alexander Reuss ◽  
Andreas du Bois ◽  
Philipp Harter ◽  
Christina Fotopoulou ◽  
Jalid Sehouli ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Cytoreductive Surgery ◽  
Advanced Ovarian Cancer ◽  
Figo Stage ◽  
Complete Resection ◽  
Peritoneal Carcinoma ◽  
Exclusion Criteria ◽  
Platinum Based Chemotherapy

BackgroundPrimary cytoreductive surgery followed by chemotherapy has been considered standard management for patients with advanced ovarian cancer over decades. An alternative approach of interval debulking surgery following neoadjuvant chemotherapy was subsequently reported by two randomized phase III trials (EORTC‐GCG, CHORUS), which were criticized owing to important limitations, especially regarding the rate of complete resection.Primary ObjectiveTo clarify the optimal timing of surgical therapy in advanced ovarian cancer.Study HypothesisPrimary cytoreductive surgery is superior to interval cytoreductive surgery following neoadjuvant chemotherapy for overall survival in patients with advanced ovarian cancer.Trial DesignTRUST is an international open, randomized, controlled multi-center trial investigating overall survival after primary cytoreductive surgery versus neoadjuvant chemotherapy and subsequent interval cytoreductive surgery in patients with FIGO stage IIIB–IVB ovarian, tubal, and peritoneal carcinoma. To guarantee adequate surgical quality, participating centers need to fulfill specific quality assurance criteria (eg, ≥50% complete resection rate in upfront surgery for FIGO IIIB–IVB patients, ≥36 debulking-surgeries/year) and agree to independent audits by TRUST quality committee delegates. Patients in the primary cytoreductive surgery arm undergo surgery followed by 6 cycles of platinum-based chemotherapy, whereas patients in the interval cytoreductive surgery arm undergo 3 cycles of neoadjuvant chemotherapy after histologic confirmation of the disease, followed by interval cytoreductive surgery and subsequently, 3 cycles of platinum-based chemotherapy. The intention of surgery for both groups is complete tumor resection according to guideline recommendations.Major Inclusion/Exclusion CriteriaMajor inclusion criteria are suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma FIGO stage IIIB–IVB (IV only if resectable metastasis). Major exclusion criteria are non-epithelial ovarian malignancies and borderline tumors; prior chemotherapy for ovarian cancer; or abdominal/pelvic radiotherapy.Primary EndpointOverall survival.Sample Size772 patients.Estimated Dates for Completing Accrual and Presenting ResultsAccrual completion approximately mid-2019, results are expected after 5 years' follow-up in 2024.Trial RegistrationNCT02828618.

Risk of breast cancer following ovarian cancer and the impact on overall survival

2014 ◽  
Vol 133 ◽  
pp. 148
Author(s):  
D.Y. Paik ◽  
F. Amersi ◽  
C. Bresee ◽  
A. Gangi ◽  
B.Y. Karlan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Ovarian Cancer ◽  
Overall Survival ◽  
The Impact

Interval Debulking Surgery After Neodjuvant Chemotherapy Vs Primary Debulking Surgery For Stage Iii Epithelial Ovarian Carcinoma

2020 ◽  
Vol 106 (1_suppl) ◽  
pp. 15-15
Author(s):  
BM Ahmed ◽  
AT Amin ◽  
MK Khallaf ◽  
A Ahmed Refaat ◽  
SA Sileem
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Disease Free Survival ◽  
Figo Stage ◽  
Stage Iii ◽  
Debulking Surgery ◽  
Free Survival ◽  
Primary Debulking Surgery ◽  
Interval Debulking Surgery ◽  
Disease Free

Introduction: Ovarian cancer is the most lethal gynecologic malignancy and is the fifth most common cause of cancer-related death among women. Approach to FIGO stage III epithelial ovarian cancer remains challengeable. This study aims to evaluate the outcome of interval debulking surgery (IDS) vs. primary debulking surgery (PDS) for FIGO stage III epithelial ovarian cancer. Materials and Methods: During a period of six years (January 2014 to December 2019), we analyzed the patients for eligibility criteria, which were: (1) FIGO stage III epithelial ovarian cancer. (2) The age of 18 years or more (3) Patients underwent either PDS or IDS and received chemotherapy at South Egypt Cancer Institute. We divided them into two groups: (1) Those received three cycles of neoadjuvant chemotherapy and then underwent IDS plus three additional cycles of adjuvant chemotherapy and (2) Those who have PDS followed by six cycles of chemotherapy. Results: This study includes 380 eligible patients. The first group included 226 patients (59.47%) underwent PDS then 6 cycles of chemotherapy, while the group of IDS included 154 patients (40.53%). The treatment modality was not significant for overall survival (OS); however disease-free survival (DFS) was significantly reduced after IDS when compared to PDS (median DFS: 33 months; 95% CI 30.23-35.77 vs. 45 months; 95% CI 41.25-48.75 respectively; p= .000). Moreover, in subgroup analysis, OS and DFS were significantly dropped after IDS in elderly patients, patients with bad performance status, sub-optimal cytoreduction as well as high grade and undifferentiated tumors when compared to those who underwent PDS. Conclusion: Although treatment modality may not impact overall survival (OS), however, PDS results in a better disease-free survival than IDS. Moreover, IDS results in a significant drop in OS and DFS in special patients subgroups when compared to PDS. Therefore patients selection should be considered.

Sign in / Sign up

Export Citation Format

Share Document