Northern England Strategic Clinical Network Conference

15th May 2015

Update - Head and Neck Site Specific Group

Eleanor AynsleyClinical Oncologist

Robotic surgery (TORS)

• Currently being used in Newcastle by Mr Vin Paleri for selected cases for selected oropharynx cases, approx 50 cases operated on

• Presented findings at 1 international and 2 national meetings

• Quicker operation time, shorter inpatient stay• Can operate on cases may not otherwise be able to• Hope to be operational in James Cook and Sunderland

in near future

Intensity Modulated RadiotherapyIMRT

• Standard for complex head and neck cases in Newcastle and Middlesbrough

• Still not in Carlisle, although offered to go to Newcastle

• Rolling out IMRT for all head and neck cases

CF 71 year old lady

• Presented with lump in left neck• PMH of hypertension and OA• Smoked 10 a day, occasional alcohol• PS 2• Histology squamous cell ca

• Had 3 cycles of neoadjuvant chemotherapy (cisplatin and 5FU) with a partial response

• 65 Gy in 30 fractions to PTV1 which was the larynx and left levels Ib to V and 54 Gy in 30 fractions to PTV2 which was right levels II to IV plus 3/6 weekly Cisplatin chemotherapy cycles.

• Was dizzy during treatment and required peg feeding

• Following treatment managing soft diet

Survivorship• Recognition important due to long term side effects of

radiotherapy such as dysphagia and after effects of surgery eg laryngectomy affecting speech and body image

• National Cancer Survivorship Initiative (collaborative between NHS England and Macmillan) has 4 main aims:1. Holistic needs assessment (HNA) to be done on all patients

at diagnosis and any other time appropriate (key times-post treatment and again 6 months after treatment ) All

2. Treatment summary Sunderland3. Cancer care review-by GP4. Health and wellbeing clinics/educational events /signposting

patients

Holistic needs assessment

Should cover the following: • Addressing any physical or practical concerns• Signposting to either local or national support groups• Information about local Health and Wellbeing Clinics, Education Events or

self management courses as available in your area.• Referral to Allied Healthcare Professionals for support if required• Advice related to lifestyle i.e. Stop smoking services• Information or referral to an appropriate physical activity programme• Information or referral for advice on diet and nutrition• Referral for counselling or psychological support• Support related to work and finance concerns• Support for spiritual needs

Clinical trials

• Head and neck 5000 recruited very well across network

• Other trials helping quality assurance of radiotherapy and surgery

SEND The role of selective neck dissection used electively in patients with early oral squamous cell carcinoma (tumour stage T1 and

T2) and no clinical evidence of lymph node metastases in the neck

. T1/T2 N0 SqCC oral cavity

Randomisation1:1

Resection of primary with simultaneousneck dissection at

presentation

Resection of primary tumour alone and

salvage treatment of neck if neck metastases develop

CI: Prof Ian Hutchison

→ plan for merged data analysis with similar RCT Tata Memorial Hospital, Mumbai – 330 patients/460 in total (of 650)

ART-DECO A Multicentre Randomised Study of Dose Intensity Modulated Radiotherapy Versus Standard Dose Radiotherapy in

Patients with Locally Advanced Laryngeal and Hypopharyngeal Cancers.

Induction chemotherapy [Optional by centre]

Diagnosis oflocallyadvancedsquamous cellcancer of thelarynx orhypopharynxrequiringdefinitiveTreatment WithRT or chemoradiotherapy

Dose escalated IMRT

67.2Gy in 28 fractions to the involved site and nodal groups56Gy in 28 fractions to nodal areas at risk of harbouring microscopic disease.

Standard dose IMRT

65Gy in 30 fractions to involved site and nodal groups54 Gy in 30 fractions to nodal areas at risk of harbouring microscopic disease.

Patients may receive a maximum of 3 (21 day) cycles of platinum based induction chemotherapy prior to radiotherapy

Concomitant cisplatin(Day 1 and Day 29)[All patients]

R

CI: Prof Chris Nutting RMH

Screen 910 biopsies from T3-T4NO, T1-4,N1-2 oropharynx SCC

HPV+ on PCR AND

p16+ on immunohistochemistry

(Central MHRA-approved Laboratory)

Randomise 330 patients 1:1Control

Concomitant Cisplatin

+ Radiotherapy (70 Gy in 30 F)

Study

Concomitant Cetuximab

+ Radiotherapy (70 Gy in 30 F)Stratified by Centre,

Tumour site, T & N stage, Smoking status

10% Lost to follow up (n=17) 10% Lost to follow-up (n=17)

Analysed (n= 148) Analysed (n= 148)

Follow-up: 2 years

Primary outcomes: Overall survival

Severe Acute and Late Toxicity: using CTCAE grading, including skin rashes, mucositis

Secondary outcomes:

Health economics using EQ-5D, Early toxicity, Quality of life: using EORTC general and head neck specific modules, Swallowing: using MDADI questionnaire and gastrostomy - dependency rates, Mortality (cause of death), disease free survival, recurrence, metastases.

Key: HPV – Human Papilloma Virus PCR – polymerase chain reaction

CTCAE – Common Terminology Criteria for Adverse Events version 3.0

MDADI – MD Anderson Dysphagia Inventory

De-escalate

PATHOS Trial schema

No adjuvant treatment

HPV positiveOPSCCT1-3

N0-N2b

Low risk

Pathology assessment

Intermediate risk

High risk

B1 60Gy in 30# (control)

B2 50Gy in 25# (test)

C1 60Gy in 30#+Cisplatin (control)

C2 60Gy in 30# (test)

TransoralSurgery

(TLM/TORS) +neck

dissection

Endpoints: swallowing function (MDADI) at 12months (phase II), overall survival (phase III)

A

B

C

Randomise

Randomise

Any questions?