Lung cancer EGFR — Oncologists

 

The therascreen EGFR RGQ PCR Kit (therascreen EGFR test) reliably detects mutations in the EGFR oncogene which are found in lung cancer. EGFR testing is used to select NSCLC patients who are being considered for treatment with either GILOTRIF (afatinib) or IRESSA (gefitinib).
Information for Oncologists

 

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The therascreen EGFR test:

  • FDA-approved test for use in selecting patients with NSCLC in whom either GILOTRIF or IRESSA are indicated
  • Clinically validated in 3 trials, which together enrolled >827 patients* with NSCLC
  • Detects mutations recommended in the NCCN Guidelines for lung cancer treatment
  • Detects clinically relevant EGFR exon 19 deletions and L858R mutation

Ask for the therascreen EGFR test at diagnosis. Quickly identify your NSCLC patients with EGFR mutant tumors.

* LUX-Lung 3 clinical trial with GILOTRIF (n=345 randomly assigned to treatment; n=229 received GILOTRIF), LUX-Lung 6 clinical trial with GILOTRIF (n=364 randomly assigned to treatment; n=239 received GILOTRIF) and the IFUM study with IRESSA (n = 118 eligible for treatment based on EGFR mutation-positive status; n=106 treatment started and eligible by EGFR mutation status)

References

  1. Sequist, L.V. et al. (2013) Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J. Clin. Oncol. 31:3327–3334.

  2. Wu, Y.L. et al. (2014) Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 15:213–222.

  3. Douillard J.Y. et al. (2014) First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a phase-IV, open-label, single-arm study. Br. J. Cancer 110: 55–62.

About the therascreen EGFR test
Reimbursement
Back to toptherascreen EGFR RGQ PCR Kit (therascreen EGFR test) clinical data
Clinical background
Activation of epidermal growth factor receptor (EGFR) via ligand binding stimulates tyrosine kinase, which leads to activation of signaling pathways associated with cell growth and survival. Mutations in the EGFR oncogene are seen in many epithelial malignancies including non-small cell lung cancer (NSCLC).
Clinical utility
The presence of EGFR mutations is correlated with response to targeted therapies in patients with NSCLC, therefore the NCCN panel recommends that all patients with adenocarcinoma are tested for EGFR mutations.
Individuals suitable for testing
Patients suitable for testing are NSCLC patients that are being considered for treatment with EGFR tyrosine kinase inhibitors (TKIs), such as GILOTRIF (afatinib) or IRESSA (gefitinib).
Study design
The LUX-Lung 3 study (1) with GILOTRIF
Study LUX-Lung 3 trial was an international, multi-center, open label, randomized Phase 3 trial of afatinib versus chemotherapy as first-line treatment for patients with stage IIIB or IV adenocarcinoma of the non-small cell lung cancer (NSCLC) harboring an EGFR mutation. The trial was conducted on 345 patients, from 133 sites in 25 countries. Stratification was conducted according to three EGFR mutation categories (L858R, Del 19 – the common mutations and ‘Other’ that comprised all other detected mutations) and race (Asian vs. Non-Asian). Randomized patients were assigned 2:1 to receive afatinib or chemotherapy.

The main outcome measure of the study was progression free survival (PFS). Patients with EGFR mutations Del19/L858R and treated with afatinib had an improved median PFS of 13.6 months compared with 6.9 months for those treated with chemotherapy (cisplatin and pemetrexed) in the first-line treatment of EGFR mutant NSCLC.

The LUX-Lung 6 study (2) with GILOTRIF
LUX-Lung 6 was an open-label, randomised phase 3 trial done at 36 centers in China, Thailand, and South Korea, and is considered the largest prospective, randomized trial to compare EGFR-directed treatment with chemotherapy for first-line treatment of advanced EGFR mutation-positive lung adenocarcinoma. After central testing for EGFR mutations, treatment-naive patients (stage IIIB or IV cancer) were randomly assigned to receive either oral afatinib or intravenous gemcitabine on day 1 and day 8 plus cisplatin on day 1 of a 3-week schedule for up to six cycles. Randomisation was stratified by EGFR mutation (L858R, exon 19 deletions, or other; block size three). The primary endpoint was progression-free survival assessed by independent central review (intention-to-treat population). 910 patients were screened and 364 were randomly assigned (242 to afatinib, 122 to gemcitabine and cisplatin). Median progression-free survival was significantly longer in the afatinib group (11. 0 months, 95% CI 9.7–13.7) than in the gemcitabine and cisplatin group (5.6 months, 5.1–6.7; hazard ratio 0.28, 95% CI 0.20–0.39; p<0·0001). The study found that first-line afatinib significantly improves progression-free survival with a tolerable and manageable safety profile in Asian patients with EGFR mutation-positive advanced lung NSCLC, and that afatinib should be considered as a first-line treatment option for this patient population.

The IFUM study (3) with IRESSA
IFUM was a single-arm, open-label, Phase 4 study that assessed the first-line use of gefitinib in Caucasian patients with stage IIIA, IIIB or IV EGFR mutation-positive NSCLC. Test results were available for 859 patients, and of these patients, 106 tested positive for EGFR deletions in exon 19, L858R, L861Q, or G719X and were eligible for treatment.

Retrospective testing of 87 specimens from patients screened for IFUM clinical trial, that were EGFR mutation positive, showed an objective response rate (ORR; 95% CI) of 71.3 % (61.0 – 79.7) with a median duration of response of 8.3 months (7.2 – 11.3).

Guidelines

The therascreen EGFR test detects clinically relevant EGFR mutations including the mutations recommended by the NCCN Guidelines. The therascreen EGFR test detects:

  • Up to 21 mutations in the EGFR oncogene present in more than 80% of EGFR-positive patients
  • Mutations with proven clinical utility and validated in clinical trials with GILOTRIF (afatinib) and IRESSA (gefitinib)
  • The T790M resistance mutation
  • Recommended mutations: e.g., exon 19 deletions and exon 21

Prescribing information for EGFR TKIs requires the use of an FDA-approved EGFR test.  

therascreen EGFR test
  • Detects 21 mutations
  • 18 mutations for which safety and efficacy of either GILOTRIF (afatinib) or GILOTRIF (afatinib) and IRESSA (gefitinib) have been established
  • Detects low % mutant DNA for common mutations Del6223 (6.4%), Del6225 (6.5%), and L858R (5.9%)
  • Highly robust and easy workflow for reproducible results
  • Test results are comparable and reproducible from day to day, from operator to operator
EGFR mutations detected using the therascreen EGFR RGQ PCR Kit
Mutation Exon Base change Cosmic ID
Deletions

19

2238_2255del18 6220
2235_2249del15 6223
2236_2250del15 6225
2239_2253del15 6254
2239_2256del18 6255
2240_2254del15 12369
2240_2257del18 12370
2239_2248TTAAGAGAAG>C 12382
2239_2251>C 12383
2237_2255>T 12384
2239_2258>CA 12387
2238_2252>GCA 12419
2238_2248>GC 12422
2235_2252>AAT 13551
L858R 21 2573T>G 6224
T790M* 20 2369C>T 6240
L861Q** 21 2582T>A 6213
G719A** 18 2156G>C 6239
S768I** 20 2303G>T 6241
Insertions* 20 2319_2320insCAC 12377
2310_2311insGGT 12378
*Safety and efficacy of GILOTRIF and IRESSA has not been established for these mutations.
**Safety and efficacy of IRESSA has not been established for these mutations.

Back to top Reimbursement

The therascreen EGFR test is:

  • An FDA-approved test and has been evaluated in clinical trials for GILOTRIF (afatinib; n=709) and IRESSA (gefitinib; n=118)
  • Important for NSCLC patients to start treatment with GILOTRIF (afatinib) or IRESSA (gefitinib)
  • A sensitive test that detects clinically proven EGFR mutations
  • Able to detect mutations recommended in the NCCN Guidelines for lung cancer

Public and private payers endorse the value of EGFR testing with strong coverage policies for approved indications.

therascreen EGFR testing: 2018 coding and payment reference 2018 CPT code CPT code description 81235 EGFR (epidermal growth factor receptor) (eg., non-small cell lung cancer) gene analysis, common variants (eg., exon 19 LREA deletion, L858R, T790M, G719A, G719S, L861Q). Related ICD 10 codes Description C33 Malignant neoplasm of trachea C34.00 Malignant neoplasm of unspecified main bronchus C34.10 Malignant neoplasm of upper lobe, unspecified bronchus or lung C34.2 Malignant neoplasm of middle lobe, bronchus or lung C34.30 Malignant neoplasm of lower lobe, unspecified bronchus or lung C34.80 Malignant neoplasm of overlapping sites of unspecified bronchus and lung C34.90 Malignant neoplasm of unspecified part of unspecified bronchus or lung C78.00 Secondary malignant neoplasm of unspecified lung Z85.118 Personal history of other malignant neoplasm of bronchus and lung

QIAGEN has a broad portfolio of companion diagnostic products in development.

Resources

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External Websites
2
Clinical practice guidelines in oncology for patients with cancer.
Information about lung cancer from the College of American Pathologists.
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