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Locally advanced colon cancer and peritoneal metastases
From biological pathway to treatment strategies
Klaver, C.E.L.
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Klaver, C. E. L. (2020). Locally advanced colon cancer and peritoneal metastases: From biological pathway to treatment strategies.
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Chapter 5
Recommendations and consensus on the
treatment of peritoneal metastases of
colorectal origin; a systematic review of
national and international guidelines
Charlotte E.L. Klaver, Hannah Groenen, Dion G. Morton, Søren Laurberg, Willem A. Bemelman, Pieter J. Tanis, on behalf of the research committee of
the European Society of Coloproctology
ABSTRACT
Aim: This systematic review aimed to provide an overview of (inter)national guidelines on the treatment of peritoneal metastases of colorectal cancer origin (PMCRC) and to determine the degree of consensus and available evidence with identification of topics for future research.
Method: A systematic search of MEDLINE, EMBASE, PubMed as well as Tripdatabase, National Guideline Clearinghouse, BMJ Best Practice and Guidelines International Network was performed to identify (inter)national guidelines and consensus statements from oncological or surgical societies on PMCRC. Quality of guidelines was assessed using the AGREE-II score. Topics followed by recommendations were extracted from the guidelines. The recommendations, highest level of supporting evidence and the degree of consensus were determined for each topic.
Results: Twenty one guidelines were included. In the majority (15) of guidelines, cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) is recommended in selected patients based on level 1B evidence. Substantial consensus was also reached for the benefit of multidisciplinary team discussion, and the achievability of a (near) complete cytoreduction (CC0-1) without supporting evidence. Both evidence and consensus are lacking regarding other topics including preoperative PET/CT, second look surgery in high risk patients, the optimal patient selection for CRS/HIPEC, procedural aspects of HIPEC and (perioperative) systemic therapy.
Conclusion: In currently available guidelines, evidence and consensus on the treatment strategy for PMCRC are lacking. Updates of guidelines are ongoing and future (randomized) clinical trials should contribute to multidisciplinary and international consensus on treatment strategies for PMCRC.
5
INTRODUCTION
Colorectal cancer is a major health problem with a world-wide incidence of 1.4 million in 2012 [1]. Besides the liver and lungs, the peritoneum is a common site of dissemination. During the resection of the primary colorectal cancer, synchronous peritoneal metastases (PMCRC) are found in about 5% of patients [2,3]. Incidences of metachronous PMCRC range between 5 and 19% in literature [4], but this is likely to be underestimated because of the limited sensitivity of imaging modalities to detect. The prognosis of PMCRC is generally poor, with a median survival of approximately 5 months if untreated. The effect of palliative chemotherapy is limited, even for modern chemotherapy regimens with or without targeted agents [5,6]. Currently, the only curative intent treatment option is the combination of cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) [7,8]. Verwaal et al performed a randomized controlled trial (RCT) [7] showing that CRS/HIPEC prolongs median survival up to 22 months in selected patients as compared to 13 months following systemic therapy only. More recent national cohorts in selected patients receiving CRS/HIPEC show median survival rates up to 33 and 47 months [9,10]. However, effectiveness of the treatment highly depends on the extent of the tumour and completeness of cytoreduction. Also, CRS/HIPEC is accompanied by substantial morbidity [9–11]. Therefore, only selected patients are eligible for CRS/HIPEC. Treatment strategy for PMCRC varies among countries and does even differ between HIPEC centres within a country.
This topic was deemed of interest for future prospective research at a debate of advanced colorectal cancer treatment during the European Society of Coloproctology (ESCP) 9th annual meeting in Dublin (sept 2015) and the need for a review of current evidence
based guidance was identified. The aim of this study was to provide an overview of the recommendations and evidence for the treatment of PMCRC as described in the currently available guidelines. Controversy and lack of evidence for different aspects of the treatment of PMCRC were identified and discussed within the context of ongoing and future research on those topics that require additional evidence.
METHODS
A systematic search was performed to identify regional, national and international guidelines and consensus documents on PMCRC on the 21st of April 2015, with the assistance of a
clinical librarian. MEDLINE, EMBASE, and PubMed have been searched with additional cross referencing. The search was extended into guideline databases, including Tripdatabase, National Guideline Clearinghouse, BMJ Best Practice and Guidelines International Network. Furthermore, websites of national health authorities and surgical and oncological societies were searched.
Guideline or consensus statements were included if the main subject was either the treatment of colorectal cancer including metastatic disease, or PMCRC. The search was performed with a time limit set for publications between 2005 and 2015. Only guidelines written in English, Dutch, German, Scandinavian or Latin languages were included. Native speakers of the relevant languages performed translation of those guidelines. Two researchers performed every step in the selection of guidelines independently and in case of disagreement, discussion took place until consensus was reached.
All topics that are followed by recommendations in the separate guidelines are included in this review. For the purpose of systematically analysing the selected documents, the topics are categorized in six ‘main topics’, as described in the results section. The ‘main topics’ covered the main clinically relevant issues in the treatment of PMCRC. The recommendations per (sub)topic were reported for each included document. The percentage of guidelines that reached consensus per (sub)topic was presented in case this was more than 50%. Per (sub)topic was assessed if the corresponding recommendation was based on a systematic search of literature. Also, per (sub)topic the publication(s) with highest level of evidence cited in the guidelines was reported and classified as sufficient or insufficient. Sufficient evidence was defined as at least one relevant source reference with a level of evidence of 3a or higher [12].
The quality of the guidelines was assessed using the following parameters: year of publication, members of professional groups involved, type of evidence, usage of GRADE method and AGREE score. The AGREE score is assessed using the Appraisal of Guidelines for Research & Evaluation II (AGREE-II) instrument. (Appendix 1).The AGREE-II instrument was developed to address the issue of variability in guideline quality [13]. Two investigators independently scored the guidelines according to the six domains of AGREE-II (Scope and Purpose, Stakeholder Involvement, Rigour of Development, Clarity of Presentation, Applicability, Editorial Independence). Furthermore, the opinion of the authors on the quality of the guidelines was expressed in their recommendation to use the guidelines or not. This is a subjective parameter based on the above mentioned quality parameters.
5
RESULTS
Guidelines
A total of 1864 hits were identified by searching MEDLINE, EMBASE and Pubmed and 146 using Tripdatabase. The further selection process was displayed in Figure 1 and led to 31 initially included documents. Four documents did not cover the treatment of metastatic disease [14–19], and the main topic was treatment of liver metastases in one consensus statement [20], and two documents were excluded because the authors were not considered to be an acknowledged working group [21,22]. Some overlapping documents were considered as one guideline, namely the NHS and NICE guideline, the colon and rectum NCCN guidelines, and the ESMO consensus statement on colorectal cancer in general and on metastatic colorectal cancer. Finally, 30 documents covering 21 guidelines were included , including 11 national guidelines, 3 regional guidelines, 6 guidelines of surgical or oncological societies and one conference based consensus document. Characteristics of these documents are displayed in Table 1 and in Table 2 the covered topics are shown. 1. CRS/HIPEC as treatment option for PMCRC?
In 15 of the guidelines included in this review, CRS/HIPEC is recommended in selected patients as curative intent treatment option for PMCRC (1,2,3,5,7,8,10,11,13,14,15,16, 19,20,21). However, because of the significant risks of morbidity and mortality, the Belgian and English guidelines (2,3) recommend special arrangements for consent and appropriate clinical governance, including audit. The ASCRS (18) does recommend cytoreductive surgery for PMCRC, but considers the role of HIPEC as insufficiently defined. The NCCN and Quebec guidelines (4,12) consider CRS/HIPEC still experimental and do not endorse this therapy outside of a trial setting. Although the treatment of metastatic colorectal cancer is described in the SIGN, French and GBI guidelines (6,9,17), these guidelines do not mention CRS/HIPEC as a treatment option for PMCRC.
Conclusion: CRS/HIPEC is a curative intent treatment option for PMCRC. Consensus reached in 71%; highest level of evidence 1b [7,23] 2. Preoperative assessment
Although not based on evidence, MDT is recommended in 15 of the 21 guidelines (1,2, 3,4,5,6,7,8,10,12,13,16,18,19,20). In two guidelines, the required members of the MDT are described. The ACO-ASSO guideline (8) recommends a MDT that at least consists of a visceral surgeon, an oncologist and a radiologist. The AHS guideline (13) recommends a surgical oncologist to be part of the MDT.
Conclusion: Treatment strategy for PMCRC should be decided upon in a multidisciplinary team discussion.
Preoperative PET/CT might contribute to the exclusion of extra peritoneal disease. Also, it can be of use for the assessment of the extent of the peritoneal disease. Two guidelines recommend PET/CT as standard part of the preoperative work-up (1,16). The Belgian guideline (1) considers PET/CT indicated for patients with potentially resectable PMCRC, to detect additional metastases. Also, the ESMO guideline (16) recommends preoperative PET/CT, on the one hand to identify new lesions, but also to give additional information on equivocal lesions. In four guidelines (2,10,14,21) PET/CT is not considered routine part of the preoperative work-up, however PET/CT is regarded of value in these guidelines in case confirmation is warranted. The NCCN and the Dutch guideline (4,5) discourage PET/CT as standard and state that PET/CT has no proven added value in the preoperative staging for CRS/HIPEC.
Conclusion: The contribution of routine PET/CT imaging prior to (surgical) treatment of patients with PMCRC remains controversial.
No evidence 3. Second look surgery
In patients that underwent a curative resection of primary colorectal cancer, that are at high risk of PMCRC , second look surgery can be expected to detect peritoneal metastasis at an early stage when CRS/HIPEC still is a treatment option. Two guidelines (1,2) mention second look surgery, in order to detect PMCRC at an early stage. According to the Belgian guideline, second look surgery (laparoscopy) can be considered one year postoperatively in perforated tumours or T4 tumours with considerable peritoneal tumour load that has been resected. In the Norwegian guideline (2), second look surgery is recommended 6-12 months after curative intent resection in the following high risk patients:
- If iatrogenic perforation of the tumour took place; - (Resected) metastases in the ovaries;
- Macroscopic radical resected PMCRC.
Conclusion: Second look surgery in patients that underwent a curative intent resection of colorectal cancer at high risk of PMCRC might be useful.
Highest level of evidence: 4 [24] 4. Indications CRS/HIPEC
Age
In the Norwegian and Danish guidelines (2,10), 75 years is considered the maximum age for CRS/HIPEC, although an age older than 75 is considered a relative contraindication. The ACO ASSO and the Catalonian guidelines use 70 years as the cut-off and the ACO ASSO also regards this cut-off as relative. The CHICG guideline considers physiologic age, and regards all patients younger than 65 years eligible, and only carefully selected patients older than 65.
5 Conclusion: Older age might be a relative contraindication for treatment with CRS/
HIPEC, the exact cut-off remains unclear. Highest level of evidence:2b [25,26] General condition of the patient
Four guidelines (2,10,14,20) use objective parameters as eligibility criteria for CRS/HIPEC. In the Norwegian and Catalonian guidelines, the ECOG score is used with a maximum score of 2. In the CHICG guideline, the ECOG score must be 0, or exceptionally 1 is accepted In the Danish guideline, patients are considered fit enough for CRS/HIPEC if the ASA-score is 2 or less. In five other guidelines, subjective descriptions are given regarding the general condition of the patient. According to these guidelines, CRS/HIPEC is confined to highly fit patients (1), to patients with a performance status sufficient to withstand a major surgical procedure (3), to patients with a good general condition (11) or a good general health status (16,19). Furthermore, some guidelines mention substantial or significant comorbidities (2,3) as exclusion criteria. According to the ACO ASSO and the Catalonian guidelines, serious cardiac, respiratory or renal comorbidities are contra indications for CRS/HIPEC. The Catalonian guideline adds serious hepatic or neurological comorbidities.
Conclusion: A patients general condition should be sufficient to undergo CRS/HIPEC. Patients with a maximum ECOG-score or ASA-score of 2 are considered eligible for CRS/HIPEC.
Highest level of evidence: 4 [27] Extent of PMCRC
In the majority of the guidelines (13/21), the extent of PMCRC is described as an eligibility criteria for CRS/HIPEC. The Peritoneal Cancer Index (PCI) is most frequently used and PCI scores of 20 (7,8,16,19,20,21), 20-25 (2), and 26 (14) are considered cut-offs. Also, the simplified PCI is regularly used. In the Danish, Dutch, Catalonian and AHS guidelines, CRS/ HIPEC is recommended in patients with PMCRC extension to a maximum of 5 of the 7 abdominal regions. The ACO ASSO guideline uses the Peritoneal Surface Disease Severity of Colon cancer (PSDSS). The PSDSS is a combination of PCI score, degree of symptoms and histological parameters with a maximum score of 22 points [28]. According to the ACO ASSO guideline, a PSDSS < III ( <8 points) is optimal, and in case of PSDSS IV (>10 points) there remains no indication for CRS/HIPEC. According to the Belgian guideline, the number of metastatic sites should be limited, but no scoring system is mentioned. With respect to involvement of specific intraabdominal locations, considerable small bowel or small bowel mesentery involvement is considered a contraindication for CRS/HIPEC in several guidelines (2,8,10,21). According to the ACO ASSO, Catolonian and CHICG guidelines (8,14,20), manifest ileus is a contra indication. The Danish guideline (10) adds PMCRC around the pancreas or porta hepatis as a contraindication for CRS/HIPEC, as well as PMCRC causing ureter stenosis, small bowel stenosis at more than one location and biliary obstruction. In
contrary, the panel of the fifth international workshop (21) did not consider obstruction of bowel segments, the biliary tract or the ureters as absolute contra indications for CRS/ HIPEC. Ascites is regarded as a contraindication following the ESMO guideline.
Conclusion: CRS/HIPEC is recommended in patients with limited PMCRC, mostly expressed by the PCI-score. The optimal cut-off value of the PCI score remains controversial. Ileus and ascites might be considered contraindications.
Highest level of evidence: 4 [28–30] Completeness of cytoreduction
Complete or near complete cytoreduction (CC0-1 (residual individual tumours being no bigger than 2.5mm diameter)) should be achievable according to most (10) guidelines (1,3,5,7,8,10,13,14,16,20). The Belgian and Dutch guidelines are less specific and recommend CRS/HIPEC in case ‘metastases can be removed radically’ and ‘adequate cytoreduction is possible’, respectively.
Conclusion: A CC0-1 should be achievable.
Consensus reached in 57%; highest level of evidence 4 [8,29] Synchronous liver and / or lung metastases
The presence of other distant metastases than PMCRC is an exclusion criteria for CRS/ HIPEC according to the Norwegian, the NICE/NHS, the Dutch, German, Danish, ESMO and EURECCA guidelines (2,3,5,7,10,16,19). The ACO ASSO, Catalonian and CHICG guidelines do not consider limited resectable liver metastases a contraindication for CRS/HIPEC, in case of a maximum of three liver metastases and if complete resection is achievable with a segment resection.
Conclusion: The presence of distant metastases other than PMCRC is a contraindication for CRS/HIPEC, with the exception of limited resectable liver metastases. Highest level of evidence 4 [31]
5. Prior CRS-HIPEC procedure
In the Dutch guideline only (5), earlier CRS/HIPEC procedure has been mentioned in the light of eligibility for CRS/HIPEC. In case of an isolated intraperitoneal recurrence, a second HIPEC is recommended, switching from mitomycin-C to oxaliplatin as chemotherapeutic agent.
Conclusion: CRS/HIPEC is still a treatment option for patient with PMCRC that underwent a prior CRS/HIPEC procedure.
5 HIPEC procedure
In the Norwegian, Dutch, Danish and ASPSM guidelines (2,5,10,15), HIPEC consisting of Mitomycin-C for 90 minutes is recommended. The recommended dosage of Mitomycin-C according to the Norwegian guidelines is 35mg/m2, with a maximum of 70mg, whereas the
ASPSM prescribes a total dosage of 40mg (30mg at time 0 and 10 mg after 60min). The Catalonian guidelines recommend the use of Oxaliplatin (460mg/m2) as chemotherapeutic
agent for HIPEC during 30 minutes, after potentiating the effect of Oxaliplatin with Leucovorin (20mg/m2) and 5-Fluorouracil i.v. (400mg/m2). The ACO ASSO, CHICG and Fifth
Workshop guidelines leave the choice for drug (Mitomycine-C or Oxaliplatin) open. The Catalonian guideline recommends the open so-called Coliseum technique, whereas the ASPSM advises a laparoscopic closed technique. The NICE/NHS, ACO ASSO and CHICG guidelines recommend both the open and closed technique.
According to the Swedish guideline, there is not enough evidence to either recommend a specific technique or drug.
With respect to inflow temperature, the Norwegian and Danish guidelines describe an optimal inflow temperature of 41-42 °C The ASPSM advises 42°C, the ACO ASSO 42-43°C and the Catalonian and CHICG guidelines a temperature of 43°C. According to the Fifth Workshop guideline (21), the optimal range of temperature is 41-43°C. In contrast, in the NCCN guideline the hyperthermia component is considered irrelevant.
Different perfusion fluids are available for HIPEC. The Catalonian guideline recommends dissolving oxaliplatin in 2L/m2 glucose 5%. During the Fifth Workshop (21), isotonic salt and
dextrose solutions were elected the advisable type of perfusate for HIPEC. The ASPSM does not specify the type of perfusate, but does recommend the use of a total of 3L perfusion fluid for its closed HIPEC with mitomycin-C.
Conclusions: Several aspects of the HIPEC procedure vary in different guidelines; - As chemotherapeutic agent, either mitomycin-C or oxaliplatin is used;
Highest level of evidence: 4 [7,8,30,32,33]
- Both an open and closed approach are described; Highest level of evidence 3a [34]
- Optimal inflow temperature ranges from 41°C up to 43°C; Highest level of evidence: 4 [35]
- Isotonic salt and dextrose solutions can be used as perfusate, approximately 3L.
6. Perioperative systemic therapy
The Belgian, ACO ASSO, Danish, Catalonian and CHICG guidelines (1,8,10,14,20) recommend preoperative systemic chemotherapy (prior to CRS/HIPEC). According to the ACO-ASSO, systemic chemotherapy should be considered if CRS/HIPEC is planned, especially in patients with secondary PMCRC and advanced disease (PSDSS III) and accordingly, the Catalonian guideline advises to consider preoperative chemotherapy in case of extended PMCRC, for example if a multivisceral resection is required. In the Danish guideline it is more a matter of logistics; a patient can undergo CRS/HIPEC within 10-14 days after laparotomy (resection of the primary colorectal tumour), otherwise chemotherapy is indicated and CRS/HIPEC should take place after 3 to 4 months. According to the Belgian guideline, patients with synchronous limited PMCRC or ovarian (Krukenberg) metastases should undergo primary tumour resection and cytoreductive surgery as a first step, followed by systemic chemotherapy and subsequently HIPEC 3-6 months after primary surgery. In the CHICG guidelines, neoadjuvant therapy is strongly recommended in case of a short interval (synchronous or < 6 months) between the primary tumour and PMCRC. In all five guidelines, responders to chemotherapy only may subsequently be candidates for CRS/HIPEC and tumour progression under systemic chemotherapy forms a (relative) contraindication for CRS/HIPEC.
Systemic chemotherapy after CRS/HIPEC can be considered according to the Dutch, ACO ASSO, Danish, AHS and Catalonian guidelines. The AHS guidelines say that careful surveillance should be considered an alternative for patients with no evidence of residual disease after CRS/HIPEC. The Danish and Catalonian guideline recommend a period of 6 months of systemic chemotherapy. In the Danish guideline, this 6 month period refers to the total period of systemic chemotherapy, including preoperative treatment (i.e. if a patient has received 3 months systemic chemotherapy prior to CRS/HIPEC, the patient will receive chemotherapy another 3 months following the CRS/HIPEC procedure).
In the Belgian, Danish and Dutch guidelines, the chemotherapeutic scheme of choice consists of oxaliplatin and 5-fluorouracil/leucovorin (5FU/LV) or capecitabine, and 5FU/LV or capecitabine monotherapy in case of insufficient patient condition or contraindications for oxaliplatin. In the ACO ASSO, Catalonian, AHS and CHICG guideline, the chemotherapeutic scheme is not specified, but they refer to the adjuvant scheme for non-metastatic colorectal cancer.
Conclusion: Perioperative systemic chemotherapy using oxaliplatin combined with 5FU/LV or capecitabine in patients with PMCRC undergoing CRS/HIPEC can be considered, but the exact timing and value remains unclear.
5 Quality of the available guidelines
The AGREE-score was higher than 0.7 in 12 of the 21 guidelines. In the majority (18/21) of the guidelines, recommendations were based on systematic searches of literature and five guidelines used the GRADE system (Table 1). However, the only topic that was assessed using systematic literature searching in the included guidelines was ‘Is CRS/HIPEC a treatment option for peritoneal metastases of colorectal origin?’ (Table 2). All other topics were not the main focus of systematic searches and the recommendations were either based on no or mostly insufficient evidence. The authors would recommend using 18 of the 21 guidelines. More detailed comments on the guidelines were presented in Supplement 1.
DISCUSSION
In this systematic review, 21 guidelines were included. Three out of 21 guidelines did not cover the treatment of PMCRC. In most other guidelines, the treatment of PMCRC was only mentioned shortly. Furthermore, the guidelines that did cover the topic mainly focussed on the value of CRS/HIPEC, but did not address many other issues regarding the treatment of PMCRC. Also, with regard to most subtopics, evidence is scarce. Substantial consensus was reached regarding two topics; the use of MDT to decide on the optimal treatment strategy for PMCRC and the need to achieve a (near) complete cytoreduction (CC0-1). Although not unanimously, the majority of guidelines covering the treatment of PMCRC (15 out of 18) agree on CRS/HIPEC as standard therapy for selected patients. However, patient eligibility and surgical procedure vary. Notably, the high-quality and up-to-date NCCN guideline (4, 2015) still considers CRS/HIPEC experimental.
Emerging evidence and topics for further research
New evidence has recently been published or can be expected from ongoing trials. Regarding the first topic – the effectivity of CRS/HIPEC – a pooled analysis was recently performed to synthesize the results of the small number of studies that compares CRS/HIPEC with systemic chemotherapy only [36]. Although only one RCT was included, they concluded that the body of evidence for the survival benefit of CRS/HIPEC is accumulating. The additional effect of HIPEC to cytoreductive surgery has been questioned, but in a case-control study improved survival rates after CRS/HIPEC were indicated [37]. A French randomized phase III trial, in which patients with resectable PMCRC are randomized between cytoreductive surgery alone and cytoreductive surgery with HIPEC (NCT00769405) is ongoing.
Currently, CT imaging reports an overall sensitivity of 75%, but sensitivity rapidly decreases with smaller lesions [38,39]. Retrospective studies assessing the value of PET/CT specifically for adequate staging of PMCRC (topic 2) suggest a superior sensitivity of PET/CT over CT, but numbers of patients are small and results remain inconclusive [40–45]. Moreover, a false-positivity rate of 11% has been shown [46]. Another increasingly applied imaging modality is magnetic resonance (MR) with diffusion weighted imaging (DWI). DWI improves sensitivity for minute peritoneal implants with reported sensitivity and specificity of 74-90% and 97% respectively [47–49]. Further prospective studies are needed to determine the role of PET/CT and MR-DWI in the selection of candidates for CRS/HIPEC. Studies of staging laparoscopy in the preoperative work-up of PMCRC [45] might be considered. With regard to the third topic – a strategy including second look surgery – Elias reported long term results of his second look laparotomy with (CRS)/HIPEC one year after curative resection of primary CRC with either perforation, ovarian metastases, or radically resected
5 CPM. He managed to ‘early’ diagnose and treat PMCRC in 23 out of 41 high risk patients,
and the remaining patients received laparotomy and ‘prophylactic’ HIPEC. He reported a 5y OS of 90%. [50]. However, literature is scarce and more research (preferably RCT’s) into the indications for and timing of second look surgery is needed. In the French ProphyloCHIP randomized trial (NCT01226394) , patients with one of these risk factors for PMCRC are randomized after 6 months of adjuvant systemic chemotherapy between second look laparotomy + HIPEC (experimental arm) and surveillance alone (control arm).
Careful selection of candidates for CRS/HIPEC is needed (topic 4). New series have shown that PCI score and completeness of cytoreduction are independent prognostic factors of survival in patients undergoing CRS/HIPEC [27,51–54], but the cut-off value has not been clearly defined. Several studies suggested a PCI score of > 20 as a threshold for poor prognosis [27,51,53], but Cashin et al showed that even patients with a high PCI could be cured as long as a complete cytoreductive surgery was achieved [52]. With respect to one subtopic - the presence of synchronous liver metastases – a systematic review has come up [55] . Six papers were included that contained retrospective data on patients that underwent curative resection for both peritoneal and liver metastases followed by (H)IPEC. Survival was lower in patients that had liver and PMCRC compared to patients that had PMCRC only. However, improved survival was suggested compared to patients treated with systemic chemotherapy only. Eligibility for CRS/HIPEC should therefore be determined by a combination of factors and must be individualised. Future experience and analyses of larger series should should add to the body of evidence that forms the basis for optimal patient selection for PMCRC.
With regard to topic 5, the HIPEC procedure, a retrospective cohort study has been published showing comparable oncological outcome and overall morbidity for oxaliplatin and mitomycin [56]. Both agents have a maximal tissue penetration of 2 mm. Furthermore, in vitro and in vivo laboratory studies [57–59] demonstrated the potentiating effect of the combination of different chemotherapeutic agents and hyperthermia. This effect varies by agent and the optimal temperature is unknown. The shorter perfusion time for oxaliplatin is an logistically advantage bearing in mind the potential side effects of intra-abdominal heating. Furthermore, various carrier solutions for HIPEC are available, e.g. 5% dextrose, 0.9% NaCl, Ringer lactate and Dianeal PD4 glucose. Metha et al [60] recently showed that the cytotoxic activity of oxaliplatin is not decreased in chloride-containing carrier solutions. The use of 5% dextrose as carrier solution in HIPEC with oxaliplatin, led to hyperglycemia and electrolyte disturbances, with an impact on postoperative complications [61–63] . The more physiologic carrier solutions as Dianeal PD4 glucose or 0.9% NaCl might seem advisable. Level 2b evidence should be considered as sufficient for these technical details and performance of a RCT does not seem appropriate.
Perioperative systemic chemotherapy schedules (topic 6) are frequently administered, including combination 5-FU based chemotherapy with oxaliplatin, irinotecan, anti-vascular endothelial growth factor (VEGF) or anti-epidermal growth factor receptor (EGFR) monoclonal antibodies, and also combined with radiotherapy. However, the additional effectivity to CRS/HIPEC is unclear. Considering the oncological importance of achieving CC0 surgery, preoperative chemotherapy aiming at lowering the extent of PMCRC could be beneficial. In retrospective series, neither preoperative nor postoperative systemic chemotherapy were independent prognostic factors for survival in patients undergoing CRS/HIPEC though [27,52,54]. In the COMBATAC German phase II trial, perioperative chemotherapy including cetuximab is currently investigated (NCT01540344) and a RCT into perioperative systemic chemotherapy will follow in the Netherlands.
Conclusion
Treatment strategy for PMCRC is not extensively described in the current guidelines and evidence is often insufficient. In addition, most guidelines would benefit from up-dating. Currently, level 3 evidence is available for specific topics and more evidence is to be expected from ongoing trials. Future (randomized) trials should seek an international platform to provide adequate sample size and maximise their value.
5
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5
Ta bl e 1. In cl ud ed g ui de lin es a nd q ua lit y as se ss m en t. SS : s ys te m ati c s ea rc h; Q : q ue sti on na ire ; E O : E xp er t o pi ni on ; G RA DE : G ra di ng o f R ec om m en da tio ns As se ss m en t, De ve lo pm en t a nd E va lu ati on ; A GR EE : A pp ra isa l o f G ui de lin es fo r R es ea rc h & E va lu ati on . G ui de lin e In sti tu tio n Ye ar M em be rs of a ll re le va nt pr of es si on -al g ro up s in vo lv ed ? Ty pe o f ev id en ce Ev id en ce as se ss ed us in g G RA D E m et ho d? AG RE E sc or e U sa ge re co m -m en de d? N ati on al 1 Be lg ia n gu id el in e[ 1] Co lle ge o f O nc ol og y 20 14 + SS + 0, 84 Ye s 2 N or w eg ia n gu id el in e[ 2] He ls ed ire kt or at et 20 15 + SS -0, 7 Ye s 3 N IC E/ N HS g ui de lin e[ 3– 5] N ati on al In sti tu te fo r H ea lth a nd C ar e Ex ce lle nc e En gl an d 20 14 + SS -0, 84 Ye s 4 N CC N g ui de lin e (U SA )[6 ,7 ] N ati on al C om pr eh en si ve C an ce r N et w or k 20 15 + SS -0, 87 Ye s 5 Du tc h gu id el in e[ 8] In te gr aa l K an ke rc en tr um N ed er la nd 20 14 + SS -0, 82 Ye s 6 SI G N g ui de lin e[ 9] Sc otti sh In te rc ol le gi at e G ui de lin es N et w or k 20 11 + SS + 0, 89 Ye s 7 G er m an g ui de lin e[ 10 ] Le itl in ie np ro gr am m O nk ol og ie d er A W M F, D eu ts ch en Kr eb sg es el ls ch aft u nd D eu ts ch en K re bs hi lfe 20 14 + SS + 0, 86 Ye s 8 AC O -A SS O g ui de lin e[ 11 ] Ö st er re ic hi sc he G es el ls ch aft fü r C hi ru rg is ch e O nk ol oi e 20 13 -SS -0, 49 Ye s 9 Fr en ch g ui de lin e[ 12 ] Ha ut e au to rit é de sa nt é, In sti tu t N ati on al d u Ca nc er 20 12 + SS -0, 56 Ye s 10 Da ni sh g ui de lin e[ 13 ] Da ni sh C ol or ec ta l C an ce r G ro up (D CC G) 20 13 + SS -0, 65 Ye s 11 Sw ed is ch g ui de lin e[ 14 ] So ci al st yr el se n 20 14 + SS -0, 78 Ye s Re gi on al 12 Q ue be c gu id el in e[ 15 ] Co m ité d e l’é vo lu tio n de s p ra tiq ue s e n on co lo gi e 20 06 + SS -0, 62 Ye s 13 AH S gu id el in e[ 16 ] Al be rt a He al th S er vi ce s 20 14 + SS -0, 7 Ye s 14 Ca ta lo ni an g ui de lin e[ 17 ] G en er al ita t d e Ca ta lu ny a, D ep ar ta m en t d e Sa lu t 20 09 -SS -0, 51 N o Su rg ic al /o nc ol og ic al s oc ie ty 15 AS PS M [1 8] Am er ic an S oc ie ty o f P er ito ne al S ur fa ce M al ig na nc ie s 20 14 + Q , E O -0, 52 N o 16 ES M O g ui de lin e[ 19 ,2 0] Eu ro pe an S oc ie ty fo r M ed ic al O nc ol og y w or ki ng g ro up 20 12 + SS + 0, 73 Ye s 17 G BI g ui de lin e [2 1] Th e As so ci ati on o f C ol op ro ct ol og y of G re at B rit ai n & Ir el an d 20 07 + SS -0, 71 Ye s 18 AS CR S gu id el in e [2 2, 23 ] Th e Am er ic an S oc ie ty o f C ol on a nd R ec ta l S ur ge on s 20 12 -SS + 0, 67 Ye s 19 EU RE CC A gu id el in e[ 24 ] Eu ro pe an R eg is tr ati on o f C an ce r C ar e 20 13 + EO -0, 72 Ye s 20 CH IC G G ui de lin e[ 25 ] Ca na di an H IP EC C ol la bo ra tiv e G ro up 20 15 + SS , E O -0, 58 Ye s Co nf er en ce c on se ns us 21 In t. w or ks ho p[ 26 –3 0] th e 5t hW or ks ho p on P er ito ne al S ur fa ce M al ig na nc y 20 08 -Q , E O -0, 54 N o
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9. SIGN Diagnosis and management of colorectal cancer. 2011. 10. S3-Leitlinie Kolorektales Karzinom Version 1.1. 2014.
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24. Cornelis J.H. van de Velde, Petra G. Boelens JMB, Jan-Willem Coebergh, Andres Cervantes LB, Regina G.H. Beets-Tan, Colette B.M. van den Broek GB, Eric Van Cutsem, Eloy Espin, Karin Haustermans BG, Lene H. Iversen, J. Han van Krieken, Corrie A.M. Marijnen GH, Jola Gore-Booth, Elisa Meldolesi, Pawel Mroczkowski IN, et al. EURECCA colorectal: Multidisciplinary management: European consensus conference colon & rectum. Eur J Cancer. 2014;50.
25. Dubé P, Sideris L, Law C, Mack L, Haase E, Giacomantonio C, et al. Guidelines on the use of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in patients with peritoneal surface malignancy arising from colorectal or appendiceal neoplasms. Curr Oncol [Internet]. 2015 Apr [cited 2016 Jun 7];22(2):e100-12. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25908915
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5
Table 2. Topics covered by the seperate guidelines. *for specification see full text. CC: completeness of cytoreduction; CRS/HIPEC: cytoreductive surgery/hyperthermic intraperitoneal chemotherapy; GRADE: Grading of recommendations assessment, development and evaluation; LM: liver metastases; MDT: multidisciplinary team discussion; PET/CT: postron emission tomography/computed tomography; PCI: peritoneal carcinomatosis index; sPCI: simplified peritoneal carcinomatosis index.
Topic Guidelines that cover relevant topic
Systematic search specifically into topic? Searched using the GRADE method?
Preoperative work up none none
MDT pro: 1,2,3,4,5,6,7,8,10,12,13,16,18, 19,20
PET/CT imaging pro:1,16; maybe:2,10,14,21; con: 4,5 second look laparoscopy pro: 1,2
Patient selection none none
Age <75y: 2,10; <70y: 8,14; < 65y: 20 General condition Fit patients*:
1,2,3,8,10,11,14,16,19,20
Extent of peritoneal disease PCI<20: 7,8,16,19,20,21; PCI<25: 2; PCI<26: 14; sPCI<5/7: 5,10,13,14 Completeness of cytoreduction CC0/1: 1,3,5,7,8,10,13,14,16,20 Synchronous liver and/or lung
metastases con: 2,3,5,7,10,16,19; max 3 resectable LM:8,14,20 Prior HIPEC procedure pro: 5
HIPEC procedure none none
Approach (open vs.
laparoscopic) open:14; closed:15; both:3,8,11,20 Chemotherapeutic agent mitomycine: 2,5,10,15; oxaliplatin:
14; both:8,11,20,21 Volume and perfusate *14,15,20
Optimal inflow temperature 41-43°C: 2,8,10,14,15,20,21; no hyperthermia: 4
Perfusion time 90min(mitomycin): 2,10,15,20; 30min(oxaliplatin):14,20
Systemic chemotherapy none none
Perioperative chemotherapy pre-operative: 1,8,10,14,20; post-operative: 5,8,10,13,14
CR/HIPEC pro: 1,2,3,5,7,8,10,11,13,14,15,16,18,
