Intraperitoneal Chemotherapy In Ovarian Cancer Research Articles

Decision-Making Analysis for Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer: A Survey by the Executive Committee of the Peritoneal Surface Oncology Group International (PSOGI)

Objectives: To assess the individual treatment strategies among international experts in peritoneal carcinosis, specifically their decision-making in the process of patient selection for hyperthermic intraperitoneal chemotherapy (HIPEC) in women suffering from ovarian cancer, to identify relevant decision-making criteria, and to quantify the level of consensus for or against HIPEC. Methods: The members of the executive committee of the Peritoneal Surface Oncology Group International (PSOGI) were asked to describe the clinical conditions under which they would recommend HIPEC in patients with ovarian cancer and to describe any disease or patient characteristics relevant to their decision. All answers were then merged and converted into decision trees. The decision trees were then analyzed by applying the objective consensus methodology. Results: Nine experts in surgical oncology provided information on their multidisciplinary treatment strategy including HIPEC for patients with advanced ovarian cancer. Three of the total of 12 experts did not perform HIPEC. Five criteria relevant to the decision on whether HIPEC is performed were applied. In patients with resectable disease, a peritoneal cancer index (PCI) <21, and epithelial ovarian cancer without distant metastasis, consent was received by 75% to perform HIPEC for women suffering from recurrent disease. Furthermore, in the primary disease setting, consent was received by 67% to perform HIPEC according to the same criteria. Discussion and Conclusion: Among surgical oncology experts in peritoneal surface malignancy and HIPEC, HIPEC plays an important role in primary and recurrent ovarian cancer, and the PCI is the most important criterion in this decision.

Role of hyperthermic intraperitoneal chemotherapy in ovarian cancer.

Epithelial ovarian cancer (EOC), has the highest worldwide mortality of all gynecological tumors, in 75% of cases is diagnosed in advanced stages. Despite of treatments with maximal cytoreductive surgery (CRS) and platinum-based chemotherapy (CT), approximately 70% of patients with advancedstage disease relapse within 18 months, given this high number of recurrences, new approaches are needed to improve outcomes for these patients. Hyperthermic intraperitoneal chemotherapy (HIPEC) has fundamentally changed the treatment of patients with ovarian cancer, with complete CRS and locoregional administration of chemotherapy. The purpose of this review is to find the most relevant, reliable published evidence of the use of HIPEC in ovarian cancer, together with an overview of peritoneal carcinomatosis (PC), procedures, therapeutic approaches in first-line and recurrent disease, the benefit of hyperthermia, selection of the ideal patient for the HIPEC procedures as well to analyze the disease free survival (DFS), morbidity, mortality and overall survival (OS) in patients with ovary cancer. So far, the small amount of evidence points favorably to the use of CRS and HIPEC as a first line of therapy, but more prospective randomized trials are needed to officially adopt this procedure as a standard of care, additionally patients need to know this option exists.

Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer.

Hyperthermic intraperitoneal chemotherapy (HIPEC) in conjunction with cytoreductive surgery (CRS) holds promise as an adjunctive treatment strategy in malignancies affecting the peritoneal surface, effectively targeting remaining microscopic residual tumor. HIPEC increases concentrations of chemotherapy directly within the peritoneal cavity compared with the intravenous route and reduces the systemic side effects associated with prolonged adjuvant intraperitoneal exposure. Furthermore, hyperthermia increases tissue penetration and is synergistic with the therapeutic chemotherapy agents used. In ovarian cancer, evidence is building for its use in both primary and recurrent scenarios. In this review, we examine the history of HIPEC, the techniques used, and the available data guiding its use in primary and recurrent ovarian cancer.

Hyperthermic intraperitoneal chemotherapy for ovarian cancer: The heat is on.

Patients with advanced epithelial ovarian cancer have a high incidence of peritoneal disease recurrence despite maximal efforts to surgically remove all visible tumor plus intravenous chemotherapy. The administration of intraperitoneal chemotherapy that specifically targets the peritoneal surface has been investigated in previous trials, but questions about the design of these studies has prevented this treatment from being widely adopted in clinical practice. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a single intraoperative approach that also targets the peritoneal surface. A randomized phase 3 trial showed significant benefit in recurrence-free and overall survival when HIPEC was added to interval cytoreductive surgery (CRS) in patients who were not eligible for primary surgery because of the extent of their disease(OVHIPEC trial; NCT00426257). The trial showed no important differences in toxicity or patient-reported outcomes between the study groups. The extent of surgery and the number of bowel resections were also similar between the 2 study groups, and the effect of HIPEC was homogeneous across the levels of predefined and post hoc subgroups. Nevertheless, the design and the results of the OVHIPEC trial were critically assessed, and this resembles the reluctance to adopt the positive results of the earlier intraperitoneal chemotherapy studies. This overview discusses the design and results of the OVHIPEC trial. The evidence that is currently available points to a clinically relevant and cost-effective benefit of HIPEC added to interval CRS for patients with stage III ovarian cancer who are not eligible for primary surgery. Ongoing collaborative research will provide further evidence regarding the role of HIPEC in ovarian cancer.

Dose-dense early postoperative intraperitoneal chemotherapy in ovarian cancer: Randomized, phase II trial.

5514 Background: Dose-dense early postoperative intraperitoneal chemo (DD-EPIC) had been carried out in advanced ovarian cancer (OC) pts in China over the past three decades but it was not proved by a prospective study. This trial was designed to confirm the benefit of DD-EPIC in delaying progression and improving survival. Methods: In a multicenter, phase 2 trial, pts with FIGO IIIC-IV OC and optimal debulking surgery (residual disease ≤1cm) were randomly allocated to receive 4 doses of weekly DD-EPIC with cisplatin (50mg/m2) and etoposide (100mg/m2) followed by 6 cycles of intravenous (iv) chemo with carboplatin and taxane every 3 weeks (DD-EPIC group), or standard iv chemo alone (iv group). (ClinicalTrials.gov, NCT01669226). Results: Between 2009 and 2015, 218 pts were randomized, of whom 215 initiated treatment (106 to DD-EPIC and 109 to iv; for efficacy analyses). Totally, 36 pts (16·7%) were received neoadjuvant chemo. With a median of 61·9 mos follow-up, 122 pts died (54 in DD-EPIC and 68 in iv group). Remarkable OS benefit of DD-EPIC was recorded (67·5 mos for DD-EPIC vs. 46·3 mos for iv; HR 0·70, 95% CI 0·49-1·00, P=0·047). Pts in DD-EPIC had a significantly increased median PFS compared with those in iv group (21·7 vs. 16·8 mos; HR 0·64, 95% CI 0·47-0·86, P=0·003). Median TFST was 25·1 vs. 18·0 mos in favor of DD-EPIC (HR 0·62, 95%CI 0·46-0·83, P=0·002). Similar findings were detected in TSST (42·2 vs. 29·3 mos; HR 0·66, 95%CI 0·47-0·94, P=0·019). Grade 3 and 4 Leucopenia (53·8% vs. 35·2%), anemia (23·6% vs. 5·6%) and gastrointestinal events (10·4% vs. 1·9%) were more common in DD-EPIC ( P=0·006, P&lt;0·001 and P=0·010, respectively). Ninety-one pts were detected by gBRCA testing, with 25·3% of cases carrying deleterious BRCAm, but PFS and OS benefit were observed in patients with BRCA-wild type (HR 0·46 and 0·55, 95%CI 0·27-0·81 and 0·27-1·11, respectively). Conclusions: DD-EPIC with a higher completion rate and acceptable treatment burden was associated with longer OS than standard iv alone. Owing to the benefit of relatively long-term OS, DD-EPIC may be considered as a valuable option for OC, particularly in developing countries and BRCA-wild type pts. Clinical trial information: NCT01669226. [Table: see text]

New Approaches to Improving Survival After Neoadjuvant Chemotherapy: The Role of Intraperitoneal Therapy and Heated Intraperitoneal Chemotherapy in Ovarian Cancer.

For women with newly diagnosed ovarian cancer, the goal of surgery is to achieve a maximal, if not complete, cytoreduction. In cases when this is not possible, whether because of the extent of disease or patient-specific reasons, neoadjuvant chemotherapy using a platinum-based combination (on a typical every-2-week schedule) is often recommended. After neoadjuvant therapy and surgery, women proceed with additional adjuvant chemotherapy, which is typically given in a similar fashion to what was done in the preoperative setting. The question remains as to whether this is the optimal strategy, particularly in light of other data suggesting the use of an alternative regimen in the adjuvant context might yield a survival advantage. In this article, we review the outcomes of randomized trials that compared primary debulking to neoadjuvant chemotherapy and contemporary neoadjuvant chemotherapy trials that incorporated a novel schedule or regimen for testing in the adjuvant setting, including both intraperitoneal and heated intraperitoneal chemotherapy. We describe our center's approach to these data, and we conclude that both options should be considered for women with ovarian cancer undergoing neoadjuvant therapy.

Sustained release paclitaxel-loaded core-shell-structured solid lipid microparticles for intraperitoneal chemotherapy of ovarian cancer

The current clinical paradigm for ovarian cancer treatment has a poor prognosis, partially due to the efficacy and toxicity concerns associated with the available chemotherapeutic formulations. To overcome these limitations, we have designed core-shell-structured paclitaxel (PTX) laden solid lipid microparticles (PTX-SLMPs) for intraperitoneal treatment of ovarian cancer. A single-step coaxial electro hydrodynamic atomization (CEHDA) process has been explored to synthesize core-shell structure of PTX-SLMPs with the particle size of 1.76 ± 0.37 µm. Core-shell PTX-SLMPs have high encapsulation efficiency of 94.73% with sustained drug release profile. In vitro evaluation of PTX-SLMPs in SKOV-3 ovarian cancer cells yield significant enhancement in cytotoxicity when compared with Taxol®. In vivo pharmacokinetic study demonstrated slower absorption of PTX into the systemic circulation after intraperitoneal (i.p.) administration of PTX-SLMPs in Wistar rats implying the PTX-SLMPs remained in the peritoneal cavity and released the PTX for prolonged period of time. Through these studies, we have demonstrated the technical potential of core-shell structured PTX-SLMPs, which can enhance passive targeting of PTX to the tumor in the treatment of not only ovarian cancer but also in other peritoneal cancer.

Role of intraperitoneal chemotherapy in ovarian cancer in the platinum-taxane-based era: A meta-analysis.

Intravenous (IV) chemotherapy has been compared with intraperitoneal (IP) chemotherapy in randomized clinical trials in advanced ovarian cancer (OC). The aim of this meta-analysis was to evaluate efficacy and toxicity of IV and IP and identify differences in outcomes. The preferred reporting items for systematic reviews and meta-analyses (PRISMA) statement was applied. Random-effects models were used. Primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and the proportion of patients with grade ≥2 acute toxicity. Four randomized clinical trials representing 2461 patients were identified. The hazard ratio (HR) of PFS was 0.88 (95% CI 0.80-0.98; p = 0.01, I2 = 24%) in favor of IP chemotherapy. IP chemotherapy was also associated with significant OS improvement compared with IV chemotherapy, with HR of 0.79 (95% CI 0.67-0.92; p = 0.003, I2 = 0%). Globally, grade ≥2 toxicities were reduced with IV chemotherapy. This meta-analysis shows the superiority of IP chemotherapy over IV infusion in terms of clinical outcomes but toxicity rates. Its precise role in the management of advanced OC remains to be determined.

Intraperitoneal Chemotherapy in Ovarian Cancer

Intraperitoneal Chemotherapy in Ovarian Cancer

Multiplex profiling identifies distinct local and systemic alterations during intraperitoneal chemotherapy for ovarian cancer: An NRG Oncology/Gynecologic Oncology Group Study

ObjectivesOvarian cancer leads to abdominal carcinomatosis and late stage (III/IV) diagnosis in 75% of patients. Three randomized phase III trials have demonstrated that intraperitoneal (IP) chemotherapy improves outcomes in epithelial ovarian cancer. While IP treatment is validated by clinical trials, there is a poor understanding of the mechanism(s) leading to the survival advantage other than the increased concentration of cytotoxic drugs within the tumor microenvironment. A better understanding of this process through analysis of dynamic biomarkers should promote novel approaches that may enhance tumor clearance. We propose this pilot study to confirm the feasibility of collecting serial peritoneal samples from implanted catheters in women receiving IP chemotherapy. We believe these specimens may be used for multiplex analysis to reveal unique biomarker fluctuations when compared to peripheral blood. MethodsFrom 13 women participating on GOG 252, 30 whole blood, 12 peritoneal fluid (PF), and 20 peritoneal wash (PW) with 30mL saline were obtained. Samples were requested prior to the first three chemotherapy cycles. Samples were assessed for volume, cell populations, protein, RNA, and miRNA content changes. ResultsMedian volume for PF was 1.6mL and 3.1mL for PW. PW is a dilution of PF capable of capturing measurable biomarkers. Peritoneal aspirates contain a unique profile of biomarkers distinct from blood. miRNA undergo earlier alteration with chemotherapy than genes. Flow cytometry does not adequately capture biomarker fluctuations. ConclusionsAs a proof of principle study, this trial provides evidence that sampling the peritoneal cavity can be adapted for biomarker analysis.

873P - Effect of age on completion of intraperitoneal chemotherapy in ovarian cancer

873P - Effect of age on completion of intraperitoneal chemotherapy in ovarian cancer

G08 - Feasibility and Tolerability of Intraperitoneal Chemotherapy in Ovarian Cancer

Background: Intraperitoneal chemotherapy (IPC) has shown to prolong OS in optimally debulked stage III ovarian cancer patients. A recent long-term survival update of GOG 114 and GOG 172 trials showed a median overall survival of 61,8 months with IPC compared with 51,4 months for intravenous (IV) chemotherapy with a reduction in the risk of death of 23%. Despite these positive results, IPC has not been widely accepted as standard of care. The hesitancy of clinicians to use IPC is mainly due to higher toxicity, permanent catheter complications, complex management of patients and, eventually, poor patients and health care providers' compliance. Aim of our study is to evaluate, in a recent real life setting, feasibility and tolerability of IPC administered with direct peritoneal puncture without permanent devices in ovarian cancer patients. Material and Methods: we collected patients (N = 8) treated at the Istituto Oncologico Veneto between November 2015 and April 2016. Eligibility criteria included stage III epithelial OC with residual disease < 1 cm after surgery and PS ≤2. Patients received IV paclitaxel 175 mg/mq and IP carboplatin AUC5 every 21 days. On the day of IPC, a Veress needle was placed in the peritoneum by an interventional radiologist under ultrasound scan control; the Veress needle was then removed at the end of each infusion. The procedure was performed at the bedside of the patient in the out patient clinic. Results: A total of 33 IP cycles have been administered: three patients have completed the planned six cycles; five patients have received 3 cycles and are still on treatment. No patients experienced G > 2 toxicities; most common adverse events were G2 anemia and neutropenia; three patients had treatment delays due to G2 afebrile neutropenia and subsequent cycles were administered at reduced doses; one patient with G2 anemia received IV iron supplementation. As far as catheter-related toxicity, one patient experienced a chemical cellulitis (due to a catheter leakage at the first infusion) that needed hospitalization for anti-inflammatory therapy and antibiotic prophylaxis. All other courses were administered without any complications. Conclusions: According to our experience, the direct intraperitoneal drug injection without permanent device appears to be feasible, safe and possibly advantageous because of minor toxicities when compared with historical series of IPC administrated by permanent catheter.

Self-reported quality of life among patients who have undergone outpatient intraperitoneal chemotherapy for ovarian cancer

Self-reported quality of life among patients who have undergone outpatient intraperitoneal chemotherapy for ovarian cancer

Intraperitoneal chemotherapy of ovarian cancer by hydrogel depot of paclitaxel nanocrystals

Intraperitoneal (IP) chemotherapy is a promising post-surgical therapy of ovarian cancer, but the full potential is yet to be realized. To facilitate IP chemotherapy of ovarian cancer, we developed an in-situ crosslinkable hydrogel depot containing paclitaxel (PTX) nanocrystals (PNC). PNC suppressed SKOV3 cell proliferation more efficiently than microparticulate PTX precipitates (PPT), and the gel containing PNC (PNC-gel) showed a lower maximum tolerated dose than PPT-containing gel (PPT-gel) in mice, indicating greater dissolution and cellular uptake of PNC than PPT. A single IP administration of PNC-gel extended the survival of tumor-bearing mice significantly better than Taxol, but PPT-gel did not. These results support the advantage of PNC over PPT and demonstrate the promise of a gel depot as an IP drug delivery system.

Self Reported Quality of Life Among Patients Who Have Undergone Outpatient IP Chemotherapy for Ovarian Cancer [11

INTRODUCTION: To assess impact of outpatient intraperitoneal (IP) chemotherapy on quality of life (QOL). METHODS: Cross sectional study of patients with optimally cytoreduced stage III and IV ovarian cancer who received IP chemotherapy between 2006 and 2011 at a single institution. A self administered, anonymous survey assessed 4 domains: physical health (PH), mental health (MH), social health (SH) and patient subjective sense of worth (WO) of IP chemotherapy. RESULTS: Seventy-one participants were mailed surveys. 52 (73.2%) returned the survey, 4 were excluded (incomplete) and 48 (67.6%) were included in the final sample. Mean age was 62.4 (±10.3). Mean time from completion of chemotherapy was 30.8 months. In the PH domain, 50.0% reported that fatigue severely affected QOL. Other aspects were pain (39.6%), GI problems (37.5%) and “chemotherapy brain” (29.2%). In the MH domain, 25% reported significant stress and 20.8% experienced anxiety. In the SH domain, 27.5% reported therapy interfered with work. The majority (83.3%) reported the effectiveness of IP chemotherapy was “worth” the side effects, 95.8% did not regret it, and 87.5% would recommend it to a friend. Eleven patients had recurrent disease, of whom 90% indicated IP chemotherapy was worthwhile and none regretted the decision to receive this therapy. CONCLUSION/IMPLICATIONS: IP chemotherapy has been shown to improve OS and PFS and yet is not universally prescribed. It is known to have more toxicities compared to IV chemotherapy. The present study suggests that while these side effects affect QOL, patients feel that the therapy is worthwhile and do not regret treatment.

Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer: Where Do We Go From Here?

The ongoing debate regarding a potential role for hyperthermic intraperitoneal chemotherapy in the management of ovarian cancer represents an excellent example of the rarely publicly discussed fundamental clash between the requirements of evidence-based medicine and the roles of clinical innovation and optimization of care for the individual patient.

Discovery of candidate tumor biomarkers for treatment with intraperitoneal chemotherapy for ovarian cancer.

Tumor mRNA expression was used to discover genes associated with worse survival or no survival benefit after intraperitoneal (IP) chemotherapy. Data for high grade serous ovarian cancer patients treated with IP (n = 90) or IV-only (n = 398) chemotherapy was obtained from The Cancer Genome Atlas. Progression free survival (PFS) and overall survival (OS) were compared between IP and IV groups using Kaplan-Meier analysis and Cox regression. Validations were performed by analyses of microarray and RNA-Seq mRNA expression data. PFS and OS were compared between IP and IV groups by permutation testing stratified by gene expression. P-values are two-tailed. IP chemotherapy increased PFS (26.7 vs 16.0 months, HR 0.43 (0.28–0.66), p = 0.0001) and OS (49.6 vs 38.2 months, HR 0.46 (0.25–0.83), p = 0.01). Increased expression of NCAM2 and TSHR and decreased expression of GCNT1 was associated with decreased PFS and OS after IV chemotherapy (p < 0.05). High tumor expression of LMAN2, FZD4, FZD5, or STT3A was associated with no significant PFS increase after IP compared to IV chemotherapy. Low expression of APC2 and high expression of FUT9 was associated with 5.5 and 7.2 months, respectively, decreased OS after IP compared to IV chemotherapy (p ≤ 0.007).

Intraperitoneal Chemotherapy for Ovarian Cancer Improves Survival but may be Underused

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Intraperitoneal Chemotherapy for Ovarian Cancer: Effective but Underutilized

In response to a demonstrated 16-month survival advantage with intravenous and intraperitoneal (IV/IP) chemotherapy, the National Cancer Institute

Abstract 414: Prospective profiling of systemic and loco-regional alterations during intraperitoneal chemotherapy for ovarian cancer, results from GOG 271

Abstract Objectives: The concept of personalized approaches for recurrence in ovarian cancer has progressed at a modest pace, compared to other cancers. This is partly due to our limited understanding of the local tumor microenvironment during and immediately following chemotherapy-induced tumor involution, which requires sampling of the peritoneal cavity. Most studies to date have focused on chemo-naive tumors and on the more easily accessible peripheral blood samples, yet these are often not reflective of local changes. We hypothesize that sequential sampling and analysis of blood and intraperitoneal (IP) fluid during IP chemotherapy is feasible and will provide molecular insight into chemotherapy-induced systemic and local changes in the tumor environment. Methods: Peritoneal fluid aspiration or wash and blood samples were obtained from patients (n = 13) at three time points (baseline and following the first and second rounds of chemotherapy, respectively) Nanostring was performed to profile miRNA from peritoneal samples and plasma. RNA extraction from peripheral blood mononuclear cells (PBMC) followed by Nanostring was performed to evaluate changes in 511 immune genes during chemotherapy. Flow cytometry for surface and intracellular immune markers was performed on PBMCs. Results: From 13 patients, 30 blood, 12 intraperitoneal fluid (PF), and 20 intraperitoneal wash (PW) samples were obtained. Despite small volumes, cell counts were measurable in 7 of 12 (58%) PF and 11 of 20 (55%) PW samples. Nanostring results revealed 12 immune genes and 29 miRNAs differentially expressed during chemotherapy (p&amp;lt;0.05). Additionally, changes amongst miRNA were noted to occur earlier than immune genes in which the majority was differentially expressed only after the second round of chemotherapy. The miRNA tended to be significantly changed, in the same direction, throughout chemotherapy. Bioinformatics analyses revealed the top immune pathways most affected by chemotherapy and included cell-to-cell signaling, immune cell trafficking, and inflammatory response among the top functions. Conclusions: Sampling of the peritoneal cavity through IP catheters during chemotherapy is feasible and can be implemented through standardized protocols. Despite a small sample size, we were able to identify chemotherapy-induced molecular changes in immune genes and miRNAs systemically and loco-regionally. The findings suggest that miRNA alterations may be more suggestive of early tumor microenvironment alterations compared to immune genes in which changes are seen after subsequent cycles of chemotherapy. Larger studies are needed for validation to assess these changes as therapeutic targets. Citation Format: Shannon Grabosch, Anda M. Vlad, Tianzhou Ma, Jyothi T. Mony, Mary Strange, Joan Brozick, Julia Thaller, George Tseng, Xin Huang, Kathleen Moore, Kunle Odunsi, Robert P. Edwards. Prospective profiling of systemic and loco-regional alterations during intraperitoneal chemotherapy for ovarian cancer, results from GOG 271. [abstract]. In: Proceedings of the 106th Annual Meeting of the American Association for Cancer Research; 2015 Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Res 2015;75(15 Suppl):Abstract nr 414. doi:10.1158/1538-7445.AM2015-414