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Case history

image A 68-year-old woman had her left great toe amputated for a 3.8 mm Breslow thickness ulcerated acral lentiginous subungual melanoma with microsatellites. Sentinel node biopsy showed multiple parenchymal deposits of melanoma; subsequent inguinal node dissection showed melanoma deposits in three of eight nodes. A staging CT scan was clear. BRAF mutation status was wild-type.

Two years after initial surgery she developed in-transit metastases in the left leg, treated with excision and cryoablation. She then presented in the plastic surgery clinic with painful fungating nodules measuring up to 1 cm on the left leg, groin and buttock. Her performance status was 1.

Her medical history included hypertension (with a non-ST segment elevation myocardial infarction 3 months previously), rheumatoid arthritis and non-insulin-dependent diabetes mellitus. She was taking aspirin, ramipril, bendroflumethiazide, naproxen and metformin. A reassessment CT scan of the head, neck, chest, abdomen and pelvis showed no visceral metastases. Her lactate dehydrogenase (LDH) level was 3.01 μkat/l (normal range 1.7–3.4 μkat/l).

She was treated with talimogene laherparepvec (T-VEC). After two treatments she had fever of 38°C, managed with paracetamol. She had paracetamol premedication with subsequent cycles and had no further fevers. During the first 3 months she developed new lesions but remained well, so treatment continued. At 6 months her disease was noted to be stable.

How did BRAF testing influence the treatment options for this patient?

What is T-VEC, and what is the evidence base for treating melanoma patients with it?

How is T-VEC administered?

How should treatment be modified in patients who develop new lesions while receiving T-VEC?

What extra precautions should patients take while they are being treated with T-VEC?

How did BRAF testing influence the treatment options for this patient?

In common with most acral lentiginous melanomas, the patient’s tumour did not exhibit a mutation in the BRAF gene. Serine/threonine-protein kinase B-Raf (BRAF) inhibitor therapy was therefore not appropriate. Immunotherapy with checkpoint inhibitors was precluded by her rheumatoid arthritis. Cytotoxic chemotherapy with dacarbazine has a low objective response rate of 10–20% and does not prolong survival.

The patient had previously been treated with excisions and cryoablation of her lesions. As the lesions were now more extensive, electrochemotherapy could have been considered, but it was not appropriate as she would have needed a general anaesthetic, which is contraindicated in patients who have had a recent myocardial infarction. Radiotherapy could have been used for lesions that were painful or bleeding, but it would not have controlled all her disease.

T-VEC has a European licence for use in adults who have unresectable melanoma that is regionally or distantly metastatic (stages IIIB, IIIC and IVM1a) and no bone, brain, lung or other visceral deposits.1 At least one lesion must be accessible for injection: cutaneous, subcutaneous and nodal metastases are acceptable. In addition, NICE guidance TA410 specifies that treatment with T-VEC may be considered if systemically administered immunotherapies ...

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