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]

Incidence of venous thromboembolism among patients receiving neoadjuvant chemotherapy for advanced ovarian cancer.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e17531-e17531
Author(s):  
Julia Salinaro ◽  
Jessie Ehrisman ◽  
Angeles Alvarez Secord ◽  
Brittany Anne Davidson
Keyword(s):  
Ovarian Cancer ◽  
Venous Thromboembolism ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Ovarian Cancer

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).

First-Line Chemotherapy With Epirubicin, Paclitaxel, and Carboplatin for Advanced Ovarian Cancer: A Phase I/II Study of the Arbeitsgemeinschaft Gynäkologische Onkologie Ovarian Cancer Study Group

1999 ◽  
Vol 17 (1) ◽  
pp. 46-46 ◽  
Author(s):  
A. du Bois ◽  
H. J. Lück ◽  
T. Bauknecht ◽  
W. Meier ◽  
B. Richter ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase I ◽  
Survival Rates ◽  
Advanced Ovarian Cancer ◽  
Phase Iii ◽  
First Line ◽  
Gynäkologische Onkologie ◽  
Combination Regimens ◽  
Level 2 ◽  
Line Chemotherapy

PURPOSE: Despite the progress that has been achieved over the years, survival rates in patients with advanced ovarian cancer are still disappointing. New methods to improve the efficiency of first-line chemotherapy are warranted. One method to improve results is to add more non–cross-resistant drugs to platinum-paclitaxel combination regimens. Anthracyclines are among the candidates for incorporation as the “third drug” into first-line regimens for advanced ovarian cancer. PATIENTS AND METHODS: We performed a phase I/II trial with escalating doses of epirubicin (60, 75, and 90 mg/m2) combined with fixed doses of paclitaxel and carboplatin in 27 previously untreated patients with advanced gynecologic malignancies. RESULTS: Dose-limiting toxicity occurred at dose level 2 (75 mg/m2 epirubicin) and consisted of myelosuppression (neutropenia, thrombocytopenia). No dose-limiting, nonhematologic toxicities were observed. The maximum tolerable dose was epirubicin 60 mg/m2 (E) combined with a 3-hour infusion of paclitaxel 175 mg/m2 (T) and carboplatin AUC 5 (Carbo). Preliminary analysis indicated promising activity against ovarian cancer. CONCLUSION: The three-drug combination ET-Carbo, given according to the outlined dose and schedule, should be considered for further phase III evaluation. A randomized German-French intergroup trial comparing ET-Carbo with carboplatin-paclitaxel has already been initiated.

Rate of venous thromboembolism during neoadjuvant chemotherapy for advanced ovarian cancer

2019 ◽  
Vol 154 ◽  
pp. 29-30
Author(s):  
J.R. Salinaro ◽  
R.B. Boccaccio ◽  
J.A. Ehrisman ◽  
L.J. Havrilesky ◽  
A.A. Secord ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Venous Thromboembolism ◽  
Neoadjuvant Chemotherapy ◽  
Advanced Ovarian Cancer

scholarly journals A phase I study of combined trabectedin and pegylated liposomal doxorubicin therapy for advanced relapsed ovarian cancer

2021 ◽  
Author(s):  
Shunji Takahashi ◽  
Munetaka Takekuma ◽  
Kenji Tamura ◽  
Kazuhiro Takehara ◽  
Hiroyuki Nomura ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Phase I ◽  
Liposomal Doxorubicin ◽  
Advanced Ovarian Cancer ◽  
Pegylated Liposomal Doxorubicin ◽  
Japanese Patients ◽  
Pharmacokinetic Analysis ◽  
Dependent Manner ◽  
Drug Concentrations ◽  
Grade 3

Abstract Background Advanced relapsed ovarian cancer has a poor prognosis, and treatment options are limited. Methods This phase I trial investigated the dosage, safety, pharmacokinetics and efficacy of trabectedin plus pegylated liposomal doxorubicin (PLD) in Japanese patients with advanced relapsed ovarian, fallopian tube, or primary peritoneal cancer. Patients received trabectedin 0.9 or 1.1 mg/m2 immediately after PLD 30 mg/m2; both drugs were given by intravenous infusion. Treatment was repeated every 21 days until disease progression or unacceptable toxicity. The maximum tolerated dose (MTD) was determined in an initial dose escalation phase, and this was used in a subsequent safety assessment phase. Safety and tumor response were monitored throughout the trial, and drug concentrations for pharmacokinetic analysis were measured during cycle 1. Results Eighteen patients were included. The MTD of trabectedin was determined as 1.1 mg/m2. Gastrointestinal adverse events were experienced by all patients, but were mostly grade 1 or 2 in intensity. Most patients had grade ≥ 3 elevations in transaminase levels or grade ≥ 3 reductions in neutrophil count, but these events were generally manageable through dose reduction and/or supportive therapies, as appropriate. There were no deaths during the trial. Trabectedin exposure increased in a dose-dependent manner. The overall response rate was 27.8%. Conclusions Trabectedin, in combination with PLD, may have clinical benefits in Japanese patients with relapsed advanced ovarian cancer. The recommended dosage of trabectedin for further study in this population is 1.1 mg/m2 once every 21 days. Clinical trial registration number: JapicCTI-163164

Incidence of venous thromboembolism among patients receiving neoadjuvant chemotherapy for advanced epithelial ovarian cancer

2020 ◽  
Vol 30 (4) ◽  
pp. 491-497 ◽  
Author(s):  
Julia Rose Salinaro ◽  
Kourtnie McQuillen ◽  
Megan Stemple ◽  
Robert Boccaccio ◽  
Jessie Ehrisman ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Pulmonary Embolism ◽  
Deep Vein Thrombosis ◽  
Venous Thromboembolism ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Epithelial Ovarian Cancer ◽  
Primary Outcome ◽  
Vein Thrombosis ◽  
Deep Vein

ObjectivesNeoadjuvant chemotherapy may be considered for women with epithelial ovarian cancer who have poor performance status or a disease burden not amenable to primary cytoreductive surgery. Overlap exists between indications for neoadjuvant chemotherapy and known risk factors for venous thromboembolism, including impaired mobility, increasing age, and advanced malignancy. The objective of this study was to determine the rate of venous thromboembolism among women receiving neoadjuvant chemotherapy for epithelial ovarian cancer.MethodsA multi-institutional, observational study of patients receiving neoadjuvant chemotherapy for primary epithelial ovarian, fallopian tube, or peritoneal cancer was conducted. Primary outcome was rate of venous thromboembolism during neoadjuvant chemotherapy. Secondary outcomes included rates of venous thromboembolism at other stages of treatment (diagnosis, following interval debulking surgery, during adjuvant chemotherapy, or during treatment for recurrence) and associations between occurrence of venous thromboembolism during neoadjuvant chemotherapy, subject characteristics, and interval debulking outcomes. Venous thromboembolism was defined as deep vein thrombosis in the upper or lower extremities or in association with peripherally inserted central catheters or ports, pulmonary embolism, or concurrent deep vein thrombosis and pulmonary embolism. Both symptomatic and asymptomatic venous thromboembolism were reported.ResultsA total of 230 patients receiving neoadjuvant chemotherapy were included; 63 (27%) patients overall experienced a venous thromboembolism. The primary outcome of venous thromboembolism during neoadjuvant chemotherapy occurred in 16 (7.7%) patients. Of the remaining venous thromboembolism events, 22 were at diagnosis (9.6%), six post-operatively (3%), five during adjuvant chemotherapy (3%), and 14 during treatment for recurrence (12%). Patients experiencing a venous thromboembolism during neoadjuvant chemotherapy had a longer mean time to interval debulking and were less likely to undergo optimal cytoreduction (50% vs 80.2%, p=0.02).ConclusionsPatients with advanced ovarian cancer are at high risk for venous thromboembolism while receiving neoadjuvant chemotherapy. Consideration of thromboprophylaxis may be warranted.

Sign in / Sign up

Export Citation Format

Share Document