annual report - paediatrics solid tumour - 2012 - final · 2016-04-04 · annual report –...

University Hospitals Bristol NHS Foundation Trust

0117 923 0000 Minicom 0117 934 9869 www.uhbristol.nhs.uk

Annual Report Paediatrics – Solid Tumour MDT

2 Annual Report – Paediatrics Solid Tumour

Agreement and Approval

Paediatrics Solid Tumour Lead Clinician Helen Rees

Date 12/09/2012 Signature (agreed via email)

Review Date

Next report due: 01/07/13

Versions

Version Date Reason Sign Off

1.0 11/05/10 Draft revision for 2010 Peer Review

2.0 13/07/11 Draft revision for 2011 Peer Review

3.0 July 2012 2012 report produced 12/09/2012

Annual report – Paediatrics Solid Tumour 3

1 Measure Checklist

Measure Number

Measure Operational Policy

Annual Report

Work Plan

Supporting Information

11-7B-401 Lead Clinician and Core Team Membership

p10-11

11-7B-402 Treatment planning meeting p12

11-7B-403 Cover arrangements for core members p10-11

11-7B-404 Core members attendance p6-7

11-7B-405 Operational policy meeting p4-6

11-7B-406 Policy for patients to be discussed by the MDT

p11,14-15

11-7B-407 Informing GP of the diagnosis p17 p14

11-7B-408 Key worker policy p18 p14

11-7B-410 EQA membership of histopathology core members

p12 p7

11-7B-411 Attendance at the national communications skills training

p12 p7

11-7B-412 Specialist training for core nurse member

p12

11-7B-413 Agreed Responsibilities for Core Nurse Members

p10-11

11-7B-414 Patients' permanent consultation record p17 p8-12

11-7B-415 Patients' experience exercise p15 p6 p13-24

11-7B-416 Provision of patient written information p17

11-7B-417 Treatment planning decision p15 p25-27

11-7B-418 PTC initial referral protocol p20

11-7B-419 PTC diagnosis and staging protocol p20

11-7B-420 PTC clinical management protocols p20

11-7B-421 PTC follow up and long term sequelae protocol

p21

11-7B-422 PTC psychosocial assessment guidelines

p20

11-7B-423 Minimum dataset p20 p13

11-7B-424 Clinical trials entry p20 p8

11-7B-425 Joint treatment planning for TYAs p15


2 Contents

1 Measure Checklist ......................................................................................................................... 3

2 Contents ........................................................................................................................................ 4

3 Introduction .................................................................................................................................... 5

4 Meeting Details .............................................................................................................................. 6 4.1 Core MDT Role Meeting Attendance ..................................................................................... 6 4.2 Core MDT Individual Meeting Attendance ............................................................................. 6 4.3 MDT Workload ...................................................................................................................... 7

4.3.1 Registration by Diagnosis .................................................................................................. 7 4.3.2 Relapses 2011/2012 ....................................................................................................... 10 4.3.3 Deaths 2011/2012 ........................................................................................................... 10 4.3.4 2nd tumours in Solid tumour patients during 2010/2011 ................................................... 10

4.4 Meetings to Discuss Operational Policies (11-7B-405) ........................................................ 11 4.5 TYA patients (11-7B-425) .................................................................................................... 11

5 Training ....................................................................................................................................... 12 5.1 EQA Scheme ...................................................................................................................... 12 5.2 Advanced Communication Skills Training (11-7B-411) ........................................................ 12

6 Data Collection (11-7B-423) ........................................................................................................ 13

7 National / Local Audit ................................................................................................................... 14 7.1 Network Audit ...................................................................................................................... 14 7.2 Local Audit .......................................................................................................................... 14 7.3 Audit of Timeliness of Diagnostic Notification to GPs (11-7B-407) ....................................... 14 7.4 Audit of Keyworker Provision (11-7B-408) ........................................................................... 14

8 Patient and Carer Feedback and Involvement (11-7B-415) ......................................................... 15

9 Research ..................................................................................................................................... 16 9.1 Available clinical trials ......................................................................................................... 16 9.2 List of Treatment Guidelines available ................................................................................. 17 9.3 Pending Phase I/II/III Studies .............................................................................................. 18 9.4 Recruitment to phase 3 clinical trials (11-7B-424) ............................................................... 19 9.5 Serious Adverse Events (SAEs) .......................................................................................... 21

10 Work plan for coming year ................................................................................................ 24


3 Introduction

This report relates to the trial reporting year 1st April 2011- 31st March 2012. We continue to strive

towards full compliance with the MDT IOG (Improving Outcomes Guidance). We still fail to have

adequate cover for our MDT coordinator; however we have recently appointed a new post CNS post

jointly covering Solid tumour and neuro-oncology. In addition we now have a second pathologist who

has been in post since October 2011.


4 Meeting Details

A full breakdown of MDT meeting attendance for core MDT members for period April 2012 – to March 2012 is as follows.

4.1 Core MDT Role Meeting Attendance (11-7B-404)

Role Combined Attendance (%)

MDT Clinical Lead 76%

Paediatric Oncologists (2) 96% (100% at least one)

Clinical Oncologists (2) 36% (88% at least one)

Surgeons 92%

Pathologist 84% (100% since cover appointed)

Radiologist 100%

Specialist Nurse* 0%

Nurse, Oncology Ward 35%

Nurse, Cancer day care facility 35%

Oncology Pharmacist 0%

MDT co-ordinator and secretary 96%

*=Appointed after the review period

4.2 Core MDT Individual Meeting Attendance

Name Job Title % attendance 11/12

Helen Rees Paediatric Oncologist 76%

Stephen Lowis Paediatric Oncologist 76%

Antony Ng Paediatric Oncologist 84%

Rachel Cox Paediatric Oncologist 72%

Mike Stevens Paediatric Oncologist 28%

Alison Cameron Clinical Oncologist 72%

Paul Cornes Clinical Oncologist 52%

Tim Rogers Surgeon 76%

Robin Garrett-Cox Surgeon 52%

Pramila Ramani Histopathologist 68%

Corina Moldova Histopathologist 80% (joined Nov 11)

Rob Hawkes Radiologist 52%

David Grier Radiologist 56%

Stephanie Mackenzie Radiologist 28%

Manigandan Subramanyam Radiologist 36%


Ken Hull CLIC Nurse, Day care facility and ward

24%

Clare Daley* CLIC Nurse, Day care facility and ward

18%

Jennifer Haylor Oncology Pharmacist 0%

Verity Thorne MDT Coordinator 96%

*=No longer core member

The Oncology Pharmacist is not job planned to attend the MDT at present

Radiology attendance - due to significant workload it has not been possible for all the radiologists to attend the MDT together, but at least one has attended every meeting. Therefore we feel that commenting on individual attendance is not helpful in this instance. In addition we feel this does not reflect lack of interest or commitment on the part of our radiology colleagues only that their job plan and current work load allow little additional time.

4.3 MDT Workload

In the period 1 April 2011 to 31 March 2012 there were 62 solid tumour patients registered in Bristol. The following section illustrates the spread of patients registered by diagnosis, region and by consultant.

4.3.1 Registration by Diagnosis

Tumour type Number registered in defined period

Osteosarcoma 3

Ewings /stPNET 1

Neuroblastoma- Stage 4 1

Neuroblastoma – Stage 3 3

Neuroblastoma- Stage 4MS 2

Neuroblastoma – Stage 1 1

Hodgkins (classical) 6

Hodgkins (LPHD) 2

Non Hodgkin’s lymphoma: Burkitt type 7

Non Hodgkin’s lymphoma: PTLPD 1

Hepatoblastoma 3

Wilms tumour 3

Rhabdomyosarcoma (RMS) 7

Non-Rhabdomyosarcoma soft tissue sarcoma (NRMS) 6

Germ cell tumour(all) 3

Langherhans’ cell histiocytosis (LCH) 3

Metastatic Melanoma 1


Retinoblastoma 4

Adenocarcinoma bowel 1

NET tumour - carcinoid 3

NET tumour - Phaeochromocytoma 1

Total 62

Registration by diagnosis - graph


Registration by diagnosis – comparison with 2010/11

Registration by shared care centre

Yeovil 1

Truro 3

Taunton 3

Bath 9

Plymouth 7

Gloucester 9

Exeter 9

Bristol 21

Total 62

Registration by Consultant


Steve Lowis (SL) 23

Helen Rees (HR) 12

Antony Ng (AN) 19

Rachel Cox (RC) 5

Mike Stevens 1

Other 2

Total 62

4.3.2 Relapses 2011/2012

There were 14 solid tumour relapses during this period two of whom (RW, BG) entered immediately into end of

life phase with supportive care only. The remainder had palliative care in the form of chemotherapy +/-

radiotherapy or surgery.

Relapses by Diagnosis - details

Diagnosis Number Details Management Outcome

Ewings 2 Local relapse, metastatic 2nd line chemo 1 Alive, 1 dead

RMS 5 2 local

2 metastatic

Chemo, surgery,RT 2 alive 2 dead

Osteosarcoma 3 metastatic Surgery , chemo 1 dead 2 ? alive

Wilms 1 metastatic Chemo, surgery,RT alive

NBL 2 Local, metastatic Chemo, RT 1 dead, 1 alive

Rhabdoid 1 Local/metastatic Palliative care died

TOTAL 14

4.3.3 Deaths 2011/2012

There were 9 deaths in solid tumour patients during this period. All the deaths were in patients who

had relapsed. There were no treatment-related deaths.

Deaths by diagnosis – details

Diagnosis Treatment Cause of death

Ewings 1 Disease progression

RMS 3 Disease progression

Osteosarcoma 2 Disease progression

NBL 2 Disease progression

Rhabdoid 1 Disease progression

Total 9

4.3.4 2nd tumours in Solid tumour patients during 2010/2011

There were two recordings of second tumours in patient with a primary solid tumour during this period.

The 1st patient had a right sided retroperitoneal soft tissue sarcoma and developed a MPNST in his leg

and the second patient had a Ewings sarcoma and developed bilateral breast cancer.


4.4 Meetings to Discuss Operational Policies (11-7B-405)

The annual Solid Tumour MDT review meeting was held on 26th April 2012. Minutes are available in the Supporting Information.

4.5 TYA patients (11-7B-425)

Fifteen patients in the TYA age range were discussed by the MDT in the review period, and were referred to the TYA MDaT for joint treatment planning.


5 Training

5.1 EQA Scheme

The MDT histopathologists, Pramila Ramani and Corina Moldova participate in an EQA scheme. Evidence is available in the supporting information.

5.2 Advanced Communication Skills Training (11-7B-411)

It is the intention for all members to receive training in this regard, and many have made attempts to do so. There is a national shortage of places available. This is an active item in the MDT work plan to complete as places on the training scheme become available.

Record of all members who have attempted or completed this.

Role Name Applied / Completed

Paediatric oncologist Helen Rees (lead) 18-20th April 2011

Antony Ng Completed 2011

Stephen Lowis 14-16th December 2010

Rachel Cox 15-17th June 2011

Michael Stevens 20th-22nd September 2011

Surgeon Tim Rogers Awaiting further courses

Robin Garrett-Cox Awaiting further courses

Radiologist David Grier Awaiting further courses

Stephanie Mackenzie Awaiting further courses

Rob Hawkes Awaiting further courses

Mani Subramanyan Awaiting further courses

Clinical Oncologist Alison Cameron 11-13th January 2011

Paul Cornes 23-25th November 2010

CLIC Sargeant Nurse Ken Hull 11-13th October 2011

Carolyn Lyons Awaiting further courses

CNS Rachel Perrow Awaiting further courses

5.3 CNS training (11-7B-412)

Rachel Perrow has completed the following training relevant to her role as CNS.

Care of the Child and Adolescent with Cancer (Level 3, 40 credits) – Southampton Uni Mentorship in Health Care – teaching and assessing (Level 3, 20 credits) - Southampton Uni Care of the Acutely ill Child (Level 3, 20 credits) - UWE Principles of Neurosciences for Health (Level 3, 20 credits) UWE.


6 Data Collection (11-7B-423)

Data is collected using the Somerset Cancer Register. An audit of data showed the following completeness (for all paediatrics patients, not just solid tumour):

Tumour status: 100%

MDT date: 91%

Treatment start date: 100%

CNS contact date: 21%

Basis of diagnosis: 51%

Diagnosis code: 99%

Diagnosis date: 100%

The Trust is working towards improving data collection and the informatics department are supporting this by developing reports to monitor completeness of clinical data on the register.


7 National / Local Audit

7.1 Network Audit

The CCNCG has not yet agreed a Network audit.

7.2 Local Audit

No audits have been completed by the Solid Tumour MDT during the period of this report.

7.3 Audit of Timeliness of Diagnostic Notification to GPs (11-7B-407)

Ten notes were selected at random and audited to see if the patient’s GP was notified within 24 hours of a patient being diagnosed. 100% had been notified within 24 hours.

Action: Continue with current policy

7.4 Audit of Keyworker Provision (11-7B-408)

Ten notes were selected at random and audited to see if a key worker’s name and contact details were recorded therein. 50% had both the name and contact details recorded, whilst the other 50% had recorded the name but not the contact details.

Action: Ensure keyworker contact details are recorded along with name


8 Patient and Carer Feedback and Involvement (11-7B-415)

The MDT, as part of the BHRC Oncology service is undertaking a prospective exercise to ascertain the views of both patients (where possible and appropriate) and carers that use the service.

The survey is made available to service users on paper, and the option is provided for the survey to be completed online if preferred.

Results are collected annually and actions identified. For full results and the questionnaire please see the Supporting Information.

Following last year’s survey the following actions were identified and undertaken.

Issue Action required Lead Timescale Update

Keyworker role needs further clarity

MSc project being undertaken looking into families requirements, assignation process and education

Ken Hull/Helen Morris

June 12

Day to day care Issues raised discussed with ward team and psychologist developing ways of further supporting nurses

Claire Harrison

Sarah Johnson

Ongoing

Facilities – ward 35 Kitchen area being reviewed

Other issues being addressed in new build

Sarah Johnson Ongoing Chillout zone now completed

Nutrition Food issues raised being discussed at food group

Use of nasogastric tubes/PEG

Helen Morris

Zoe Hull

Ongoing

Discharge process Further review of medical discharge summaries

Consultants Ongoing


9 Research

There are currently 6 solid tumour phase 3 clinical trials open and recruiting. We also have 2 early

phase clinical trials, one open in Bristol, which are currently open and recruiting for children where

standard treatment has failed. We have a number of Pharmacokinetic (PK) studies open and recruiting

that the research nurses run.

Treatment Guidelines

There remain a number of diagnoses where a clinical trial is currently not available. In these

circumstances the MDT will recommend CCLG treatment guidelines as appropriate. Individual clinician

decision to treat “off protocol” will be discussed and agreed at the MDT. In this case an individualized

protocol and schedule is required to be produced by the named consultant and signed off by the

pharmacist.

9.1 Available clinical trials

Phase 3 trials

Trial Tumour Type Clinical Trials Unit

High Risk

Neuroblastoma

(HR NB 2002 06)

High risk neuroblastoma CRCTU

(University of Birmingham)

EuroEwings 99

(EE99)

Ewings Tumour (All stages) CRCTU

EuroNetPHL-C1 Trial Hodgkins Lymphoma CRCTU

Siopel 6 Hepatoblastoma CRCTU

EPSSG RMS 2005 Rhabdomyosarcoma CRCTU

EPSSG NRSTS 2005 Non Rhabdomyosarcoma Soft

Tissue Sarcomas (including

Rhabdoid tumours)

Manchester

Early Phase Studies – Phase 1/2

Name Year

Opened

Sponsor Phase


BERNIE (Phase II) 2008 Roche II

Open Pharmacokinetic & Biological studies

We did not open any new pharmacokinetic studies in 2011/2012. However we closed Cis-Retinoic

Acid Monitoring study as accrual had been reached. We are expecting several new PK studies

embedded within ALL2011 to open in 2012/2013. We are also hoping to open a Next Generation

Sequencing study for children who experience pyrexia of unknown origin after transplantation. Dr Colin

Steward will be the Chief Investigator for this study.

Name Type of

study

Additional Information

BuMel PK Embedded in phase III

Actinomycin D (PK 2006 07) PK

Anticancer in infants (PK 2006 09) PK Under 1yr receiving

cyclophosphamide

CYP3AP Ifos Nephrotoxicity (PK 2007 02) PK

Cis retinoic acid monitoring (PK 2008 03) PK Closed to accrual

20/02/2012

FACT Study QoL

HRNBL Biological Study PK Embedded in phase III

SIOPEL 6 (PK) PK Embedded in phase III

Lung Function in Wilms QoL closed to accrual 2012

9.2 List of Treatment Guidelines available

Treatment guidelines supported by CCLG are currently being reviewed by the appropriate interest

group and will be updated before being uploaded onto new CCLG website which is due to be

launched in early July. Any significant changes will be circulated to the MDT.

• Early Stage Lymphocyte Predominant Hodgkin’s Lymphoma

• Paediatric Endocrine Tumours

• Langerhans Cell Histiocytosis (LCH)

• Relapsed high risk neuroblastoma

• Localised but unresectable neuroblastoma

• Infant neuroblastoma (< 1 year), all stages

• Burkitt/Burkitt like and B large cell Non-Hodgkin Lymphoma

• Melanotic Neuroectodermal Tumour of Infancy


• Adrenocortical tumours (ACT) and Adrenocortical carcinoma (ACC)

• Nasopharyngeal carcinoma

• Melanoma

• Pancreatic tumours

• Retinoblastoma 1st line

• Retinoblastoma 2nd line

• Anaplastic Large Cell Lymphoma

• Osteosarcoma

• Wilms tumour

9.3 Pending Phase I/II/III Studies

The following studies are due to open imminently in Bristol

VIT- 0910 – International randomized phase II trial of the combinations of vincristine and

Irinotecan with or without Temozolomide (VI or VIT) in patients with refractory or relapsed

rhabdomyosarcoma

Tumour types eligible: refractory or relapsed rhabdomyosarcoma

Principal Investigator: Dr Helen Rees

Date open at site pending

Current recruitment N/A

Euronet PHL LP1- First international Inter-Group Study for nodular lymphocyte-predominant

Hodgkin’s Lymphoma in Children and Adolescents

Tumour types eligible: Nodular lymphocyte-predominant Hodgkin’s

lymphoma

Principal Investigator: Dr Steve Lowis



Future studies that will open during 2012/2013

A Phase I/II dose schedule finding study of CH14.18/CHO continuous infusion combined with

subcutaneous aldesleukin (IL-2) in patients with primary refractory or relapsed Neuroblastoma

Tumour types eligible: Primary refractory or relapsed Neuroblastoma

Principal Investigator: Dr Helen Rees




9.4 Recruitment to phase 3 clinical trials (11-7B-424)


Clinical Trial /Treatment Guideline Number of

patients

registered

Number

on trial

Number

not on

trial

% on

trial

Reason

given not to

recruit

EuroNet PHL-C1 (HD 2007 01)

(classical Hodgkin’s’ disease)

6 6

0

100

Euramos 1

(Osteosarcoma)

3 1 2 33 Study

closure

EuroEwings 99 (ET 2000 03)

Bony Ewings + soft tissue PNET

1 1 0 100

HR NBL (NB 2002 06) 1 1 0 100

SIOP Wilms (WT 2002 01) 3 3 0 100 Study

closure

EpSSG RMS (STS 2006 04) 7 4 3 57 1 on BERNIE

2 clinician

decision

EpSGG NRSTS (STS 2006 03) 6 3 3 50 1 on BERNIE

1 clinician

decision

1 parental

refusal

SIOPEL 6 (LT 2007 03) 1 1 0 100

High risk hepatoblastoma 2 0 2 0 No trial

Germ cell tumour(all) 3 0 1 0 No trial

Langerhans’ cell histiocytosis (LCH) 3 0 2 0 No trial

Metastatic Melanoma 1 0 1 0 No trial

Retinoblastoma 4 0 4 0 No trial

Adenocarcinoma bowel 1 0 4 0 No trial

Neuro-endocrine tumour

Carcinoid - 3

Phaeochromocytoma-1

4 0 4 0 No trial

Low risk NBL 6 0 6 0 No trial

Other Lymphoma

LPHD

Non Hodgkin’s

lymphoma

PTLPD

10 0 10 o No trial

Total 62 20 42

Number of patients where trial

available

26 (42%)

20 6 (23%) 77


Summary

Of the 62 patients registered, there were 26 (42%) patients where a clinical trial was available.

Of the 26 patients where there was a clinical trial available 20(77%) patients were successfully

recruited.

There were 6 patients (23%) for whom a clinical trial was available but the patients weren’t

recruited. Reasons given:

• 2 recruited onto BERNIE phase 2 instead of phase 3

• 3 clinician decision

• 1 parental refusal

In total there were 14 diagnoses for which there were only 8 clinical trials open and recruiting at

the beginning of March 2011. Of these, 2 closed to recruitment during the last financial year.

9.5 Serious Adverse Events (SAEs)

Most occurred in Bristol

The majority of SAEs occur with patients treated on High risk NBL protocol with EE99 and EURAMOS

running a close 2nd. There were a number of SAE related to the antiGD2/IL2 combination.

Serious Adverse Events by Treatment Protocol

Protocol Number of

SAES

Number of

patients

Euramos 2 1

EE99 3 2

NBL 4 3

Wilms 1 1

SIOPEL 6 1 1

Total 11 8

Serious Adverse Events by reporting centre


Serious Adverse Events by grade

Details of events by type

Event Presumed cause Number Protocol

Pain AntiGD2 2 HR NBL

Small bowel obstruction

Adhesions 1 Wilms

GI bleed IL2 -related 1 HRNBL

Renal impairment Chemo 1 EE99

Radiation burn RT + chemo recall 1 EE99

MTX clearance Adjuvant medications/renal issues in some but not all cases

3 Euramos

Infection Neutropenia 1 EE99

Reporting

centre Number

Bristol 8

Exeter 1

Gloucester 1

Plymouth 1

Total 11

Grade number

1 0

2 3

3 8

4 0

Total 11


Infection Neutropenia 1 Siopel 6

Total 11


10 Work plan for coming year

Work plan for coming year

Continue to Improve documentation and audit the process

Document new/relapsed/progression and deaths at each MDT

Log all relapsed with treatment plan to collect prospectively for ECMC

Complete further radiology proforma and audit use (see table below for update on

progress)

Radiology Proforma

Diagnosis Early Draft Reviewed FINAL

Wilms tumour √

Osteosarcoma √

Ewings sarcoma √

HR Neuroblastoma √

Hodgkins lymphoma √

Rhabdomyosarcoma √

Hepatoblastoma √

Non RMS soft tissue sarcoma √

We would like to express our sincere thanks to the data managers who diligently collect and maintain

the data bases and provided all the information within this document. Many thanks also to the whole of

the research team who work is invaluable in the opening, running, recruitment and data collection on

all clinical trials. I would also like to thank Verity Thorne our MDT coordinator for all her help and

support in managing and continuing to improve the service offered by the solid tumour MDT.

Dr Helen Rees

Lead for Solid Tumour MDT

June 2012

annual report - paediatrics solid tumour - 2012 - final · 2016-04-04 · annual report –...

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