scholarly journals Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e046415
Author(s):  
Miao-Fang Wu ◽  
Li-Juan Wang ◽  
Yan-Fang Ye ◽  
Chang-Hao Liu ◽  
Huai-Wu Lu ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Intraperitoneal Chemotherapy ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Controlled Trial ◽  
Progression Free Survival ◽  
Control Group ◽  
Chemotherapy Response ◽  
Open Label ◽  
Surgical Morbidity ◽  
Experimental Group

BackgroundNeoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone.MethodsThis study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60–75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.Ethics approval and disseminationThis study was approved by the Ethics Committee of Sun Yat-sen Memorial Hospital (approval number: 2020-ky-050). Results will be submitted to peer-reviewed journals and presented at national and international conferences.Trial registration numberChiCTR2000038173.

scholarly journals Observations on the Use of Different Modes of Cisatracurium Administration in Hyperthermic Intraperitoneal Chemotherapy

2021 ◽  
Author(s):  
Jing Zhang ◽  
Danyang Gao ◽  
Pengfei Liu ◽  
Tianzuo Li
Keyword(s):  
Heart Rate ◽  
Mean Arterial Pressure ◽  
Tidal Volume ◽  
Intraperitoneal Chemotherapy ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Residual Effects ◽  
Control Group ◽  
Blood Oxygen ◽  
Blood Oxygen Saturation ◽  
Experimental Group

Abstract Objective: To investigate the residual effects of cis-atracurium with different administrations in patients with hyperthermic intraperitoneal chemotherapy.Methods: 60 patients undergoing hyperthermic intraperitoneal chemotherapy were randomly divided into two groups with 30 cases in each group. All patients were induced with sufentanil 0.4ug/kg, propofol 2.0mg/kg and cis atracurium 0.2mg/kg. During the operation, sevoflurane and remifentanil were used to maintain anesthesia. BIS value was 45-55. The control group intermittently received cis-atracurium injection with 0.1mg/kg/h. The experimental group received continuous injection of cis-atracurium at a rate of 1.5ug/kg/min. Cis-atracurium was discontinued 30min before the end of the operation, sevoflurane inhalation was stopped 20min before the end of the surgery and remifentanil was discontinued 10min before the end. At the end of the operation, no muscle relaxant antagonism were applied. General information of patients was recorded. Mean arterial pressure (MAP), heart rate (HR), tidal volume (VT), respiratory rate (F), and blood oxygen saturation (SpO2) were recorded before anesthesia (T1) , at the time of tracheal catheter extraction (T2).Besides, the total amount of cis-atracurium, the time of recovery of spontaneous tidal volume to 6ml/kg (t1), the time of continuous lifting of the head for 5 s (t2), and the time from the withdrawal of muscle relaxant to the removal of the tracheal catheter (t3) were recorded. Blood gas analysis was also performed to record PaO2 and PaCO2 before anesthesia, when leaving the operating room and SICU. Moreover, relevant adverse reactions were recorded.Results: 1) general situation: there was no difference in body weight, operation time, ASA classification and other indicators between the two groups (P>0.05). 2) comparison of residual effects of muscle relaxants: the values of t1, t2 and t3 in the experimental group were significantly shorter than those in the control group (P<0.05). There was no significant difference between the two groups in PaO2 and PaCO2 before anaesthesia, when out of the operating room and when out of SICU (P>0.05). 3) hemodynamic comparison: there were no statistically significant differences in mean arterial pressure, heart rate, tidal volume, respiratory rate and blood oxygen saturation between the two groups at time points T1 and T2 (P>0.05). 4) comparison of adverse events: no adverse events occurred in either group.Conclusion: Compared with intermittent infusion, continuous infusion of cis-atracurium did not result in significant residual muscle relaxation and no significant histamine release. Therefore, continuous infusion is more suitable for long-term surgery.

The Safety and Efficacy of Transarterial Chemoembolization with Bleomycin for Hepatocellular Carcinoma Unresponsive to Doxorubicin:A Prospective Single-center Study

2020 ◽  
Author(s):  
jinxin fu ◽  
yan wang ◽  
jinlong zhang ◽  
kai yuan ◽  
jieyu yan ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Transarterial Chemoembolization ◽  
Controlled Trial ◽  
Objective Response ◽  
Progression Free Survival ◽  
Control Group ◽  
Safety And Efficacy ◽  
Post Procedure ◽  
Significant Difference ◽  
Experimental Group

Abstract Purpose To investigate the safety and efficacy of transarterial chemoembolization (TACE) with bleomycin for hepatocellular carcinoma (HCC) unresponsive to doxorubicin.Methods We did a randomized controlled trial in HCC patients resistant to TACE with doxorubicin to assess the survival benefits of the experimental group (TACE with bleomycin) compared with the control group (TACE with doxorubicin). 170 patients were allocated randomly between December 2015 and December 2017 and 80 patients of each group were accomplished and analyzed finally. The modified response evaluation criteria in solid tumors (mRECIST) was used to evaluated the tumor response every 4-6 weeks. The primary endpoint was median progression-free survival (mPFS) and median overall survival (mOS). Safety was assessed by post-procedure complications.Results The study was stopped in October 2018. Objective response rate (ORR) of the experimental group was 27.5% (22/80) , mPFS and mOS was 5.8 and 8.1 months. ORR of the control group was 7.5% (6/80) , mPFS and mOS was 2.9 and 4.0 months. The ORR were significantly different between two grous ( χ²= 0.348, P＜0.05). The differences of mPFS and mOS between the two groups were statistically significant (χ² = 2.865, P＜0.05 and χ² = 0.926, P＜0.05, respectively). There were no significant difference in post-procedure complications (P＞0.05) and no major complications occurred.Conclusion It is suggested that TACE with bleomycin is a safe and effective method for HCC and bleomycin can be a second-line chemotherapeutic agent for the HCC patients unresponsive to TACE with doxorubicin.

Consolidation hyperthermic intraperitoneal chemotherapy for the treatment of advanced stage ovarian carcinoma: A 3-year experience.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17094-e17094
Author(s):  
Alberto Mendivil ◽  
Lisa Nicole Abaid ◽  
John V. Brown ◽  
Kristina Mori ◽  
Katrina Lopez ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Disease Progression ◽  
Cancer Patients ◽  
Intraperitoneal Chemotherapy ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Progression Free Survival ◽  
Advanced Stage ◽  
Free Survival ◽  
Primary Induction

e17094 Background: Hyperthermic intraperitoneal chemotherapy (HIPEC) potentially confers significant survival benefits in the management of ovarian cancer although the long-term data remain scant. We sought to compare the survival rates of advanced stage ovarian cancer patients who were treated with primary induction therapy alone or in conjunction with consolidation HIPEC. Methods: Sixty-nine ovarian cancer patients who underwent surgery and completed their primary induction chemotherapy were treated with consolidation carboplatin (AUC 10) based HIPEC and compared to a historical cohort that received surgery and primary chemotherapy alone (n=69). The demographic and clinical characteristics in which we were primarily interested included: patient age, body mass index, surgery and pathology data, chemotherapy regimen, toxicity, and progression free/overall survival. Results: The two patient groups were similar in terms of tumor characteristics, cyto-reductive status, distribution of neoadjuvant chemotherapy and number of maintenance chemotherapy cycles administered (P> 0.05). Progression free survival was significantly more pronounced in the HIPEC (25.1 months) patients compared to the control group (20 months) (P=0.024) and there was a decreased risk of disease progression accorded to the patients treated with HIPEC (HR, 2.1028; 95% CI: 1.2941 to 3.4167; P=0.0027). However, we did not discern any HIPEC related overall survival advantages (P=0.29). Conclusions: The results from our ovarian cancer study suggest that adjunctive HIPEC proffers a significant progression free survival advantage and a decreased risk for disease progression. There was, however, no overall survival advantage discerned in the HIPEC group. We also recognize that HIPEC remains controversial and thus, randomized studies evaluating HIPEC compared to standard chemotherapy in the management of ovarian cancer are warranted.

scholarly journals Survival Outcomes after Hyperthermic Intraperitoneal Chemotherapy for a First Ovarian Cancer Relapse: A Systematic Evidence-Based Review

Cancers ◽  
2021 ◽  
Vol 14 (1) ◽  
pp. 172
Author(s):  
Jean-Marc Classe ◽  
Bernard Asselain ◽  
Loic Campion ◽  
Dominique Berton ◽  
Jean-Sébastien Frenel ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Intraperitoneal Chemotherapy ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Case Control ◽  
Control Group ◽  
Level Of Evidence ◽  
Control Series ◽  
Cancer Relapse ◽  
Meta Analyses

Background: Hyperthermic intraperitoneal chemotherapy (HIPEC) is routinely used in the treatment of a first ovarian cancer relapse. Methods: This systematic review, in accordance with Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, aimed to assess the quality of scientific proof of the survival benefits of HIPEC, using Medline and Google Scholar. Qualitative analysis using the Oxford CEBM Levels of Evidence 2011 grading is reported. Results: Of 469 articles identified, 23 were included; 15 based on series of patients treated with HIPEC without a control group, and 8 case control series of patients treated with or without HIPEC. The series without a control group showed median overall survival (OS) ranged from 23.5 to 63 months, highlighting a broad standard deviation. Considering the case control series, OS was significantly better in the HIPEC group in 5 studies, and similar in 1. The current review showed considerable heterogeneity and biases, with an Oxford Level of Evidence grading of 4 for 22 selected series and 2 for one. Conclusions: There is no strong evidence to suggest efficacy of HIPEC in improving survival of patients treated for a first relapse of ovarian cancer due to the low quality of the data.

scholarly journals Perioperative outcomes of cytoreductive surgery with hyperthermic intraperitoneal chemotherapy in elderly women with epithelial ovarian cancer: analysis of a prospective registry

2021 ◽  
pp. ijgc-2021-002622
Author(s):  
Laura M Chambers ◽  
Meng Yao ◽  
Molly Morton ◽  
Anna Chichura ◽  
Anthony B Costales ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Overall Survival ◽  
Elderly Patients ◽  
Intraperitoneal Chemotherapy ◽  
Hyperthermic Intraperitoneal Chemotherapy ◽  
Elderly Women ◽  
Multivariable Analysis ◽  
Progression Free Survival ◽  
Perioperative Outcomes ◽  
Free Survival

ObjectiveTo evaluate perioperative outcomes in elderly versus non-elderly women with advanced or recurrent epithelial ovarian cancer undergoing surgery with hyperthermic intraperitoneal chemotherapy (HIPEC).MethodsA single-institution prospective registry was analyzed for women with ovarian cancer who underwent surgery with HIPEC from January 2014 to December 2020. Elderly age was defined as ≥65 years at surgery. Complications were defined according to the Accordion scale. Univariate and multivariable analysis was used to compare progression-free survival and overall survival.ResultsOf 127 women who underwent surgery with HIPEC, 33.1% (n=42) were ≥65 and 17.3% (n=22) were ≥70 years old. The median age for non-elderly and elderly patients were 55.7±8.3 versus 72.0±5.4 years, respectively (p<0.001). The majority of non-elderly versus elderly patients underwent HIPEC at the time of interval cytoreductive surgery following neoadjuvant chemotherapy (52.9% vs 73.8%, p=0.024). There were no differences in moderate (15.3% vs 26.2%) or severe postoperative complications (10.6% vs 11.9%, p=0.08), acute kidney injury (7.1% vs 16.7%, p=0.12), and length of stay (5.0 vs 5.0 days, p=0.56) for non-elderly versus elderly patients. With a median follow-up of 20 months (95% CI 9.1 to 32.7 months), there was no difference in progression-free survival (18.8 vs 15.7 months, p=0.75) or overall survival (61.6 months vs not estimable, p=0.72) for non-elderly versus elderly patients. Comparing patients 65–69 versus ≥70 years, progression-free survival (33.0 vs 12.5 months, p=0.002) was significantly improved in patients aged 65–69, without difference in overall survival (not estimable vs 36.0 months, p=0.91). On multivariable analysis, age ≥65 did not impact progression-free survival (p=0.74).ConclusionsIn this prospective registry of women with ovarian cancer, perioperative morbidity is not increased for non-elderly versus elderly patients following surgery with HIPEC. While age should not exclude patients from surgery with HIPEC, additional research is needed regarding oncologic benefits in elderly women.

Sign in / Sign up

Export Citation Format

Share Document