Case study 9 Provided by Dr Qamar Ghafoor Clinical Oncology Consultant University Hospital Birmingham TAGRISSO osimertinib Prescribing Information for Great Britain may be found here ID: 1040498
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2. FIRST-LINE EGFRm+ NSCLC PATIENT CASE STUDYCase study 9Provided by Dr Qamar Ghafoor, Clinical Oncology Consultant, University Hospital BirminghamTAGRISSO▼(osimertinib) Prescribing Information for Great Britain may be found hereTAGRISSO▼(osimertinib) Prescribing Information for Northern Ireland may be found hereAdverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting contactazmedical.astrazeneca.com or by calling 0800 783 0033.GB-29761Date of Prep: September 2021Case study slide development funded by AstraZeneca
3. Osimertinib as a monotherapy is indicated for:The adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations The first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC
4. Background**This is a real patient caseCT, computed tomography; MRI, magnetic resonance imagingProvided by Dr Qamar Ghafoor, Consultant Medical Oncologist, University Hospitals Birmingham.August 2020: presents with nausea, headaches and vomiting On questioning, he is also short of breath on minimal exertionProceeds to have CT and MRI of brain, and CT of chest, abdomen and pelvis21-year-old manNever smokedAsian origin Strong family history of cancer, including uncle who passed away aged 28 from lung cancerMember with lung cancer Unaffected
5. Initial imagingProvided by Dr Qamar Ghafoor, Consultant Medical Oncologist, University Hospitals Birmingham.Multiple brain metastasesStaging T2bN3M1c
6. Molecular resultsALK, anaplastic lymphoma kinase; EGFR, epidermal growth factor receptor; NTRK, neurotrophic tyrosine receptor kinase; PD-L1, programmed death-ligand 1; ROS1, c-ros oncogene 1Provided by Dr Qamar Ghafoor, Consultant Medical Oncologist, University Hospitals Birmingham.NTRK – NegativeEGFR – Deletion in Exon 19ALK – No translocationPD-L1 <1%ROS1 – Negative
7. Biopsy confirmed that patient had NSCLCIs there any role for surgery to brain, SRS or whole brain radiotherapy? Consensus – hold off given EGFR mutationInitial MDT discussion & planEGFR, epidermal growth factor receptor; MDT, multidisciplinary team; NSCLC, non-small cell lung cancer; OD, once daily; PMH, past medical history; SRS, stereotactic radiosurgery1. Osimertinib SmPC. Available from: https://www.medicines.org.uk/emc/product/7615 (Last accessed, September 2021). 2. Dexamethasone SmPC. Available at: https://www.medicines.org.uk/emc/product/5411/smpc#gref (Last Accessed, September 2021). Provided by Dr Qamar Ghafoor, Consultant Medical Oncologist, University Hospitals Birmingham.Commenced on osimertinib1 80mg OD (no other PMH & only on dexamethasone2 for oedema around brain metastases)
8. 2-week patient review* The toxicity results are based on one patient and therefore can not be generalised, please refer to osimertinib and dexamethasone summary of product characteristics for exhaustive list of adverse eventsProvided by Dr Qamar Ghafoor, Consultant Medical Oncologist, University Hospitals Birmingham.2-week review complete resolution of left sided weaknessBreathing betterRepeat ctDNA sample – mutation cleared from plasmaDramatic improvementHeadaches resolvedNo serious toxicities*
9. 3-month repeat imaging3/12, 3 monthsProvided by Dr Qamar Ghafoor, Consultant Medical Oncologist, University Hospitals Birmingham.Pre-treatment 3/12 on osimertinib
10. 3-month repeat imaging3/12, 3 monthsProvided by Dr Qamar Ghafoor, Consultant Medical Oncologist, University Hospitals Birmingham.Pre-treatment 3/12 on osimertinib
11. 10 months on osimertinibOsimertinib SmPC. Available from: https://www.medicines.org.uk/emc/product/7615 (Last accessed, September 2021).Provided by Dr Qamar Ghafoor, Consultant Medical Oncologist, University Hospitals Birmingham.Remains wellBack at collegeDisease remains controlled
12. What next?Continue treatment until progression3/12 scan of brain & body (or sooner if symptoms are present)Panel 500 NGS sent to give information for clinical trials in future, if neededAEs, adverse events; NGS, next-generation sequencing1. Osimertinib SmPC. Available from: https://www.medicines.org.uk/emc/product/7615 (Last Accessed, September 2021).Provided by Dr Qamar Ghafoor, Consultant Medical Oncologist, University Hospitals Birmingham.The most commonly reported AEs with osimertinib were diarrhoea (47%), rash (45%), paronychia (33%), dry skin (32%), and stomatitis (24%). Grade 3 and Grade 4 AEs across both studies were 8.5% and 0.1%, respectively1In patients treated with TAGRISSO 80 mg once daily, dose reductions due to AEs occurred in 3.2% of the patients. Discontinuation due to AEs was 4.6% in the FLAURA trial1