Reflex EGFR/ALK Testing in Lung Cancer

PatientsClark McDonald, Pathology

Mathew Kang, Radiation OncologyLiChung Ku, Radiation Oncology

Tiffany Taylor, Radiation OncologySarah Dawson, Laboratory

Laura Duddy, Clinical Decision Support

Special thanks to: Sean Stack (Radiology), Kamran Firoozi (Pulmonology) and Adam Miller (IT)

AIM STATEMENT

• 100% of lung adenocarcinoma patients with known or clinically suspected stage IIIb and stage IV will have reflex EGFR/ALK testing sent at the time of pathologic diagnosis by January 15, 2015

Introduction

• Patients with stage IIIb or IV lung adenocarcinomas are eligible for novel treatment with EGFR tyrosine kinase inhibitors but only if the EGFR/ALK molecular status of the tumor is known

• New National Comprehensive Cancer Network Clinical Practice Guidelines recommend EGFR/ALK testing on all stage IIIb and IV lung adenocarcinomas

• Old practice was to wait for Oncologist to call and order EGFR/ALK testing which created delay of treatment planning up to 2-3 weeks after diagnosis

Results

• Average number of days from biopsy sign out to sent out for EGFR/ALK testing

Baseline Data

Old Process

Old Process Radiologist Pulmonologist

Transbronchial biopsy or lymph note

EBUS-FNA

Lung or Solid Organ biopsied

Pathology requisition filled out by Pulmonologist or

Pathologist without staging information

Send Sample to Pathology

Pathology does diagnostic review & creates report

Report goes to Oncologist, Oncologist sees patient and reviews staging information. If indicated, EGFR is

requested by Med/Onc and sent out by Pathology to OHSU

Time of Biopsy

Pathology requisition is completed in Epic without

staging information

Radiologist reviews any available imaging

Process Delay

Benefits of Change

• Having the EGFR/ALK status at the time of initial consultation with the treating Oncologist allows a treatment plan to be developed and initiated rather than having to order the EGFR/ALK testing and waiting for the results (7-10 days for testing)

• Reduces time to treatment• Reduce patient anxiety while waiting for

treatment plan• Compliance with the national treatment guideline

Test of Change #1

• Pathologists to reflexively send biopsy material for EGFR/ALK testing on cases with known stage IV lung adenocarcinoma- eg. Metastasis or positive pleural effusion- we know these are stage IV

Now what about the rest?

• The pathologists need to know the clinical staging at the time of tissue diagnosis to reflexively order EGFR/ALK testing on the lung biopsies

• Old standard work did not encourage clinical staging to be provided on the pathology requisitions

• Without this staging, appropriate reflex EGFR/ALK could not be accomplished

PROBLEM• Lung biopsies are performed by radiologists and

pulmonologists• Some cases (EBUS-FNA) have pathologists filling out the

pathology requisitions

Test of Change #2 Dr. Firoozi

• Dr. Kamron Firoozi agreed to begin staging his suspected lung cancer patients at the time of biopsy and provide the information on the pathology requisition

• 2/2 bronchoscopic lung biopsy cases were staged at the time of biopsy and documented on the pathology requisitions

Test of Change #3 Radiology

• Dr. Sean Stack agreed to communicate with all of the interventional radiologists that perform image guided lung biopsies to provide clinical staging of suspected lung cancer and include on the pathology requisition

• Staging tool was developed and posted at the work station as reminder for staging

Test of Change #4 Rest of Pulmonologists• Dr. Firoozi agreed to communicate with the

remaining pulmonologists to provide clinical staging of all suspected lung cancers on the pathology requisition at the time of biopsy

Test of Change #5 Pathologists-EBUS• Communicate with the pathologists that attend

Endobronchial Ultrasound Guided Fine Needle Aspiration Biopsies to query the pulmonologist about the clinical staging in suspected lung cancer cases at the time of the procedure and document on the pathology requisition

New Process

Radiologist Pulmonologist

Radiologist reviews any available imaging for clinical staging for

suspected lung cancers

Clinical evaluation of stage

Lung or solid organ biopsied

Transbronchial biopsy or lymph node EBUS-

FNA

If diagnosis is adenocarcinoma and the requisition clinical stage is 3b or 4, reflex EGFR/

ALK testing is sent same day to OHSU

Time of Biopsy

Pathology requisition is completed in Epic with staging

information

Sample sent to Pathology

Pathology does diagnositc review and creates report

Pathology requisition is completed by the Pulmonologist or Pathologist with

clinical staging

New Process

Balance Measures

• Avoid REFLEX testing on all lung adenocarcinomas regardless of stage

Lessons Learned

• Multiple locations and specialties are relied upon to provide appropriate staging made project challenging

• Education is not always the best way to initiate change

• Compliance diminished over time and needed strengthening

• Visual tool at the point of order was effective• Epic best practice alert would capture more staging

information • Current Epic transition will delay Epic best practice

tool

Next steps

• Build Epic best practice tool limited to practitioner and lung biopsy specific procedure

• Epic order build approved January 14, 2015, cannot begin work until March 10th, 2015 after go live date for Epic 2014

• Development and placement of staging visual aid tool pathologists and pulmonologists for bronchoscopy suites

• EGFR/ALK testing will be broadened to include stage 3A lung adenocarcinomas based on new clinical trial Salem Hospital is participating in