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Neo-TAXIS Feasibility Questionnaire

Returning?

A A A

We would like to assess the feasibility of opening the Neo-TAXIS study in the UK.

Neo-TAXIS is the UK arm of the international TAXIS randomised trial, and will investigate whether it is possible to avoid an axillary node clearance (ANC) in node positive patients having neoadjuvant chemotherapy who do not have a complete pathological response in the axilla following completion of treatment.

Neo-TAXIS will randomise patients who do not have a complete pathological response in the axilla to standard care (axillary clearance) or targeted axillary dissection (removal of abnormal/clipped nodes + sentinel node biopsy) followed by nodal radiotherapy. The primary outcome will be disease free survival. Secondary outcomes include quality of life and lymphoedema.

We would therefore like to understand the current management of node positive patients having neoadjuvant chemotherapy and what happens to them following completion of systemic treatment.

We would be very grateful if you could complete the questionnaire on behalf of your MDT (one feasibility questionnaire per Unit).

Many thanks in advance

Shelley Potter and Stuart McIntosh

on behalf of the Neo-TAXIS Study Team

Name of person completing the feasibility questionnaire

Name of Unit

Approximately how many patients per year have neoadjuvant chemotherapy (NACT) in your centre?

< 25 25-50 51-75 76-100 >100

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Approximately how many of the patients having NACT in your unit are node positive at presentation?

< 25 25-50 51-75 76-100 >100

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Does your unit routinely clip or mark the involved node/most abnormal node before starting NACT?

Yes for all patients with biopsy proven nodal disease

Most abnormal node clipped in certain circumstances (please give details)

No, we do not routinely clip involved nodes in patients undergoing NACT

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If you clip involved nodes in certain circumstances, please give details

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In patients with node positive disease at diagnosis, do you routinely re-assess the axilla at the end of NACT?

Yes, we routinely re-assess the axilla for all node positive patients after NACT

We re-assess the axilla in certain circumstances (please give details)

No, we do not routinely re-assess the axilla at the end of NACT

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If you only re-reassess the axilla in certain circumstances, please give details of when re-assessment is performed

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How is the axilla re-assessed?

USS of the axilla

MRI

Other (please give details)

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If other method of axillary re-assessment is used, please give details

If abnormal/involved lymph nodes are seen on imaging after systemic treatment, is the axilla routinely re-biopsied?

Yes - all patients with radiologically abnormal nodes post NACT are re-biopsied to guide axillary surgery

No - if nodes are still abnormal on imaging post NACT, further biopsy is not performed but an axillary clearance is recommended

Abnormal nodes are biopsied in certain circumstances (please give details)

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If you only re-biopsy the axilla in certain circumstances, please give details of when repeat biopsy is performed following completion of systematic treatment

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What axillary surgery is routinely performed in patients with involved nodes (either on biopsy or imaging) following completion of NACT

Axillary node clearance

Targeted axillary dissection

Sentinel node biopsy

Other (please give details)

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If 'other' surgery is performed, please give details

What surgery is routinely recommended to patients who were initially node positive but who have had a complete radiological response in their axilla following completion of NACT?

Sentinel node biopsy

Targeted axillary dissection (SNB + excision of clipped/localised node)

Axillary node clearance

Other (please give details)

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If 'other' surgery performed, please give details

How does your unit currently manage patients who have a positive sentinel node biopsy/targeted axillary dissection (ITC/micro or macrometastases) following completion of NACT?

Recommended completion axillary node clearance

Recommended axillary radiotherapy

Recommended either completion axillary node clearance or axillary radiotherapy dependant on patient preference

Not recommended any further axillary treatment

Other (please give details)

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If 'other' management of patients with a positive sentinel node biopsy/targeted axillary dissection (ITC/micro or macrometastases) following completion of NACT, please give details

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Is your unit participating in the ATNEC study?

Yes - actively recruiting to ATNEC

Planning to open ATNEC

Not planning to open ATNEC

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