ICARuS Post-operative Intraperitoneal Chemotherapy (EPIC) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) After Optimal Cytoreductive Surgery (CRS) for Neoplasms of the Appendix, Colon or Rectum With Isolated Peritoneal Metastasis
Ontology highlight
ABSTRACT:
DISEASE(S): Appendix Cancer,Colorectal Cancer,Hyperthermia,Appendiceal Neoplasms,Neoplasms,Fever
PROVIDER: 2141886 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Appendiceal cancer patients treated with cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) often demonstrate an unpredictable variability in survival outcomes. Biomarkers predictive of CRS/HIPEC efficacy could better guide treatment decisions. In this study we hypothesized that variation in the transcriptional programming of appendiceal tumors might distinguish molecular subtypes with differential outcomes after CRS/HIPEC. The goal of this study was to investigate the potential of a prognostic gene signature to discriminate patients with favorable and unfavorable outcomes in a “discovery” set of patient (the original tumor series (n=24)), and confirm its prognostic value in a second “validation” series (the validation cohort (n=39)).
2015-12-02 | GSE75535 | GEO
Project description:In recent years, cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) have substantially improved the clinical outcome of pseudomyxoma peritonei (PMP) originating from mucinous appendiceal cancer. However, current histopathological grading of appendiceal PMP frequently fails in predicting disease outcome. We recently observed that the integration of cancer cell transcriptional traits with those of cancer-associated fibroblasts (CAFs) improves prognostic prediction for tumors of the large intestine. We therefore generated global expression profiles on a consecutive series of 24 PMP patients treated with CRS plus HIPEC. Multiple lesions were profiled for nine patients. We then used expression data to stratify the samples by a previously published "high-risk appendiceal cancer" (HRAC) signature and by a CAF signature that we previously developed for colorectal cancer, or by a combination of both. The prognostic value of the HRAC signature was confirmed in our cohort and further improved by integration of the CAF signature. Classification of cases profiled for multiple lesions revealed the existence of outlier samples and highlighted the need of profiling multiple PMP lesions to select representative samples for optimal performances. The integrated predictor was subsequently validated in an independent PMP cohort. These results provide new insights into PMP biology, revealing a previously unrecognized prognostic role of the stromal component and supporting integration of standard pathological grade with the HRAC and CAF transcriptional signatures to better predict disease outcome.
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Project description:Interventions: Cytoreductive surgery (CRS), Hyperthermic intraperitoneal chemotherapy (HIPEC), Early postoperative intraperitoneal chemotherapy (EPIC)
Primary outcome(s): safety
Study Design: Single arm Non-randomized
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Project description:Peritoneal carcinomatosis is a common event in the natural history of colorectal and other digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients with peritoneal carcinomatosis arising from different malignancies such as colorectal cancer, gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both patient survival and quality of life. CRS, i.e., removal of all visible metastatic abdominal and pelvic disease with peritonectomy along with HIPEC (for 90 min at a temperature of 42º C) and/or early postoperative intraperitoneal chemotherapy (EPIC) in order to eradicate all microscopic metastasis.
CRS with HIPEC is a long and complex procedure with significant blood and fluid loss during debulking, hemodynamic, hematological, and metabolic alterations before and during the HIPEC phase, and even in the early postoperative period, with resultant significant morbidity and mortality. Despite that most of the reported patients are in American Society of Anesthesiologist class I and II, without significant comorbidities or systemic disorder; the morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated team of anesthesiologist, surgeons and intensivist and other ancillary services can result in good outcome. This study will see the challenges faced by the team regarding the pathophysiological alterations during the CRS with HIPEC in the perioperative period.
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Project description:Water lavage (WL) during gastrointestinal cancer surgery has osmotically mediated lytic effects on tumor cells. We investigated the safety and efficacy of WL with CRS-HIPEC.This is a retrospective review, 1/2003-7/2014, of a single institution experience with CRS-HIPEC comparing patients who had WL (WL+) to those who did not (WL-).Of 157 CRS-HIPECs, 16 (10.2%) were WL+. WL+ had more PCI scores >20 compared to WL- (56.3% vs 19.4%, respectively, p = 0.003); however, the completeness of cytoreduction (CC) was similar. There were no differences in hospital length of stay or post-operative complications. The average POD 1 sodium (Na) level was statistically lower in the WL+ group (133.6 ± 2.5 vs 135.5 ± 3.2 mEq/L, p = 0.023); however, the average Na at discharge for each group was 140 mEq/L. There were no differences in 3-year OS (3WL+:0.63 vs WL-:0.68, p = 0.97) or RFS (WL+:0.32 vs WL-:0.39, p = 0.47). A subset analysis for patients with PCI >20 showed no difference between groups.WL offers a low cost, safe and theoretically efficacious method of tumor cell lysis for peritoneal malignancy.
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Project description:Peritoneal carcinomatosis of gastric origin is an aggressive tumor entity. Historically it has been considered a terminal disease with no long-term survival, due to limited therapeutic options. However, as a better understanding of tumor biology has evolved in recent years, novel multimodal treatment strategies incorporating intraperitoneal (IP) chemotherapy-hyperthermic intraperitoneal chemotherapy (HIPEC), early postoperative intraperitoneal chemotherapy (EPIC), neoadjuvant intraperitoneal-systemic chemotherapy protocol (NIPS)-and cytoreductive surgery (CRS) have demonstrated promising oncologic outcomes and even long-term survival in selected patients. Most of the studies published to date are retrospective in nature. These studies involve heterogenous patient populations, a wide variety of chemotherapeutic drugs, and show wide variation in outcomes between institutions. Thus, it is difficult to evaluate the results. This review summarizes our current knowledge regarding IP chemotherapy and CRS for peritoneal metastases (PM) in gastric cancer (GC). We describe our institutional treatment regimens. We also provide a brief overview of new, targeted therapies that may show promise in the future.
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Project description:BACKGROUND AND OBJECTIVE:Previous studies about the prognostic value of the HIPEC have yielded controversial results. Therefore, this study aims to assess the impact of HIPEC on patients with ovarian cancer. RESULTS:We included 13 comparative studies, and found that the overall survival (OS) and progression-free survival (PFS) in HIPEC groups were superior to groups without HIPEC treatment in the all total population (HR?=?0.54,95% CI:0.45 to 0.66, HR?=?0.45, 95% CI: 0.32 to 0.62). Additionally, the subgroup analysis showed that patients with advanced primary ovarian cancers also gained improved OS and PFS benefit from HIPEC (HR?=?0.59,95% CI:0.46 to 0.75, HR?=?0.41,95% CI:0.32 to 0.54). With regard to recurrent ovarian cancer, HIPEC was associated with improved OS (HR?=?0.45,95% CI:0.24 to 0.83), but for the PFS, no correlation was observed between HIPC group and the non-HIPEC group (HR?=?0.55,95% CI:0.27 to 1.11). HIPEC also led to favorable clinical outcome (HR?=?0.64,95% CI:0.50 to 0.82, HR?=?0.36,95% CI:0.20 to 0.65) for stage III or IV ovarian cancer with initial diagnosis. CONCLUSION:The review indicated that HIPEC-based regimens was correlated with better clinical prognosis for patients with primary ovarian cancers. For recurrent ovarian cancers, HIPEC only improved the OS but did not elicit significant value on the PFS.
| S-EPMC6472063 | biostudies-literature
Project description:Patients affected by gynecological or gastrointestinal tract neoplasms that evolve to peritoneal carcinomatosis experience a significant drop in their quality of life, high morbidity and short survival times with currently available chemotherapeutic schemes. The surgical treatment based on cytoreduction and the employment of hyperthermic intraperitoneal chemotherapy in the intra-operative period is a true challenge to anesthesiologist.A 67 years old patient diagnosed with mucinous adenocarcinoma of the Appendix associated with mucinous carcinomatosis, was submitted to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC), under general anesthesia and epidural block. Volume replacement was performed with crystalloids, colloids and blood products to support an important ascites volume drained during the procedure. The target was the strict control of hydro-electrolytic and acid-basic equilibrium. The patient was referred to the ICU and evolved to a hospital discharge on the third postoperative day.The neoplastic compromise of the peritoneum has long been considered to be a pre-terminal state. The advent of CRS/HIPEC represent an alternative promising with numerous challenges to the anesthesiologist regarding the metabolic and hemodynamic adjustment, which once again demand training and ongoing study from the perioperative team.
| S-EPMC5512179 | biostudies-other
Project description:BackgroundCytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is increasingly used to prevent or treat peritoneal metastases (PM) in selected indications. The objective of this article was to review published, recruiting or planned randomized controlled trials (RCTs) evaluating CRS and HIPEC versus standard of care. Comparator was systemic chemotherapy and/or CRS alone.ContentSystematic review according to PRISMA guidelines. Electronic searches for published RCT using PubMed (from 1980 to November 2016) and for ongoing RCT in the United States and European clinical databases (until November 2016). Current update on ongoing trials from the 10th PSOGI meeting in November 2016 in Washington DC. Fourteen RCTs on CRS and HIPEC were excluded for various reasons.SummaryThirty-eight trials designed for randomizing 7,303 patients were identified: 11 in colorectal cancer (6 for prevention of PM, n=1,107 patients; 5 for therapy, n=781), 10 in ovarian cancer (5 in frontline therapy, n=438 patients; 5 for treating recurrence, n=1,062) and 17 in gastric cancer (14 for prevention of PM, n=3,659 patients; 3 for therapy, n=256). Results of 9 RCTs have been published: 1 in colorectal cancer (105 patients), 1 in ovarian cancer (130 patients) and 7 in gastric cancer (together 669 patients). Five RCTs have completed recruitment and follow-up is ongoing. There is a clear trend in recent trial design from therapeutic to preventive indications.OutlookThe number of published RCT evaluating CRS and HIPEC in prevention or therapy of PM is relatively small. There is some evidence that CRS and HIPEC improve survival in recurrent colorectal origin, evidence in ovarian and gastric cancer remains debated. A large number of studies is ongoing that might deliver additional evidence. Trial design and interpretation of results remain difficult because of multiple methodological challenges.
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Project description:The goal of this prospective phase II unicentric Canadian clinical trial is to clarify the feasibility of modified early post-operative intraperitoneal chemotherapy (mEPIC) following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in the clinical context of peritoneal carcinomatosis from colorectal and appendicular neoplasms.
The primary objective of this study is to confirm the feasibility of mEPIC by evaluating its completion rate compared to the one of historical standard early post-operative intraperitoneal chemotherapy (EPIC) cohorts. The secondary objectives of the study are to evaluate the safety of the mEPIC protocol by monitoring adverse events arising during the protocol and to assess logistical implementation barriers for the nursing and Oncology pharmacy teams, respectively.
Participants will undergo a modified schedule of EPIC (mEPIC) designed to maximize therapeutic benefit by exploiting the known pharmacokinetics and pharmacodynamics properties of fluorouracil (5-FU) while limiting the logistical issues of the standard protocol. mEPIC consists in shortening the original protocol from five to two days of postoperative intraperitoneal chemotherapy. Additionally, instead of solely administering a singular 5-FU bolus per 24 hours-period, mEPIC is based on the De Gramont intravenous regimen and consists of administering one intraperitoneal bolus of 5-FU (400 mg/m2) followed by a 24 hours-intraperitoneal infusion of 5-FU (1200 mg/m2) on postoperative days 1 and 2.
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