scholarly journals PIPAC EstoK 01: Pressurized IntraPeritoneal Aerosol Chemotherapy with cisplatin and doxorubicin (PIPAC C/D) in gastric peritoneal metastasis: a randomized and multicenter phase II study

2018 ◽  
Vol 3 (2) ◽  
Author(s):  
Clarisse Eveno ◽  
Ingrid Jouvin ◽  
Marc Pocard

AbstractBackgroundPeritoneal metastasis (PM) from gastric cancer often remains undiagnosed until it reaches an advanced stage. Despite curative management combining perioperative systemic chemotherapy, cytoreductive surgery (CRS), and hyperthermic intraperitoneal chemotherapy (HIPEC), treated patients’ 5 year survival rate remains under 20 % when patients are carefully selected. Palliative intravenous chemotherapy in patients with non-resectable cancer is frequently associated with poor long-term benefit and an estimated survival time below 1 year. Recently, two retrospectives studies reported that Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) improves patients’ overall survival without impairing their quality of life (QoL). This promising result needs however to be studied on large randomized clinical trial to validate the effect of PIPAC on survival and QoL of patients with gastric PM.MethodsPIPAC EstoK 01 is a prospective, open, randomized multicenter phase II clinical study with two arms that aims at evaluating the effects of PIPAC with doxorubicin and cisplatin on patients with PM of gastric cancer with peritoneal cancer index (PCI)>8, treated with systemic chemotherapy between two PIPAC procedures. Patients were randomized at the end of explorative laparoscopy and after signing a written consent. Patients received in the first experimental arm a treatment associating PIPAC and systemic chemotherapy (1 PIPAC then 2 IV Chemo) and systemic chemotherapy only in the control arm. Primary endpoint was progression-free survival from the date of surgery to the date of death, or to the end of the 5 year follow-up. Secondary endpoint was 2 year overall survival, morbidity, QoL and secondary resectability rate. The number of patients randomized was calculated to be 94.Trial registrationRetrospectively registered.

Author(s):  
Yutaka Yonemura ◽  
Emel Canbay ◽  
Takuji Fujita ◽  
Shouszou Sako ◽  
Satoshi Wakama ◽  
...  

Our aim was to clarify the effects of neoadjuvant hyperthermic intraperitoneal chemoperfusion (NLHIPEC) followed by intraperitoneal/systemic chemotherapy (NIPS) on peritoneal metastasis from gastric cancer. After carrying out exploratory laparoscopy to determine the peritoneal cancer index (pretreatment PCI: Pre-PCI) in 150 patients, we performed NLHIPEC for 60 min. with peritoneal port placement: a series of 3-week cycles of NIPS using S1, docetaxel, and cisplatin two weeks after NLHIPEC: performed cytoreductive surgery in 86 patients four weeks after NIPS, and subsequently measured PCI (Post-PCI). Positive cytology in 38 patients changed to negative in 26 (68.4%) patients at laparotomy. The post-PCI (6.7±7.8) was significantly lower than the pre-PCI (10.6±10.2) (P=0.0001). The PCI was ≥14 in 30 patients at pretreatment and ≤13 in 19 (63.3􀀁) of these patients at posttreatmjent. Post-PCI cut-off level (≤13 vs ≥14) and cytology after NIPS (negative vs positive) emerged as independent indicators of prognosis. Postoperative mortality was 1.2% (1/86). NLHIPEC and NIPS are safe and effective modalities for reducing Post-PCI below the cut-off level and eradicating peritoneal free cancer cells.


2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Ting-Ying Lee ◽  
Guo-Shiou Liao ◽  
Hsiu-Lung Fan ◽  
Chung-Bao Hsieh ◽  
Teng-Wei Chen ◽  
...  

Background. Patients with advanced gastric cancer (AGC) with peritoneal carcinomatosis (PC) usually have poor outcomes and high mortality risk, even with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). This study analyzed the prognostic factors of AGC with PC and evaluated laparoscopic HIPEC (LHIPEC) plus neoadjuvant intraperitoneal and systemic chemotherapy (NIPS) as a conversion surgery for AGC patients with PC with a poor initial prognosis. Patient and Methods. We retrospectively evaluated 127 patients with AGC and PC from January 1, 2012, to March 1, 2020. After the exclusion of 32 ineligible patients, the conversion group comprised 34 patients who underwent LHIPEC + NIPS as a conversion surgery followed by CRS plus HIPEC. The CRS + HIPEC group included 15 patients who underwent CRS with HIPEC alone. Additionally, the C/T group comprised 23 patients who received systemic chemotherapy, and the palliative group comprised 23 patients who received only conservative therapy or palliative gastrectomy. Results. The conversion group demonstrated a significantly better mean overall survival compared to the CRS + HIPEC, C/T, and palliative groups ( p < 0.001 ). Patients in the conversion group who underwent LHIPEC + NIPS had significantly decreased peritoneal cancer index (PCI) scores ( p < 0.001 ) and ascites ( p = 0.003 ). Malignant ascites amount also significantly decreased after treatment in the LHIPEC + NIPS group ( p < 0.001 ). Conclusions. LHIPEC + NIPS can significantly improve the overall survival, the PCI score, and malignant ascites amount in peritoneal cytology-positive gastric cancer with PC, and an initially high PCI score. Therefore, it may be a feasible conversion strategy for AGC patients with PC.


2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 418-418
Author(s):  
Frederic Mercier ◽  
Iris Amblard ◽  
David L. Bartlett ◽  
Edward Allen Levine ◽  
Dario Baratti ◽  
...  

418 Background: Peritoneal metastasis from biliary carcinoma (PMC) is associated with poor prognosis when treated with chemotherapy. The objective was to evaluate the impact on survival of cytoreduction surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), and compare with conventional palliative chemotherapy for patients with PMC. Methods: A prospective multicenter international database was retrospectively searched to identify all patients with PMC treated with a potentially curative CRS/HIPEC (CRS/HIPEC group). The overall survival (OS) was compared to patients with PMC treated with palliative chemotherapy (systemic chemotherapy group). Survival was analyzed using Kaplan-Meier method and compared with Log-Rank test. Results: Between 1995 and 2015, 34 patients were included in the surgical group, and compared to 21 in the medical group. In the surgical group, median peritoneal cancer index was 9 (range 3-26), macroscopically complete resection was obtained for 25 patients (73%). There was more gallbladder localization in the surgical group compared to the medical group (35% vs. 18%, p= 0.001). Median OS was 21.4 and 9.3 months for surgical and medical group, respectively (p =0.007). Three-year overall survival was 30% and 10% for surgical and medical group, respectively. Conclusions: Treatment with CRS and HIPEC for cholangiocarcinoma with peritoneal metastasis is feasible and may provide survival benefit when compared to palliative chemotherapy.


2018 ◽  
Vol 38 (10) ◽  
pp. 5975-5981 ◽  
Author(s):  
MASAYUKI SHINKAI ◽  
MOTOHIRO IMANO ◽  
YASUTAKA CHIBA ◽  
YOKO HIRAKI ◽  
HIROAKI KATO ◽  
...  

2020 ◽  
Author(s):  
Wenle Chen ◽  
Zixu Yuan ◽  
Aiwen Wu ◽  
Ming Cui ◽  
Zhongyi Yue ◽  
...  

Abstract Background: Synchronous peritoneal metastases (PM) is a difficult issue to tackle and the prognosis is poor. The aim of this study is to construct a nomogram to predict the overall survival (OS) for synchronous colorectal peritoneal metastasis.Method: In this retrospective study, 332 patients with synchronous PM were included. The training cohort consisting of 251 patients underwent abdominal surgery from February 2007 to February 2018. The risk factors related to prognosis were analyzed by Kaplan-Meier curve and Cox regression model. 81 patients from other two hospitals were enrolled as validation cohort. The prediction effect of this nomogram was evaluated by C-index and the calibration curve. Result: Five predictors were enrolled into this nomogram after multivariate analysis, including age, peritoneal cancer index (PCI), completeness of cytoreductive surgery (CRS), CA19-9, and albumin. The nomogram showed the accuracy to predict the OS at 0.5, 1, 2, and 3 years. The C-index of the nomogram in the training cohort and validation cohort were 0.713 (95% CI, 0.674–0.752) and 0.642 (95% CI, 0.563-0.720) separately. Both training and validation cohorts showed good discrimination of the nomogram for OS. Calibration curves have shown the predicted OS of nomogram are consistent with actual survival.Conclusion: This novel nomogram, combined with age, PCI, CRS, CA19-9, and albumin, has shown good accuracy to predict OS in patients with synchronous PM, which could be used as an easy-to-use tool for clinicians and surgeons to make decisions.


2012 ◽  
Vol 16 (12) ◽  
pp. 2190-2196 ◽  
Author(s):  
Motohiro Imano ◽  
Atsushi Yasuda ◽  
Tatsuki Itoh ◽  
Takao Satou ◽  
Ying-Feng Peng ◽  
...  

2019 ◽  
Vol 4 (4) ◽  
Author(s):  
John Spiliotis ◽  
Vasileios Kalles ◽  
Ioannis Kyriazanos ◽  
Alexios Terra ◽  
Anastasia Prodromidou ◽  
...  

AbstractBackgroundCombining cytoreductive surgery (CRS) with Hyperthermic IntraPeritoneal Chemotherapy (HIPEC) can benefit patients with peritoneal metastasis from colorectal cancer. The present study evaluates the small bowel subset of the Peritoneal Cancer Index (Small-Bowel-PCI score (SB-PCI), min-max 0–12) as a prognostic factor in such patients.MethodsWe retrospectively analyzed patients that underwent CRS and HIPEC for recurrent colorectal cancer with peritoneal metastasis. Patient characteristics, procedure details, and clinical outcomes were evaluated.ResultsEighty patients were included. The mean intraoperative PCI-score was 16.8, with a mean SB-PCI score of 5.9. CC0/1 was achieved in 62/80 patients. The mean follow-up period was 26.3 months. Univariate regression analysis showed that the ECOG status, the presence of severe complications, the HIPEC regimen (oxaliplatin vs. mitomycin-C), the PCI score, the SB-PCI score and the completeness of cytoreduction correlated significantly with overall survival. In multivariate analysis, the SB-PCI and CC score were identified as independent prognostic factors of survival. When the SB-PCI was stratified in three groups (0–4, 5–8 and 9–12), Kaplan–Meier curve analysis showed significant difference in survival (p<0.001).ConclusionsThe SB-PCI correlates with overall survival in patients with peritoneal metastases secondary to colorectal cancer in this retrospective cohort. Its use should be validated in prospective patient series.


Cancers ◽  
2020 ◽  
Vol 12 (1) ◽  
pp. 116 ◽  
Author(s):  
Yutaka Yonemura ◽  
Aruna Prabhu ◽  
Shouzou Sako ◽  
Haruaki Ishibashi ◽  
Akiyoshi Mizumoto ◽  
...  

The present study demonstrated prognostic factors for long-term survival in patients after a comprehensive treatment (CHT) for peritoneal metastasis (PM) from gastric cancer (GC). Materials and Methods: Among 419 patients treated with neoadjuvant intraperitoneal/systemic chemotherapy (NIPS), 266 (63.5%) patients received complete resection (CC-0) of the macroscopic tumors. In total, 184 (43.9%) patients were treated with postoperative systemic chemotherapy. Results: All patients treated who received incomplete cytoreduction (CC-1) died of GC within 6 years. In contrast, 10- year survival rates (-YSR) of CC-0 resection were 8.3% with median survival time (MST) of 20.5 months. Post-NIPS peritoneal cancer index (PCI) ≤11, and pre-NIPS PCI ≤13 were the significant favorable prognostic factors. Patients with numbers of involved peritoneal sectors ≤5 survived significant longer than those with ≥6. Both negative pre- and post-NIPS cytology was associated with significant favorable prognosis. Multivariate analyses identified pre-PCI (≤13 vs. ≥14), and cytology after NIPS (negative cytology vs. positive cytology) as independent prognostic factors. Ten year-survivors were found in patients with involvement of the greater omentum (9%), pelvic peritoneum (3%), para-colic gutter (13.9%), upper jejunum (5.6%), lower jejunum (5.5%), spermatic cord (21.9%), rectum (9.5%), ureter (6.3%), ovary (6.7%), and diaphragm (7.0%) at the time of cytoreduction. Twenty-one patients survived longer than 5 years, and 17 patients are still alive without recurrence. Conclusions: GC-PM should be removed aggressively, in patients with PCI after NIPS ≤11, PCI before NIPS ≤13, mall bowel PCI ≤2, and complete cytoreduction should be performed for metastasis in ≤5 peritoneal sectors.


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