Author(s) Approval date: 12/05/16. Committee. June Operational Date: Review: Version No. 1.1 Supercedes 1.0 Links to other policies

Transcription

1 Reference No: Title: Author(s) Ownership: Approval by: Operational Date: Systemic Anti-Cancer Therapy (SACT) Guidelines for Peritoneal Mesothelioma Professor Richard Wilson (Consultant/Chair in Cancer Medicine), Dr Vicky Coyle (Consultant/Senior Lecturer in Medical Oncology) and Dr Awais Jalil (Registrar in Medical Oncology) on behalf of the N. Ireland Gastro-intestinal Oncologists group based at the Cancer Centre, Belfast City Hospital, BHSCT. NICaN NICaN Drugs & Therapeutics Committee June 2016 Version No. 1.1 Supercedes 1.0 Links to other policies Version control for drafts: Approval date: Next Review: NICaN Peritoneal Mesothelioma SACT Protocols 12/05/16 June 2018 Date Version Author Comments August 2015 February Professor Richard Wilson 1.1 Professor Richard Wilson Final version issued Reviewed. No change Page 1 of 7

2 Authorisation of Systemic Anti-Cancer Therapy (SACT) Guidelines for Peritoneal Mesothelioma These SACT guidelines are being submitted by the authors on behalf of the GI oncologists group. Page 2 of 7

3 1.0 INTRODUCTION / PURPOSE OF POLICY 1.1 Background Systemic anti-cancer therapy (SACT) is an important treatment in managing peritoneal mesothelioma. These guidelines describe the agreed management for patients with mesothelioma arising in the peritoneal cavity. 1.2 Purpose To ensure consistent use of SACT for patients with peritoneal mesothelioma. 2.0 SCOPE OF THE POLICY This document is aimed at all clinical staff involved in the management of patients receiving SACT for peritoneal mesothelioma. 3.0 ROLES/RESPONSIBILITIES It is the responsibility of all clinical staff involved in the management of patients receiving SACT for peritoneal mesothelioma to familiarise themselves with these guidelines. 4.0 KEY POLICY PRINCIPLES 4.1 Management of limited disease Surgery: While very rarely diagnosed early, surgical resection with R0 margins is the management for an isolated area of peritoneal mesothelioma with no evidence of dissemination at laparotomy or on imaging Imaging: Baseline staging pre- (or post-operatively if emergency presentation) with CT scan of chest, abdomen and pelvis (or CT chest with MRI abdomen and pelvis if necessary) should be performed for all cases Review: Clinical review 6 monthly for the first 2 years, then yearly for 3 more years and discharge after 5 years Adjuvant chemotherapy: There is no evidence base for adjuvant therapy in this setting. 4.2 Management of diffuse disease Background Diffuse malignant peritoneal mesothelioma is a rare and difficult tumour to treat with no widely accepted curative approaches. Treatment options are relatively limited. Patients with low volume tumours without pleural involvement, who are otherwise well, are potential candidates for radical surgery. The number of these patients is small, and may be Page 3 of 7

4 considered for radical peritoneal stripping with HIPEC (hyperthermic intra-peritoneal chemotherapy). Such patients should be discussed in the appropriate HSC Trust GI MDM, and then referred to one of the UK supra-regional peritoneal tumour centres (currently in Basingstoke and Manchester). On their advice, up to 24 weeks of down-staging chemotherapy (eg with gemcitabine and cisplatin) may be considered as an initial debulking therapy prior to attempted radical peritoneal stripping with HIPEC. The vast majority of patients are not suitable for a radical approach to treatment and are considered for palliative surgical debulking of peritoneal tumour, and for palliative chemotherapy. The Belfast HSC Trust Lower GI MDM, through Mr William Wallace and Mr Jack Lee (consultant colorectal surgeons) and Dr Richard Wilson and Dr Vicky Coyle (consultant GI medical oncologists), have a particular interest in peritoneal tumours and are willing to receive referrals from the GI MDMs in the other HSC Trusts across N. Ireland for specialist patient management. In malignant pleural mesothelioma, combination treatment with cisplatin and pemetrexed is the gold-standard first-line chemotherapy and NICE approved pemetrexed for treatment of MPM in January However, such approval was not extended to malignant peritoneal mesothelioma. Consideration is given based on fitness in first-line therapy and beyond to gemcitabine and cisplatin, gemcitabine and carboplatin, gemcitabine monotherapy, carboplatin monotherapy and to clinical trials of investigational agents. There is no evidence base for maintenance therapy and this approach remains investigational. Trials are ongoing with novel agents such as immune checkpoint inhibitors combined with chemotherapy, on their own or as maintenance therapy to improve durability of response. Second-line chemotherapy for peritoneal mesothelioma should be reserved for those patients who have responded to first-line treatment and have had at least 3 months between best response achieved with first-line treatment and disease progression. The response rates with secondline treatments are lower than in first-line and the balance of benefits and toxicity need to be carefully considered and discussed with each patient Imaging: CT Scan of chest, abdomen and pelvis at baseline, after 3 and 6 cycles Follow up: 2 monthly with imaging as clinically indicated and only if the patient is fit for further therapy. It is best to ensure palliative care input at an early stage. Page 4 of 7

5 4.2.4 Chemotherapy Regimens: Gemcitabine and Cisplatin Indication: Palliative treatment for fit patients with diffuse peritoneal mesothelioma suitable for relatively intense doublet chemotherapy Downstaging for later potential radical peritoneal surgery & hyperthermic intraperitoneal chemotherapy (HIPEC) Performance status ECOG PS 0-1 Adequate renal function, liver, bone marrow and cardiac function. Day 1: FBP, calculated GFR, oncology profile. Day 8: FBP, oncology profile. Regimen: Cisplatin 80 mg/m 2 IV Day 1 and Gemcitabine 1250 mg/m 2 IV Days 1 and Gemcitabine/ Carboplatin Indication: Palliative treatment for relatively fit patients with diffuse peritoneal mesothelioma suitable for doublet chemotherapy but not for cisplatin Performance status ECOG PS 0-1 but to be considered in those of ECOG PS 2 Adequate renal function, liver, bone marrow and cardiac function Patients for whom cisplatin or fluid load would be contraindicated. Day 1: FBP, calculated GFR, oncology profile. Day 8: FBP, oncology profile. Page 5 of 7

6 Regimen: Carboplatin AUC5 IV Day 1 and Gemcitabine 1250 mg/m 2 IV Days 1 and Gemcitabine monotherapy Indication: Palliative treatment for patients with diffuse peritoneal mesothelioma suitable for single agent chemotherapy Performance status ECOG PS 0-2 Adequate renal function, liver, bone marrow and cardiac function Day 1: FBP, oncology profile. Day 8: FBP, oncology profile. Regimen: Gemcitabine 1250 mg/m2 IV Days 1 and Carboplatin monotherapy Indication: Palliative treatment for patients with diffuse peritoneal mesothelioma suitable for single agent chemotherapy Performance status ECOG PS 0-2 Adequate renal function, liver, bone marrow and cardiac function Day 1: FBP,DWCC, U&E, Ca, Mg, LFTs, calculated GFR Regimen: Carboplatin AUC5 IV Day 1 only Page 6 of 7

7 5.0 IMPLEMENTATION OF POLICY 5.1 Dissemination This policy will be agreed by all consultant oncologists treating patients with SACT for peritoneal mesothelioma. The guideline will form the basis for development of the SACT regimen specific protocols. It will be available on the intranet for use by all doctors, nurses and pharmacists involved in all stages of SACT assessment and delivery in patients with peritoneal mesothelioma. 6.0 MONITORING Use of these guidelines will be monitored using audit. 7.0 EVIDENCE BASE / REFERENCES 8.0 CONSULTATION PROCESS N. Ireland GI oncologists group. 9.0 APPENDICES / ATTACHMENTS Authorisation signature sheet EQUALITY STATEMENT In line with duties under the equality legislation (Section 75 of the Northern Ireland Act 1998), Targeting Social Need Initiative, Disability discrimination and the Human Rights Act 1998, an initial screening exercise to ascertain if this policy should be subject to a full impact assessment has been carried out. The outcome of the Equality screening for this policy is: Major impact Minor impact No impact. Page 7 of 7